Workers Comp & Injury Law Blog

Indiana Delays Clean Up of Deadly Vinyl Chloride Found Near School

2009-08-11T23:55:00.002-04:00

Jeers to Fort Wayne Indiana officials are just getting around to cleaning up the goundwater and soil contaminated with the deadly chemical vinyl chloride and believed to be situated just a few yards from a local middle school.

Notwithstaning Wayne Metal Protection Company's notification in 2004, red tape and delays have kept the remediation from starting.

Vinyl chloride has no safe level of exposure according to the U.S. Environmental Protection Agency (EPA) and has been associated with angiosarcoma, brain cancer, liver cancer, lung cancer, raynaud's syndrome,scleroderma, cholangiocarcinoma or acroosteolysis.

If you or a loved on has been exposed to vinyl chloride, contact Bagolie Friedman now for a confidential and free consultation by calling 1-866-333-3529 or visit us on the web.

Workers' Compensation Reform Coming to New Jersey

2008-05-31T07:33:00.005-04:00

The recent Star Ledger series highlighting problems with New Jersey's workers' compensation system really got the State's attention. The powerful Senate Labor Committee has held hearings and is drafting new legislation to help injured workers get benefits. Alan Friiedman of Jersey City's Bagolie Friedman Injury Lawyers has been invited to testify in support of these worker friendly bills. Lets hope they make it out of committee, get passed and signed into law

Does Confocal Microscopy Help Detect Acanthamoeba Keratitis?

2007-08-22T16:19:00.000-04:00

Confocal laser scanning microscopy (CLSM or LSCM) is a valuable tool for obtaining high resolution images and 3-D reconstructions. The key feature of confocal microscopy is its ability to produce blur-free images of thick specimens at various depths.

According to an article in Healthy For Life on Eye Infection Detection

EYE INFECTION DETECTION
If you wear contacts, your risk of getting a blinding eye infection goes up. Until recently there has been no easy way to diagnose the infection, but, a new technique is helping patients keep their eyesight.

Lori McRae used to live in darkness.

Lori McRae Had eye parasite infection
"We put black plastic over all the windows, and basically tried to shut out all light in the house."

She was in extreme pain and losing sight in one eye. She went to six different doctors before getting the correct diagnosis - a parasite called Acanthamoeba

William Mathers, M.D.
Ophthalmologist
Oregon Health & Science University
Portland, OR
"It's extremely common. There's amoeba everywhere. It's in our drinking water. It's all in the soil, and in all water."

Lori doesn't know how she got the infection. The amoeba could have been in the water when she washed her hands before putting in her contacts.

Whatever the cause, she was lucky to find doctor mathers. He uses a special microscope to look for the infection.

William Mathers, M.D.
"We can actually see the organisms in the eye, living in the eye without hurting the person at all.

The more common way to diagnose the infection is to culture the amoeba. Many doctors don't go to the trouble because the symptoms are similar to other eye infections.

Lori was treated for pink eye and herpes first. She was finally given the right medications, but it was too late for them to work.

She needed a cornea transplant to restore her sight. She says she hopes the new microscope will prevent others from having to go through what she has.

Lori McRae
"I'm very lucky to have come from that point to be where I am."

Even if she could, lori says she'll never go back to contacts.

If you're going to wear contacts, Doctor Mathers suggests disposable or daily wear lenses. He says people who wear their contacts overnight are ten times more likely to get infections.

BAGOLIE FRIEDMAN AMO CONTACT LENS SOLUTION RECALL INJURY LAWYERS

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Note: The above information is an opinion and does not constitute legal advice. Unless a retainer agreement has been signed, Rcky E. Bagolie and/or the Law offices of Bagolie Friedman, LLC is not your legal representative. The information contained in this electronic communication is confidential and may be a privileged attorney-client communication. It is intended only for the use of the recipient named above. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication, or any of its contents, is strictly prohibited. If you have received this communication in error, please reply to the sender and delete the original message and any copy of it from your computer or facsimile system. Thank you.

Moisture Plus Contact Lens Solution Recall Lawsuits

2007-06-13T09:43:00.000-04:00

Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution
The U.S. Food and Drug Administration is alerting health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced Medical Optics of Santa Ana, Ca.

The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).

Consumers who wear soft contact lenses should stop using the solution, discard all partially-used or unopened bottles and replace their lenses and storage container.

"We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available."

Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.

Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing but Acanthamoeba is more difficult to treat.

It is estimated that Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not. Additional information regarding the CDC results is available at the CDC website http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d526a1.htm.

"The ongoing CDC investigation is a collaborative effort," said Michael Beach, M.D., a Division of Parasitic Diseases team leader with CDC. "We are working with FDA, state, territory, university, and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections."

All contact lens users should closely adhere to the following measures to help prevent eye infections:

Remove contact lenses before any activity involving contact with water, including showering, using a hot tub, or swimming.
Wash hands with soap and water and dry them before handling contact lenses.
Clean contact lenses according to manufacturer guidelines and instructions from an eye care professional.
Use fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Never reuse or top off old solution.
Never use saline solution and rewetting drops to disinfect lenses. Neither solution is an effective or approved disinfectant.
Schedule regular eye exams with your eye care professional
Wear and replace contact lenses according to the schedule prescribed by your eye care professional.
Store lenses in a proper storage case.
Storage cases should be irrigated with sterile contact lens solution (never use tap water) and left open to dry after each use.
Replace storage cases at least once every three months.
FDA and CDC want to gather information related to Acanthamoeba keratitis in contact lens users. Report adverse events related to these products to MedWatch, the FDA's voluntary reporting program: www.fda.gov/medwatch/report.htm; Phone: (800) 332-1088; Fax: (800) 332-0178; Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

Consumers who believe they are in possession of the recalled product may call the company at 1-888-899-9183.

Additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.

Have you or someone you love been suffering from a severe eye infection or have been diagnosed with Acanthamoeba keratitis, cornea damage or blindness? Trust Bagolie Friedman Injury Lawyers to fight for your rights and obtain the justice you deserve. We offer aggressive representation and free consultations.

We are personal injury and workers' compensation trial lawyers. Contact us now for a free, confidential and no risk consultation if you have questions about any type of accident, injury, disability, workers' compensation or disease claim. Whatever legal problem you have, our personal injury attorneys want to help. This resource offers information on a wide variety of personal injury case types and is intended to help injury victims find the information they need to understand their legal rights and make informed decisions. If you would like to discuss a potential case please feel free to call toll free 1-866-333-3LAW (1-866-333-3529)or submit a FREE online case review.

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Workers Comp & Injury Law Blog: Pet Food Tainted with Rat Poison

2007-03-24T03:21:00.000-04:00

Workers Comp & Injury Law Blog: Pet Food Tainted with Rat Poison

Pet Food Tainted with Rat Poison

2007-03-24T03:16:00.000-04:00

Pet food produced by Menu Foods was tainted with the rat poison aminopterin. Dogs and cats that have eaten the bad food have suffered from kidney failure and death.
Over 60 million cans and pouches of the Company's "wet pet" food, some of which was canned in New Jersey and sold in over 90 brands, have been recalled.

Contact Bagolie Friedman Injury Lawyers now to discuss your rights at no charge.

Pet Food Recall Danger

2007-03-23T08:15:00.000-04:00

A Chicago woman sued Menu Foods on Tuesday, alleging the pet food manufacturer delayed announcing a recall of 60 million containers of dog and cat food despite knowing its products were contaminated and potentially deadly.

Dawn Majerczyk, 43, said her orange tabby, Phoenix, fell sick last week just two days after he ate a single package of Special Kitty. It is one of 95 cat and dog food brands recalled by Menu Foods of Canada. Friday's recall came two weeks after nine cats died during routine company taste tests of its products, the Food and Drug Administration said. Majerczyk said she took the 9-year-old cat to its first-ever veterinarian visit the day of the recall. The cat had lost six pounds in four days and was lethargic, dehydrated and nearly blind. She returned over the weekend to have him put down after his organs began to fail.

Her suit seeks class-action status. ``I want my vet bills and I want some compensation for what they did to my kids __ and for the company's neglect,'' Majerczyk, a medical assistant in a dermatology office. The company said it had not seen the suit and had no comment. The FDA had no comment on the company's delay in announcing the recall. The FDA so far has confirmed the deaths of 13 cats and one dog that had reportedly eaten the company's ``cuts and gravy'' style pet food. The wet food was sold throughout North America under store brands carried by Wal-Mart, Kroger, Safeway and other large retailers, as well as private labels like Iams, Nutro and Eukanuba.

FDA has sent inspectors to company plants in New Jersey and Kansas. Most complaints stem from products made at the latter factory, though both received shipments of wheat gluten, identified as a likely source of contamination, from the same supplier, said Stephen F. Sundlof, the FDA's chief veterinarian. The ingredient is a protein source used to thicken the pet food gravy. The FDA is screening pet food samples for substances known to be toxic to the kidneys, like toxins produced by molds.

A complete list of the recalled products along with product codes, descriptions and production dates was available from the Menu Foods Web site, http://www.menufoods.com/recall . The company also designated two phone numbers that pet owners could call for information __ (866) 463-6738 and (866) 895-2708. FDA inspectors had never before visited the Kansas plant. The FDA warned the company following a 2004 inspection of its New Jersey factory after it failed to flag food made for zoo cats of the risk of mad cow disease if the product were fed to cattle. Menu Foods is majority owned by Menu Foods Income Fund of Streetsville, Ontario.

Contact Bagoie Friedman Injury Lawyers now for a free consultation to discuss your rights. Call toll free 1-866-333-3529.

Beware Ford Electrical Switch Engine Fire Danger

2007-03-21T01:13:00.000-04:00

Texan's death rekindles Ford switch issue
Family of retiree files suit blaming component linked with engine fires. Ford expands recall.
March 6, 2007
Detroit News

Al Gavegan Sr.'s death in a house fire last summer left family and friends in San Antonio searching for answers -- and they say the evidence leads straight to Ford Motor Co. and a faulty electrical switch. The retired government contractor was well-known as the guy who operated the time clock at high school football games and taught kids with special needs. On birthdays, he asked friends to forgo gifts in favor of teddy bears he could donate to sick children at a local hospital.
Hundreds attended his funeral after the 76-year-old died Aug. 14 in a blaze that started when a late-night fire spread from his 1994 Mercury Marquis parked in his attached garage, investigators found.

A police report listed the fire's probable cause as "an electrical malfunction in the engine compartment of the vehicle." Gavegan's family soon discovered that his Grand Marquis was one of 16 million Ford vehicles built with an electrical switch that has been linked to nearly 550 fires and about 1,500 complaints.
Since 1999, Ford has recalled 6.85 million vehicles with the switches, making it one of the largest auto safety recalls in U.S. history. On Monday, Ford again expanded the recall of vehicles with the speed control switches in question. The latest recall included 155,000 2003 model SUVs and pickup trucks. But millions of vehicles with the switch, including Gavegan's Grand Marquis, have not been recalled.
Ford spokeswoman Kristen Kinley said the company has been vigilant in recalling vehicles. "We're continually looking at our products in light of how difficult this particular recall has been."

Despite five recalls and an exhaustive federal safety investigation, Ford has been unable to put an end to switch issue. Ford faces more than 20 lawsuits around the country -- including a wrongful death lawsuit to be filed today by the Gavegan family in Bexar County Court in Texas. Kinley says it is investigating the cause of the Gavegan fire and hasn't reached any conclusions.

Ford said its decision not to recall all 16 million vehicles with the switches is based on a National Highway Traffic Safety Administration investigation and its own research that show only certain vehicles with the switches are at risk of catching fire. Ford, which initially denied that the switches were defective, says an "interaction" between faulty switches and their placement in certain vehicles is to blame, not the switches alone.

NHTSA spokesman Rae Tyson said Ford has expanded the recall "whenever it has become clear" it was necessary. "This is a problem that seems to be dependent on the age of the vehicle. It's possible that higher-than-normal failure rates didn't show up right away," Tyson said.

The switch is used to deactivate a vehicle's cruise control when a driver taps a brake pedal. Most of the suits allege fires began well after the vehicles were turned off. Ford stopped using the $21 Texas Instruments switch in 2002 after a decade of use. In 1999, the company recalled the 1992 and 1993 Mercury Grand Marquis models to replace the switch, but not the 1994 model that Gavegan drove. Ford says a specific batch of switches were to blame.

Mark Chalos, a Nashville lawyer representing the Gavegan family, contends there was no significant engineering difference between the 1993 and 1994 Grand Marquis. "These companies have known for years about the fire dangers of these switches. They have chosen not to recall affected vehicles," Chalos said Monday.
The Gavegans' suit also names Texas Instruments Inc. The company sold the division that made the switches in 2006 to Sensata Technologies. Of the 6.85 million vehicles recalled, Ford has fixed 45 percent. That's a better-than-average rate for auto safety recalls, since many owners ignore letters.

A key reason the switches are a fire hazard is that they have electricity running through them after vehicles are shut off. The fix dealers install is a fused wiring harness to prevent a fire from starting.

How switch fault began

In the late 1980s, Ford asked Texas Instruments to build a fourth-generation version of a speed control switch first introduced in the 1960s. By spring 1992, Ford asked Texas Instruments to develop a quieter switch. In May 1999, following complaints, Ford recalled 279,000 1992 and 1993 model Mercury Grand Marquis sedans -- among other vehicles that had the switch. In 2000, NHTSA began a new probe of the fires from additional vehicles. In September 2002, it upgraded its investigation to an engineering analysis that lasted 22 months. At the time, NHTSA declined to take any action because of the low incidence of fires.

In November 2004, NHTSA opened another investigation into the switches after getting 36 complaints of engine fires in Ford trucks and SUVs. Two months later, Ford recalled 740,000 F-150s, Ford Expeditions and Lincoln Navigators. Ford has argued there was no conclusive evidence the systems were malfunctioning and sparking fires until September 2005, when it recalled 3.8 million pickups and SUVs from the 1994 to 2002 model years, including the Ford F-150.

At the time, Ford told owners to immediately have their cruise control switches deactivated, even though they didn't have all of the replacement parts. In August 2006, Ford recalled another 1.2 million vehicles as NHTSA closed one of the most exhaustive defect investigations in the agency's history. NHTSA's 29-page report said fatigue failure of a brake seal allows fluid to corrode the cruise control switch when it's pointed up and catch fire. Ford recently settled a widely publicized lawsuit connected to a suspected switch fire.

Darletta Mohlis of Westgate, Iowa, was killed in a May 2005 fire that the family claims started in her 1996 Ford F-150 and spread to the house. Ford denies wrongdoing, but settled the lawsuit last October. The terms are confidential.
Fire kills beloved volunteer Al Gavegan used to fall asleep watching The Tonight Show and family members believe that's likely what happened Aug. 14 when the fire broke out just before 11 p.m. After the fire started, neighbors pounded on the windows, trying to wake Gavegan. Gavegan was an Air Force veteran who tested nuclear weapons systems as a government contractor. He was an usher at St. Mary Margaret's Catholic Church, who stuffed collection envelopes and delivered Meals on Wheels. After his four children grew up, "he kind of took of the school children in the district as his kids," says his daughter, Judy Freeman, a retired school teacher in Ohio.

He was a baseball umpire and refereed football games before moving to the press box in the late 1970s to be a timekeeper at Alamo Field. Three nights a week in the fall, he ran the 30-second play clock for the San Antonio school district. This fall, in honor of Gavegan, the district silently counted down the 30-second clock before the season's first three games. I pick up the phone and find myself dialing his number," said his daughter, Janice Scott, of San Jose, Calif. "Nobody should have to suffer and go through the shock and disbelief like this."

Vehicles recalled
• May 1999: 1992-93 Ford Crown Victoria, 1992-93 Lincoln Town Car, 1992-93 Mercury Grand Marquis
• January 2005: 2000 F-150, 2000 Ford Expedition, 2000 Lincoln Navigator, 2001 Ford F-Series Super Cab truck
• September 2005: 1994-99 and 2001-02 Ford F-150 and F-150 FD, 1997-99 and 2001-2002 Ford Expedition; 2002 Lincoln Blackwood, 1994-96 Ford Bronco
• August 2006: 1996-2002 Ford E-450, 1994-96 Ford Econoline, 2000-02 Ford Excursion, 1998 Ford Explorer, 1994-2002 F-250, 1994-2002 Ford F-550, 1998 Mercury Mountaineer
• March 2007: 2003 F-150, 2003 F250-550, 2003 Ford Excursion, 2003 Lincoln Blackwood
For more information, call 888-327-4236, or go to nhtsa.gov.

Bagolie Friedman Injury Lawyers offers free legal help to victims of swithc fires. Call toll free at 1-866-333-3529.

Public Citizen Petitions FDA to Ban Some Birth Control

2007-03-01T07:57:00.000-05:00

Petition to the FDA to Ban Third Generation Oral Contraceptives Containing Desogestrel due to Increased Risk of Venous Thrombosis (HRG Publication #1799)
February 6, 2007

Andrew Von Eschenbach, M.D., Commissioner
U.S. Food and Drug Administration
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Von Eschenbach:

Public Citizen, representing more than 100,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA) pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30, to immediately ban the third generation oral contraceptives containing desogestrel due to the approximately doubled risk of venous thrombosis (30 cases for every 100,000 users per year of third generation oral contraceptives compared to 15 cases for every 100,000 users of second generation oral contraceptives) and lack of evidence of clinical benefit as compared to the second generation oral contraceptives. The third generation oral contraceptives containing desogestrel are:

Desogestrel and Ethinyl Estradiol (Duramed/Barr and Watson Pharmaceuticals)
Desogen (Organon)
Mircette (Duramed/Barr)
Velivet (Duramed)
Apri-28 (Duramed/Barr)
Kariva (Duramed/Barr)
Ortho-Cept (Ortho-McNeil)
Reclipsen (Watson)
Cyclessa (Organon)
It is estimated that women in the U.S. filled more than 7.5 million prescriptions for third generation oral contraceptives this past year (November 2005 to October 2006) (IMS, National Prescription Audit). By banning third generation oral contraceptives, the FDA will potentially save hundreds of young women a year from developing venous thrombosis and its disabling and sometimes fatal consequences.

Venous thrombosis (blood clot) most typically manifests itself in the lower extremities but can occur in the abdomen, the veins of the brain, the upper extremities, and in superficial veins of the extremities. Symptoms of venous thrombosis are pain, swelling, and redness in the affected extremity. The blood clot can travel from the site where it formed and block blood flow at another location, a phenomenon known as venous thromboembolism. The potentially lethal complication of venous thrombosis is pulmonary embolism in which the blood clot becomes dislodged from a peripheral vein and travels to the lungs where it can cause partial or total obstruction of blood flow to the lungs resulting in shortness of breath because of a loss of lung function. One study found that 2% of patients with a first-recognized episode of venous thromboembolism who were younger than 40 years, died in the hospital, most of them probably from a pulmonary embolism.[1]

In addition to a risk of a fatal pulmonary embolism, venous thrombosis contributes to significant functional disability, with an estimated one-third to over one-half of patients with venous thrombosis developing post-thrombotic syndrome, a chronic complication that consists of pain, swelling, and occasionally ulceration of the affected extremity.[2],[3],[4] Finally, the recurrence risk of venous thrombosis is high at several percent per year.[5]

Background

Combination oral contraceptives contain both estrogen and progestins. Second and third generation oral contraceptives (OCs) differ in their progestin component. Third generation OCs contain desogestrel (available in the US), or gestodene (not available in the US), while second generation OCs contain norgestrel, levonorgestrel, norgestimate[*] , or norethindrone. Third generation oral contraceptives were developed in the 1980s with a goal of producing an oral contraceptive that had less androgenic adverse effects such as hirsutism and acne typically associated with the first and second generation oral contraceptives.

The use of any combined oral contraceptives has long been associated with an increased risk of venous thrombosis. But three independent studies published in December 1995 all concluded third generation oral contraceptives had about twice the risk of venous thrombosis when compared to second generation oral contraceptives.[6],[7],[8] Numerous similar studies have found generally the same increased risk with the most common estimate of this risk being 1.5 to 2.4 -fold higher compared to second generation oral contraceptives.[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19] The difference in venous thrombosis risk between second and third generation OCs is even higher among women who use oral contraceptives for the first time.[17]

Another alarming report came from a case-control study of fatal pulmonary embolism in New Zealand women. The increased risk of death from a pulmonary embolus for women who took levonorgestrel OCs was 5.1 to 1(compared to non pill-users), but the risk of death from a pulmonary embolus for women who took desogestrel or gestodene containing OC’s was 14.9 to 1. Our calculation for the risk of fatal pulmonary embolism comparing 3rd generation OC users with 2nd generation OC users is 2.1 (95% CI 0.45-10.15). The authors state that “the high mortality in New Zealand may partly reflect the extensive use of third-generation oral contraceptives, which seem to carry a higher risk of VTE than older contraceptives.”[20]

Accounting for possible flaws in study design and methods in previous studies, two meta-analyses in 2001 both concluded that oral contraceptives containing desogestrel increases the risk of venous thrombosis more than those OCs containing levonorgestrel (a 2nd generation OC) by a factor of 1.7.[21],[22] These studies are summarized in Table 1. The overall risk estimates from the two meta-analyses are likely to be conservative; the studies with lower risk estimates in these meta-analyses were studies sponsored by the manufacturers.[21]

Table 1. Summary of studies comparing 3rd vs. 2nd Gen. OCs and the risk of venous thrombosis

Source
Study Design
3rd vs. 2nd Gen. OCs (Estimated Relative Risk or Odds Ratio with 95% CI)

Bloemenkamp et al,[8]1995
Case-Control
2.2 (0.9-5.4)

Spitzer (Transnational),[9] 1996
Case-Control
1.5 (1.1-2.2)

Bloemankamp et al,[13] 1999
Case-Control
1.9 (0.8-4.5)

Jick et al (UK-GPRD),[14] 2000
Cohort/
Case-Control
1.9 (1.3-2.8)/
2.3 (1.3-3.9)

Farley et al (WHO),[6] 1995
Case-Control
2.4 (1.3-4.6)

Jick et al (UK-GPRD),[7] 1995
Cohort/
Case-Control
1.9 (1.1-3.2)/
2.2 (1.0-4.7)

Lidegaard et al,[12] 1998
Case-Control
1.44 (0.83-2.50)
2.19 (1.17-4.07)[a]

Andersen et al,[15] 1998
Case-Control
9.7 (0.4-259.6)[b]

Heinemann et al,[16] 2002
Case-Control
1.7 (0.9-3.6)

Farmer (UK-MediPlus),[10] 1997
Cohort/
Case-Control
1.76 (0.91-3.48)/
0.84 (0.38-1.85)

Farmer et al,[11] 1998
Case-Control
0.77 (0.38-1.57)

Herings et al,[16] 1999
Cohort
4.2 (1.7-10.2)

Farmer et al,[18] 2000
Cohort/
Case-Control
1.0 (0.6-1.6)

Lidegaard et al,[19] 2002
Case-Control
1.6 (1.0-2.4)

WHO,[23] 1995
Case-Control
1.66 (1.04-2.65)[c] (Europe)
3.42 (1.35-8.65)[c] (Developing countries)

Kemmeren et al,[21] 2001
Meta-analysis
1.7 (1.4-2.0)

Hennessy et al,[22] 2001
Meta-analysis
1.7 (1.3-2.1)
2.1 (1.6-2.8)[d]

[a] Our calculations of OR and 95% CI for 3rd gen. OCs containing desogestrel vs. 2nd gen. OCs.
[b] 3rd gen. OCs vs. 1st and 2nd gen. OCs.
[c] Our calculations of OR and 95% CI for 3rd gen. OCs vs. 2nd gen. OCs.
[d] 3rd gen. OCs containing desogestrel vs. 2nd gen. OCs.

Based on the epidemiologic evidence from these studies, including two meta-analyses, Public Citizen has concluded that third generation oral contraceptives essentially double the risk of venous thrombosis when compared to second generation oral contraceptives. The FDA acknowledged this in a statement in November 1995 stating “new studies indicate about a two-fold increase in the risk of venous blood clots associated with products containing desogestrel.” The risk essentially translates to about 1.5 additional incidents of thromboembolic disease per 10,000 women-years.

Kemmeren et al, in their meta-analysis of case-control and cohort studies assessing risk of venous thromboembolism among women using oral contraceptives before October 1995 calculated that four deaths per 1,000,000 woman-years could be prevented by switching from third to second generation oral contraceptives.[21] These lives are tragically being sacrificed for a class of drugs with double the risk of venous thrombosis and no proven superior clinical benefit when compared to safer classes of oral contraceptives with exactly the same efficacy profile.

The epidemiologic evidence that third generation oral contraceptives containing desogestrel are more prone to causing blood clots than 2nd generation oral contraceptives led to research investigating the underlying biological mechanisms.

Biological PLAUSIBILITY

Blood coagulation is a complex process of pro-coagulant proteins (they stimulate the formation of a clot) and anti-coagulant proteins that inhibit these proteins, as well as proteins that break down a clot once it has formed. Normal blood clotting depends upon a specific, delicately-balanced interaction between these classes of proteins. If one class of proteins has more activity than the other class, an abnormal state exists and a person becomes either at risk of excessive clotting (thrombosis) or excessive bleeding. It has long been known that changes in the female hormonal status seen in pregnancy, hormone replacement therapy, or oral contraceptive usage increase pro-coagulant activity in the coagulation process. Oral contraceptives affect levels of almost all of the proteins involved in the coagulation process. The progestogen found in third generation oral contraceptives, desogestrel, appears to cause resistance to one of the anti-coagulant proteins, activated Protein C (APC).[24] As compared to second generation oral contraceptives, third generation oral contraceptives significantly decrease total and free Protein S and cause a more pronounced APC resistance.[25] When APC and Protein S are not allowed to perform their natural function of inhibiting coagulation, clots tend to form more easily, thereby increasing the risk of venous thrombosis. These studies provide a biological explanation to the increased risk of venous thrombosis with third generation oral contraceptives containing desogestrel, compared to second generation OCs.

The Current Label

All of the third generation oral contraceptives contain the following warning in their product labels regarding the risk of venous thrombosis. The warning is not bolded and is under the heading “Risks of taking Oral Contraceptives.” The warning provides proof that Organon and Ortho-McNeil acknowledge this increased risk of venous thrombosis with third generation oral contraceptives.

Risk of developing blood clots:

Blood clots and blockage of blood vessels are one of the most serious side effects of taking oral contraceptives and can cause death or serious disability. In particular, a clot in the leg can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blockage of the vessel carrying blood to the lungs. The risks of these side effects may be greater with desogestrel-containing oral contraceptives, such as [brand name of drug] (desogestrel and ethinyl estradiol), than with certain other low-dose pills. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.

3rdGEN. OCs SHOW NO CLINICAL BENEFIT COMPARED TO 2ndGEN. OCs

The FDA acknowledged the lack of any clinical benefit of third generation oral contraceptives compared to second generation oral contraceptives. The FDA sent a letter to Organon on July 28, 1999 in response to their “false and misleading” advertising for Desogen. The FDA stated that “no clinically significant differences between Desogen and other oral contraceptives have been demonstrated in adequate and well-controlled comparative studies” and “furthermore, there are no adequate and well-controlled studies that have demonstrated that the body can sense a difference between oral contraceptives.”

The FDA also wrote in this letter “claims that imply that Desogen is superior to other oral contraceptive products because it has less side effects (i.e. hirsutism [unwanted hair] or weight gain) are false or misleading because they lack adequate substantiation from well-controlled clinical trials.”

In an extensive literature review, we found no non-industry sponsored randomized controlled trials comparing supposed clinical benefits of third generation oral contraceptives to second generation contraceptives. Since there is no evidence of any superior clinical benefit, it is impossible to recommend that third generation oral contraceptives remain on the market when second generation oral contraceptives are equally effective and do not cause an increased risk of blood clots.

Lessons Learned from the British Pill Scare of 1995

The Committee on Safety of Medicines (CSM) in Britain issued a statement on October 18, 1995 based on, at the time, three unpublished studies warning that third generation oral contraceptives were associated with a higher risk of venous thromboembolism than oral contraceptives containing second generation progestogens. The CSM sent a “Dear Doctor” letter to 190,000 physicians and pharmacists along with a supplement to the press and broadcast media outlining this doubled risk. The end of the statement attempted to provide reassurance suggesting that “Women taking one of the relevant pills should, if possible, see their doctor before their current cycle ends. No one need stop taking the pill before obtaining medical advice.” Subsequently, a “pill scare” developed in Europe, spurring various regulatory agencies to react with their recommendations concerning third generation OCs, and many investigations examining the public health impact of the pill scare.

Although there was initial concern that the pill scare may have increased conception and abortion rates, closer analysis of pharmaco-epidemiologic data showed no such effects. In the United Kingdom, there was no peak in pregnancies or pregnancy terminations.[26] Most women using third generation OCs switched to another oral contraceptive,[26],[27],[28] Women in the Netherlands also simply switched from third to second generation OCs.[29] Another study from the Netherlands showed a marked decrease in the number of women prescribed third generation OCs after 1995, without any change in overall use of oral contraceptives from 1995 to 2000.[30]

Still, FDA removal of third generation OCs from the market should be accompanied by a campaign directed at consumers and with advanced warnings to doctors and pharmacists so that they are prepared to talk to their patients.

Current users of third generation OCs should be advised to speak with their doctor about safer alternatives to birth control. Second generation OCs that do not show an increased risk of blood clots compared to third generation OCs are those containing low dose estrogen and levonorgestrel, norgestrel, or norethindrone. Examples of such second generation birth control pills are generic drugs such as Levonorgestrel and Ethinyl Estradiol, Levora and Trivora. Women should be warned that if the correct procedure for switching pills is not followed, there is a risk of pill-failure.

Of note, Public Citizens lists Yasmin (ethinyl estradiol and drospirenone) and Ortho Evra patch (ethinyl estradiol and norelgestromin) as “Do Not Use” drugs. Yasmin potentially increases the blood levels of potassium, while there is evidence that Ortho Evra increases the risk of blood clots.

CONCLUSIONS

Although third generation OCs have not shown any clinically significant benefit over second generation oral contraceptives, multiple studies and two meta-analyses show third generation oral contraceptives containing desogestrel are associated with a higher risk of venous thrombosis than are the second generation oral contraceptives. Evidence exists of a biological mechanism underlying the association between desogestrel and blood clots. Venous thrombosis can lead to significant functional disability and possibly death.

Currently, the FDA gives the physician the authority to decide which type of oral contraceptive to prescribe to patients. Vandenbroucke et al, in a New England Journal of Medicine review article on oral contraceptives and the risk of venous thrombosis, state that “the ability to prescribe prudently by withholding oral contraceptives from women with known risk factors is limited by the absence, in the majority of cases, of clinically recognizable risk factors for venous thrombosis. An investigation in New Zealand of a series of deaths due to pulmonary emboli suggested that in most cases physicians could not have foreseen the risk.”[31]

The FDA must ensure the well-being and safety of women in the U.S. and ban third generation oral contraceptives containing desogestrel. Women should discuss with their doctor alternative methods of birth control, such as the second generation oral contraceptives, and how to safely switch contraceptive methods.

ENVIRONMENTAL IMPACT STATEMENT

Nothing requested in this petition will have an impact on the environment.

CERTIFICATION

We certify that, to the best of our knowledge and belief, this petition includes all information and views on which this petition relies, and that it includes representative data and information known to the petitioners which are unfavorable to the petition.

Sincerely,

Jay Parkinson, MD, MPH
Research Analyst

Sylvia Park, MD, MPH
Research Analyst

Sidney M. Wolfe, MD
Director, Public Citizen’s Health Research Group

Frits Rosendaal, MD
Professor of Clinical Epidemiology, University of Leiden
Netherlands

[*] Although norgestimate was developed after the second generation oral contraceptives and is therefore sometimes referred to as a third generation progestagen, because it is partially metabolized to a second generation progestagen and because the studies showing increased risk of third generation pills are almost exclusively limited to desogestrel or gestodene, many researchers consider it more like a second generation progestagen.

References

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[1]Anderson FA, et al. (1991). A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT study. Arch Intern Med, 151:933-938.

[2]Kyrle PA, Eichinger S. (2005). Deep Vein Thrombosis. Lancet, 365:1163-1174.

[3]Prandoni P, et al. (2004). Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med, 141:249-256.

[4]Brandjes DP, et al. (1997). Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet, 340:759-762.

[5]Christiansen SC, Cannegieter SC, Koster T, Vandenbroucke JP, Rosendaal FR. (2005). Thrombophilia, clinical factors, and recurrent venous thrombotic events. JAMA, 293: 2352-2361.

[6]Farley TMM, Meirik O, Chang CL, Marmot MG, Poulter NR, for the World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception Investigators. (1995). Effect of different progestagens in low oestrogen oral contraceptives on venous thrombo-embolic disease. Lancet, 346:1582-1588.

[7]Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. (1995). Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet, 346:1589-93.

[8]Bleomenkamp KWM, Rosendaal FR, Helmerhorts FM, Buller HR, Vandenbroucke JP. (1995). Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestogen. Lancet, 346:1593-6.

[9]Spitzer, WO. (1996). Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. Transnational Research Group on Oral Contraceptives and the Health of Young Women. BMJ, 312(7023):83-8.

[10]Farmer, R. (1997). Population-based study of risk of venous thromboembolism associated with various oral contraceptives. Lancet, 349(9045):83-8.

[11]Farmer, R. (1998). The risks of venous thromboembolic disease among German women using oral contraceptives: a database study. Contraception, 57(2):67-70.

[12]Lidegaard, O. (1998). Oral contraceptives and venous thromboembolism. A case-control study. Contraception, 57(5):291-301.

[13]Bloemenkamp KWM, Rosendaal FR, Buller HR, Helmerhorst FM, Colly LP, Vandenbroucke JP. (1999). Risk of venous thrombosis with use of current low-dose oral contraceptives is not explained by diagnostic suspicion and referral bias. Arch Intern Med, 159:65-70.

[14]Jick H, Kaye JA, Vasilakis-Scaramozza C, Jick SS. (2000). Risk of venous thromboembolism among users of third generation oral contraceptives compared with users of oral contraceptives with levonorgestrel before and after 1995: cohort and case control analysis. BMJ, 321:1190-1195.

[15]Andersen BS, Olsen J, Nielsen GL, et al. (1998). Third generation oral contraceptives and heritable thrombophilia as risk factors of non-fatal venous thromboembolism. Thromb Haemost, 79:28-31.

[16]Heinemann LAJ, Lewis MA, Assmann A, Thiel C. (2002). Case-control studies on venous thromboembolism: bias due to design? A methodological study on venous thromboembolism and steroid hormone use. Contraception, 65:207-214.

[17]Herings RMC, Urquhart J, Leufkens HGM. (1999). Venous thromboembolism among new users of different oral contraceptives [published correction appears in Lancet.1999;354:1478]. Lancet, 354:127-128.

[18]Farmer R, Lawrenson RA, Todd J-C, et al. (2000). A comparison of the risks of venous thromboembolic disease in association with different combined oral contraceptives. Br J Clin Pharmacol, 49:580-590.

[19]Lidegaard Ø, Edstrom MB, Kreiner S. (2002). Oral contraceptives and venous thromboembolism: a five-year national case-control study. Contraception, 65:187-196.

[20]Parkin L, Skegg DCG, Wilson M, Herbison GP, Paul C. (2000) Oral contraceptives and fatal pulmonary embolism. Lancet, 355:2133-2134.

[21]Kemmeren, JM. (2001). Third Generation oral contraceptives and risk of venous thrombosis: meta-analysis. BMJ, 323(7305): 131 – 139.

[22]Hennessy S, Berlin JA, Kinman JL, Margolis DJ, Marcus SM, Strom BL. (2001). Risk of venous thromboembolism from oral contraceptives containing gestodene and desogestrel versus levonorgestrel: a meta-analysis and formal sensitivity analysis. Contraception, 64:125-133.

[23]World Health Organization. (1995). Venous thromboembolic disease and combined oral contraceptives: results of international multicentre case control study. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Lancet, 346:1575–1582.

[24]Rosing, J. (2001). Oral contraceptives, thrombosis and haemostasis. European Journal of Obstetrics & Gynecology and Reproductive Biology, 95:193-197.

[25]Tans, G. (2000). A randomized cross-over study on the effects of levonorgestrel- and desogestrel-containing oral contraceptives on the anticoagulant pathways. Thromb. Heamost, 84(1):15-21.

[26]Jick SS, Vasilakis C, Jick H. (1998). Pregnancies and terminations after 1995 warning about third-generation oral contraceptives. Lancet, 351:1404-1405.

[27]Allison, C. (1996). Aftermath of the oral contraceptive scare. Br. J. Sex. Med. Nov/Dec, 13-16.

[28]Martin RM, Hilton SR, Kerry SM. (1997). The impact of the October 1995 ‘pill scare’ on oral contraceptive use in the United Kingdom: analysis of a general practice automated database. Family Practice, 14:279-284.

[29]De Vries CS, Van den Berg PB, De Jong-van den Berg LTW. (1998). Oral Contraceptive use before and after the latest pill scare in the Netherlands. Contraception, 57: 247-249.

[30]De Jong-van den Berg L, Tobi H, Bijker B, Van den Berg P. (2003). Influence of the third generation pill controversy on prescriptions for oral contraceptives among first time users: population based study. BMJ, 326: 254.

[31]Vandenbroucke JP, Rosing J, Bloemenkamp KWM, Middeldorp S, Helmerhorst FM, Bouma BN, Rosendaal FR. (2001). Oral Contraceptives and the Risk of Venous Thrombosis. N Engl J Med, 344:1527-1535

Bagolie Friedman Injury Lawyers offers aggressive representation and free consultations. Call them toll free now at 1866-333-3529.

Beware Ortho Evra Birth Control Patch Danger

2007-02-24T12:10:00.000-05:00

Ortho Evra® birth-control patches may cause:

Increased risk of blood clots
Increased risk of heart attacks
Increased risk of strokes

The Ortho Evra® contraceptive patch delivers increased levels of hormones to the bloodstream through the skin.

The FDA says " In general, increased estrogen exposure may increase the risk of blood clots."The FDA also says "Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks."

If you or a loved one have been prescribed Ortho Evra® and have had a heart attack, stroke or blood clots, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation. Call toll free at 1-866-333-3529 now or email us at info@bagoliefriedman.com.

School Board to Test for Vinyl Chloride

2007-02-23T11:21:00.000-05:00

The Corona-Norco school board voted Tuesday night to test the air at two local schools for a cancer-causing chemical that has been found at Norco High.

Over the next month, new science buildings at El Cerrito Middle and Corona High will be tested to see if plastics in the building are emitting a vapor called vinyl chloride.

Low levels of the same chemical have been found at Norco High for more than a year, but officials have presumed that the gas was coming from an underground plume of pollution from a nearby toxic-waste site.

However, earlier this month soil gas tests showed no link to the underground plume, prompting state regulators to consider building materials as the potential source.

Test results at the other two schools could reveal whether Wyle or the building materials are to blame for Norco High's problems. If the schools do test positive for the chemical, the district would also have to decide how to deal with the pollution.

Board member Bill Hedrick spearheaded this week's unanimous decision to test at other schools.

There is "no safe level" of vinyl chloride, he said.

"Whether they find a small amount or a large amount, it's got to be mitigated," Hedrick said. "Unfortunately, this is such a bad player you really don't want any of it."

Hedrick said mortgage companies have been reluctant to make loans for homes in the area.

"If mortgage companies look at it and go, we have questions, how much more of an obligation do we have as a school district to ensure safety?" he said.

It is not the first time the school district has grappled with hazardous materials in the schools, said Ted Rozzi, the district's assistant superintendent for facilities.

Over the past decade, the district mitigated hazardous mold and cancer-causing formaldehyde vapor from materials used to make portable classrooms. If found elsewhere, air circulation systems could help treat the vinyl chloride gas, he said.

In the meantime, officials with California's Department of Toxic Substances Control will continue to test for a link between the contamination at Norco High and the plume from Wyle Labs, a former hazardous-testing facility across the street from the school.

As for the building materials, the potential sources are the same poly vinyl tiles, carpets and wall coverings used in the other schools and in buildings around the nation. Such materials are capable of "off-gassing" -- defined as emission through evaporation.

According to the Environmental Protection Agency, vinyl chloride is a carcinogen that chemically alters DNA in ways that could lead to the development of tumors, liver cancer, brain cancer and angiosarcoma.

The levels found so far don't pose a health threat to students but could slightly increase the risk of cancer for teachers working in the building over a period of decades, said a state toxicologist.

At least four cases of leukemia among Norco High students in recent years have raised concerns about students' health.

No such illnesses or concerns have been linked to Corona High, said Patti Anders, the school's Parent Teacher Association president.

"I think it's good that they're testing," she said. "At least this way, they can find out what's causing the problem at Norco High School."

Bagolie Friedman Injury Lawyers can help victims of vinyl chloride and PVC exposure. Contact them now, toll free at 1-866-333-3529 for a confidential and free consultation.

Workers Comp & Injury Law Blog: Beware of Kugel Hernia Mesh Patch Injury

2007-02-18T23:01:00.000-05:00

Workers Comp & Injury Law Blog: Beware of Kugel Hernia Mesh Patch Injury

Beware of Kugel Hernia Mesh Patch Injury

2007-02-18T22:45:00.000-05:00

Patients who have had a hernia repair that utilized a mesh patch are urged to contact their hernia surgeons or the hospital where their hernia repair surgery took place to find out if the recalled Composix® Kugel Hernia Mesh Patch was used in their hernia repair. The FDA list of recalled Composix® Kugel Hernia Mesh Patch

The FDA has advised patients who have been implanted with one of the recalled devices to seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.

Lawyers that practice in the area of defective medical devices have begun to prepare cases against Davol, the manufacturer of the recalled Bard Composix® Kugel Mesh Hernia Patch. Bagolie Friedman Injury Lawyers are investigating claims on behalf of patients who have received the recalled hernia mesh patches.

Proper testing of this device by the manufacturer would have revealed the defects with the device and saved many of these patients from multiple additional surgeries, complications and a lifetime of pain. We offer aggressive representation and free consultations and there is no fee if there is no recovery

The Composix® Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a memory recoil ring that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

The memory recoil ring can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to numerous complications including infections, bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Contact Bagolie Friedman Injury Lawyers now for a no risk consultation.

Beware: The ORTHO EVRA PATCH - Whare the adverse reactions ORTHO EVRA causes?at

2007-02-10T07:55:00.000-05:00

Blood clots and the birth control patch — Blood clots in the leg and blood clots lungs are behind the calls for a recall on the Ortho Evra patch.

Blood clots were the adverse reactions Ortho caused in the lungs of two women given the drug in clinical trials conducted before the drug was approved and in addition to many similar cases in women after the drug was marketed.

Adverse reactions ortho evra caused are now in the new warning. The FDA belatedly acknowledges the increased dangers of using ORTHO EVRA. These adverse reactions were first noted by the FDA physician who reviewed the drug before the agency approved it.

Despite the adverse ortho reactions that the FDA has now admitted -- that women who use the ORTHO EVRA birth control patch are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill, the FDA still allowed the ORTHO EVRA on the market and is unwilling to ban or recall it.

The problem is that hundreds of pharmaceutical lobbyists put pressure on the government to keep the drugs on the market.

Birth control is prescribed to young, healthy women and should be associated with the lowest possible risk of serious adverse drug reactions. There is no evidence that the ORTHO EVRA birth control patch is a superior contraceptive compared to older birth control pills.

The Associated Press used the Freedom of Information Act to obtain adverse drug reaction reports for ORTHO EVRA from the FDA. They reported that in 23 cases where death was the outcome, doctors found that 17 of the patients’ death appeared to be blood clot-related, including 12 from last year. The FDA estimates that it receives reports of only 1 in 10 to 1 in 100 of the serious adverse drug reactions that actually occur, meaning that the actual rate of adverse reactions for Ortho Evra may be much higher.

Additionally, the Associated Press looked at the reviews of clinical trial results done by FDA physicians and scientists prior to the weekly birth control patch’s approval. The results were submitted for review by drug manufacturer Ortho-McNeil in support of ORTHO EVRA.

Ortho-McNeil and the FDA medical officer reviewing ORTHO EVRA disagreed about whether or not two cases of blood clots in the lungs (pulmonary embolus/PE) in young women participating in the pre-approval clinical trials were caused by the birth control patch. The FDA medical officer wrote:

The FDA reviewer did not agree with Ortho-McNeil’s above conclusions. The two blood clot cases of pulmonary embolus/PE, a serious and potentially fatal condition, must be counted as two cases in the original group. Furthermore the FDA insisted that ORTHO EVRA’s labeling include the possible risk of fatal blood clots such as venous thromboembolism (VTE).

The FDA also expressed concern that 211 out of 3,088 women ( or 6.8 percent) in the pre-approval clinical trials gained 10 or more pounds in the trials and the contraceptive effectiveness of the ORTHO EVRA birth control patch was reduced in women weighing more than 198 pounds.

Precautions to consider before taking ORTHO EVRA:
You could be at high risk for developing certain serious diseases that can be life threatening or may cause temporary or permanent disability or death. The risks associated with using the ORTHO EVRA birth control increase significantly if you:
• Smoke
• Have high blood pressure, diabetes, or high cholesterol
• Have or have had clotting disorders, heart attack, stroke, chest pain (angina pectoris), and cancer of the breast or reproductive organs, jaundice, or malignant or benign liver tumors

Before using the ORTHO EVRA birth control patch, you must consult your doctor and pharmacist about all the prescription drugs, vitamins, and supplements you are taking:

Are you allergic to estrogens, progestins, or other medications?

Be sure to mention any of the following: Tylenol, antibiotics, anticoagulants such as blood thinners, Lipitor, cyclosporine, HIV protease inhibitors, medications for seizures, Phenobarbital, morphine, oral steroids, thyroid medications, St. John Wort, and many more. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

In our 21st century pill popping society – drug interactions can be fatal and/or could alter the effectiveness of the ORTHO EVRA birth control patch.

Why take the risk when birth control pills are a much safer option? Women should be empowered to make the right choice for their bodies and long term health goals.

If you or a loved one has experienced problems from using the Ortho Evra Birth Control Patch, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation.

Beware: Permax (pergolide mesylate) 2003 Safety Letter

2007-01-27T14:25:00.000-05:00

Source | FDA

Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285

Dear Health Care Professional,

During postmarketing surveillance for Permax®, a small number of individuals have been identified as developing cardiac valvulopathy involving one or more valves during Permax therapy. Based on Lilly safety data and scientific publications, the pathological assessment of valves that were surgically removed was consistent with the valvulopathy associated with carcinoid syndrome and with the use of other ergot alkaloid drugs. While a clear causal relationship between pergolide and the valvulopathy seen in these patients can not be established, given the nature of the lesions and known similar effects of other ergots, the Warnings section of the US Package Insert for Permax will be modified to reflect these reports.

In the reports made to Lilly, aortic, mitral and tricuspid valves were involved. In some cases the symptoms or manifestations of valvulopathy improved with cessation of pergolide therapy. Valve replacement was required in two patients.
It is not known whether the fibrotic valvular changes are related to retroperitoneal, pleural, and pericardial fibrosis, which are very rare but well known adverse effects seen with Permax.

Since Permax was first launched in the United States in 1989, a very limited number of cases have been reported to Lilly and to the FDA. Of the estimated 500,000 people who have been treated with pergolide since 1989, valvulopathy has been reported in less than 0.005%.

Based on these reports, the Warnings section of the US Package Insert for Permax will be modified as follows (new wording underlined):
Serous Inflammation and Fibrosis–There have been rare reports of pleuritis, pleural effusion, pleural fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves, or retroperitoneal fibrosis in patients taking pergolide. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide. Pergolide should be used with caution in patients with a history of these conditions, particularly those patients who experienced the events while taking ergot derivatives. Patients with a history of such events should be carefully monitored clinically and with appropriate radiographic and laboratory studies while taking pergolide.

If you have additional questions regarding Permax, you may contact Amarin Pharmaceuticals, Inc., our US licensee for Permax, at 1-800-969-4877.
Sincerely,
Valerie E. Simmons, MD, FFPM
Director
Worldwide Pharmacovigilance and Epidemiology
Eli Lilly and Company
Permax® is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson’s disease. Please see accompanying Prescribing Information. Permax is a registered trademark of Eli Lilly and Company, and is licensed exclusively in the United States to Amarin Pharmaceuticals, Inc.

Do I Have a Permax or Dostinex Lawsuit?

If you or a loved one have taken Permax or Dostinex and suffered from any of the side effects, you should contact Bagolie Friedman Injury Lawyers immediately for a free and confidential consultation.

Blood Thinner Medication Warfarin Linked To Brain Bleeds In Elderly

2007-01-23T23:27:00.000-05:00

(Posted by Tom Lamb at DrugInjuryWatch.com)

The January 9, 2007 edition of the medical journal Neurology has a report concerning a new study which reveals that elderly patients using the blood-thinning medicine warfarin may be at greater risk for having a serious brain hemorrhage. Warfarin is sold under various different brand names, with one of the more popular being Coumadin.

According to a January 9, 2007 Newsday article by staff writer Jamie Talan about this Neurology article regarding the new warfarin study:

Scientists at the University of Cincinnati College of Medicine found that use of the anticoagulant medicine increased in the 1990s, and the surge in prescriptions caused a rise in the number of drug-induced intracerebral hemorrhages, especially in people over age 80.

"We've had no idea how often this was happening," said Dr. Matthew Flaherty, lead author of the study that appears in the journal Neurology. Use of the blood thinner increased after many studies showed warfarin was effective at preventing ischemic strokes in people with atrial fibrillation, an abnormal heart rhythm.

As background, ischemic strokes are caused by a blood clot that forms in the brain or travels to the brain. By contrast, intracerebral hemorrhages involve a blood vessel bursting in the brain; as such, it is commonly referred to as a brain bleed. An intracerebral brain hemorrhage is a relatively rare form of stroke, accounting for less than ten percent of total annual stroke events.

The practical effect of this news about the increased risk of brain bleeds in elderly patients using warfarin, or Coumadin, was covered in a January 8, 2007 article by HealthDay reporter Steven Reinberg:

One expert thinks that doctors need to evaluate a patient's risk of stroke versus their risk of bleeding before prescribing warfarin.

"This study demonstrates that we need to be careful when we use these therapies," said Dr. Michael B. Rothberg, an associate professor of medicine at Tufts University School of Medicine.

Not all patients with atrial fibrillation will benefit from warfarin, Rothberg added. "Not all patients with atrial fibrillation should be getting warfarin," he said. "Patients at the highest risk for stroke will benefit the most, and patients at the highest risk for bleeding will benefit the least," he said.

Rothberg noted that although warfarin is standard treatment for atrial fibrillation, not everyone with atrial fibrillation is at the same risk of stroke. "I don't think that most doctors prescribing warfarin are assessing their patient's risk of stroke and risk of bleeding, but they should be," he said.

In closing, we want to make an important point: As with all prescription medications, patients should talk to their doctors before making any decisions not to take warfarin, or Coumadin.

Bagolie Quoted in Herald News Medical Malpractice Article

2007-01-13T09:35:00.000-05:00

Bagolie Friedman Injury Lawyers founding partner Ricky Bagolie was recently interviewed by Betsy Querna of The Herald News for an article entiltled

When Medical Care Makes Things Worse.

Legal remedy

Many turn to the legal system for recourse, though it is often in vain. "If you see 100 cases, 99 turn out not to be something actionable or worth filing," says Ricky Bagolie, a malpractice lawyer who grew up in Clifton. "A bad result doesn't mean it was negligent or bad care."

Buchalla contacted a lawyer about filing a lawsuit for allegedly bad care. He was told nothing could be done because there was no proof of wrongdoing.

Santos Sanchez, 52, of Passaic, says he contacted several lawyers, but none would take his case. He was unhappy with a breast-reduction surgery earlier this year.

If you or a loved one has been hurt or has been a victim of medical mistake or malpractice, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation.

Bagolie & Friedman Lecture to Lawyers on Workers' Compensation Practice

2006-12-12T23:45:00.000-05:00

New Jersey - December 2006 - Workers' Compensation Trial Lawyers Ricky Bagolie and Alan Friedman were invited to speak to a group of lawyers interested in advanced workers' comp trial tips. The unique program took place on December 2 at Pines Manor in Edison and was sponsored by the Association of Trial Lawyers of America - New Jersey (ATLA-NJ). It featured a panel of some of the most respected workers’ compensation attorneys in the state.

The program was packed with practice pointers that have proven successful in matters ranging from Using Epidemiology to Cross Examining Defense Experts, Post Settlement Enforcement Motions, Navigating the Latest Lien Issues and the Ethical Considerations in Dealing with Problem Clients. "Attendees took home new ideas that they could immediately apply to their current and future cases", said Bagolie.

Ricky Bagolie and Alan Friedman have lectured to attorneys locally, nationally as well as internationally and are the founding members of Bagolie Friedman Injury Lawyers, of Jersey City & Clifton, NJ and affiliate offices in Hollywood, Florida and Brisbane, Australia may be reached toll free at 1-866-333-3529, via e-mail at info@bagoliefriedman.com

OSHA Report Of Asbestos in Brake Pads Gets Congressional Scrutiny

2006-12-06T03:15:00.000-05:00

Andrew Schneider of the Baltimore Sun reported that OSHA had threatened to suspend an employee for refusing to withdraw an OSHA bulletin describing the hazards of asbestos in brake pads, Asbestos-Automotive Brake and Clutch Repair Work. The article also suggested that former Assistant Secretary of Labor for OSHA, John Henshaw, had inappropriately influenced the agency to rescind the bulletin.

Congressman George Miller (D-CA), soon-to-be chairman of the House Committee on Education and the Workforce sent a letter to Secretary of Labor Elaine Chao saying that he was "alarmed to learn that OSHA was withdrawing and replacing" the bulletin.

Equally disturbing, according to Miller, is the news that DOL proposed to suspend the OSHA employee who drafted the original safety bulletin."

Miller requested all documents relating to communications between OSHA and the Office of Management and Budget, documents relating to Henshaws communications with the Department relating to the bulletin and all documents relating to the development of the bulletin.

Thank goodness that, finally, we have someone in Congress that will be looking out for worker safety.

Will New Jersey Workers' Comp Benefits Be Extended to Same Sex Couples

2006-10-28T11:40:00.000-04:00

"Disparate treatment of committed same-sex couples, moreover, directly
disadvantages their children. We fail to see any legitimate
governmental purpose in disallowing the child of a deceased same-sex
parent survivor benefits under the Workers' Compensation Act or
Criminal Injuries Compensation Act when children of married parents
would be entitled to such benefits."

Mark Lewis and Dennis Winslow, et al. v. Gwendolyn L. Harris, etc., et al. (A-68-05) Complete Decision: http://www.judiciary.state.nj.us/opinions/supreme/a-68-05.pdf

Bagolie Friedman Injury Lawyers are looking to investigate workers' compensation claims involving same sex couples and may be reached toll free at 1-866-333-3529.

Bankruptcy Court Approves Owens Corning's Plan of Reorganization

2006-10-28T11:22:00.000-04:00

Toledo, Ohio – September 26, 2006 – Owens Corning (OWENQ.OB) today announced
that Judge Judith Fitzgerald of the United States Bankruptcy Court for the District of Delaware approved the company’s Plan of Reorganization. The Bankruptcy Court’s
approval of the plan paves the way for Owens Corning to emerge from bankruptcy by
the end of October 2006.

“The court’s approval of Owens Corning’s Plan of Reorganization is a significant
accomplishment for our company,” said Dave Brown, president and chief executive
officer. “As a direct result of the hard work of our employees and the continued support of our customers, suppliers and business partners, Owens Corning has the strong business performance and financial resources necessary to make this plan possible. We are pleased to have court approval on a plan that deals fairly and equitably with all our creditors and permanently resolves our asbestos liability.

“Throughout the Chapter 11 process, Owens Corning has remained committed to fairly
compensating individuals who were made sick by exposure to asbestos-containing
products that we produced until 1972,” said Mr. Brown. “This plan allows us to achieve that objective through the funding of a Trust that will allow those affected by asbestos to be compensated in the near future.”

Owens Corning’s creditors and shareholders overwhelmingly supported the plan,
including the asbestos, bondholder, and trade creditor classes, and bank debt holders. Before Owens Corning can emerge from bankruptcy, the plan must also be approved by Judge John P. Fullam of the United States District Court for the Eastern District of Pennsylvania. Following district court approval of the plan, Owens Corning must complete certain administrative steps before it can emerge from Chapter 11.

“We will emerge as a strong company,” said Mr. Brown. “Since 2002, we have
strengthened our financial performance, including increased sales, improved income
from operations and reduced SG&A. These financial achievements are reflected in the
preliminary investment-grade credit ratings that we received from both Standard &
Poor’s and Moody’s, an unprecedented accomplishment for a company emerging from a
bankruptcy restructuring.”

The agreement assumes a total distributable value of $8.627 billion, consisting of the total enterprise value of $5.858 billion, assumed excess cash of $1.432 billion, and Fibreboard trust and asbestos trust assets of $1.491 billion, less existing debt of $55 million and $99 million in assumed value of new shares reserved for employee incentive programs. The full Plan of Reorganization and related Disclosure Statement are available at http://www.ocplan.com.

Owens Corning’s exit financing will come from a combination of new equity, new debt
financing and existing debt at non-debtor Owens Corning entities. The company will
begin distributions to creditors upon the effective date of its emergence from Chapter 11.

About Owens Corning

Owens Corning is a world leader in building materials systems and composite solutions. A Fortune 500 company for more than 50 years, Owens Corning people redefine what is possible each day to deliver high-quality products and services ranging from insulation, roofing, siding and stone, to glass composite materials used in transportation, electronic, telecommunications and other high-performance applications. Since the company’s founding in 1938, Owens Corning has become a market-leading innovator of glass fiber technology with sales of $6.3 billion in 2005 and 20,000 employees in 26 countries. Additional information is available at http://www.owenscorning.com.

On October 5, 2000, Owens Corning and 17 United States subsidiaries filed voluntary petitions for relief under Chapter 11 of the U. S. Bankruptcy Code in the U. S. Bankruptcy Court for the District of Delaware. The Debtors are currently
operating their businesses as debtors-in-possession in accordance with provisions of the Bankruptcy Code. The Chapter 11 cases of the Debtors are being jointly administered under Case No. 00-3837 (JKF). The Chapter 11 cases do not
include other U. S. subsidiaries of Owens Corning or any of its foreign subsidiaries. The Debtors filed for relief under Chapter 11 to address the growing demands on Owens Corning's cash flow resulting from the substantial costs of
asbestos personal injury liability.
...................

Reference
Owens Illinois Bankruptcy Site:
http://www.occlaims.com/

Excessive Cancer Deaths Found Among IBM Manufacturing Employees

2006-10-26T08:08:00.000-04:00

Excessive Cancer Deaths Found Among IBM Manufacturing Employees
Alliance@IBM CWA Local 1701 Calls on IBM to Take Action
Oct 23, 2006 | PRNewswire
A study by Dr. Richard Clapp an epidemiologist at Boston University School of Public health, and published in Environmental Health Journal has raised alarms with IBM employees and retirees. The study, called "Mortality among US employees of a large computer company: 1969-2001," specifically details cancers and mortality rates among IBM employees.

The study confirmed that overall and cancer related mortality is considerably higher among workers engaged in manufacturing computers and component parts when compared with the general population. While this was generally known, this study includes data from the largest database so far IBM's own "Corporate Mortality File." The data comes from 31,941 records about the deaths of people who had worked at IBM's plants for at least 5 years. The study is on the Alliance web site at http://www.allianceibm.org

Earl Mongeon, Alliance@IBM Vice President and a manufacturing worker at the IBM Burlington Vermont site, said: "This study confirms to those of us working in IBM manufacturing processes that the rumors and talk about high levels of cancers and other health problems from working with toxic substances wasn't just idle shop floor talk."

The Alliance@IBM, the advocate group for IBM employees, is calling on IBM and local, state and federal officials to take the following actions in response to this study:

Health surveillance of all who worked at IBM by the company and appropriate Health agencies.
Increase the use of non-toxic substances in all processes and reduce the use of harmful substances.
Employee exposure levels of toxic substances within IBM facilities be reduced significantly.
States and municipalities with computer manufacturing plants to compile cancer maps of areas around the facilities and areas where employees are likely to reside. Results to be made public.
The setting up of a fund to help alleviate the medical costs of affected IBM employees and their families

If you or a loved one developed a cancer that may be related to the job, contact Bagolie Friedman Injury Lawyers now for a confidetial and free consultation.

Idaho Teen Sues J&J, Ortho McNeil Over Ortho Evra Birth-Control Patch

2006-10-18T05:12:00.000-04:00

Idaho Teen Sues J&J, Ortho McNeil Over Ortho Evra Birth-Control Patch

A new lawsuit was filed in federal court regarding the safety of the popular but controversial birth-control patch Ortho Evra. In the suit, Idaho’s Katy McKellips Braman, who was 17 when she was first prescribed the patch in 2004, claims that Johnson & Johnson and drug company Ortho McNeil failed to sufficiently test the patch before putting it on the market and that they knowingly misled consumers about the risks of the patch when compared to other birth-control alternatives. Braman’s suit is one of hundreds that have been filed throughout the United States.

Braman alleges that she developed deep vein thrombosis, a serious and potentially fatal blood-clot condition, in her left leg because of her use of Ortho Evra. She had been using the drug for little more than a month when she noticed pronounced swelling in the leg, which gradually worsened over the course of days. The condition required hospital treatment and has forced her to take anti-clotting medications on a daily basis. She is suing the companies for damages and all future medical costs related to the condition.

Only last month, the Food and Drug Administration added a warning to the Ortha Evra label, notifying consumers of the increased risks of clotting in legs and lungs for the patch as opposed to the pill. The patch works by releasing estrogen and progestin into the blood. Since it is applied only on a weekly basis, it contains significantly more hormones than more traditional forms of birth control–making the risk of side effects more severe. Last year, there were nearly 9.5 million prescriptions written for Ortho Evra.

In April of this year, the New York Post reported that “women who suffered life-threatening blood clots and strokes on the Ortho Evra birth-control patch have been receiving cash settlements from the manufacturer.” In September, the Post said that “FDA records, obtained by The Post under the Freedom of Information law, show that 17 patch users, ages 17 to 30, suffered fatal heart attacks, blood clots, and possible strokes since August 2002” and added that “scores of other women using the Ortho Evra patch have suffered complications, including 21 ‘life-threatening’ cases of blood clots and other ailments, according to Food and Drug Administration reports obtained by The Post.”

Johnson & Johnson reported in an SEC filing earlier this year that roughly 500 women had filed suit against them over the patch. Earlier today, the company announced profits of more than $2.7 billion in the third quarter alone, on revenues of $13.3 billion. However, hormonal contraceptive sales declined by 4 percent, largely because of the safety issues related to the patch.

Contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation now.

Jury awards a former railroad employee $1.8 million after he claimed exposure to cleaning solvent at work in Louisville and Corbin caused permane

2006-10-08T04:07:00.000-04:00

By James Bruggers
jbruggers@courier-journal.com
According to The Courier-Journal

A Jefferson Circuit Court jury has awarded a former railroad employee $1.8 million after he claimed exposure to cleaning solvent at work in Louisville and Corbin caused permanent brain damage.

Terry L. Williams, 59, of Corbin, had targeted his former employer, CSX Transportation, in the lawsuit. He declined to be interviewed.

CSX spokesman Gary Sease declined to comment. Sease has previously said that the company does not believe solvents sickened workers at CSX or companies that CSX acquired, such as the Louisville & Nashville Railroad.

But the 9-3 verdict in the two-week trial is the latest in a string of litigation in several states involving hundreds of railroad workers.

The Louisville jury awarded Williams $500,000 for medical expenses, $500,000 for loss of income, $500,000 for past mental and physical pain and suffering and $500,000 for future mental and physical pain and suffering, according to court documents filed Tuesday.

Because the jury attributed 10 percent of the negligence to Williams, CSX will be obligated to pay 90 percent of the award, or $1.8 million.

Williams worked for the railroad 34 years, leaving in 2000 after having been diagnosed with toxic encephalopathy. Williams' career as a machinist working on locomotives started at the L&N's old South Louisville shops and ended at a maintenance facility in Corbin.

In 2001 The Courier-Journal found that more than 600 U.S. railroad employees had been diagnosed with brain damage after working years with solvents with little or no protection.

CSX had, as of 2001, paid $35 million in settlements or awards to 466 current or former employees who filed claims under the federal compensation law for railroad employees. Jury verdicts have gone both ways, with railroad companies claiming other factors may have caused illnesses.

Railroads largely phased out use of the chemicals in question by the early 1990s.

Earlier this year, researchers in West Virginia documented that solvents used by railroad workers shrank an area that helps the two sides of the brain communicate.

Contact Bagolie Friedman Injury Lawyers to discuss your potential railroad claim.

Workers Comp & Injury Law Blog: Lawsuit Accuses Security Firm of Failing to Pay Overtime

2006-09-06T20:56:00.000-04:00

Workers Comp & Injury Law Blog: Lawsuit Accuses Security Firm of Failing to Pay Overtime

Lawsuit Accuses Security Firm of Failing to Pay Overtime

2006-09-06T20:44:00.000-04:00

According to Business Wire, Inter-Con, a global security firm, faces a lawsuit for failing to pay current and former employees for required pre-shift overtime work and violating state and federal laws. The class consists of about 2,000 security guards in CA and there is possibility of more throughout other states. The lawsuit seeks an injunction that would require Inter-Con to pay overtime wages and compensation for all current and former employees who were denied overtime pay in CA.

If you feel that you were cheated out of overtime, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation.

BAGOLIE FRIEDMAN
INJURY LAWYERS

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Federal Prosecutors Will Appeal Pending Asbestos Case Rulings

2006-08-30T23:09:00.000-04:00

Federal Prosecutors Will Appeal Pending Asbestos Case Rulings

A case against W.R. Grace and Co. over an asbestos conspiracy will be appealed by federal prosecutors who disagree with recent court rulings. The prosecutors accuse the company of violating the Clean Air Act and knowingly poisoning former workers and residents. Three rulings however, have undermined their case by dismissing one count of conspiracy and barring the use of "critical evidence" of asbestos samples and scientific research. The Washington Post, Boston Globe 08/25/2006

asbestos lawyer

Beware of Asbestos in Automotive Brake & Clutch Repair Work

2006-08-30T22:32:00.000-04:00

Asbestos-Automotive Brake and Clutch Repair Work
SHIB 07-26-2006
"OSHA is issuing this Safety and Health Information Bulletin to inform employees and employers in the automotive brake repair industry of the precautions that must be taken when working with automotive brakes and clutches containing asbestos. In the case of do-it-yourselfers *, OSHA does not have jurisdiction, and OSHA does not require theses practices to be followed. To reduce the potential exposure to asbestos, EPA strongly recommends that all automotive brake and clutch repair work be done by professional auto mechanics. "

If you or a loved one suffers from an asbestos related injury, contact Bagolie Friedman Injury Lawyers for a confidential and free consultation.

asbestos lawyer

Workers Comp & Injury Law Blog: Bay Area asbestos removers settle suit

2006-08-29T01:04:00.001-04:00

Workers Comp & Injury Law Blog: Bay Area asbestos removers settle suit

2006-08-29T01:04:00.000-04:00

Workers Comp & Injury Law Blog: Bay Area asbestos removers settle suit

Workers Comp & Injury Law Blog: Ortho Evra Lawsuit Filed

2006-08-29T01:03:00.000-04:00

Workers Comp & Injury Law Blog: Ortho Evra Lawsuit Filed

Ortho Evra Lawsuit Filed

2006-08-26T01:55:00.000-04:00

A law suit has been filed against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc. (NYSE:JNJ), on behalf of a 34 year-old woman. The woman was diagnosed with a severe pulmonary embolism after using the Ortho Evra birth control patch less than two years. The suit was filed in the United States District Court for the District of New Jersey earlier this month.

Workers Comp & Injury Law Blog: Injured by the Duragesic Fentanyl Patch?

2006-08-18T00:46:00.000-04:00

Workers Comp & Injury Law Blog: Injured by the Duragesic Fentanyl Patch?

2006-08-18T00:45:00.000-04:00

Workers Comp & Injury Law Blog: Injured by the Duragesic Fentanyl Patch?

Workers Comp & Injury Law Blog: Nationwide Recall of Duragesic Patches Expanded

2006-08-12T05:35:00.000-04:00

Workers Comp & Injury Law Blog: Nationwide Recall of Duragesic Patches Expanded

Charite Artificial Disc Recipients Take Legal Steps

2006-08-12T05:16:00.000-04:00

Artificial Disc Recipients Take Legal Steps
There are success stories, but more than two dozen patients claim the device is too risky
Aug 4, 2006 | Rong-Gong Lin II | Los Angeles Times
Since the moment a decade ago when Dane Titsworth picked up a box and a disc in his spine burst, he has been in ever-worsening pain.

So it was with great hope that the Bakersfield building maintenance manager agreed last year to a new procedure. It meant replacing the deteriorating disc in his lower back with a Charite-brand artificial one the first artificial replacement disc approved in the U.S.

"The artificial disc was going to restore my full motion and relieve all my pain," he recalled being told by his doctor. "I would be like a new person."

But after the surgery, he said, the pain became excruciating, virtually immobilizing him. He could no longer work, garden, play catch or ride his motorcycle. After about 10 months on sick leave, he lost his job.

"It failed," said Titsworth, 45, a married father of a 13-year-old son and 2-year-old daughter. "It's pretty much stopped my life." And now he is suing the disc's maker, DePuy Spine Inc., a Raynham, Mass.-based subsidiary of Johnson & Johnson.

Used in Europe since the 1980s and approved by the Food and Drug Administration in 2004, the Charite disc is marketed as an alternative to spinal fusion and is part of the growing and sometimes controversial use of spinal surgery.

The disc's maker says the product is safe and has helped thousands of patients. But DePuy had no comment on Titsworth's case or 27 similar lawsuits filed since January. Five involve California plaintiffs.

The suits allege that the disc is "unreasonably dangerous."

"They've designed a defective product that does not work as intended or as advertised, and in fact causes some horrific side effects," said Titsworth's lawyer.

DePuy spokeswoman Debbie Williams says the product garnered high satisfaction rates among patients and surgeons in a two-year, industry-funded study that was filed with the FDA before its approval.

"As with all surgical procedures, there is a potential for adverse events or complications," Williams said in an e-mail. Still, "the clinical evidence shows the Charite artificial disc is an effective treatment and an option for appropriate patients."

She said that the product "preserves some motion" and "has demonstrated a shorter recovery time compared to fusion." Spinal fusion, the leading surgical treatment for damaged discs, involves placing bone grafts around two or more of the vertebrae during surgery. The body then heals the grafts over several months, which "welds" the vertebrae into a rigid section.

Dr. John Regan, a Beverly Hills surgeon who performs surgery using the artificial disc, said fusion might add stress on adjacent, healthier discs, increasing the risk of future damage.

In contrast, an artificial replacement disc is designed to keep the damaged area flexible, said Regan, who receives some royalties from DePuy unrelated to surgeries he has performed.

Some patients say the Charite disc has given them a new chance for an active lifestyle they thought had been lost forever.

Ron Osborn, 57, of Saugus, said he was surprised at how well his Charite disc has performed. The natural disc it replaced had deteriorated so much that the bones on his spine were crushing a major nerve, leaving him unable to walk for weeks at a time.

"Now I'm back," said Osborn, a sales manager for a golf company. "I've got 100% restoration. I have a back of a 20-year-old."

Similarly, Rick Zayed, 38, an aerospace mechanical engineer from Hermosa Beach, went from struggling to lift a laundry basket to swimming, running and mountain biking.

"So far, everything they said it would do, it's been doing," Zayed said.

But Dr. Allyson Fried-Cain, a former foot-and-ankle surgeon who has sued the manufacturer, said that she suffered such an increase in pain after a Charite disc implantation that she lost her practice and had to sell her Marina del Rey home.

"I couldn't do surgery anymore. I couldn't bend over," said Fried-Cain, 52, a former marathon runner whose back injury resulted from a car accident.

"This implant has destroyed my life," she said.

The Charite disc is advertised on its website with the trademarked slogan "natural motion is back," along with a photo of a family walking through a field.

The suits come as spinal surgery is becoming a very lucrative business, with at least $3.2 billion spent last year in the U.S. on spinal fusion.

Millions of Americans who suffer from persistent lower back pain are looking for relief, and employers lose billions of dollars every year from lost work time due to back pain.

Other medical device companies, including West Chester, Pa.-based Synthes Inc. and Minneapolis-based Medtronic Inc., are developing disc replacements.

"It's an enormous commercial opportunity," said Phil Nabone, a medical technology analyst at RBC Capital Markets.

But since its launch, the Charite disc has been controversial.

Although two national insurance carriers and 60 regional providers cover the device, a medical advisory panel for the Blue Cross Blue Shield Assn. said in an evidence-based review last year that there was "no immediately evident advantage" to using the artificial disc.

And this year, the U.S. Centers for Medicare and Medicaid Services questioned the disc's overall effectiveness.

The original two-year trial sent to the FDA showed only that the disc was no worse than a specific type of spinal fusion surgery, the agency said in a 45-page report released in May.

The study is sometimes criticized because it compared the disc with a spinal fusion technique that has fallen out of favor among surgeons.

The trial submitted to the FDA found that 57% of Charite patients achieved "overall clinical success," compared with 47% in the spinal fusion procedure. More than 3 in 5 Charite disc patients who were considered successes continued taking narcotic pain killers two years after the surgery; while 4 in 5 did so in the control group.

But a higher percentage of Charite disc patients suffered severe or life-threatening events than the spinal fusion group: 15% compared with 9%, according to an FDA clinical review.

As a result, the agency ruled that Medicare would bar coverage of the device for anyone older than 60. Local Medicare contractors were allowed to make the decision for anyone younger.

"This composite outcome is unconvincing as a demonstration of health benefit," the Medicare report said.

Some doctors are equally skeptical.

Dr. Sohail Mirza, a University of Washington medical professor, took issue with Charite disc's marketing slogan of "natural motion is back." It "implies that the artificial disc creates a normal spine; it does not," he wrote in the journal Spine last year.

"Contrary to optimistic marketing, the data … argue for caution by patients and surgeons. Hope for a cure of back pain and a marketing bonanza must be held in check," he wrote.

Dr. Charles Rosen, associate clinical professor of spine surgery at UC Irvine, said he has seen 10 patients since late last year, including Titsworth, complaining of worsening pain after they received the Charite disc.

Rosen said he believes the disc is unsafe and should never have been approved by the FDA. After the surgery, some patients suffered fracturing and an abnormal pulling apart of the joints of the spine, he said. Rosen said the two-year study was too short for a disc that will remain in the spine for many years; the average age of a disc recipient is 40.

"There is no solid evidence that this will last for more than five or 10 years and they will not need to have another operation," Rosen said.

Regan, who helped conduct the clinical trial for the Charite disc, said he is convinced the disc is good technology.

"When you focus on the failures, everyone's thinking, 'What's wrong with this?' " Regan said. "Then it spoils it for the many, many patients who are doing great."

If you or a loved one suffer from problems due to a Charite Artificial Disc, contact Bagolie Friedman Injury Lawyers for a confidential and free consultation.

Injured by the Duragesic Fentanyl Patch?

2006-08-12T04:59:00.000-04:00

Injured by the Duragesic Patch?
On July 15, 2005 the FDA issued a Public Health Advisory concerning the use of Duragesic Patches (Fentanyl transdermal) in response to reports of deaths in patients using the patch. The FDA is conducting an investigation into the deaths associated with these patches.

The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.

There has been an expanded recall of Duragesic Patches due to possible leaks. Janssen Pharmaceutica, the manufacturer of the Duragesic Patch notified healthcare professionals of an expanded recall of the Duragesic 75 mcg/h, in February 2004. Four additional lots have been subject to the present expanded recall. Some patches from the recalled lots may leak medication due to improper sealing of one of their edges.

If the medication leaks out of the patch, exposure to the medication can result in inadvertent ingestion or increased transdermal absorption of the active opiate component fentanyl, leading to potentially life-threatening complications. In addition, leakage of the medication could lead to inadequate dosing, resulting in treatment failure and/or opiate withdrawal.

The Duragesic Patch is indicated for the management of severe, chronic pain (such as cancer pain) that cannot be managed with less powerful drugs such as acetaminophen-opioid combinations and nonsteroidal analgesics.

Moreover, only patients who are already on and tolerant to opioid therapy, and require continuous opioid administration should use the patch. Approved by the U.S. Food and Drug Administration (FDA) in 1990, the Duragesic patch releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is available only by prescription.

If you or a loved one used a Duragesic Patch and suffered side effects, please fill out the form at the right for a free lawsuit case evaluation by Bagolie Friedman Injury Lawyers.

Injured Civilian Contractor Employees Injured in Iraq or Anywhere in the World May Receive Benefits Under the Defense Base Act

2006-07-29T10:02:00.000-04:00

If you are injured while working as a civilian for a company supporting the U.S. Department of Defense in Iraq, Kuwait or anywhere overseas, you may be entitled to receive Federal workers' compensation benefits under the Defense Base Act (42 U.S. Code § 1651). One of the benefits, established by the U.S. Congress, is to have attorney representation for free. No attorney’s fees come from a worker’s weekly benefits or settlement. They are awarded to the attorney by the U.S. Department of Labor based on his reasonable time spent on the case.

Established in 1941, the primary goal of the Defense Base Act was to cover workers on military bases outside the United States. The act was amended to include public works contracts with the government for the building of non-military projects such as dams, schools, harbors, and roads abroad. A further amendment added a vast array of enterprises revolving around the national security of the United States and its allies. Today, almost any contract with an agency of the U.S. government, for work outside the U.S., whether military in nature or not, will likely require Defense Base Act coverage.

Claims must be filed in the appropriate district office of the United States Department of Labor. The New York District is located in Manhattan near Bagolie Friedman Injury Lawyers. The New York District covers all claims arising in Iraq, Afghanistan as well as all of Central and South American, Europe and Africa.

All consultations are free and confidential.

Researchers Say ″Killer″ Asthma Inhalers Should Be Recalled

2006-07-05T23:15:00.001-04:00

Jun 20, 2006 | Consumer Affairs

Researchers from Cornell and Stanford universities have concluded three common asthma inhalers containing the drugs salmeterol or formoterol may be causing four out of five U.S. asthma-related deaths per year and should be taken off the market.

The researchers made their recommendation after concluding a search of medical literature.

They base these conclusions on a statistical analysis of 19 published trials involving 33,826 patients. This so-called meta-analysis found that patients who inhaled the long-acting beta-agonists salmeterol (trade names Serevent and Advair, both made by GlaxoSmithKline) or formoterol (trade name Foradil, made by Novartis Pharmaceuticals) were 3.5 times more likely to die from asthma and 2.5 times more likely to be hospitalized (whether or not death resulted), compared with those taking a placebo.

The reason, say the researchers, is because although these medications relieve asthma symptoms, they also promote bronchial inflammation and sensitivity without warning.

Asthma death is relatively rare, 15 patients in the meta-analysis who were taking the beta-agonists died, compared with three in the placebo group, over a six-month period.

"In total, there are about 5,000 deaths a year due to asthma, whether or not a person is taking a long-acting beta-agonist," said Edwin Salpeter, the J.G. White Distinguished Professor of Physical Sciences Emeritus at Cornell, who led the statistical analysis in the study.

An eminent astrophysicist, Salpeter has more recently focused his attention on medical statistics.

"We can show that overall it is statistically significant that, compared to patients taking a placebo, these long-acting beta-agonists kill a lot of people," he said.

"These asthma deaths are generally in healthy young adults," said his daughter, Shelley Salpeter, the lead author of the paper appearing online and in the June 20 issue of Annals of Internal Medicine. She is a clinical professor of medicine at Stanford's School of Medicine and a physician at Santa Clara Valley Medical Center in San Jose, Calif.

"We estimate that approximately 4,000 out of the 5,000 asthma deaths that occur in the U.S. each year are actually caused by these long-acting beta-agonists, and we urge that these agents be taken off the market," she added.

Adding an anti-inflammatory drug to a long-acting beta-agonist adds little benefit, report the Salpeters.

Advair, for example, (the fourth bestselling drug in the world with $5.6 billion in annual sales), combines salmeterol with an anti-inflammatory drug to provide some protection against bronchial inflammation associated with beta-agonists. But hospitalizations still doubled for patients inhaling a long-acting beta-agonist combined with an anti-inflammatory drug compared with asthma patients taking a placebo and an anti-inflammatory drug by itself.

Of the 19 studies surveyed in the meta-analysis, the largest the Salmeterol Multicenter Asthma Research Trial with 26,000 participants reported a fourfold increased risk for asthma-related deaths and a twofold increase in life-threatening asthma events in patients using salmeterol.

If older people who also suffered from chronic obstructive pulmonary disease were removed from the analysis, the Salpeters report, salmeterol would be associated with a six times greater risk for asthma-related deaths.

The meta-analysis found that 53 of 3,083 patients inhaling beta-agonists were hospitalized for an asthma attack compared with 12 of 2,008 patients who received a placebo, meaning that there was one hospitalization for every 71 patients treated with a long-acting beta-agonist per year.

The Salpeters say that these two long-acting beta-agonists can result in death because tolerance to them develops over time.

"These agents can improve symptoms through bronchodilation at the same time as increasing underlying inflammation and bronchial hyper-responsiveness, thus worsening asthma control without any warning of increased symptoms," said Shelley Salpeter.

"It is particularly frightening that long-acting beta-agonists are detrimental, whether salmeterol or formoterol, whether taken alone or with anti-inflammatory drugs, both for children and for adults," said Ed Salpeter.

Researchers Say ″Killer″ Asthma Inhalers Should Be Recalled

2006-07-05T23:15:00.000-04:00

US FDA sets strong warnings for asthma drug labels

2006-07-05T23:13:00.000-04:00

US FDA sets strong warnings for asthma drug labels
May 15, 2006 | Reuters
The U.S. Food and Drug Administration said on Monday that product labels for three popular asthma medications have been updated to state that the drugs could increase the chance of severe asthma attacks that could result in death.

The warnings, first proposed last November, involve long-acting bronchodilator medicines Advair and Serevent, made by GlaxoSmithKline Plc, and Foradil from Novartis AG.

In a public health advisory issued on its Web site, the FDA said the inhaled drugs should only be used after other medicines, such as inhlaed corticosteroids, fail to control asthma.

Bay Area asbestos removers settle suit

2006-06-29T23:42:00.000-04:00

Bay Area asbestos removers settle suit
Jun 29, 2006 | AP
An asbestos removal contractor and a property management company agreed to pay air-quality regulators $430,000 to settle claims they improperly removed asbestos from San Francisco Bay Area buildings.

The fines were the largest asbestos reporting and removal penalties the Bay Area Air Quality Management District has levied, the agency said Tuesday.

USA Properties Fund Inc. and USA Multifamily Management Inc. agreed to pay $300,000 on allegations it used unqualified workers to remove asbestos from the ceiling of a Concord apartment complex.

Two companies fined $430,000 for asbestos violations

2006-06-29T23:32:00.000-04:00

Associated Press
OAKLAND, Calif. - An asbestos removal contractor and a property management company agreed to pay air quality regulators $430,000 to settle claims they improperly removed asbestos from San Francisco Bay area buildings.

The fines were the largest asbestos reporting and removal penalties the Bay Area Air Quality Management District has levied, the agency said Tuesday.

A Roseville property management company, operating as USA Properties Fund Inc. and USA Multifamily Management Inc., agreed to pay $300,000 on allegations it used unqualified workers to remove asbestos from the ceiling of a Concord apartment complex.

The workers failed to protect themselves and apartment residents from exposure, according to a lawsuit filed in Contra Costa County Superior Court in March.

In the second case, a Hayward asbestos abatement contractor, operating as Synergy Environmental Inc. and Synergy Enterprises Inc., agreed to pay $130,000 in penalties for allegedly failing to properly notify regulators of more than 250 removal jobs it performed in 2002 and 2003.

Calls to both companies were not immediately returned Wednesday.

Inhaling asbestos fibers can cause lung cancer and other serious diseases.

Worker Dies in Industrial Leak Near Pensacola

2006-06-07T23:10:00.000-04:00

Worker Dies in Industrial Leak Near Pensacola
Jun 7, 2006 | www.wsfa.com
Investigators are working to determine the cause of a toxic gas leak at an industrial plant near Pensacola that killed one worker.

Authorities say the victim died after inhaling toxic hydrogen sulfide gas at the Blackjack Creek Treating Facility in Allentown, about 20 miles northeast of Pensacola. The toxic chemical is created in the process of making crude oil. Joseph Smith was injured, but has been treated and released from the hospital.

Fire officials say Monday's leak did not affect anything outside the plant or its boundaries. The plant was closed by the Florida Department of Environmental Protection in 2002 while extensive repairs were made to reduce sulfur dioxide and possible hydrogen sulfide emissions.

The company paid $125,000 in civil penalties and completed a pollution prevention project instead of the balance of the penalties, according to a consent order

First trial in nationally consolidated welding cases starts

2006-06-06T07:53:00.000-04:00

First trial in nationally consolidated welding cases starts
Jun 4, 2006 | M.R. KROPKO | AP
Ernesto G. Solis often welded as part of his maintenance work at a naval air station in Corpus Christi, Texas.

Solis, 57, married and the father of four adult children, still works, but avoids welding. He believes that years of exposure to welding fumes has taken a serious toll on his health. His lawyers say his physical skills have gradually deteriorated.

Solis has become the focus of a federal court trial here that may help set a national legal precedent for thousands of other cases in which workers allege manganese exposure from welding has led to Parkinson's disease.

Solis' case would be the first welding fume case to go to trial among the thousands that were consolidated in U.S. District Court in Cleveland in 2003. Judge Kathleen M. O'Malley asked lawyers to be ready with opening statements Monday, and the trial could last about three weeks.

Defendants in the case are Lincoln Electric Holdings Inc., Hobart Bros. Co., TDY Industries Inc. and the ESAB Group.

"We don't believe that welding is responsible for Mr. Solis' alleged ailments," said Brandy Bergman, a spokeswoman in New York for lawyers representing welding industry defendants. "We are confident that this Cleveland jury will join the overwhelming majority of other juries around the country that have already heard and rejected similar claims."

Other welding fume cases were tried in state courts and in federal courts before the 2003 consolidation. There are about 40 percent fewer such cases pending than there were a year ago, Bergman said.

Solis' lawsuit began four years ago in Texas and contends that from 1973 to 2001 he was exposed to toxic manganese fumes from welding. The lawsuit alleges that manganese in more than trace amounts can damage the human nervous system and limit a person's ability to think, talk and move.

To coordinate the pretrial process of thousands of similar cases, they were consolidated in O'Malley's court in Cleveland, a process known as an MDL, or multidistrict litigation. There are at least 3,800 consolidated cases pending. Some of those may end up in other courts, after the first few are tried to give attorneys guidance on which arguments will succeed and which won't.

Drew Ranier, one of a team of lawyers representing Solis, said Friday before jury selection began that welding fumes are an ongoing public health concern among workers in construction and manufacturing.

"The overall picture is that there are thousands of welders being exposed to welding fumes, and there will be more cases until this is stopped," Ranier said.

The Solis lawsuit asks a jury to determine an appropriate award of damages, but does not specify an amount.

In September, another case nearly became the first to go to trial before O'Malley, but was settled for at least $1 million shortly before jury selection.

Charles Ruth, of Lucedale, Miss., had been a welder at Ingalls Shipyard, in Pascagoula, Miss., and began having various physical problems. His lawyers said he suffered shakes, balance and speech problems.

Because of the settlement, a jury did not decide whether welding fumes could be linked to Ruth's problems

Abused children may get more time to sue

2006-05-30T21:11:00.000-04:00

Bill would increase statute of limitations to six years from two

May 30, 2006 | BETH MILLER | The News Journal
Victims of child sexual abuse by an adult would have more time to sue for damages under a bill expected to reach the General Assembly today.

The bill, sponsored by Rep. Greg Lavelle, R-Sharpley, and Sen. Karen Peterson, D-Stanton, would extend the time from two years to six years after the abuse occurs or to six years after the abuse is discovered to be the cause of a victim's emotional or physical damage.

The bill also would give new life to claims of abuse that have been barred by Delaware's civil statute of limitations, granting a two-year window in which such claims could be filed.
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"That would be awesome," said Valerie Marek, executive director of Survivors of Abuse in Recovery, which supports the recovery of many abuse victims. "A lot of kids are threatened into keeping their mouths closed. By the time they are strong enough to confront it, it's years later and major damage has been done."

California passed a similar law, some states revised their statute of limitations, and other states are debating the issue, which gained prominence after the scandal of child sexual abuse by priests emerged nationally in 2002.

Navy Lt. Cmdr. Kenneth Whitwell urged Delaware lawmakers to change the state's statute of limitations last fall, when he filed suit claiming he was sexually abused by a priest who taught at Archmere Academy in the mid-1980s. Some of the abuse occurred during ski trips to Vermont, Whitwell said.

Delaware's statute of limitations would have barred Whitwell's suit, so it was filed in federal court to leverage the Vermont statute of limitations, which is six years past the time of the abuse or six years after the damage caused by the abuse is recognized.

"A civil window is the single most effective step we have toward preventing future abuse," Whitwell said Friday. "It exposes the predators now and it exposes people who enable the abuse, who protect those people, who shield molesters, who destroy documents. We know there are people out there who don't want this to get out into the open."

The legislation is meant to address abuse by individuals and the institutions that employ them. It does not target the Catholic Church or any other group, said Lavelle, who is Catholic.

"It's much broader than that," he said. "This impacts anyone whose charge it is to be responsible and watch over children; Boy Scouts, Girl Scouts, the YMCA, day cares, private schools."

Split support

Tony Flynn, lawyer for the Catholic Diocese of Wilmington, which includes parishes throughout Delaware and the Eastern Shore of Maryland, said the diocese generally supports changing the civil statute.

"We think whatever clock runs against a victim of sexual abuse should not begin to run until they are an adult," Flynn said. "If you create a period of time long enough, you can deal with the valid concern that victims of sexual abuse as minors have difficulty coming to grips with the abuse and its effects."

But, he said, the diocese sees problems in the "discovery approach," in which the time limit does not begin until the victim remembers the abuse or realizes that emotional or physical difficulties were the result of the abuse. And it would "vigorously oppose" any effort to revive claims already barred by the statute of limitations.

"There are a number of ways to deal with this, so I'm not drawing a line in the sand for this particular solution," Lavelle said. "I view this as the beginning of a public discussion."

Extending the two-year civil limit has broad support, Lavelle said. Addressing old claims with a retroactive bill is likely to face tougher debate.

Retroactive problems

Delaware lawmakers removed the statute of limitations for criminal prosecution of child sexual abuse a few years ago, including a window of opportunity during which older cases could be revived and prosecuted. But shortly after that bill was signed into law, the U.S. Supreme Court ruled on a similar case, striking down the retroactive window as unconstitutional.

"But the average age of an abused child is 9 years old," Peterson said. "What child is going to hire an attorney and file suit before he or she is 11? And with a lot of older cases people from my generation didn't talk about it. If you did, you got spanked and sent to your room. It was a whole different mentality in those days. You didn't cause problems in the family."

Reviving old cases raises many problems, Flynn said.

"Somebody abused 50 years ago could file suit," he said. "The evidence is lost, the witnesses are lost, dead or unavailable, documents are difficult to find in my view that is a denial of due process. Once a claim is barred by operation of a statute, a defendant has the right to rely on that and clear the books of the claim. Insurance programs and risk management are all predicated on what the statutes of limitation are. If you buy insurance and the rules change, you're stuck."

Ed Burke, a member of St. John's-Holy Angels parish near Newark who was abused by a priest as a boy in Iowa, said the law would give children justice and additional protection. He works with the northern Delaware chapter of Voice of the Faithful, formed to support survivors of priest abuse.

"My hope is that the state legislators will take the high ground and force the spiritual leaders to offer some form of justice to the abused, who in many cases have suffered from years of neglect," he said.

Flynn doubts legislators have enough time to devote to such a significant issue before their June 30 deadline.

"There are only 16 legislative days left in June," he said. "I doubt they can have the kind of discussion and analysis that's required for a bill of such sweeping scope. It's something that deserves more reflective consideration."

And, Flynn said, the bill still doesn't address another arena of abuse.

"If the aim of the bill is to prevent abuse, which is a major priority of the church, we're leaving untouched in this legislation a place where abuse occurs the public school system," he said. "It is immune from these suits."

Jersey City Lawyer Wins $16.4 million Jury Award for Asbestos Victims in Brooklyn

2006-05-20T13:56:00.000-04:00

Jersey City, NJ - May 5, 2006 A Brooklyn jury awarded three retired Long Island Railroad (LIRR) workers a total of 16.4 million dollars for lung disease caused by their exposure to asbestos while working for the railroad. Following an eight day jury trial before the Honorable Lawrence Knipel, Albito Velez-Zapata of Massepequa Park, New York was awarded 8 million dollars, Lincoln Aguirre of Deer Park, New York was awarded 6 million dollars and James Harrington of Brookville, New York was awarded 2.4 million dollars. The consolidated claims were filed under the Federal Employee's Liability Act (FELA), a special law designed to protect interstate railroad workers.

The workers, represented by Alan T. Friedman of Jersey City's Bagolie Friedman Injury Lawyers and Paul Garner, affiliated with Jersey City's Horn Shechtman, were exposed to deadly asbestos fibers while grinding gaskets on a high revolution wire wheel and while working around contaminated rail cars and locomotives. The jury found that the railroad knew about the dangers of asbestos dust beginning in the 1930s and failed warn their workers of the dangers and failed to protect them from the deadly fibers.

LIRR argued that the dust masks were available to the workers, despite the fact that their own Asbestos Awareness Program advised that dust masks were not adequate protection for workers exposed to asbestos. This Asbestos Awareness Program was not implemented until the 1990's, long after other industries had reacted to their asbestos problems. Additionally, the Long Island Railroad was fined by the State of New York in the 1990's for failing to implement a Right to Know program to advise their workers of workplace hazards. A Federal law requiring this type of program had been passed in the 1980's.

"The LIRR treated these workers as if they were expendable or disposable, just like the machines that it was their job to repair. The railroad considered them human overhead. This jury told the LIRR in a loud, clear voice that this is no way to treat your employees"

said attorney Alan Friedman.

Alan T. Friedman has been certified as a Civil Trial Attorney by the New Jersey Supreme Court and is a founding partner of Bagolie Friedman Injury Lawyers, with offices in Jersey City and Clifton, New Jersey, Hollywood, Florida and an international affiliation in Brisbane, Australia. He can be reached toll free at 1-866-333-3529, via e-mail at alan@bagoliefriedman.com, or on his website at www.bagoliefriedman.com.

My New Blog

2006-05-20T13:44:00.000-04:00

I must be a glutton for punishment but, alas, I have a new blog. It is the Jersey City Personal Injury Lawyer Blog and it can be found at http://jerseycity.injuryboard.com. The most recent posting is on Truck and Tractor Trailer accidents. Check it out.

Formaldehyde fears in FEMA trailers

2006-05-19T18:49:00.000-04:00

By Sean Gardiner
South Florida Sun-Sentinel
Posted May 18 2006

Using air-monitoring badges supplied by a Boca Raton company, a national environmental organization found high levels of formaldehyde in trailers supplied by FEMA for those stranded after hurricanes in Mississippi and Louisiana.

The Sierra Club announced Wednesday that only two of the 31 FEMA trailers tested in those states were below the formaldehyde air safety limit recommended by the federal Environmental Protection Agency and the American Lung Association, said Chris Smith of the Sierra Club.

Smith said he expects further formaldehyde tests will be conducted on FEMA-issued trailers in Mississippi and New Orleans but wasn't sure if any testing will be done in Florida.

Currently there are more than 1,500 FEMA trailers and mobile homes housing Florida hurricane refugees, according to FEMA statistics.

In a news release issued on Wednesday about the testing, the Sierra Club stated that formaldehyde -- a colorless, strong smelling gas that is a carcinogen -- usually comes from pressed particleboard or glue.

2006-05-19T18:37:00.000-04:00

Humira or Remicade May Triple Risk of Cancer

2006-05-18T01:43:00.000-04:00

Humira or Remicade May Triple Risk of Cancer

CHICAGO, Illinois (AP) — Rheumatoid arthritis patients taking Humira or Remicade face triple the risk of developing several kinds of cancer and double the risk of getting serious infections, a study led by the Mayo Clinic found.The analysis builds on previous reports about the risks associated with Abbott Laboratories’ Humira and Centocor’s Remicade. But the earlier research focused mostly on one kind of cancer — lymphoma — and infections such as tuberculosis and pneumonia.

The new study found an apparent link to other cancers, too, including skin, gastrointestinal, breast and lung tumors. It also quantifies the risks and says high doses appear to be the riskiest.

While the drugs’ packaging information mentions some of the risks, the manufacturers said the new study does not prove that the medication is at fault, and they said the research was flawed.

To read full story, click here.

Contact Bagolie Friedman Injury Lawyers for a confidential and free consultation.

Birth-control patch linked to blood clots, strokes

2006-05-12T16:05:00.001-04:00

Dozens of womanm have sued Ortho Evra manufacturer Ortho-McNeil Pharmaceutical Inc. and its parent company, Johnson & Johnson, arguing that the country's only birth-control patch causes debilitating blood clots, strokes and even death. The patch is still on the market.

In U.S. District Court in Newark, N.J., where 37 cases have been filed, the stories are similar: An otherwise healthy Georgia woman develops a pulmonary embolism; a Maine woman suffers from a blood clot in her right lung; a 12-year-old girl in Indiana is diagnosed with deep-vein thrombosis.

Julie Keenan, spokeswoman for Ortho-McNeil, declined to comment on the allegations because of the ongoing litigation.

For many of the women, the long-term effects have been devastating. Some will be on blood thinners for the rest of their lives.

The lawsuits contend that Ortho-McNeil rushed the patch onto the market without adequate testing. The company may have been nervous that it would lose money when its patent for the birth-control pill Ortho Tri-Cyclen ran out, the suits say, and pushed to get the patch on pharmacy shelves to offset any red ink.

Lawyers handling the cases, which have been filed in federal courts across the country as well as in Superior Court in Hudson and Middlesex counties, say they are more clear-cut than other recent pharmaceutical litigation, such as the Vioxx lawsuits.

"You're dealing with primarily women ages 18 to 35 who don't have a lot of pre-existing conditions to begin with," said, a Hackensack lawyer who is working with a South Carolina law firm on a dozen cases. "The reason why people are getting the blood clots is a lot cleaner."

At a hearing last week in U.S. District Court in Ohio, where the federal cases have been consolidated, a Johnson & Johnson lawyer announced the company hopes to settle the lawsuits. Already, 11 women who filed suit in Hudson County have received settlements, although the amounts are sealed.

Generally lawsuit settlements are viewed as positive outcomes for plaintiffs, but they can be a mixed blessing in drug cases.

Respironics PLV Continuum Ventilator: Class 1 recall due to air flow valve breakage and failure to ventilate

2006-05-06T08:36:00.000-04:00

Respironics and FDA notified healthcare professionals about the Class 1
recall of this device, a mechanical ventilator used to control or assist
breathing. The ventilator is intended for home, institutional and
portable settings and may be used for invasive as well as noninvasive
ventilation. A design flaw can cause lead wires in the air flow valve to
break during use. When this happens the ventilator stops providing
mechanical ventilation. Customers should safely transition patients in
their care from the PLV Continuum Ventilator onto other comparable
patient support devices. If customers do not have a suitable ventilator
to use for their patients, they should contact Respironics at
760-918-7328 to make suitable substitute arrangements.

If you or a loved one has been injured by this device, contact Bagolie Friedman
Lawyers now for a confidential and free consultation.

Read the complete MedWatch 2006 Safety summary including a link to the
recall notice, by clicking here.

NYC Wrong on WTC Rescue and Recovery Worker Injuries

2006-04-18T00:20:00.000-04:00

From Newsinferno

Date Published: Sunday, April 16th, 2006
By Steven DiJoseph

When it comes to human tragedies, there is always a big difference between what people know and what they will admit to. The facts determine the former while money, as in all other aspects of life, often determines the latter.

Consider the following examples of this rather insincere view of reality:

Everyone knew safer cars could be designed and built but, for decades, the auto industry was able to delay the implementation of such things as seat belts, air bags, and emission systems because of the added expense involved. In the meantime, hundreds of thousands of people died needlessly.
Cigarettes kill people, period. No secret there, right? Yet for decades, big tobacco hid and denied that fact while it continued to market its products without warnings and in a way that enticed people to smoke rather than to avoid it at all costs. Unnecessary death toll? Millions, at the very least – and continuing.
Agent Orange, the defoliant, that the U.S. saturated Viet Nam with from the air up until 1971, was loaded with powerful chemical agents that really had no business being dropped on civilians and military personnel. The dioxins Agent Orange (as well as Agents Purple, Pink, Blue, and Green) contained are carcinogens as well as teratogens. Once responsible scientists and doctors began linking cancers and other serious diseases in thousands of servicemen and their offspring directly to their exposure to those chemicals, the U.S. government, Dow Chemical and Monsanto refused to admit any such connection because it would have meant paying out damages to victims and additional benefits to veterans. Only decades of litigation have managed to coerce the government and the chemical companies into settlements with Americans, Australians, South Koreans, New Zealanders, and Canadians. The Vietnamese, however, remain uncompensated for the carnage the chemicals caused.
Every day, insurance companies that maintain they have their policyholders’ wellbeing in mind and advertise their willingness to pay quickly and fully on claims made by those policyholders, deny benefits whenever possible for a variety of bogus or highly questionable reasons. Many companies have been sued and found liable for such conduct. Of course, none of this ever stopped an insurance company from collecting its premiums.
In the case of many dangerous prescription drugs, pharmaceutical companies have repeatedly refused to admit having known and withheld data concerning adverse reactions and side-effects that appeared during clinical trials. Manipulation and deletion of information has also been proven in many cases where approved drugs have had to be pulled from the market after injuring and killing hundreds or thousands of people.
So, is it any wonder that the City of New York, through its Health Commissioner, Dr. Thomas Frieden, has taken the rather questionable position that he would be “surprised” if anyone could conclusively link the death of someone like NYPD Detective James Zadroga to the hundreds of hours he spent breathing in the toxic air at ground Zero as he helped in the rescue and recovery efforts.

The Commissioner stated: “An autopsy can determine whether there was damage to the lungs and it can determine whether that damage might have been related to foreign bodies. But whether that was related to [the World Trade Center], I don’t think that would be easy to say definitively.”

Of course, there is a very good reason why the Frieden has taken this position. Any admission by the City or the NYPD would have far reaching effects since it would potentially force the re-classification of disability pensions and death benefits due to the injured police officers or their survivors.

It would also seriously affect the ongoing litigation against the City and other defendants that focuses on the negligent handling of the cleanup efforts that exposed thousands of city and private-sector workers and volunteers to the toxic hazards that were produced when the twin towers collapsed.

While the City often heaps additional benefits and posthumous promotions on police officers and firefighters killed in the “line of duty.” It has refused to acknowledge any such heroism on the part of the men and women who toiled without rest or regard for their own safety at the WTC site.

Speeches, plaques, and monuments are apparently one thing; conferring monetary benefits and admitting potential liability are something else.

Besides the anger and frustration expressed by Det. Zadroga’s parents, who now care for his orphaned 4-year-old daughter Tylerann, there is the medical and scientific evidence that 9/11 was not only a tragedy that killed almost 3,000 people instantly, but it was also an environmental catastrophe that has sickened countless people, had demonstrable effects on children born to mothers who lived near Ground Zero, and will probably kill or have long-term health effects on tens of thousands of people who were exposed to the toxic cloud that hovered over the site of the twin towers for months.

In an effort to demonstrate the causal connection between exposure to those toxins and the growing number of deaths, cancers, and other diseases, the Detectives’ Endowment Association (DEA) released the results of an autopsy done on Det. James Zadroga by the Ocean County, New Jersey, Medical Examiner.

That autopsy found that Det. Zadroga died as a direct result of respiratory failure brought on by the exposure to toxic substances and fine particles that he inhaled while working for some 470 hours at Ground Zero.

Det. Zadroga’s wife died of a stress-related heart attack only last year. His death earlier this year left his daughter an orphan.

The DEA wants Det. Zadroga’s death re-classified as having been in the “line of duty” so that his daughter will be able to receive a larger pension (100% instead of 75%) for at least seven additional years.

A number of other detectives appeared at the news conference. Each is suffering from serious respiratory problems or cancers that have left them totally disabled or terminally ill.

These NYPD officers are but a small number of the thousands of rescue workers and other responders who are claiming that the toxic cloud of airborne chemicals and solid particles that hung over the WTC site for weeks has killed and permanently injured many of them.

Shortly after Det, Zadroga’s death in January, the New York Daily News reported that 22 other relatively young men may also have died from respiratory-related illnesses caused or accelerated by their exposure to the same toxic environment while aiding in the post-9/11 cleanup.

Like Zadroga, most of the 22 men were only in their 30s and 40s. According to their families, they have died as a result of the deadly mixture of chemicals they were exposed to as they searched for survivors in the ruins of the World Trade Center or aided in the clean-up efforts in the days and weeks following the terrorist attack.

While the attack was immediately responsible for killing almost 3,000 innocent victims who were in and around the WTC, it now appears 9/11 has had, and will continue to have, far reaching effects on possibly thousands of other individuals who responded to the catastrophe that day and in the weeks that followed as part of the massive rescue, recovery, and cleanup efforts, without any regard to their own personal safety.

Many medical experts have already expressed serious concern that the first responders, rescue and recovery workers, volunteers of all kinds, and construction workers at the scene will inevitably suffer significant, if not fatal, health consequences as a result of their protracted exposure to all types of dust, debris, toxins, and other dangerous substances that polluted the WTC disaster site for several months following the collapse of the WTC buildings.

Among the additional 22 who have died are private employees, a sanitation worker, a correction officer, a utility worker, transit workers, firefighters, and police officers. Some, like Zadroga, suffered from black lung disease, while others died from cancers of the esophagus and pancreas.

David Knecht, a Lucent Technologies employee, worked for two months to re-establish communications at businesses near Ground Zero. At 35 he was diagnosed with lung cancer and died in March 2005, leaving behind two girls, now ages 3 and 4.

His wife Cathleen Knecht, 38, of Berkeley Heights, N.J. said “He was a nonsmoker and a swimmer.”

Knecht was one of many who have claimed to have been sickened with debilitating and potentially deadly ailments related to their presence at the WTC site. Thousands are sick and suffering from respiratory illnesses. Nearly 400 firefighters and paramedics have left the job because of career-ending illnesses that followed their work at Ground Zero.

David Worry, the attorney for approximately 7,300 Ground Zero workers says that rescue and clean-up workers were not properly protected for the dangerous job they had to perform. “This was a toxic waste site. People should have been walking around in moon suits.”

He anticipates there will be many more deaths and illnesses from worker’s exposure to deadly waste at Ground Zero. It is estimated that as many as 50,000 people worked at the site in the months after 9/11.

Worry’s firm has filed a class-action lawsuit, which is pending in United States District Court in Manhattan. The suit alleges that government officials and construction contractors negligently exposed workers to dangerous levels of toxins at the cleanup site.

The attorneys for the City deny any direct medical link between exposure to debris and the respiratory illnesses and cancers. Some doctors treating Ground Zero workers are also skeptical because cancers resulting from toxic exposure can take up to 15 to 20 years to develop.

They are disturbed, however, by the substantial number of young and otherwise healthy people who have died or become ill following similar exposure to the same environmental conditions.

“It’s still too early to say if WTC responders are at increased risk for cancer,” said Dr. Robin Herbert, director of the World Trade Center Health Effects Treatment Program at Mount Sinai School of Medicine. “But we remain very concerned.”

Another death involved Bob Shore, a city correction officer, who worked at the makeshift morgue at Ground Zero for at least two weeks, wearing only a paper mask. At the end of his first day handling body parts, Shore climbed into the shower fully dressed and cried for two hours.

Shore, a 53-year-old father of two died last August from pancreatic cancer. His doctor attributes his disease, which caused the once 300-pound bodybuilder to waste away to 110 pounds and to have his gallbladder, spleen, and pancreas removed, to his work at Ground Zero.

Shore’s widow, like many families of 9/11 recovery and rescue workers, says she now faces the impossibility of paying the medical bills, as much $200,000 for all her husband’s treatments.

Nevertheless, Michelle Shore remembers her husband’s selfless contribution to the recovery efforts: “He never regretted doing it,” she said “He was my hero, the city’s hero.”

Among the 7,300 plaintiffs in the class-action are several cancer cases including at least eleven for what is normally a rare, and often deadly, form of brain cancer. Three of the victims have already died and many of the others are seriously ill or dying. In all, 41 deaths are now alleged to have been caused by toxic exposure.

The police union and the attorney representing the plaintiffs in the class-action have pointed to police officers, firemen, a Red Cross worker, an EMS technician, an EPA employee, a construction worker, and other responders as examples of what appears to be an alarming (and growing) number of brain cancer victims.

In addition to these concerns was, and still is, the impact on babies of mothers who were pregnant when the attacks occurred and who lived within two miles of the World Trade Center.

As we reported only last month, the Columbia Center for Children’s Environmental Health (CCCEH) at the Columbia University Mailman School of Public Health has been conducting an ongoing study called the World Trade Center Pregnancy Study. Other institutions, organizations, and independent researchers have also studied the actual and potential future effects the massive amounts of toxins that were released as a result of the fine particles of pulverized building materials and the fires that incinerated the debris thereby releasing any number of cancer-causing chemicals into the air. (http://www.mailman.hs.columbia.edu/ccceh/research/wtc_pregnancy.html)

A number of articles were published between August 2003 and late 2004 that documented the fact that babies born to mothers who were pregnant when the attacks occurred and who were in or near the collapsing towers or who lived in close proximity to the site were smaller and had lower birth weights.

On August 5, 2003, the Associated Press reported that:

“Exposed pregnant women in the study faced double the risk of delivering babies who were up to about a half-pound smaller than babies born to non-exposed women.

The size differences among babies born to women exposed to dirt and soot from the attacks suggest a condition called intrauterine growth restriction, or IUGR, which has been linked with exposure to air pollution.

Previous research also has found that babies affected by IUGR may be at increased risk for heart disease, hypertension and other health problems in adulthood, said Dr. Philip Landrigan, chairman of Mount Sinai School of Medicine’s community and preventive medicine department, and one of the researchers.

While duration of the exposure was relatively short, ’the intensity of exposure to soot and dust was extraordinarily high,’ Landrigan said.

The study appears in Wednesday’s Journal of the American Medical Association.” http://www.cbsnews.com/stories/2003/08/05/health/main566807.shtml

The CCCEH study has published extensive amounts of information on the subject including the following:

“The destruction of the World Trade Center (WTC) on September 11, 2001 was an unprecedented environmental disaster, with enduring effects on the physical and psychological well-being of a nation. In lower Manhattan, the event released large amounts of dust and toxic pollutants into the air, including fine particulate matter derived from the burning of materials during the explosion and fires, construction debris, and asbestos. These exposures are known to be especially toxic to the vulnerable populations of pregnant women and their unborn infants, and have been linked to reduced fetal growth and subsequent neurodevelopmental problems. Widespread psychological distress could also affect birth outcomes and subsequent child functioning.

The Center’s study, launched in December 2001, is assessing the effects of prenatal exposure to contaminants released by the WTC destruction on gestational age, birth size, respiratory health, and neurocognitive development in 300 women who had term pregnancies. Thus far, study results show that babies born to women who were pregnant on 9/11 and lived near the WTC in the weeks after 9/11 were born lighter and shorter than were babies born to women living further away. Previous research shows that even small reductions in birth weight may lead to learning and behavioral problems.

The Center’s WTC Pregnancy Study is the only one of its kind to compare women with known exposure levels living and working close to the WTC site to a control group living and working further away from the site. The study is also unique in that pregnant women were enrolled prior to delivery, thereby eliminating participation bias that could arise from already knowing the outcome of their pregnancy.

Preliminary Findings

Results on birth size from the World Trade Center Study were published recently in Environmental Health Perspectives, a peer-reviewed journal (please click here to read the EHP paper):

Babies born to women who were living within 2 miles of the WTC in the month following 9/11/01 were on average 5 ounces lighter than babies born to women who lived further away.
Babies born to women who were living near the WTC in the month following 9/11 were on average 1/3 of an inch shorter at birth than babies born to women living further away.
All women were full term, however; women in their first 13 weeks of pregnancy on 9/11 (regardless of their distance from the WTC) had a shorter pregnancy by an average of 3.6 days compared to women who were in a later stage of pregnancy on 9/11. Babies born to mothers with shorter pregnancies had smaller head circumference than other babies.
Findings of decreased birth weight and length among full term infants of mothers who resided within 2 miles of the WTC site are potentially important for subsequent health and development. Lower birth weight, even within the normal range (>2500 g), is associated with increased fetal mortality, neonatal mortality, and infant mortality, subsequent poorer health, delayed physical and cognitive development, and increased susceptibility to stress in adulthood.”

In March, The New York Post ran an “EXCLUSIVE” by Susan Edelman that did an excellent job of bringing the public up to date on the progress and most recent findings of the CCCEH study.

In that article, interviews with investigators and the director of CCCEH, Dr. Frederica Perera, revealed that, as feared, genetic damage to the children being studied has been greater than in the case of other city children.

In fact, a considerable number of the children (about 50%) have DNA profiles with “significant levels of combustion-related toxins” (NY Post).

These findings are a sign of genetic damage and present the possibility of developmental damage and an increased risk of cancer although no such conclusions have been made at this point.

In light of this mountain of medical, scientific, and circumstantial evidence it is difficult to understand how the City can deny any causal connection between 9/11 and deaths like Det. Zadroga’s. Difficult to understand only until the money involved is considered, that is.

Regardless of whether some degree of liability is found on the part of the City of New York or any governmental agency, there seems to be little doubt that the number of victims of 9/11 will continue to climb for years or decades to come and that the full extent of the injuries and deaths caused to those who lived, worked, responded to, or were born near Ground Zero may never be known. The Zadroga autopsy may have supplied the first hard evidence of the connection despite what Commissioner Frieden says since his opinion appears to be driven more by economics than by medicine and science.

Bagolie Friedman Injury Lawyers

Treating Doctors vs. Defense Expert, Who Wins?

2006-04-14T19:23:00.000-04:00

Very often in New Jersey workers' comp, the job will send an injured worker to one of their so called "independent" expert doctors. Usually, this is done when the insurance company disagrees with the treating doctor and wants to cut off treatment. When treatment and benefits are wrongfully terminated, it needs to be fought in Court and then it becomes a battle of the doctors.

There is hope for New Jersey's injured workers as their treating doctor will be given more weight than the insurance company's hired gun.

Pursuant to case law established in New Jersey, any conflict of opinion between
medical experts, generally greater weight is given to the opinion of the
treating physician. See Muews v. Union Bldg. & 'Contr. Cop., 45 N.J. Super.
89 (App. Div. 1957). Generally the physician treating the patient is in a
better position to express an opinion as to the cause and effect than one
making an examination in order to give expert testimony. Celeste v.
Progressive Silk Finishing Co., 72 N.J. Super. 233 (App. Div. 1962). Where
medical testimony is in conflict, greater weight ordinarily will given to
the testimony of the treating physician. Albelit v. General Motors Corp.,
46 N.J. Super. 475 (App. Div. 1957).

If you or a loved one has a work related injury, contact Bagolie Friedman Injury Lawyers now for a free and confidential consultation now.

Bausch & Lomb Urges Removal Of ReNu Contact Lens Solution

2006-04-14T15:20:00.000-04:00

Apr 14, 2006 | Nishad Majmudar | www.democratandchronicle.com
Bausch & Lomb Inc. has asked all U.S. retailers to remove ReNu with MoistureLoc contact lens solution from their shelves.

"We find ourselves in a position where the safety of one of our products is in question," Chief Executive Ronald Zarrella wrote in a letter to consumers.

In the letter, which will appear today and Sunday in newspapers across the country, Zarrella said testing by the company and the Food and Drug Administration has so far not found a definitive link between the solution and reported case of a rare but threatening eye infection.

But he added, "Bausch & Lomb's first priority is the health and safety of consumers. If there is a problem with our product, we'll find it and we'll fix it. If there's not, when we come back, you'll be able to know with absolute certainty that we've taken every possible step to ensure your safety."

The company is recommending that consumers switch to another contact lens solution until an investigation into 109 U.S. cases of Fusarium keratitis is complete.

B&L said in a statement that it would offer product refunds.

The company had suspended U.S. sales of ReNu with MoistureLoc earlier this week because a disproportionately large number of the eye infections studied by public health authorities involved contact lens wearers who used a B&L lens cleaner made in the company's Greenville, S.C., plant.

B&L stock has fallen about 20 percent since Monday, but it rose slightly Thursday, finishing at $46.17, up 56 cents. But other ripple effects are now being felt.

Though no safety issues have arisen in Europe, two retail chains in Scandinavia, where B&L continues to ship ReNu with MoistureLoc, advised customers to change to a different brand until U.S. authorities have pinpointed the cause of the infections in the United States.

The chains were Synsam, which operates about 300 stores in Sweden, Finland and Norway, and Specsavers Blic Optik, which has about 40 stores in Sweden.

"Until this has been investigated in the U.S.A., the suspicion still remains," said Synsam's chief executive, Gunnar Harbom. "And for us, the suspicion is enough."

Several national retail chains, including Kmart, Sears, Walgreens, CVS, Rite Aid and Wal-Mart, had already pulled the product.

If you or a loved one experiences eye problems, contact Bagolie Friedman Injury Lawyers for a free and confidential consultation now.

Bausch & Lomb Urges Removal of ReNu Contact Lens Solution

2006-04-14T15:18:00.000-04:00

FOSAMAX ®, AREDIA ®, ZOMETA ® and ACTONEL ® Linked to Bone Death of the Jaw

2006-04-14T14:44:00.000-04:00

FOSAMAX ®, AREDIA ®, ZOMETA ® and ACTONEL ® Bone Death of the Jaw
FOSAMAX ®, AREDIA ®, ZOMETA ® and ACTONEL ® are bisphosphonate medication used for bone loss. It's usage has been linked to the catastrophic condition known as "Dead Jaw" , also known as ONJ - Osteonecrosis of the Jaw or necrosis of the jaw or other bones.

If you or a loved one have taken any of these drugs for osteoporosis,cancer or multiple myeloma & you have experienced complications, contact Bagolie Friedman Injury Lawyers now for a free and confidential consultation.

In the U.S. Package Insert for both Aredia and Zometa, the following information on osteonecrosis had previously been added to the Adverse Reactions section under Post-Marketing Experience.

"Cases of osteonecrosis (primarily involving the jaws) have been reported in patients treated with bisphosphonates. The majority of the reported cases are in cancer patients attendant to a dental procedure. Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (e.g., anemia, coagulopathies, infection, pre-existing oral disease). Although causality cannot be determined, it is prudent to avoid dental surgery as recovery may be prolonged."

If you have been injured by Fosamax®, Actonel ®, Aredia®, or Zometa®, contact Bagolie Friedman Injury Lawyers now for a free and confidential consultation. Call toll free at 1-866-333-3529 or email at info@bagoliefriedman.com

Merck Sued Over Fosamax Health Risks

2006-04-14T13:18:00.000-04:00

Merck Sued Over Fosamax Health Risks
From Bloomberg News
April 11, 2006

Merck & Co., which faces more than 9,000 lawsuits over its Vioxx painkiller, misrepresented the safety of its osteoporosis drug Fosamax by withholding warnings that it could kill jawbone tissue, according to a lawsuit filed Monday.

Linda Secrest, 59, sued Merck, accusing it of failing to warn doctors and patients that Fosamax could hamper blood flow to the jaw. Secrest, who began taking the drug in 2000, says she was diagnosed with jawbone tissue death in 2005. The condition is irreversible.

Merck should be ordered to change the Fosamax prescribing information given to doctors and pay the cost of medical monitoring for users, Secrest says.

The complaint, in federal court in Fort Myers, Fla., seeks to represent more than 10 million Fosamax users. It is the second of about 200 suits that Secrest's attorney said he planned to file.

Merck spokesman Chris Loder said claims of jawbone tissue death caused by Fosamax were "exceedingly rare." A warning notice was added to the drug's label in July 2005 at the Food and Drug Administration's request, he said.

Fosamax and Fosamax Plus D together are the most-prescribed medicine for osteoporosis in post-menopausal women.

If you or a loved one suffers from bone problems, contact Bagolie Friedman Injury Lawyers for a free and confidential consultation now

Merck Sued Over Fosamax Health Risks

2006-04-14T13:15:00.000-04:00

Bausch & Lomb Suspends Contect Lens Solution Shipment

2006-04-11T13:39:00.000-04:00

Officials Probe Eye Infection Outbreak
Apr 10, 2006 ANDREW BRIDGES AP

Bausch & Lomb voluntarily suspended shipment of a contact lens solution after federal health officials linked it Monday to a fungal eye infection that can cause temporary blindness.The

Centers for Disease Control and Prevention is investigating 109 reports of Fusarium keratitis infection in patients in 17 states since June 2005.Federal and state health officials have interviewed just 30 of those patients. However, of the 28 who wore soft contact lens, however, 26 reported using Bausch & Lomb's ReNu brand contact lens solution or a generic type of solution also made by the Rochester, N.Y., company.Bausch & Lomb said it would temporarily suspend shipments of ReNu with MoistureLoc made at its Greenville, S.C., plant."The CDC data released today are both troubling and perplexing, as there is an apparent disproportionate representation of U.S.-manufactured ReNu with MoistureLoc in the underlying data.

The source of these infections has not been determined," company chairman and chief executive officer Ronald Zarrella said. Five of the 26 patients also reported using other types of solutions in addition to ReNu, Bausch & Lomb said. And nine said they wore their lenses overnight, which is known to increase the risk of infection, the CDC said.Dr. Daniel Schultz, director of the Food and Drug Administration's Center for Devices and Radiological Health, said it was too early to determine if Bausch & Lomb's solution was the cause of the infections. Both the FDA and CDC are investigating a growing number of reports of infection by the fungus. An estimated 30 million Americans wear soft contact lenses."We are relatively early in this investigation. It may be we will find this particular product does not have an association. We may find a strong association," Schultz told reporters.

The fungus is commonly found in plant material and soil in tropical and subtropical areas. Singapore health officials noticed an increase in reports of infection in January and discovered 39 cases involving contact lens users from 2005 to February of this year. Cases have also been reported in Malaysia and Hong Kong.In February, Bausch & Lomb halted sales of its ReNu contact lens solution in Singapore and Hong Kong.Without treatment, which can last two to three months, the infection can scar the cornea and blind its victims. Eight U.S. patients have required cornea transplants.Soft contact users with eye redness or pain, tearing, increased light sensitivity, blurred vision or discharge should stop wearing contacts and contact a doctor immediately, said Dr. Malvina Eydelman, director of the FDA's Division of Ophthalmic and Ear, Nose and Throat Devices. The FDA also advises users to wash their hands well with soap and water before handling lenses and to follow cleaning and storage guidelines.In addition, contact lens wearers who use ReNu with MoistureLoc should do so with caution, the FDA said.

Compulsive Gambling Linked To Parkinson's Drug

2006-03-24T19:20:00.000-05:00

As reported in HighRollerLife.com

Ever since Las Vegas has been in the business separating people from their money, there have been customers who have tried to get their money back. Of course, it almost never works. However, a recent complaint filed in U.S. District Court in Austin, Texas, claims that a man who suffers from Parkinson's disease took a drug that caused him to lose $10 million at the tables here. And based on early clinical studies of the drug prescribed for his disease, he may have a chance to recoup his losses.

Austin resident Max Wells, who suffers from Parkinson's, lost those millions gambling between September 2005 and January 2006. Most, if not all, of it right here in Las Vegas. At the end of January, his wife found out. In fact, she discovered that prior to the $10 million he lost here, he had already lost a few million dollars more. On Feb. 27, Wells filed a civil action in Austin seeking $21.5 million from six Las Vegas casinos and a drug company he claims were responsible for his losses. "Obviously, you can always go to Nevada and sue a casino, but you get a completely different jury and atmosphere," gaming law expert I. Nelson Rose, professor at Whittier Law School, said. "People in Texas are going to say, 'This guy lost $12 million and was taken advantage of.' People in Nevada might say, 'Oh, come on. Just because you lose money doesn't mean you can sue and get it back.' "It's not a frivolous claim by any means, but he's got a few steps he's going to have to show to get the connection there," he added.

The complaint against the casinos hinges on four crucial points: * Is there sufficient correlation to draw a link between a prescription drug that Wells was taking and compulsive gambling? * Can Wells prove negligence because the drug company was obliged to properly alert him about the possible side effect? * Can he prove that the casinos knew about the compulsion? * Was there sufficient interaction between the casinos, the state of Texas and Wells in his home state so that Austin is the proper venue to hear the case?

THEFT LIABILITY ACT
The plaintiff names the parent companies of the Wynn Las Vegas, Venetian Resort Hotel-Casino, Mandalay Bay Resort-Casino, Treasure Island, Harrah's Las Vegas hotel-casino and the Hard Rock Hotel & Casino. Wells is suing the casinos under provisions of the Texas Theft Liability Act for "unlawfully appropriating his property." Wells' attorney, Tom Thomas of the, declined to comment on the case.

The lawsuit makes two separate claims: First, it targets Pennsylvania-based drug company GlaxoSmithKline over its prescription drug Requip. Wells asserts the company failed "to give adequate, proper and nondeceptive warnings" that the medication could "cause its users to develop an irresistible impulse to gamble." Requip, which is manufactured by GlaxoSmithKline, is a dopamine agonist that can help ease symptoms associated with Parkinson's. Similar to another Parkinson's drug, Mirapex, both drugs have been linked to compulsive behavior, including gambling, in two separate studies. According to the complaint, Wells was diagnosed with Parkinson's disease in 2000. Over time, he was first prescribed Mirapex, which is produced by Boehringer Ingelheim Pharmaceuticals. He then was switched to Requip in November 2004 after "Wells became aware that he was developing an irresistible compulsion to gamble" while taking Mirapex, according the complaint. The court papers describe the behavior as "contrary to (Wells') pre-Mirapex habits, practices and routines."

A 2003 report in the academic journal "Neurology" showed that out of 529 patients, eight who took Mirapex developed gambling addictions. The study was done by the Muhammad Ali Parkinson Research Center at the Barrow Neurological Institute in Arizona. The study was followed in July 2005 by researchers at the Mayo Clinic, stating that 11 patients developed gambling problems while taking "Mirapex or similar drugs" from 2002 to 2004 and an additional 14 also were later identified as having the same problem.

Calls seeking comment from GlaxoSmithKline had not been returned by press time. However, neither drug's Web site lists problem gambling as a possible side effect when taking their medications. WARNING SIGNALS? The complaint alleges that the drug company "could reasonably foresee" that Parkinson's patients on Requip "could develop an irresistible gambling compulsion" by mid-2005 and that the company was negligent because it "failed to warn the public or physicians." "The claim ... is that Wells was, by reason of intoxication, unable to make reasonable property dispositions," said University of Texas Law School professor George Dix via e-mail, after reading the complaint. "We do not let an accused rely on 'irresistible impulse' caused by mental illness to escape liability, but I am unaware of an absolute bar to relying on it as the plaintiff does here." After being confronted by his wife, Wells stopped taking Requip and he no longer gambles, according to the complaint.

The second part of the claim argues that the casinos were aware of Wells' condition, and that "in some instances" knew he was on either Mirapex and Requip. It also tries to lay claim to jurisdiction. The question arises to what the casinos knew, when they knew it and were they expected to know it and does it violate Texas penal code? That state defines theft as unlawfully appropriating property with the intent to deprive the owner of the property and that appropriation is unlawful if it is without "effective consent" of the owner. Texas Penal Code, Chapter 31.01(3) (C) says consent is not effective if "given by a person who by reason of youth, mental disease or defect, or intoxication is known by the actor to be unable to make reasonable property dispositions." "The weakest part of the case is not the connection that the drug caused compulsive gambling, which is still going to have to be proved," said Rose, who has also read the original complaint, "but that the casinos knew about it. They have to know that he is drugged and taking a medicine that has been shown to cause this."

CASINOS 'SPECIFICALLY AWARE'
The complaint against the casinos seems to rely on a belief that the casinos were "specifically aware" of the drugs' addictive side effects due to "heavy publicity surrounding the publication" of the 2005 Mayo Clinic study. Rose, who has written on compulsive gambling for 20 years and lost a family member to Parkinson's, says he only became familiar with the possible connections between Requip and Mirapex and problem gambling in the "last few months." Wells claims he was soon recognized by the properties as a heavy gambler and given a casino host whose job it was to induce gambling. The casinos also provided free first-class airfare to Las Vegas, free suites, meals, entertainment, expensive gifts, extension of a credit line and even a free Alaskan cruise. The properties also paid for Wells' wife to go shopping. The hosts also solicited him in Texas, even offering to discount his losses. The complaint attempts to set up jurisdiction by claiming the losses were paid out of accounts located in Texas and that $1.2 million worth of markers were sent to him in Texas, in addition to the gifts and phones calls sent to Texas by the casinos. "He may have trouble proving all this," said University of Texas Law School professor Douglas Laycock via e-mail after reading the complaint. "But if I were representing a casino, I would be inclined to settle before taking this one to a jury." The Mirage and Harrah's declined comment on pending litigation; the Venetian and Hard Rock Hotel did not return inquiries for comment by press time. A spokesperson for the MGM/Mirage, parent company for Treasure Island and Mandalay Bay, described the complaint as being "without merit."
mirapex

Parkinson's Drug Linked to Gambling

2006-03-24T18:37:00.000-05:00

Parkinson's drug link to gambling
Sunday Mar 19 22:19 AEDT
Medical researchers are investigating suspicions drugs prescribed to treat Parkinson's disease could turn patients into compulsive gamblers, the Washington Post reports.
Scientists at the US Food and Drug Administration have found a strong association between pathological gambling and the drugs, which boost the level of dopamine in the brain, according to the newspaper.
Dopamine, a chemical naturally produced in the human body, plays a key role in the way the brain controls movements. A shortage of dopamine causes Parkinson's disease. But the chemical is also associated with addictive behaviours such as drug use and pleasurable experiences such as sex and food.
Researchers, according to the Washington Post, are looking into the possibility that drugs for treating Parkinson's are turning "some patients into obsessive pleasure seekers".
But the article also said no firm links have been made between dopamine enhancers and compulsive gambling.
Some patients have filed lawsuits against drug manufacturers, citing lost jobs and gambling problems.
Pharmaceutical firms such as Germany's Boehringer Ingelheim have toughened warning labels on drugs as the company investigates reports, according to the newspaper.
But Eli Lilly and Co, noting the lack of scientific consensus, raised the possibility that gambling problems in Parkinson's patients could be related to more legalised gambling, the newspaper reported.

Ortho Evra Patch Case Lawsuits

2006-03-10T07:51:00.000-05:00

Ortho Evra Patch Cases
Ortho Evra Patch CasesThe following Ortho Evra Patch Cases warrant investigation:

Our criteria is basically DVT, PE, CVA or MI suffered while on the patch, or shortly thereafter (I.e. during the week that the patch is not warn). In certain circumstances we are taking cases where there is a longer latency if there had been recorded complaints of related symptoms.

Please feel free to use this intake if you think it will help you.

If you have any questions don't hesitate to ask.

ORTHO EVRA QUESTIONNAIREDate: Name: Address: City: State: Zip: Age: Birth Date: Email: _____Home Phone: Work Phone: Cell Phone: Fax: Best time to contact you: Alternate Contact: Have you suffered: Date/State of Occurrence: Stroke (CVA): Yes No ____ Pulmonary Embolism (PE): Yes No Heart Attack (MI): Yes No Deep Vein Thrombosis (DVT): Yes No Primary Pulmonary Hypertension (PPH): Yes No Blood Clots (where?): Yes No Hospitalization (for above/how long?): Yes No Are you a smoker? Yes No Have you quit smoking? Yes No Describe smoking history (how much/how long): ORTHO EVRA HISTORYWhen did you begin to use Ortho Evra? When did you stop using Ortho Evra? What were the adverse symptoms? When did you first notice adverse symptoms? Current medications (Coumadin/Warfarin, Plavix, Aspirin, etc.): Other medications: Notes:

Ortho Evra Patch Case Lawsuits

2006-03-10T07:50:00.000-05:00

Lawsuit Against EPA For Deeming WTC Site Safe Allowed To Go Forward

2006-03-04T21:05:00.000-05:00

Lawsuit Against EPA For Deeming WTC Site Safe Allowed To Go Forward

A federal judge has cleared the way for a civil suit to proceed against the Environmental Protection Agency and its former head on the grounds that the agency misled the public when it deemed Ground Zero safe for workers and area residents to return.
The class action lawsuit was filed in 2004 by residents, students and workers in Lower Manhattan and Brooklyn who say they were exposed to hazardous dust and debris. They claim the EPA had no way of knowing whether it was safe or not to return, but told them to anyway.
The judge says former EPA head Christie Todd Whitman's assurance that the World Trade Center site was safe shortly after the 9/11 terror attacks was "conscience-shocking."
Just two days after 9/11, Whitman and the EPA declared the air seemed safe to breathe. An internal review later found the agency gave misleading assurances, at the White House's urging.
Critics say that the EPA was in a rush to declare that the air quality was good so that officials could reopen the New York Stock Exchange to help the economy. They also say the Bush administration didn't want to face the possibility of spending billions of dollars to clean people's homes.
Senator Hillary Clinton was highly critical of the EPA's decision.
"This is outrageous,” said Senator Clinton. “You know, New Yorkers should be able to depend on the federal government to provide them with accurate information about the air that we breathe and we should be able to count on the federal government to assess the level of ongoing risks."
The lawsuit seeks unspecified damages and reimbursement for cleanup costs. It also asks the court to order a medical monitoring fund be set up to track the health of those exposed to trade center dust.
Whitman defended the EPA, saying in a statement: "Every action taken...was designed to provide the most comprehensive protection and the most accurate information to the residents of Manhattan. To imply otherwise is completely inaccurate."
The EPA is expected to appeal, which means it could be months or even years before the case is settled.

Public Misled on Air Quality After 9/11 Attack, Judge Says

2006-03-04T21:03:00.000-05:00

Public Misled on Air Quality After 9/11 Attack, Judge Says
By JULIA PRESTONNY Times

Christie Whitman, when she led the Environmental Protection Agency, made "misleading statements of safety" about the air quality near the World Trade Center in the days after the Sept. 11 attack and may have put the public in danger, a federal judge found yesterday.
The pointed criticism of Mrs. Whitman came in a ruling by the judge, Deborah A. Batts of Federal District Court in Manhattan, in a 2004 class action lawsuit on behalf of residents and schoolchildren from downtown Manhattan and Brooklyn who say they were exposed to air contamination inside buildings near the trade center.
The suit, against Mrs. Whitman, other former and current E.P.A. officials and the agency itself, charges that they failed to warn people of dangerous materials in the air and then failed to carry out an adequate cleanup. The plaintiffs are seeking monetary damages and want the judge to order a thorough cleaning.
In her ruling, Judge Batts decided not to dismiss the case against Mrs. Whitman, who is being sued both as former administrator of the E.P.A. and as an individual.
As a legal matter, the ruling established that the suit's charges were well-documented and troubling enough to meet a legal standard to go forward. But Judge Batts also criticized Mrs. Whitman's performance in the days after the collapse of the towers unleashed, by the E.P.A.'s estimates, one million tons of dust on lower Manhattan and beyond.
"The allegations in this case of Whitman's reassuring and misleading statements of safety after the Sept. 11, 2001 attacks are without question conscience-shocking," Judge Batts said.
Calls to the Whitman Strategy Group, Mrs. Whitman's current business, and to Glenn S. Greene, the Justice Department lawyer who is representing her and the E.P.A. in the case, were not immediately returned. Mrs. Whitman, a former New Jersey governor, was administrator of the E.P.A. from 2001 to 2003.
Mrs. Whitman knew that the towers' destruction had released huge amounts of hazardous emissions, Judge Batts found. But as early as Sept. 13, Mrs. Whitman and the agency put out press releases saying that the air near ground zero was relatively safe and that there were "no significant levels" of asbestos dust in the air. They gave a green light for residents to return to their homes near the trade center site.
"By these actions," Judge Batts wrote, Mrs. Whitman "increased, and may have in fact created, the danger" to people living and working near the trade center. Judge Batts said that Mrs. Whitman was not entitled to immunity because she was a public official. Judge Batts allowed the suit to proceed on some counts against the E.P.A. She dismissed claims against Marianne L. Horinko, an assistant administrator of the E.P.A. at the time.
Lawyers for the plaintiffs were "very gratified that the court has recognized that the E.P.A. failed in its obligation to protect the residents of downtown Manhattan and Brooklyn," said Justin Blitz, a lead lawyer on the case.
In a statement yesterday, Senator Hillary Rodham Clinton called the E.P.A.'s conduct "outrageous."
"New Yorkers were depending on the federal government to provide them with accurate information about the air they were breathing," she said. "I continue to believe that the White House owes New Yorkers an explanation."
About 2,000 tons of asbestos and 424,000 tons of concrete were used to build the towers, and when they came crashing down they released dust laden with toxins. After an expert panel failed last year to settle on a method for organizing an E.P.A. cleanup, the agency said it would proceed anyway with limited testing and cleaning of apartments in downtown Manhattan below Canal Street.

Ground Zero Team Sues Over Illness

2006-03-04T21:00:00.000-05:00

Ground Zero Team Sues Over Illness

8/14/04
Hundreds of people who worked on the World Trade Centre clean-up have filed a class-action lawsuit alleging companies did little to protect workers from dust, asbestos and other toxins in the air.
The legal battle targets the leaseholder of the New York towers and those who supervised the job, including the subsidiary of an Australian company.
The lawsuit was filed in a US federal court on Friday and made public today.
It has been brought against Silverstein Properties and the four construction companies hired to oversee the removal of 1.5 million tonnes of debris after the September 11, 2001 terror attacks.
They include Bovis Lend Lease, a unit of Australian real estate firm Lend Lease.
David Worby, a lawyer for the plaintiffs, said he was seeking billions of dollars in compensation for victims.
The lawsuit also asks for the establishment of a system to track all those who were exposed for the next 20 years.
It alleges that many workers did not have access to protective gear, and those who did were not taught how to wear it properly.
Some of the plaintiffs suffer from afflictions ranging from tumours to heartburn.
Others have joined the action because they fear they risk developing cancer in the future.
Mr Worby said: "The tragic reality is that so many of the brave heroes who worked so tirelessly and unselfishly are becoming a second wave of casualties of this horrific attack, and we're only seeing the tip of the iceberg."
The companies involved said they had not seen the complaint and had no immediate comment.
The class-action case, with about 800 plaintiffs, was filed on the last day before a federal three-year statute of limitations expired for lawsuits related to the terrorist attack.
The US Government is already funding six health screening programs to monitor ground zero workers, but none are funded beyond 2009.
Last week, the federal Centres for Disease Control and Prevention released a study showing that many recovery workers suffered from respiratory problems long after the clean-up concluded, and that some were still battling ailments.
Problems identified included asthma, sinusitis, constant coughing and stuffy nose, facial pains, chest tightness, wheezing and shortness of breath.
Proper respiratory gear would have allowed the workers to block out smoke, dust, diesel exhaust, pulverised cement, glass fibres, asbestos and other chemicals and could have prevented throat and lung diseases, according to the CDC study.
It found that only about one in five of the workers wore respirators while they worked at the site.
The three companies in the clean-up with Bovis Lend Lease were Turner Construction, AMEC Construction and Tully Construction.
According to AMEC's website, the company stationed safety experts on site during the clean-up and provided respirators, hard hats and safety goggles to workers.

Ground Zero Team Sues Over Illness

2006-03-04T20:59:00.000-05:00

NYPD Officer Who Collapsed And Died Worked At WTC Site

2006-03-04T20:54:00.000-05:00

January 29, 2006
The police officer who collapsed and died during a pursuit Friday night, reportedly spent a lot of time at the World Trade Center Site.
While the cause of death is still unclear, Kevin Lee's family members told the Daily News they fear he may have gotten sick because of the long hours he worked at the site after September 11th.
The Medical Examiner is working to determine the cause of death. Officer Lee collapsed while he and his partner were chasing three men on the Upper East Side wanted for stealing a laptop from a Lexington Avenue store.
Early reports suggested that Lee suffered a heart attack, but the hospital did not confirm that information.
Lorenzo Walter, 18, and 19-year-old Julio Marquez were arrested Friday night, Rico Banks, 19, surrendered to police Satruday. All three men face robbery charges.
Police say Lee struggled with one of the men right before he collapsed.
Lee, a 10-year veteran of the NYPD and a member of the department's Grand Larceny Unit, was rushed to Lenox Hill Hospital where he was pronounced dead. He lived in the Bronx and is survived by a wife and 6-year-old son.
Mayor Michael Bloomberg spoke with Lee's mother who told him that being an officer was something her son always wanted.
"All his life, all he wanted to do was be a cop. In high school there was some kind of a program where he could study what police offers do. It's all he ever talked about. He attended John Jay College and decided what her really wanted to do is be a cop."
Police officer Lee was the second officer to collapse during a pursuit this year. Earlier this month, police officer Francis Hennessey collapsed and died from a brain aneurysm while on duty.

FDA Finds Benzene in Soft Drinks

2006-03-04T00:16:00.000-05:00

FDA finds benzene in soft drinks
Mar 3, 2006 DAVID GOLDSTEIN Knight Ridder Newspapers
When small amounts of benzene, a known cancer-causing chemical, were found in some soft drinks 16 years ago, the Food and Drug Administration never told the public.That's because the beverage industry told the government it would handle the problem and the FDA thought the problem was solved.A decade and a half later, benzene has turned up again. The FDA has found levels in some soft drinks higher than what it found in 1990, and two to four times higher than what's considered safe for drinking water.Both the FDA and the beverage industry said the amounts were small and that the problem didn't appear to be widespread."People shouldn't overreact," said Kevin Keane, a spokesman for the American Beverage Association. "It's a very small number of products and not major brands.""The issue here is not something that should cause anyone alarm or terrific concern," said George Pauli, a top food safety expert at the FDA, "but if there's something that can be reduced, we want to reduce it."Neither Keane nor Pauli would identify the drinks being tested because the investigation is still under way.Pauli said that people ingest more benzene by breathing than they would if they drank a can of soda containing the chemical. Small amounts of the chemical also are naturally present in some foods such as fruits, vegetables and dairy products.Still, Pauli added, "You want to avoid it in any degree you can."Of the 60 or so varieties of sodas, sports drinks, juice drinks and bottled waters that the FDA has tested so far, benzene levels have ranged from two and three parts per billion to more than 10-20 parts per billion.The Environmental Protection Agency's safety standard for benzene in drinking water is five parts per billion. If it exceeds that, authorities are required to notify the public.Keane said it was "tough to compare" the safety standard for water with soft drinks because the water rule is based on the fact that people drink more water each day.Benzene is an industrial chemical that's found in tobacco smoke, car exhaust and vapors from household products such as paint, detergents and furniture wax. Long-term exposure can cause leukemia and other cancers of the blood, according to the Centers for Disease Control and Prevention.Benzene can show up in soft drinks when two common ingredients react: ascorbic acid, otherwise known as vitamin C, and either sodium benzoate or potassium benzoate. Both are preservatives used to prevent the growth of bacteria.But the presence of these chemicals doesn't necessarily produce benzene."It's not as simple as looking at the label, and if you see those two, there will be problems," Keane said.Pauli said that a catalyst such as temperature or light is needed to trigger the formation of benzene. That's what scientists suspect occurred in 1990 when authorities found benzene in products made by Cadbury Schweppes and Koala Springs, an Australian beverage company.But a health safety watchdog organization said the FDA should inform the public, particularly since so many soft drinks are marketed to children."Most people would prefer there are no known human carcinogens in what they drink," said Jane Houlihan, vice president for research at the Environmental Working Group, a nonprofit, nonpartisan scientific research group that studies toxic chemicals. "This is a case where industry agreed to get it out of the products, and all the evidence says they didn't."Soft drink manufacturers PepsiCo and Coca-Cola declined to comment and referred calls to the American Beverage Association.When benzene first turned up 16 years ago, FDA officials met with representatives of the beverage industry who "expressed their concern about the presence of benzene traces in their products and the potential for adverse publicity associated with this problem," according to an internal FDA memo from December 1990.Keane said the industry told the FDA that it was reformulating its products to alleviate the problem. Adding sugar, for instance, or replacing the vitamin C, can inhibit the chemical reaction that produces benzene, Pauli said.An FDA official who asked not to be identified said that the agency didn't inform the public about the benzene problem 16 years ago because it didn't consider it a public health concern since the levels were low and the companies were reformulating.He said the FDA conducted follow-up testing in the early 1990s, but not since because "we thought the problem was gone and over. Then it resurfaced."The current investigation began when an activist concerned about soft drink machines in schools tried to get the FDA interested in the issue. He then sent lab results showing some soft drinks with higher-than-normal benzene levels."Our first reaction was, `Yes, we looked at this in 1990 and essentially there was nothing there,'" Pauli said. "Then he came up with some numbers and we said, `That's not what we came up with back then. We have to go back and look.'"Asked why the problem would resurface 16 years later, Keane said the industry took the necessary steps at the time, but it's possible some manufacturers just didn't know."It's a very fast-growing industry, both in terms of companies and new brands, so a lot has changed in the last 16 years," he said.Food safety authorities in Great Britain and Australia also are testing soft drinks for benzene.
benzene lawyer

Workers Comp Law Blog: Chromium Industry Hid Cancer Risks, Report Says

2006-02-24T16:33:00.000-05:00

Workers Comp Law Blog: Chromium Industry Hid Cancer Risks, Report Says

Chromium Industry Hid Cancer Risks, Report Says

2006-02-24T14:27:00.000-05:00

Chromium Industry Hid Cancer Risks, Report Says

Researchers charge that businesses skewed data to weaken a proposed federal standard

Feb 24, 2006 Marla Cone Los Angeles TimesAs federal regulators are poised to announce a new standard for protecting workers, a team of scientists reported Thursday that the chromium industry and its consulting scientists withheld and skewed data that suggested workers exposed to low levels of chromium were dying from lung cancer.David Michaels, a professor of environmental and occupational science at George Washington University, and two other researchers detailed what they called an orchestrated campaign by the chromium industry to manipulate scientific data to persuade the Occupational Safety and Health Administration to weaken a proposed workplace standard.

Chromium-producing corporations and metal-finishing companies have opposed stricter limits on workers' exposure to hexavalent chromium since 1976, when OSHA first proposed changes in the regulation. The agency faces a court order to announce its new standard by Tuesday.About 380,000 U.S. workers are exposed to hexavalent chromium, which is widely used in metal-plating, aerospace production, stainless steel processing and dye manufacture, among other businesses.

Chromium is considered one of the most dangerous toxic contaminants in California's air.Classified as a human carcinogen, hexavalent chromium has been tied to lung cancer for about 50 years. But the debate over the new standard centers on whether low levels now found at modern plants increase workers' cancer rates.Michaels' report faults the handling of a cancer study at four large chromium production plants in the U.S. and Germany."This was a 10-year campaign to shape the science to fit the industry's agenda rather than shape the regulation to fit the science," Michaels, director of the Project on Scientific Knowledge and Public Policy at George Washington University's school of public health, said in an interview Wednesday.

Michaels and the two other researchers, whose report was published in the online journal Environmental Health, obtained internal documents through an industry foundation's bankruptcy proceedings that showed the industry representatives were aware in 2002 of an elevated cancer risk reported among workers.A representative of Elementis Chromium, the world's largest chromium producer, said there was no conspiracy. He said that during the period the study was conducted, the industry was in turmoil with plants shutting down and changing owners which led to delays and problems with the data's release."I would categorically say there was not an orchestrated effort to hide anything," said Joel Barnhart, vice president of technical issues at Elementis Chromium's plant in Corpus Christi, Texas. "What I can say is that it certainly may have not been handled well."Kate McMahon, an attorney for the Chrome Coalition, an industry trade group, called the allegations "completely and utterly baseless and absolutely dead wrong."OSHA officials declined to comment Thursday on the report, saying only that they expected to meet Tuesday's deadline for the chromium standard.The agency has been reviewing whether to tighten its chromium standard, which was set 35 years ago. A federal appeals court, ruling in a case filed by a union and the Public Citizen Health Research Group, ordered OSHA to act by this year.The workplace standard is 52 micrograms of chromium per cubic meter of air. In 2004, OSHA proposed 1 microgram. Michaels and others say the agency will probably adopt a standard of 5 micrograms.Industry groups say the agency's 1-microgram proposal would bankrupt businesses and cost the metal-finishing industry $380 million annually.In the mid-1990s, a foundation working for the Chrome Coalition commissioned a study of workers at four production plants, "the results of which confirmed the elevated lung cancer risk," Michaels wrote.The consultants who conducted the study reported their findings to the industry foundation in 2002. But the industry did not tell OSHA, according to Michaels. "Even when the agency specifically asked for precisely these sorts of data during its 2004-2005 rulemaking proceedings, the chromium industry and the authors remained silent," Michaels' report says.Then, the industry consultants, employees of ENVIRON, an international environmental consulting firm, rewrote the findings to remove the elevated cancer data, Michaels said. They divided the study into two parts: one with data from the American plants and one with data from the German plants.Originally, the study of the four plants found increased cancer at low chromium levels. But after the data from the U.S. and German plants were separated, the study at the U.S. plants, which was published in April in a peer-reviewed occupational medicine journal, reported no cancer link, and the German results reported elevated cancer only at high chromium levels.

Michaels said that splitting the workers into two groups disguised the cancer rate, and that industry groups used that misleading data to support their claim to OSHA that a strict standard was unwarranted.

The ENVIRON consultants, in a letter published in a medical journal in October, commended the industry for sponsoring research of its employees and said there was a valid scientific reason for dividing American and German workers: Their exposure was measured differently, monitoring air in the United States and urine in Germany.But Michaels said data from all four plants needed to be combined to create a study large enough to be statistically sound something the consultants emphasized in their original proposal. "It's not sound to look at your results and split them because you don't like the results," Michaels said. "The scientifically honest approach is to report the results using the method you said you would use."The handling of the studies "raise troubling questions about the ability of government to effectively issue rules protecting public health when studies are conducted, controlled and selectively published by the regulated industry," Michaels and his co-authors said in their report.The two U.S. plants, in Texas and North Carolina, are now owned by Elementis, a British company.Barnhart, of Elementis Chromium, said the study data came at a time of "chaos." The foundation that funded the study, he said, went bankrupt, two German plants shut down and the North Carolina plant was purchased by the British corporation. He said the companies involved did not review the findings and did not tell the consultants to change or withhold the cancer data."There certainly wasn't any conspiracy," Barnhart said. "It was as much ineptitude by me and maybe others who were aware of [the study] but didn't push to get it released in a form that was useful."

chromium lawsuit

Tell Your Senator to Vote NO On The Asbestos Bailout Bikk

2006-02-15T00:54:00.001-05:00

On February 6, 2006, Senator Bill Frist (R-TN) brought to the floor of the US Senate an asbestos bill that is just another special-interest bailout- this one for the corporations that knowingly poisoned hundreds of thousands of Americans. The asbestos companies put people at risk, even long after they knew that asbestos caused cancer and other diseases. They knowingly poisoned people and covered it up. Now, they've come to Congress looking for a bailout that would leave some victims without enough money to cover their medical costs and could potentially leave the American taxpayers with as much as a hundred-billion-dollar tab. http://action.peopleoverprofits.org/ctt.asp?u=33562&l=116303

Tell Congress to oppose the Asbestos Bailout Bill As a result, people like Charles Sales, 23, of Hot Springs, AR, suffer with mesothelioma, an always fatal cancer caused only by asbestos. A non-smoker and in excellent health before his diagnosis, Charles and his wife, who have a two year-old daughter, planned on expanding their family. His wife will soon be a widow though, as most victims don't live longer than twelve months after their diagnosis. Charles' father and grandfather, employed at the lumber mill where he would eventually work, carried asbestos fibers home on their clothing, exposing young Charles to the deadly product.

Read about other asbestos victims http://action.peopleoverprofits.org/ctt.asp?u=33562&l=116304

Tell Congress to oppose the Asbestos Bailout Bill Before being diagnosed with asbestos-related cancer, Sandy Linden of Omaha, NE was an active, athletic mother of five; she had even taken part in a marathon. Now, she spends her time traveling between Omaha and Chicago for CT scans, surgery, and chemotherapy treatments. Since her mesothlioma diagnosis, Sandy has had her diaphragm, a lung, and two ribs removed. She can only sleep on one side of her body because of the pain, and the entire left side ofher chest and breast are numb. At times she feels that she is suffocating from the Gore-Tex that replaced the sac around her heart and lung. She can no longer work and is unable to secure long-term care.

Read about other asbestos victims Tell Congress to oppose the Asbestos Bailout Bill http://action.peopleoverprofits.org/ctt.asp?u=33562&l=116303

Facts about the Asbestos Bailout Bill The asbestos companies kept putting people at risk for thirty years after they learned that asbestos caused cancer and other diseases. They knowingly poisoned people and covered it up. The bill creates new obstacles and delays for victims, designed to protect asbestos companies. Under this bill, many asbestos victims will die of their disease before receiving compensation. Most studies show that the actual cost of compensating asbestos victims over the next thirty years will be at least one hundred billion dollars more than the size of the trust fund created by this bill. The last thing we can afford is a bill that gives a hundred-billion-dollar handout to big asbestos companies. Corporations should pay the cost of the illnesses they caused, not taxpayers. The asbestos bailout bill allows big asbestos companies to pay only twenty-five percent of the real cost of compensating their victims, so it's no surprise these companies support this bill.

Please tell Congress to oppose the asbestos trust fund, a trust fund victims can't trust.

Learn More About the Asbestos Bailout Billhttp://action.peopleoverprofits.org/ctt.asp?u=33562&l=116305 Then Tell a Friend about this blatant corporate bailout http://action.peopleoverprofits.org/ctt.asp?u=33562&l=116306

Tell Your Senator to Vote NO On The Asbestos Bailout Bikk

2006-02-15T00:54:00.000-05:00

Overdose Deaths Linked To Fentanyl Pain Patch Being Investigated By Jersey Law Firm

2006-02-01T13:07:00.000-05:00

Overdose Deaths Linked to Fentanyl Pain Patch Being Investigated By Jersey Law Firm

The New Jersey, USA Offices of Bagolie Friedman Injury Lawyers are investigating overdose deaths linked to the fentanyl pain patch. Known as the Duragesic Trans dermal Patch, it is a device developed to alleviate chronic pain which could possibly leak, exposing patients to dangerous levels of fentanyl, a powerful opiate based pain reliever.

The fentanyl patch is comprised of an outer impermeable plastic shell and a drug permeable inner lining. The patch is applied directly to the skin where heat from the body activates a regular release of fentanyl over a 72 hour period. This drug is a powerful opiate pain-reliever held in a gel suspension between the two linings of the patch. The inner lining only lets a certain amount of the drug into the body based on the needs of the patient, typically between 25 to 100 micrograms per hour. Sales of Duragesic earned Janssen Pharmaceutica over a billion dollars between the year 2002-2003. Unfortunately a problem in the seal between the linings was discovered in February 2004, prompting Janssen to initially recall one group of the patches, but an additional four groups of the patch were removed from the market later in April. The company has since recalled over two million of the patches.

Bagolie Friedman Injury Lawyers, with affiliate offices in Jersey City and Clifton New Jersey, Hollywood Florida and Brisbane, Australia, have begun to review and accept injury cases from surviving family members and individuals who have suffered from Fentanyl overdose. "We will be reviewing potential cases from the United States, Australia and Europe," said founding partner, Ricky Bagolie. Duragesic is no longer the only fentanyl pain patch being marketed. On January 28, 2005, the U.S. Food and Drug Administration (FDA) granted final approval for Mylan Laboratories, Inc. to market a generic fentanyl transdermal system. The manufacturer of Duragesic® has also begun to market an authorized generic version of the fentanyl patch through an agreement with Sandoz. Other generic companies have applications pending at the FDA to market similar fentanyl patches, therefore, other generic versions may soon be available. Problems associated with these newer generic patches have also been reported.

"It is very difficult for a person examining a fentanyl patch to detect a defect or leak. This can lead to a dangerous situation as exposure to an excessive amount of fentanyl can lead to serious injury or death." says attorney Alan Friedman.If you believe that you, or a member of your family, has been injured or suffered from an overdose as a result of receiving a fentanyl pain , contact Ricky Bagolie or Alan Friedman toll free at 1-866-333-3529, e-mail them at info@bagoliefriedman.com or visit http://www.bagoliefriedman.com/ now for a confidential and free consultation.
fentanyl

Fisher-Price Recalls Infant Musical Toy Chair Posing Strangulation Hazzard

2006-01-24T09:43:00.000-05:00

Product Recalls
Fisher-Price Recalls Infant Musical Toy Chair Posing Strangulation Hazard

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer products. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Fisher-Price® Laugh & Learn™ Musical Learning Chair™
Units: About 614,000
Manufacturer: Fisher-Price, of East Aurora, N.Y.
Hazard: A child can become lodged between the seatback and side table of the chair, possibly leading to an entrapment of the neck. This can pose a strangulation hazard to young children.
Incidents/Injuries: Fisher-Price has received three reports of young children getting their necks lodged between the seatback and the side table of the toy, including one report of a child receiving a welt on the neck.
Description: The recalled Laugh & Learn Musical Learning Chair is a plastic infant toy that measures about 17 inches high. It plays music and teaches children numbers and letters. It also features a blue chair with four green plastic legs and a side table with a purple base and white top. The table holds a clock, book, and a lamp. Smiley faces are displayed on the lamp and seat back. “Fisher-Price” is written on the front of the chair. The packaging states that the toy is intended for children 12 months through 36 months of age. The model numbers are H4609, H7167 through H7173, H8157, H8998, and J0272 through J0275 can be found on the underside of the seat of the chair.
Sold by: Discount department and toy stores nationwide from May 2005 through January 2006 for about $27.
Manufactured in: China
Remedy: Consumers should take the recalled musical chair away from children immediately and contact Fisher-Price to receive a free repair kit that contains a plastic piece that connects in between the seatback and side table, preventing the possibility of entrapment.

Consumer Contact: Contact Fisher-Price at (866) 552-3914 anytime or visit the firm’s Web site at www.service.fisher-price.com

Fisher Price Toy Recall
Fisher Price Toy Recall

Federal Gov't. Muscles Into State Temporary Disability Payments

2006-01-22T08:37:00.000-05:00

The Federal Government usually provides the majority of the funding to State vocational rehabilitation services [Voc Rehab]. It is an eligibility program and not an entitlement program. All SSA DIB beneficiaries are automatically eligible for the program. The Government is now moving aggressively to expand their involvement to get disabled people back to work and targeting the work related injured.

The initiative provides vocational rehabilitation with an easily identifiable cohort; An opportunity for the Feds to seek reimbursement from the employer/insurance carrier for contracted services; Allows reduction in Federal SSA payments; and Entangles the Feds into the State WC programs and may further delay adjudication of claims. Questions:1. Does your State require continuation of temporary disability payments during the period before acceptance into the Voc Rehab program?2. Does your State require continuation of temporary disability payments while participating in the Voc Rehab program?

The Ticket to Work Program
The goal of the Ticket Program is to increase opportunities and choices for Social Security disability beneficiaries to obtain employment, vocational rehabilitation (VR), and other support services from public and private providers, employers, and other organizations. http://www.yourtickettowork.com/program_info US Department of Education
RSA's major Title I formula grant program provides funds to state vocational rehabilitation (VR) agencies to provide employment-related services for individuals with disabilities, giving priority to individuals who are significantly disabled. http://www.ed.gov/about/offices/list/osers/rsa/index.html

The client should be cautioned as to the specific interpretations and consequences of what constitutes work under his/her state's specific statute. The rush of industry to enact fraud prevention statutes has created a conflict with the TICKET TO WORK legislation. On the one hand, the Federal government is encouraging a return to work in most states through the continuation of the payment of benefits, and on the other hand, the states provide no such latitude. The state fraud acts make it a criminal offense to make a false or misleading statement. The fraud acts also establish civil penalties if any person wrongfully obtains benefits, which could result in immediate forfeiture of present and future benefits and require reimbursement of past benefits with interest. See NJSA 34:15-74.

Workers’ compensation lawyers should discuss these issues with their clients in advance of the injured worker’s attempt to return to work. The client should be cautioned as to the specific interpretations and consequences of what constitutes work under his/her state’s specific statute. Failure to do so may subject the injured worker to severe civil and criminal penalties.

workers compensation

Duragesic Fentanyl Pain Patch Overdose Claims

2006-01-20T10:47:00.000-05:00

Bagolie Friedman Injury Lawyers are now investigating Duragesic Fentanyl Pain Patch Overdose claims. Contact us now for a free consultation.

Our website, http://bagoliefriedman.com/ is now searchable in google under the following terms:
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FeedBlitz News: Take your login on a trip down memory lane

2006-01-19T21:52:00.000-05:00

FeedBlitz News: Take your login on a trip down memory lane

http://bagoliefriedman.com

http://bagoliefriedman.blogspot.com

Pain Patch Required Special Monitoring

2006-01-16T14:36:00.000-05:00

Pain patch required special monitoring

The FDA's probe into deaths involving painkiller fentanyl underscores the lack of oversight for new drugs after they are approved for sale.

Nov 27, 2005 www.miami.com
Dory Bauler prides herself on staying active despite painful back problems. But earlier this year, she was getting so short of breath that she could barely walk. Doctors could find nothing wrong.It never occurred to them that the medicinal patch she was using to deliver pain relief might also be poisoning her.''I was just shutting down,'' said Bauler, 76, a retired paralegal from Laguna Woods, Calif., who suffers from a severe curvature of the spine.Bauler's patch was delivering fentanyl, a narcotic many times more powerful than morphine. Like morphine and other opioid drugs, fentanyl controls pain but also reduces respiratory function. Luckily, Bauler figured out what was happening in time to stop using the drug. Too much fentanyl can shut down the respiratory system.The leading brand of the fentanyl patch is Johnson & Johnson's Duragesic; last year, pharmacists filled more than 4 million prescriptions for it.

The drug was developed to help people in extreme, constant pain. Misuse can be lethal.The fentanyl patch illustrates a broad and still-unresolved problem with the nation's system for protecting patients against drug risks: Neither the FDA nor the pharmaceutical industry has a comprehensive system for monitoring what happens after a new drug is approved for market.Sometimes, as with the highly publicized discovery of heart and stroke risks associated with the painkiller Vioxx, the problem is that dangers show up only after millions of people begin using a drug. At other times, as with fentanyl, the problem is that a drug approved for one purpose can be prescribed and used for other purposes. Known as off-label use, the risks are not always understood.Cancer patients, for whom the fentanyl patch was developed, are usually monitored closely by a physician. Often, however, the patches are being prescribed for other conditions, sometimes without close monitoring.

The FDA says it is investigating about 130 fatalities that occurred over a 15-year period. Results of autopsies in Los Angeles and Florida suggest the number of fentanyl-related deaths may be much higher.''There are hundreds more cases not evaluated by the FDA,'' said Bruce Goldberger, director of toxicology at the University of Florida Medical School.In Los Angeles County, criminalist Daniel Anderson of the coroner's office said the ''vast majority'' of the 237 people whose deaths involved fentanyl had used the patch. The deaths occurred over a 5 ½-year period.Of those, 127 were classified as accidental, suggesting that patients misunderstood how to avoid the drug's risks.In Florida, state authorities reported 115 deaths from fentanyl poisoning in 2004, records show. Goldberger, whose office handles about one-fourth of the autopsies in the state, said the majority involved the patch.Drug abuse involving fentanyl also is on the rise. Emergency room mentions of the drug rose from 28 in 1994 to 1,506 last year, according to the federal Substance Abuse and Mental Health Services Administration.Duragesic sales more than doubled from 2000 to 2004 as manufacturer Johnson & Johnson touted its safety in advertising to doctors that the FDA called ''misleading.'' Yet as early as 2001, a drug safety group had publicly warned that patients on the patch were dying of overdoses.It took another four years for the FDA to issue its own nationwide alert, on July 15.Dr. Robert Meyer, head of the FDA office that oversees painkillers, said that earlier this year safety officers noticed a trend of adverse reactions involving the drug.''The system in place, though never ideal, does work well,'' Meyer said. ``The FDA did the right thing in [issuing] its communication. One of the things we need to think about in the future is continuing communications in terms of drugs like this that have some safety concerns.''
duragesic overdose

Nationwide Recall of Duragesic Patches Expanded

2006-01-16T12:51:00.000-05:00

Janssen Pharmaceutica Expands Nationwide Recall Of 75 mcg/Hour DURAGESIC (Fentanyl Transdermal System) CII Patches

Apr 5, 2004 www.jnj.comJanssen Pharmaceutica Products, L.P., is expanding its U.S. recall of DURAGESIC® (fentanyl transdermal system) CII 75 mcg/hour patches to include five manufacturing lots (control numbers 0327192, 0327193, 0327294, 0327295 and 0330362). No other dosage strengths or control numbers are affected. Available by prescription only, DURAGESIC® patches contain a potent opiate medication. The company recalled one lot of DURAGESIC® 75 mcg/hour patches (control number 0327192) in February 2004 after determining that some patches in this lot might leak medication along one edge. Since then, patches with the same problem have been identified in one additional lot. As a precaution, the company is recalling four additional lots of 75 mcg/hour patches that were produced on the same manufacturing line during the same period.DURAGESIC® patches contain a strong opiate in the form of a gel. If the gel leaks from the patch, patients can get either too much or too little medication. Exposure to too much medication can occur if the gel leaks directly onto the skin and the body absorbs a higher than intended amount or if any of the medication is swallowed accidentally. This overexposure may cause potentially life-threatening complications. If the drug leaks out, there may not be enough medicine to achieve the desired effect and the patient may experience withdrawal symptoms.The gel should not be touched if it leaks from a DURAGESIC® patch. If a patient or caregiver has unintended contact with the gel, they should immediately wash the affected area with large amounts of water only; soap should not be used. Patients should speak with their pharmacist or physician for further instructions.Anyone who has 75 mcg/hour DURAGESIC® patches should examine the control number that appears on the bottom flap of the outer carton or back of the foil pouch. Those who have patches from lots with control numbers 0327192, 0327193, 0327294, 0327295 and 0330362 must contact their physician or pharmacist immediately for specific instructions on returning patches from recalled lots and obtaining a new supply. Patients wearing other dosage strengths or DURAGESIC® patches that are not from the recalled lots can continue to wear them. Sudden discontinuation of DURAGESIC® can cause serious health problems.The affected lots were shipped only to distributors in the U.S. between mid-December 2003 and early March 2004. Based on historic usage rates, the company estimates that the majority of patches in these lots already have been used. The company has consulted closely with the U.S. Food and Drug Administration on this expanded recall as well as the initial recall of DURAGESIC® 75 mcg/hour patches in February 2004.DURAGESIC® patches are available in four dosage strengths – 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour. Only DURAGESIC® 75 mcg/hour patches from lots with control numbers 0327192, 0327193, 0327294, 0327295 and 0330362 are affected by this expanded recall. No other lots of the 75 mcg/hour patches are affected. No other dosage strengths are affected.

duragesic overdose

Drug Company Expanding Recall of Pain Patches

2006-01-16T12:48:00.000-05:00

Drug Company Expanding Recall of Pain Patches

Apr 4, 2004 APJanssen Pharmaceutica Products is expanding a recall of 75 microgram-per-hour prescription Duragesic patches, which are used to treat moderate to severe chronic pain.Janssen recalled a single manufacturing lot of 440,000 patches in February after determining that some of them were leaking medication along one edge.The Johnson & Johnson subsidiary said Monday that it is adding patches from four additional manufacturing lots to the initial lot included in the original recall.A total 2.2 million patches from five lots with the control numbers 0327192, 0327193, 0327194, 0327195 and 0330362 are now affected.About 21 percent of those patches may still be in distribution, said Janssen spokeswoman Carol Goodrich. No other dosage levels are affected, the company said.If the medication leaks from the patch, patients can get either too much or too little medication.It's possible for a person to absorb a higher than intended amount if the medicine leaks directly onto the skin. Overexposure may cause nausea, sedation, drowsiness or potentially life-threatening complications.If too little medication is left, it may not be enough to provide adequate pain control, and the patient may experience withdrawal symptoms.

duragesic overdose

Boston Scientific Enteryx Device

2006-01-02T13:16:00.000-05:00

Boston Scientific Enteryx Device

The FDA & Boston Scientific notified healthcare professionals and patients about serious adverse events, including death, occurring in patients treated with the Enteryx device. On September 23, 2005, Boston Scientific ordered a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution. Additionally, Boston Scientific Corp. recently suspended sales of it's Enteryx Device after more than two dozen reports of problems. The notice was posted on the company's Web site, during the week of September 19, 2005.

An estimated 3,800 patients have been treated with Enteryx device, which was approved in 2003 by the FDA. The company's recall notice stated some doctors accidentally punctured the wall of the esophagus while injecting the substance, causing adverse events.

Based upon reports filed with the FDA, patients suffered leakage, swelling, and ulcers in the esophagus. One elderly patient died last year after a doctor accidentally hit the wall of the patient's aorta, the body's largest artery.

Boston Scientific sold about $5.5 million worth of Enteryx kits in 2004.

Boston Scientific Corp. said the U.S. Food and Drug Administration is looking into reports of one death and six injuries linked to the use of its treatment for acid-reflux disease. Boston Scientific, said the FDA is looking into its Enteryx device, an injectable treatment for acid reflux, after the death of an elderly woman last month, three weeks after treatment. The agency will try to determine whether the death was linked to the device or to physician technique.
We've reported this to the FDA and we're working cooperatively with them," said Paul Donovan, a Boston Scientific spokesman. FDA spokeswoman Kathleen Quinn confirmed the agency was reviewing the adverse events.

The Enteryx treatment, which the company had identified as one of its top products in terms of sales growth potential involves the injection of a plastic substance into the esophagus to help protect patients from acid backing up from the stomach.

In July 2004, the company issued an alert to doctors about the product and is updating the product label. In the case of the patient who died, some of the polymer had been injected into the woman's aorta, which ruptured, causing her to bleed to death.

If you or a loved one suffered injuries from a Boston Scientific Enteryx Device, please contact Bagolie Friedman Injury Lawyers now for a free lawsuit case evaluation. Visit http://bagoliefriedman.com

Recall of Guidant Defibrillators

2006-01-01T20:39:00.000-05:00

Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators

Audience: Cardiologists and other healthcare professionals

[UPDATE December 29, 2005] FDA issued an update to the July and October, 2005, Preliminary Public Health Notification. The updated PPHN provides numbers of deaths and serious injuries for the three devices as of December 12, 2005. FDA's recommendations have not changed.

[Posted 07/18/2005] FDA issued a Preliminary Public Health Notification and advice for patients for Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators to provide clinicians with current information and guidance concerning malfunctions occurring with these devices, which were the subjects of a Class I recall announced by FDA on July 1, 2005. The malfunction that is the subject of the recall causes damage to the device’s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail. The affected devices are: VENTAK PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004.

[December 28, 2005 UPDATE- Preliminary Public Health Notification - FDA] [October 13, 2005 UPDATE- Preliminary Public Health Notification - FDA] [July 18, 2005 - Recall Notice for Ventak PRIZM 2 - FDA] [July 18, 2005 - Recall Notice for CONTAK RENEWAL and CONTAK RENEWAL 2 - FDA] [July 14, 2005 - Preliminary Public Health Notification - FDA] [July 15, 2005 - Advice for Patients - FDA]

Voluntary Product Recall of Selected Powerlink System Delivery Catheters

2005-12-20T23:51:00.000-05:00

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Endologix and FDA notified healthcare professionals of the voluntary product recall of selected Powerlink System delivery catheters marketed in the U.S.,used to deliver minimally invasive treatment for abdominal aortic aneurysms.Endologix initiated the recall as a result of an analysis of three recentreports of tip separation from the catheter sheath inner core duringprocedures. This action does not include the Powerlink stent grafts thathave been implanted in patients or the large diameter 34 mm Powerlink Systembeing evaluated under an investigational device exemption or PowerlinkSystems sold outside of the U.S.

Read the complete MedWatch 2005 Safety summary, including a link to thefirm's press release, at: http://www.fda.gov/medwatch/safety/2005/safety05.htm#Powerlink

Law Office Reviewing Cases Involving Victims of ETS

2005-12-16T17:36:00.000-05:00

Our office is reviewing several cases involving victims of ETS. We can answer your questions for free.

Contact Alan Friedman or Ricky Bagolie toll free at 1-866-333-3529, by e-mail at info@bagoliefriedman.com or check out our website at http://www.bagoliefriedman.com

Palmar hyperhidrosis, where the hands sweat profusely and uncontrollably, results in an unnecessary thoracoscopy with sympathectomy. It is a complex and risky procedure in which a surgeon makes an incision under the patient's armpit, inserts a surgical probe through the incision, collapses the patient's lung to gain access to the spinal area, and then severs or clamps a nerve near the spine that controls perspiration of the hands. This surgery can produce serious complications, including bleeding in the chest cavity, pneumothorax (a condition that impedes breathing), infection, significant pain, and greatly increased sweating in other parts of the body.

Serious Health Events Due To Enteryx Device

2005-12-13T14:03:00.000-05:00

The FDA & Boston Scientific notified healthcare professionals and patients about serious adverse events, including death, occurring in patients treated with the Enteryx device.

On September 23, 2005, Boston Scientific ordered a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution. Additionally, Boston Scientific Corp. recently suspended sales of it's Enteryx Device after more than two dozen reports of problems. The notice was posted on the company's Web site, during the week of September 19, 2005.

An estimated 3,800 patients have been treated with Enteryx device, which was approved in 2003 by the FDA. The company's recall notice stated some doctors accidentally punctured the wall of the esophagus while injecting the substance, causing adverse events. Based upon reports filed with the FDA, patients suffered leakage, swelling, and ulcers in the esophagus. One elderly patient died last year after a doctor accidentally hit the wall of the patient's aorta, the body's largest artery.

Boston Scientific sold about $5.5 million worth of Enteryx kits in 2004. Boston Scientific Corp. said the U.S. Food and Drug Administration is looking into reports of one death and six injuries linked to the use of its treatment for acid-reflux disease. Boston Scientific, said the FDA is looking into its Enteryx device, an injectable treatment for acid reflux, after the death of an elderly woman last month, three weeks after treatment. The agency will try to determine whether the death was linked to the device or to physician technique. We've reported this to the FDA and we're working cooperatively with them," said Paul Donovan, a Boston Scientific spokesman. FDA spokeswoman Kathleen Quinn confirmed the agency was reviewing the adverse events.

The Enteryx treatment, which the company had identified as one of its top products in terms of sales growth potential involves the injection of a plastic substance into the esophagus to help protect patients from acid backing up from the stomach. In July 2004, the company issued an alert to doctors about the product and is updating the product label. In the case of the patient who died, some of the polymer had been injected into the woman's aorta, which ruptured, causing her to bleed to death.

Recall of Boston Scientific ENTERYX Injector Packs

2005-12-13T13:37:00.000-05:00

Recall of Boston Scientific ENTERYX® Injector Single Packs for Treatment of
Gastroesophageal Reflux Disease (GERD)

October 14, 2005

There are serious adverse events, including death, occurring in
patients treated with Boston Scientific’s ENTERYX® for gastroesophageal reflux disease
(GERD), and to provide recommendations on avoiding future occurrences.

On September 23, 2005, Boston Scientific Corporation issued a recall of ALL
ENTERYX® Procedure Kits and ENTERYX® Injector Single Packs from commercial
distribution. Physicians should stop injecting ENTERYX® immediately and follow the
manufacturer’s procedures for returning unused product.

Nature of the Problem
ENTERYX® is a liquid chemical polymer which is intended to be injected into the lower
esophageal sphincter. The device polymerizes into a spongy material shortly after
injection and once injected cannot be removed.

The serious adverse events involve unrecognized transmural injections of ENTERYX®
into structures surrounding the esophagus. Transmural injections can potentially result in
death or serious injury. Signs and symptoms of transmural injection can potentially
include: chest pain, flu-like symptoms, pneumonia, atelectasis, reactive pneumonitis,
mediastinitis, pneumo-mediastinum, reactive pleuritis, pleural effusion, pericardial
effusion, syncopal episodes, and flank pain. Some cases of transmural injection were not
recognized at the time of the procedure or during immediate follow-up; these occurred
even though fluoroscopy was used throughout the procedure. Three weeks was the
longest period that we know of in which a transmural injection went unrecognized by a
physician.

At this time, it is not possible to provide accurate estimates of the number of adverse
events associated with transmural injection of ENTERYX®, or to describe all of the
possible outcomes. Reports received thus far suggest ENTERYX® has been injected into
various sites outside the esophagus including the mediastinum, pleural space and the
aorta. When injected into the aorta, ENTERYX® may migrate to and occlude blood
vessels which supply other organs including the kidneys. One reported death was due to
injection of the ENTERYX® into the wall of the aorta, which resulted in an aorto-enteric
fistula. Another patient experienced a partial reduction in renal function due to partial
embolization. It is not known at this point whether ENTERYX® injected outside the
esophagus can be removed.

FDA is aware that not all injuries are caused by user technique or transmural injection.
Recent literature cites 2 cases in which serious mediastinal events suggestive of possible
inflammatory reactions occurred even though proper procedure was followed. Other
adverse events not associated with transmural injection have also been reported to the
FDA, some of them presenting 4 to 7 weeks after ENTERYX® injection. They include
dysphagia from esophageal stenosis or stricture that required dilation procedures, and
weight loss. These later-onset events appear to be different from the immediate onset,
short-lived events observed during the approval trial for ENTERYX®.

Recommendations
Physicians are advised to immediately stop using ENTERYX®.
If transmural injection of ENTERYX® has occurred or is suspected at the time of
implantation, the patient should be monitored carefully for at least 30 days.
For all patients who have received ENTERYX®, we recommend that you:
1. advise your patients to seek medical evaluation immediately if they experience
the onset of symptoms which may indicate transmural injection. These include
chest or epigastric pain, flu-like or respiratory symptoms (fever, cough, shortness
of breath), syncope or flank pain. You may wish to provide them with a copy of
FDA’s "Advice for Patients with ENTERYX® for Gastroesphageal Reflux
Disease," available at
http://www.fda.gov/cdrh/medicaldevicesafety/atp/101405-enteryx.html.
2. perform tests, as clinically indicated, including chest x-rays, barium swallows,
and/or chest/abdominal CT scans to confirm or rule out transmural injection.
3. advise patients to:
• continue with their regularly-scheduled follow-up appointments; and
• go immediately to an emergency room if they experience chest pain or
syncope.
Since physicians should no longer be implanting ENTERYX®, the FDA is not making
recommendations about techniques in using the product.

Reporting Adverse Events to FDA
FDA requires hospitals and other user facilities to report deaths and serious injuries
associated with the use of medical devices. If you suspect that a reportable adverse event
was related to the use of ENTERYX®, you should follow the reporting procedure
established by your facility. Prompt reporting of adverse events can improve FDA’s
understanding of and ability to communicate the risks associated with devices and assist
in the identification of potential future problems.

We also encourage you to report adverse events related to ENTERYX® that do not meet
the requirements for mandatory reporting. You can report these directly to the device
manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program.
You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-
FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.
Consumers can also report directly to MedWatch.

Getting More Information
For more information about the recall, contact Boston Scientific Corporation at 1-800-
862-1284. For more information on litigation, contact Bagolie Friedman at 1-866-333-3529 or visit http://www.bagoliefriedman.com

Chronology - Key events in the history of Merck's Vioxx

2005-12-13T08:02:00.000-05:00

CHRONOLOGY-Key events in the history of Merck's Vioxx
A timeline of Vioxx's history follows:
1998
*Nov. 1998 - Merck files an application with the FDA seeking U.S. approval of Vioxx.
1999
Jan. 1999 - Vioxx Gastrointestinal Outcomes Research (VIGOR) trial begins, aiming to show whether Vioxx causes fewer ulcers and other gastrointestinal problems than the standard arthritis treatment naproxen.
*Feb. 1999 - Merck begins first clinical trial of Vioxx to see whether it can treat Alzheimer's disease. A second trial begins in April 2000.
May 20, 1999 - FDA approves Vioxx for the relief of osteoarthritis symptoms, management of acute pain and primary dysmenorrhea, or painful menstruation.
2000
March 2000 - Merck unveils data from Alzheimer's trials, which it said showed no difference in heart problems between patients on Vioxx and others taking a placebo.
June 2000 - Merck submits to the FDA final data from the VIGOR study, which it said showed a decrease in gastrointestinal problems but a four-fold higher risk of heart attacks compared with naproxen.
2001
Feb. 2001 - FDA Arthritis Advisory Committee meets to discuss the gastrointestinal VIGOR study.
2002
April 11, 2002 - FDA approves changes to Vioxx label which include cardiovascular risks, gastrointestinal benefits and a new use to treat rheumatoid arthritis.
2004
Sept. 27, 2004 - Merck tells the FDA a study to see if Vioxx could prevent colon polyps showed twice the risk of heart attacks among patients taking Vioxx for 18 months as those who took placebos.
Sept. 28, 2004 - FDA officials meet with Merck, which tells the agency it will voluntarily withdraw Vioxx. Two days later Merck announces the withdrawal.
Nov. 18, 2004 - Congress holds hearing on Merck and the FDA's handling of the drug's safety issues.
2005
Aug. 19, 2005 - Merck is found negligent in the marketing and design of Vioxx and is ordered to pay $229 million in punitive damages and $24 million for mental anguish and loss of companionship to the widow of a Texas man.
The total award is expected to be cut to about $26 million because of Texas laws limiting damages.
Nov. 3, 2005 - Merck is exonerated in a New Jersey lawsuit involving a man who suffered a heart attack after taking Vioxx but survived. The case was the first tried of thousands of cases filed against Merck in the state.
Dec. 8, 2005 - The New England Journal of Medicine says Merck deleted dangers linked to Vioxx, including three heart attack deaths among users, in its analysis of the VIGOR study.
Dec. 12, 2005 - A U.S. judge declares a mistrial in the first federal lawsuit after a jury fails to reach a unanimous verdict in a case brought by the widow of a Florida man. The case is expected to be retried in 2006.
Source: FDA--

FDA Slow to Sound Alarm on Duragesic Pain Drug

2005-11-30T05:46:00.000-05:00

It appears that LA County California has had it's share of Fentanyl related overdoses.

November 25, 2005 latimes.com THE NATION

FDA Slow to Sound Alarm on Pain Drug
Fentanyl's overdose rate and side effects show holes in monitoring medicine on the market.

By Ricardo Alonso-Zaldivar, Times Staff Writer
WASHINGTON — Dory Bauler prides herself on staying active despite painful back problems. But at one point this year, she was getting so short of breath that she could barely walk. Doctors could find nothing wrong.
It never occurred to them that the medicinal skin patch she was using to deliver pain relief might also be poisoning her.
"I was just shutting down," said Bauler, 76, a retired paralegal from Laguna Woods in Orange County, who suffers from a severe curvature of the spine. "There were literally times I felt I wasn't getting any oxygen at all."
Bauler's patch was delivering fentanyl, a narcotic many times more powerful than morphine. Like morphine and other opioid drugs, fentanyl controls pain but also reduces respiratory function — and too much fentanyl can shut down one's breathing entirely. Luckily, Bauler figured out what was happening in time to stop using the drug.
The leading brand of the fentanyl patch is Johnson & Johnson's Duragesic; last year, pharmacists filled more than 4 million prescriptions for it.
The drug was developed to help people with extreme, unremitting pain, such as cancer patients. But it is increasingly being used for other medical conditions and, in some cases, by drug abusers.
Misuse can be lethal.
In the last six years, the Los Angeles County coroner's office has investigated more than 230 deaths involving fentanyl. Of the deaths, records show 127 were classified as "accidental"— suggesting that the victims inadvertently had taken too much. And evidence from other states and the Food and Drug Administration suggests there may be many more such cases nationwide.
The fentanyl patch illustrates a broad and still-unresolved problem with the nation's system for protecting patients against drug risks: Neither the FDA nor the pharmaceutical industry has a comprehensive system for monitoring what happens after a new drug is approved for market.
Sometimes, as with the highly publicized discovery of heart and stroke risks associated with the painkiller Vioxx, the problem is that dangers show up only after millions of people begin using a drug. In other cases, as with fentanyl, the problem is that a drug approved for one purpose and in one context can be prescribed and used for other purposes. Known as off-label use, the risks of such use are not always understood.
"You've got a spectrum of the [drug safety] problem here," said Dr. Alastair J.J. Wood, associate dean at Vanderbilt University Medical School and an advisor to the FDA. "There isn't one easy solution. You need to have doctors think through whether this is the appropriate medicine for the patient."
Cancer patients, for whom the fentanyl patch was developed, are usually monitored closely by a physician. Increasingly, however, the patches are being prescribed for other patients and conditions, sometimes without close monitoring.
The FDA says it is investigating about 130 fatalities that occurred over a 15-year period. Evidence from autopsies in Los Angeles and Florida suggests the number of fentanyl-related deaths may be much higher. The federal reporting system picks up a fraction of bad drug reactions.
"There are hundreds more cases not evaluated by the FDA," said Bruce A. Goldberger, director of toxicology at the University of Florida Medical School.
In Los Angeles County, criminalist Daniel T. Anderson of the coroner's office said the "vast majority" of fentanyl-related deaths involved the patch. The deaths occurred over a 5 1/2 -year period ending this summer.
For the 127 classified as accidental, it is believed that patients often misunderstood how to avoid the drug's risks.
"Typically, the people we see here are people who have a legitimate use for the patch," Anderson said. He had called attention to overdose deaths involving the Duragesic patch in a professional journal article published in 2000.
In Florida, state authorities reported 115 deaths from fentanyl poisoning in 2004, records show. Goldberger, whose office handles about one-fourth of the autopsies in the state, said the majority involved the patch.
Drug abuse involving fentanyl also is on the rise. Emergency-room cases involving the drug rose from 28 in 1994 to 1,506 last year, according to the federal Substance Abuse and Mental Health Services Administration.
"It is definitely a neglected drug safety problem," Goldberger said.
FDA Slow to Sound Alarm on Pain Drug
As Congress weighs changes to strengthen the drug safety system, the history of the fentanyl patch shows that the FDA and many in the medical community knew of risks but failed to closely monitor the growing use of a potent narcotic.
Duragesic sales more than doubled from 2000 to 2004, as manufacturer Johnson & Johnson promoted it as safe in advertising to doctors that the FDA called "misleading." With $1.2 billion in sales in 2004, Duragesic surpassed Vioxx, according to Drugtopics.com, a pharmaceutical website. Yet as early as 2001, a drug safety group had warned that patients on the patch were dying of overdoses. Some doctors were prescribing the patch for patients who did not tolerate opioid drugs well, cautioned the Institute for Safe Medication Practices in Pennsylvania.
It took another four years for the FDA to issue its own nationwide alert, on July 15.
The FDA warnings, though welcome, are not enough, in the view of Michael Cohen, president of the safety group that initially sounded the alarm. Cohen, a pharmacist, said he was frustrated that the agency took so long to recognize the problem.
"We are the main safety organization for medication error reporting, and the FDA receives our information," Cohen said. "Sometimes, information that is provided by us does seem to get lost within the FDA."
Dr. Robert J. Meyer, head of the FDA office that oversees painkillers, said that safety officers this year noticed a trend of adverse reactions involving the drug.
"The system in place, though never ideal, does work well," Meyer said. "The FDA did the right thing in [issuing] its communication. One of the things we need to think about in the future is continuing communications in terms of drugs like this that have some safety concerns."
Cohen's organization is calling for more aggressive FDA action, including a program to educate patients about the risks of the patch, new instructions for disposing of used and unwanted patches, and wider use of childproof packaging.
Vanderbilt's Wood does not believe that warnings will suffice. "It's like the warnings on an SUV: Beware of rollover," he said. "The lawyers are happy with that, but does it prevent rollovers? Warnings probably don't work."
Bauler, the Laguna Woods paralegal, said reading a newspaper report about the FDA warning may have saved her life. She took herself off the patch, and her breathing problems cleared up in a few days.
"It was like having to be my own detective," Bauler said. "Then I got angry. I have been through this hell that could have been prevented."
Others were not so fortunate. Among the victims was a preschooler from East Toledo, Ohio. Four-year-old Timothy Rhodes was found dead in January after he got hold of a Duragesic patch prescribed for his mother, Stephanie, her family said.
A spokesman for Johnson & Johnson, which makes Duragesic, said the drug met an important need for cancer patients and others with chronic pain. The company is working with the FDA, doctors and patients to make sure it is used safely — and has introduced child-resistant packaging, Doug Arbesfeld said.
"We take the health and safety of the patients who use this product very seriously," Arbesfeld said. "We work very closely with the FDA to look into all reports of serious adverse consequences, and we believe that the product is safe and effective when used as directed."
The manufacturer had promoted Duragesic to doctors as superior medication for back pain and other problems.
"Game, uninterrupted," reads the caption on a Duragesic brochure that showed a middle-aged man shooting pool.
Another photo showed a pair of hands kneading dough. "1,360 loaves … and counting," read the caption. "Work, uninterrupted."
Last year, the FDA sent the company a sharply worded letter about its advertising to doctors. The agency said many of the claims about Duragesic were not substantiated.
And, "by suggesting that Duragesic has a lower potential for abuse compared to other opioid products, the [promotional material] could encourage the unsafe use of the drug, potentially resulting in serious or life-threatening hypoventilation" — a reduced capacity to breathe, the FDA said.
FDA Slow to Sound Alarm on Pain Drug
Arbesfeld said the company had stopped using the literature.
The FDA approved Duragesic in 1990 to treat chronic pain. The patch consists of a drug reservoir encased in a soft plastic film. When applied to the body, it releases fentanyl through a membrane. The drug is absorbed into the upper layers of the skin and circulates through the bloodstream. From the beginning, Duragesic carried strong warnings. Doctors were cautioned about fentanyl's potency. Patients were warned not to use more than one patch and to avoid seemingly innocuous actions that could cause the drug to be released more rapidly, such as wearing a heating pad or sunbathing.
Physicians and pharmacists say the patch is a good treatment for patients with severe pain. Each patch can be worn for 72 hours, maintaining a stable level of painkiller in the body.
"If you have a patient who can't swallow pills, it is really important to have patches available," said Dr. Judith Ford, a professor of radiation oncology at UCLA's Jonsson Comprehensive Cancer Center. Ford says she starts her patients with a small dose and asks them to keep diaries to track the results.
"Fentanyl is a useful drug, but the market is not very big," said Larry Sasich, a pharmacist who teaches drug policy at the Lake Erie College of Osteopathic Medicine in Erie, Pa. "This is a serious drug for serious pain, and that is a pretty limited market."
But the fact that Duragesic comes in a patch may have made it seem more benign to patients than other strong painkillers.
Ford said she recalled a conversation with a patient who did not want to take another narcotic because he feared becoming addicted. But the same patient had no problems with using the patch, although fentanyl also can create dependency.
Roslyn Joress of Boynton Beach, Fla., said her doctor put her on the Duragesic patch for pain for a connective tissue disorder called fibromyalgia.
"I didn't even realize that I was on a narcotic for the longest time," said Joress, 67. "I thought it was like another medication they come out with in patch form and that it was going to relax the muscles. If the doctor had said to me, 'This is like morphine,' never in my wildest dreams would I have taken it."
Joress said she found out Duragesic was a narcotic from another woman she saw wearing a patch at poolside.
When Joress tried to strike up a conversation about the patch, the woman responded, "Oh yeah, I'm a junkie."
Joress got scared and decided to quit the drug, but went through intense withdrawal symptoms.
"I went from an addiction I didn't even know was an addiction, to needing sleeping aids," she said.
As for her pain, "it's nothing a couple of Tylenol won't take care of."
*
Pain patch profits
From 2000 to 2004, sales of Duragesic, the leading brand-name painkiller patch, more than tripled, and the number of prescriptions more than doubled.
Revenue
(In millions) 2000: $352.9
2001: $530.0
2002: $752.7
2003: $1,049.8
2004: $1,208.4
--
Prescriptions
(In thousands)
2000: 1,766
2001: 2,426
2002: 3,009
2003: 3,659
2004: 4,114
Source: Drugtopics.com

Beware of Duragesic Pain Patch Use

2005-11-23T08:07:00.000-05:00

Duragesic Pain Patch Issues
The Duragesic patch is indicated for the management of severe, chronic pain (such as cancer pain) that cannot be managed with less powerful drugs such as acetaminophen-opioid combinations and nonsteroidal analgesics. Moreover, only patients who are already on and tolerant to opioid therapy, and who require continuous opioid administration should use the patch.

Approved by the U.S. Food and Drug Administration (FDA) in 1990, Duragesic releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is made by Janssen Pharmaceutica and available by prescription only.

A boxed warning indicates that Duragesic is not to be used in the following circumstances: to manage acute or postoperative pain, including pain after outpatient surgery for mild or intermittent chronic pain that can be managed with less powerful drugs at a dose higher than 25 micrograms per hour by children under age 12 by patients under age 18 who weigh less than 110 lbs. Side effects include, but may not be limited to, nausea, vomiting, constipation, drowsiness, weakness, dry mouth, hypotension and loss of appetite. Users are warned to avoid exposure to external heat sources such as heating pads and electric blankets, hot tubs, heated water beds, heat lamps, etc., because of a potential for temperature-dependent increases in fentanyl release that may lead to an overdose.

In February 2004, Janssen and the FDA notified healthcare professionals of a Class I recall of DURAGESIC 75 mcg/h. Only Control Number 0327192 (expiration October 2005) is subject to this recall. A potential seal breach on one edge may allow the drug to leak from the patch and could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications. Conversely, if the hydrogel contents leak out of the patch, there may not be adequate medication to treat the patients' pain. In an opioid tolerant patient, this may lead to withdrawal symptoms, which include sweating, sleeplessness and abdominal discomfort. Over 400,000 patches are included in the recall.

In April 2004, Janssen expanded the Duragesic patch recall to include a total of 2.2 million patches. Health officials believe that over 20 percent of the recalled patches are still in use.In July 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued identifying several important safety precautions for the use of fentanyl transdermal patches. These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal.

The FDA is conducting an investigation into the deaths associated with these patches. The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.The Agency is working closely with the manufacturers of fentanyl patches to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose.

See your doctor if you suffered an adverse side effect while using the Duragesic patch. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

Duragesic Lawsuit

On Apr-05-04, Janssen Pharmaceutical Products LP issued an urgent recall for defective patches. The recall applies only to specific manufacturing lots of the 75mcg strength patches, which have a faulty seal that permits full strength fentanyl to leak from the patch. This could result in patients being given an overdose of fentanyl, which can cause fatal respiratory and/or cardiac arrest.

Only the following lot numbers are affected:NDC no. 50458-035-05Lot Control nos. 0327192, 0327193, 0327294, 0327295, and 0330362

Symptoms of Overdose Symptoms of a fentanyl overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness or coma, confusion, tiredness, cold and clammy skin, and small pupils. Continued exposure to uncontrolled amounts of fentanyl can lead to addiction and dependency.

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About the Charite Medical School.

2005-11-20T08:18:00.000-05:00

Charité - Universitätsmedizin Berlin

The Charite Medical school and university hospital of the Berlin Humboldt University with three campuses: “Campus Mitte”, “Campus Virchow-Klinikum”, and “Campus Berlin Buch”. This facility is not to be confused with the Charite Artificial Replacement Disc, the subject of controversey and litigation and currently being investigated by Bagolie Friedman Injury Lawyers.

The largest university hospital in Europe, with 2,307 beds in 49 clinics, treating roughly 100,000 inpatients and 250,000 outpatients per year with support from 26 theoretical institutes. An employer of 9,384 people, including 2,120 scientists. Educational facility for 4,905 students in human medicine and dentistry, nursing education and nursing science and medical physics. A large business enterprise using state-of-the-art data processing and management technology in medicine and administration. It has a total budget of 1.3 billion marks, 0.88 billion of which goes directly to patient care. A medical complex with three campuses: “Campus Virchow- Klinikum”, completed in 1998 and one of the most modern university hospitals in Europe; “Campus Mitte”, Germany’s oldest medical treatment facility still located on its original site; and “Campus Buch”, which provides the link to a large national research facility. The only medical school in Europe whose name is both a virtue and a mission: charity. Charite

charite

Bagolie Friedman Now Searchable in Google and Yahoo

2005-11-20T08:14:00.000-05:00

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Ghoul case transplant recipients may face risk of HIV, syphilis, other ailments

2005-11-20T08:09:00.000-05:00

Ghoul case transplant recipients may face risk of HIV, syphilis, other ailments
BY WILLIAM SHERMANDAILY NEWS STAFF WRITER

Daily News dug up scandal Oct. 8. Biomedical president Michael Mastromarino. A body-snatching ring that illicitly harvested bone and tissue from corpses has placed thousands of transplant patients at risk for contracting infectious diseases.In a product recall notice, Tutogen Medical Inc. warned that human cadaveric tissue obtained from Biomedical Tissue Services Ltd. could be tainted.
The diseases could include HIV, syphilis, hepatitis and viral infections, according to regulatory authorities.
"There is a lack of assurance that appropriate [corpse] donor identification, donor screening and medical history data collection was performed and therefore, a risk of infectious disease exists," states the warning issued to doctors and hospitals throughout North America.
Tutogen, among others, distributed bone and tissue products it bought from Biomedical until earlier this month when the Daily News disclosed that the operation was under investigation by the Brooklyn district attorney's office.
The recall notice cited The News' disclosures on the ring, which is headed by Biomedical president Michael Mastromarino, a former dentist based in Fort Lee, N.J.
Along with others, Mastromarino personally carved up corpses and sold body parts to tissue processing companies that then distributed the products to doctors, dentists and medical centers for final transplant into human beings.
The Food and Drug Administration last week said that corpses harvested by the body-snatching ring "may not have been properly screened for certain infectious diseases."
"Some recipients of the tissues may be at increased risk of infections that could potentially be transmitted," the FDA said.
The agency also said that the risks of infection are low and that no adverse reactions have been reported so far, adding, "however, the actual infectious risk is unknown."
HIV, hepatitis, syphilis and viral infections are among the possible diseases cited by U.S. and Canadian health authorities.
Transplants possibly affected include bone for dental implants and a variety of orthopedic reconstructive procedures, skin for burn victims, fatty thigh tissue for cosmetic procedures and tendons and ligaments for those who have torn them.
FDA officials and the Centers for Disease Control and Prevention recommended blood tests for patients who got the questionable products.
The latest developments sent shock waves through the tissue transplant industry and doctors who use the products.
Dr. David Behrman, chief of the division of oral surgery at New York Weill Cornell Medical Center, said, "Many surgeons have been notified by their suppliers of bone-graft material that likely came from some of these questionable donors."
"We are awaiting guidance from the FDA as to what should be done and whether we should begin testing our patients for infectious disease among other recommendations," he said.
In Canada, Calgary public health officials immediately moved to quarantine product derived from Biomedical and said they will test one at-risk patient for HIV, hepatitis B and C, human T-cell lymphotrophic virus and syphilis.
"We confiscated the product, and traced it back, found one patient, contacted the patient, and we will begin the blood tests," said Leanne Niblock, spokeswoman for the Calgary Health Region.
Although the incidence of transplant recipients contracting disease from corpse body parts has been rare, several scandals have shaken the industry.
Three years ago, a 23-year-old Minnesota man died of an infection that came with transplanted ligaments inserted during knee surgery. The tissue was supplied by CryoLife, an Atlanta tissue bank, and the infection was identified as the rare bacterium Clostridium soredelli.
More recently, dozens of patients in Oregon were infected with hepatitis C contracted from tissue supplied from a single corpse.
Mastromarino's body parts were carved from hundreds of corpses obtained at funeral homes throughout the city and other states beginning in 2002 in an enterprise that continued until this month.
Mastromarino is under investigation by Brooklyn prosecutors for allegedly creating forged relatives' consent forms and phony medical records for the deceased in the harvesting scam.
The alleged medical record forgeries were designed to conceal conditions that would normally render the products unacceptable for sale. Those conditions include cancer, habitual intravenous drug use and many contagious diseases.
Joseph Nicelli of Staten Island an embalmer who was once Mastromarino's partner in the tissue recovery business, is also under investigation along with numerous funeral home directors who provided bodies.
After harvesting, the bone, tissue and other body parts were frozen by BTS and then shipped out overnight to Tutogen and other companies for processing before final transplant.
The other four processing companies are Lifecell Corp. of Branchburg, N.J., Lost Mountain Tissue Bank of Kennesaw, Ga., Blood and Tissue Center of Central Texas in Austin and Regeneration Technologies Inc. of Alachua, Fla.
All but Lost Mountain Tissue Bank told The News they were unaware of Mastromarino's allegedly illegal activities and that they follow extensive tissue testing and sterilization procedures of their own before they ship any product out.
James Wade, director of Lost Mountain, said, "I have no comment at all; we're following the FDA guidelines. I can't say more than that."
Originally published on October 30, 2005

FDA Provides Information on Investigation into Human Tissue for Transplantation

2005-11-15T13:44:00.000-05:00

The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. At this time, the implicated tissues from BTS include human bone, skin, and tendons. These products represent only a small percentage of the overall U.S. tissue supply.

While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown. FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.

The following tissue processors received tissue from BTS:LifeCell Corporation of Branchburg, NJ Lost Mountain Tissue Bank of Kennesaw, GA Blood and Tissue Center of Central Texas in Austin, TX Tutogen Medical, Inc., of Alachua, FL Regeneration Technologies, Inc., of Alachua, FL These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility. FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed.

While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed. Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at http://www.fda.gov/medwatch. Additional information is available on FDA’s web site at http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.####

NAPO FILES $77.5 MILLION+ LAWSUIT OVER BULLETPROOF VESTS

2005-11-07T21:05:00.000-05:00

NAPO FILES $77.5 MILLION+ LAWSUIT OVER BULLETPROOF VESTS

Ft. Meyers, Florida, April 7, 2004--The National Association of Police Organizations (NAPO) and Lieutenant Scott Ashby of the Sanibel Police Department filed a national class action suit against Armor Holdings (NYSE:AH), Toyobo, America, Inc. and Toyobo Co., Ltd. (Toyobo Japan) for sale of defective body armor to more than 100,000 persons, agencies and entities all across the United States at an average price of $775. NAPO filed suit in Michigan State court against another manufacturer, Second Chance that utilizes Zylon® in their vests. It should be noted that Second Chance discontinued the sale of two of its vests, ULTIMA® and ULTIMAX® and has issued free "Performance Pacs" to its customers because as Second Chance's President stated "Unfortunately, for all involved these results indicated unexpected decrease in the Zylon® fiber strength."

The petition claims that the vests represented and warranted to have certain qualities and performance characteristics, which, in fact they do not have. "It's a travesty to have men and women who risk their lives everyday in an effort to make our lives safer, to have been misled and given a false sense of security by depending on a vest that is ineffective," said attorney Michael G. Crow. The petition currently seeks compensatory damages in the amount of $77.5 million with Crow stating that "if counsels' suspicions are confirmed the complaint will be amended to seek punitive damages in the amount of treble compensatory damages."

About NAPO: NAPO is a coalition of police unions and associations from across the United States that serves to advance the interests of America's law enforcement officers through legislative and legal advocacy, political action and education. Founded in 1978, NAPO is now the strongest unified voice supporting law enforcement officers in the United States. NAPO represents police unions and associations whose law enforcement officers are located across the country including: New York, Chicago, Los Angeles, Phoenix and Dallas to name a few. NAPO also represents almost half of the sworn law enforcement officers in the country plus 11,000 retired officers and more than 100,000 citizens who share a common dedication to fair and effective crime control and law enforcement.

Additional information: The Special Report "Status Report to the Attorney General on Body Armor Safety Initiative Testing and Activities" dated March 11, 2004 can be downloaded here.

A Comment On New Jersey Workers' Compensation Claims

2005-11-07T21:02:00.000-05:00

Regarding workers compensation aka workmans comp aka workmens comp in New Jersey: Since workers compensation cases, among the various types of disability claims, provide some of the most antagonistic and inhospitable situations for injured and sick workers in new jersey to endure, it is very important have suitable representation. Because, unfortunately, and all too often, the individual who became ill as a result of their work environment or was injured on the job, does not find relief from the workman's comp system. Quite the opposite, sick and/or injured workers find themselves in a undesirable position where it is them versus both their employer and the workers compensation carrier. Amazingly, many sick and injured workers pursue workmens comp claims without the benefit of attorney representation. Such a position is hardly unwise and for several reasons: a worker may end up losing their battle for workman's comp benefits or take a settlement that is clearly not in their best interest. For this reason, a new jersey worker who has become ill or injured because of an accident at work should seek qualified legal counsel before going ahead with a workmans comp claim.

Mesothelioma and Asbestosis Still A Threat To Workers

2005-11-06T10:15:00.000-05:00

Mesothelioma is a very serious but rare form of cancer that is almost always caused by exposure to asbestos. The most common forms of Mesothelioma affect the lining of the lung (the pleura) or the lining of the abdominal cavity (the peritoneum). Approximately 3,000 people are diagnosed with Mesothelioma in the United States each year.Even a brief or minimal exposure to asbestos can cause Mesothelioma. For example, in several cases we have represented the wives and children of workers who unknowingly brought asbestos dust into their homes on their work clothes. Mesothelioma is also a "dose response" disease. This means that the more a person is exposed to asbestos, the greater the risk he has for developing the disease.Mesothelioma has a long latency period. This means that victims of Mesothelioma were exposed to asbestos many years before the cancer developed. The average latency period for Mesothelioma is approximately 30 years, but can be shorter than 15 years or longer than 40 years. Victims of Mesothelioma may also have another asbestos-related disease such as asbestosis or pleural disease. These non-cancerous conditions, although caused by asbestos, are medically separate and distinct diseases from Mesothelioma. Therefore, a disease such as asbestosis does not "develop" into Mesothelioma. Because asbestosis has a shorter latency period than Mesothelioma, some Mesothelioma victims also develop asbestosis many years before developing the cancer. Many medical experts believe that less than 15% of asbestosis victims will ever develop Mesothelioma. Also, a person can develop Mesothelioma but never have asbestosis or any other asbestos-related disease. If you have mesothelioma, you were likely exposed to asbestos. Many asbestos manufacturers and distributors have known for years that asbestos was hazardous. These companies were well aware of the health implication of their products yet they made the business decision not to warn the public and their customers of those hazards. You may have a right of recovery against those manufacturers because these companies are now being held responsible for compensating mesothelioma sufferers and their families. This could help defray the costs of treatment and provide compensation for you and your loved ones for your pain and suffering.We are currently focusing our efforts on aiding persons who have been diagnosed with mesothelioma. We will review mesothelioma claims anywhere in the country.

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