Fisher-Price Recalls Infant Musical Toy Chair Posing Strangulation Hazzard

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

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

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

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

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

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http://bagoliefriedman.blogspot.com

Pain Patch Required Special Monitoring

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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.####