Tuesday, January 24, 2006

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

Sunday, January 22, 2006

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.

Friday, January 20, 2006

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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Monday, January 16, 2006

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.''

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.

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.

Monday, January 02, 2006

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

Sunday, January 01, 2006

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]