Archive for the ‘Medical Devices Recall’ Category

Motion Filed to Centralize Johnson and Johnson – DePuy ASR Recall Lawsuits Filed

Thursday, September 23rd, 2010

Plaintiff Attorneys representing injured victims of the recalled Johnson & Johnson DePuy ASR hip implant are seeking to bring the lawsuits in to a consolidated multidistrict litigation. A motion filed on behalf of a woman who originally filed a Johnson & Johnson DePuy ASR hip implant lawsuit in California has made the consolidation request to the U.S. Judicial Panel on Multidistrict Litigation.

Johnson & Johnson recently recalled their DePuy ASR Hip Implant system after medical data collected from the National Joint Registry of England and Wales showed 12%-13% or approximately 1 out of 8 of those individuals who had received the recalled ACR devices were required to have a revision surgery within five years of receiving those implants. The ASR XL Acetabular System, which is a hip socket, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur are part of the recalled hip devices. The ASR XL Acetabular System is the only recalled hip implant that was approved in United States.

The symptoms of a potentially failing ASR hip implant may include an increase in pain or difficulty walking.

Patients who received one of the ACR hip implants are advised to call their surgeon and schedule a follow-up appointment, even if they are not experiencing symptoms or pain. The manufacturer may not maintain a list 0f the hip replacement implant patients, so patients who had the hip surgery after July 2003 are being advise to contact their surgeon or hospital to find out if there hip implant is part of this recall.

A multidistrict litigation (MDL) would allow all of the claimants that have or will file lawsuits against Johnson & Johnson DePuy in regards to the ASR recall lawsuit to be litigated under one federal judge for pretrial litigation. This is to prevent or avoid any duplicative discovery from being entered in as evidence, and to prevent inconsistent rulings from other federal judges. This MDL filing, if granted, will conserve some of the resources of each party such as expert witnesses, court costs, and court time.

If you have any questions about this hip implant recall or would like to see if you have a claim with this ACR Hip Implant Recall lawsuit, call the Tennessee attorneys of The Nahon Firm, PLC at (615) 324-2000 for a free consultation.

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Johnson & Johnson Unit Recalls Two Hip Replacement Devices – ASR XL Acetabular System and ASR Hip Resurfacing System

Thursday, September 2nd, 2010

Healthcare giant Johnson & Johnson has announced a voluntary recall of two hip-replacement systems due to a higher rate of revision surgeries required by patients. The recall adds to the company’s growing list of quality issues and comes just days after the company was warned by the FDA that is improperly marketing two other products.

DePuy Orthopaedics Inc., the orthopaedics unit of Johnson & Johnson, said that the recalled devices are the ASR XL Acetabular System, which is the cup portion of a replacement hip joint, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the hip bone or femur.

The ASR Hip Resurfacing system was introduced in 2003 and is only approved for use outside the U.S. The ASR XL Acetabular system was first launched in 2004 and has been available worldwide.

DePuy said it initiated the recall based on new, unpublished data from the National Joint Registry of England and Wales which showed that more people than expected who received the ASR Hip System experienced pain and other symptoms, leading to a second hip replacement surgery, called a revision surgery.

Specifically, the data shows that five years after implantation, about 12% of patients who had received the ASR resurfacing device and 13% of patients who had received the ASR total hip replacement needed to have a revision surgery.

DePuy noted that very few of these hip systems remain on the market after the company decided to discontinue sales last year due to declining demand and to focus on new products.

The company advised patients with an ASR device to visit their surgeons for evaluation of device performance and recommended yearly monitoring to ensure the device is functioning well, even in the absence of symptoms. The company said it intends to cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall.

The recall comes just days after the FDA issued a warning letter to DePuy for selling hip and other joint products without the agency’s approval. The FDA said in its letter dated August 19 that the company has been selling its TruMatch Personalized Solutions System, which makes artificial knee products, and the Corail Hip System without marketing clearance and in violation of the Federal Food, Drug, and Cosmetic Act. The FDA has given DePuy 15 days to correct the violations.

Johnson & Johnson has come under intense scrutiny by the FDA and federal prosecutors over the past year. On Monday, the company’s Vision Care Inc. unit reportedly issued a voluntary recall for about 100,000 boxes of “1 Day Acuvue TruEye” contact lenses sold in Asia and Europe, citing a manufacturing problem.

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