The evidenced disclosed in the course of this trial has been eye-opening. It will come as a surprise to many that reporting adverse events to the FDA is not mandatory.
New York, New York (PRWEB) February 19, 2013
Bernstein Liebhard LLP continues to closely follow developments in the nation’s first trial involving the DePuy ASR hip recall. Among other things, evidence disclosed during the trial currently underway in Los Angeles Superior Court has revealed that in the years leading up to the recall, certain doctors who used the ASR repeatedly warned DePuy Orthopaedics about problems with the device. Yet these same doctors rarely made corresponding reports to the U.S. Food & Drug Administration (FDA), or took steps to warn their peers about problems associated with the metal-on-metal hip implant. According to a news analysis recently published by The New York Times, such reporting is not the standard in the medical community.* (Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles))
“The evidenced disclosed in the course of this trial has been eye-opening. It will come as a surprise to many that reporting adverse events to the FDA is not mandatory,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices, including hundreds of individuals affected by the DePuy ASR hip recall. The Firm is currently offering free DePuy ASR hip lawsuit consultations to individuals affected by the 2010 recall.
The New York Times analysis cites many reasons for physicians’ failure to make adverse event reports to the FDA, including the amount of paperwork involved in the process, and financial relationships doctors may have with a device or drug maker. According to court filings in the Los Angeles trial, several physicians providing information about the ASR’s performance to DePuy were paid consultants for the company.
DePuy ASR Recall
The DePuy ASR hip recall was announced in August 2010, after data indicated the device was failing in 12 percent of recipients within just 5 years of implantation.** Court records indicate that Johnson & Johnson and its DePuy unit are now facing more than 10,000 DePuy ASR hip lawsuits stemming from the recall. Most of those have been filed in a federal multidistrict litigation underway in U.S. District Court, Northern District of Ohio. (In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, MDL 2197) However, thousands of others are pending in state courts in California and elsewhere.
The DePuy ASR hip is a metal-on-metal hip implant in which the ball and cup are made from a chromium-cobalt alloy. On January 17, 2013, the FDA advised doctors to consider metal ion testing if patients are experiencing symptoms of hip implant failure. The agency has also proposed a new regulation that would make all-metal hips ineligible for its 510(k) approval system, which allowed products like the ASR to come to market without human testing. According to the FDA, metal debris released by all-metal hips may cause damage to bone and/or soft tissue surrounding the implant and joint. Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause additional symptoms or illnesses.***
Bernstein Liebhard LLP is actively filing DePuy ASR hip lawsuits in the federal litigation underway in Ohio. The first trials in that proceeding are scheduled to begin this spring. Firm partner Jeffrey S. Grand is serving on the Plaintiffs’ Steering Committee in the federal DePuy Pinnacle litigation underway in U.S. District Court, Northern District of Texas, involving a metal-on-metal version of the Pinnacle Hip Replacement System. Court documents indicate that the first DePuy Pinnacle hip replacement lawsuit will go to trial in September 2014. (In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation - MDL No. 2244).
Bernstein Liebhard LLP is currently offering free legal evaluations to victims of alleged DePuy hip implant complications. A wealth of information about the DePuy ASR hip recall and other metal-on-metal hip implants is available on Bernstein Liebhard LLP’s website, http://www.consumerinjurylawyers.com/ . For additional information, please contact one of our attorneys by calling 877-779-1414.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.
Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Felecia L. Stern, Esq.
Bernstein Liebhard LLP