DePuy Phased Out Hip Implants Rather Than Provide FDA With Data On ASR Failure Rates
Bernstein Liebhard LLP reports on a March 22, 2012 article published in the New York Times revealing that Johnson & Johnson executives decided to phase out its ASR hip implants after the U.S. Food and Drug Administration (“FDA”) asked the Company to provide more data on the safety of the devices in order to receive market approval.* Specifically, the August 2009 letter from the FDA notified DePuy that it was turning down the company’s application to sell the ASR resurfacing device in the United States. A “sister version” of the device was used both in the U.S. and abroad for traditional total hip replacement surgery. In this confidential letter to DePuy that the New York Times obtained via a Freedom of Information Act request, the FDA cited high ASR failure rates as well as “high concentration of metal ions” in patients who received the devices. The FDA noted that they found the high concentration of metal ions “concerning” and that other countries reported that the devices were performing “somewhat more poorly” in comparison to the data submitted by DePuy.
In response to the letter, according to the New York Times, DePuy executives chose to phase out the device by ceasing production of the ASR implants and selling off its existing stocks. Instead of disclosing the issues raised by the FDA to doctors or patients, the Company simply encouraged orthopedic surgeons to use other models manufactured by DePuy.
High ASR Failure Rates Lead To Worldwide Hip Implant Recall
DePuy executives maintain that their decision to phase out the model was based on declining product sales, rather than safety concerns over the ASR failure rates or the FDA’s decision to deny approval. However, in August 2010, after receiving data from the National Joint Registry of England and Wales that 1 out of every 8 patients (12%-13%) who received its metal-on-metal ASR hip implants had to undergo revision surgery within five years of implant, DePuy issued a worldwide voluntary hip implant recall of all variations of the ASR hip implants. An estimated 93,000 individuals worldwide were affected by the hip implant recall. It is not known how many of those individuals received the ASR resurfacing device between the time it was rejected by the FDA and the hip implant recall.
The DePuy hip replacement lawyers at Bernstein Liebhard LLP are actively filing cases on behalf of individuals who have been implanted with metal-on-metal hip implants manufactured by DePuy in the following actions: In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (“MDL No. 2197”), which is currently underway in the U.S. District Court for the Northern District of Ohio and In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation (“MDL No. 2244”), which is currently underway in the U.S. District Court for the Northern District of Texas. The lawsuits allege that the ASR hip replacement and the metal-on-metal Pinnacle hip replacement systems were defectively designed.
Since Johnson & Johnson recalled the ASR hip implants in August 2010, Bernstein Liebhard LLP has provided a wealth of consumer information concerning the ASR hip systems on its website, www.consumerinjurylawyers.com. Those who received a DePuy ASR hip implant and have experienced hip replacement pain or had to undergo revision surgery may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries.
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 nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.
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