Johnson & Johnson Sold ASR Hip Implants Abroad Following FDA Rejection
Bernstein Liebhard LLP reports on a February 15, 2012 article published in the New York Times revealing that Johnson & Johnson (“J&J”) continued to sell one model of its DePuy ASR hip replacement implants abroad after the U.S. Food and Drug Administration (“FDA”) rejected J&J’s application for approval to market and sell the metal-on-metal artificial hip replacement device in the United States. According to the New York Times, in August 2009, the FDA sent J&J a confidential letter stating that studies and clinical data submitted to the agency by J&J were inadequate to determine the safety and effectiveness of the ASR Hip Resurfacing System. J&J was not required to disclose the FDA’s decision to foreign health regulatory agencies. Therefore, notwithstanding the FDA’s decision, J&J continued to sell thousands of the devices in Europe before issuing a worldwide ASR hip recall in August 2010. The August 2010 recall included all variations of the DePuy ASR hip implants, and was issued after DePuy Orthopaedics, a subsidiary of J&J, received data from the National Joint Registry of England and Wales that 1 out of every 8 patients (12%-13%) who received the ASR hip implants had to undergo revision surgery within five years of implant. It is not known how many people overseas received the ASR Hip Resurfacing System after the FDA denied its approval in 2009.
Hip Replacement Lawsuits Mount Following DePuy ASR Hip Recall
Since the recall, litigation over the defective ASR hip implants has surged. The New York Times estimates that 5,000 hip replacement lawsuits have been filed against J&J over the implants that were subject to the ASR hip recall. In January 2012, J&J took a special $3 billion charge, much of which is related to anticipated legal and medical expenses stemming from the recall.
The DePuy hip recall lawyers at Bernstein Liebhard LLP are actively filing cases on behalf of individuals allegedly injured by the artificial ASR metal-on-metal hip implants in 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.
Since J&J issued its hip replacement recall 2010, Bernstein Liebhard LLP has provided a wealth of consumer information concerning the ASR hip systems on its website, www.consumerinjurylawyers.com. Those who underwent hip replacement surgery and 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.
For more information about filing a DePuy ASR lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at email@example.com.
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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