FDA Warns DePuy To Cease Sales Of Artificial Joint Replacements Lacking Proper Approval
Bernstein Liebhard LLP reports that on December 8, 2011, the U.S. Food and Drug Administration (“FDA”) sent a warning letter to Johnson & Johnson subsidiary, DePuy Orthopaedics, to stop selling joint replacements that have not been properly approved by the FDA. According to the Wall Street Journal, the FDA notified DePuy that certain products lacked valid applications for premarket approval or investigational device exemptions. Additionally, the FDA found that DePuy failed to properly notify regulators of its plans to distribute 14 products as custom devices. The FDA letter explained that the devices at issue were not custom because they “do not deviate from generally available devices or from applicable performance standards, and they have common, standardized design characteristics, chemical and material compositions, or manufacturing processes.” In response to the FDA warning, DePuy has halted sales of certain products.
FDA Cites ASR Hip Implants As Support For Quality Control Issues
In addition to selling products that did not receive FDA approval, DePuy was also cited for lacking effective quality control procedures. The FDA noted that DePuy failed “to adequately employ appropriate statistical methodology where necessary to detect recurring quality problems.” In support of this violation, the FDA cited a 2008 study involving failure rates of its ASR implants, which were eventually subject to the August 2010 DePuy ASR hip recall. Following the August 2010 worldwide recall, numerous lawsuits have been filed against DePuy involving the ASR hip replacement implants. 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 Johnson & Johnson 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. If you or a loved one received a DePuy ASR hip implant during hip surgery and have experienced hip replacement pain or had to undergo revision surgery, you 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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