In its October 13th Enforcement Report, the Food and Drug Administration released the lot numbers for hip implants affected by the DePuy recall. The defective implants include models within the ASR 100 and ASR 300 series. The enforcement report mentions “component loosening, component malalignment, infection, pain, fracture, dislocation and metal sensitivity” as reasons behind the recall. According to the report, there are 36,486 defective models in the stream of commerce at the time of publication.
A federal agency, the FDA, is charged with administering rules and regulations pertaining to food and medical products sold and marketed throughout the United States. The agency also acts as a watchdog to ensure medical devices are safe for consumer use prior to market approval. When the FDA or a manufacturer discover a product is defective after it has entered the marketplace, the FDA can use its regulatory powers to enforce a market recall.
As a matter of FDA compliance, DePuy, a Johnson & Johnson company, announced the recall of thousands of its hip implants in August amidst reports that 1 in 8 recipients had incurred some type of injury after insertion. Perhaps the most severe injury reported was metallosis, a condition that occurs when metal shavings from the implant lodge themselves into surrounding muscle and skeletal tissue. Metallosis is caused by the defective design of the DePuy implant, especially metal components that rub together without any lubricant or cushion in between them.
Due to the sheer amount of defective units released into the marketplace, DePuy hip implant recipients have been retaining attorneys for legal advisement during the past few months. One issue sure to define the direction of upcoming litigation is how long DePuy had knowledge of the hip implant defect before initiating the recall. Surfaced documents have suggested the company knew as far back as 2005 that the implants posed serious dangers to its users. Moreover, similar documents indicate the recalled hip implants were never properly approved for domestic use in the United States and thus were never scrutinized under usual consumer safety testing procedures. If this is the case, then the potential remedies for aggrieved individuals are sure to increase in scope.
Additionally, complications have arisen for recipients whose injuries were so serious that revision surgery was required. For those who had to incur a second surgery to rectify the harm caused by the implants lost wages, increased medical bills, and pain and suffering were all dreadful consequences these particular individuals endured in order to remedy their injuries. Clearly, the fallout from this recall will prove to be substantial.
The Berniard Law Firm has worked diligently in the past months to gather the facts and circumstances surrounding the DePuy hip implant recall. The firm has been adequately preparing for eventual litigation in order to assist recipients in the recovery for injuries caused by the implants.
If you have received a hip implant since 2003 or know somebody who has, please contact The Berniard Law Firm today. Attorneys are available to discuss any concerns or worries you may have pertaining to actual or potential complications stemming from hip implant surgery.