In August 2010, DePuy Orthopaedics (a Johnson & Johnson Company) issued a worldwide recall of two hip replacement devices: the ASR XL Acetabular System and the ASR Hip Resurfacing System. The recall was prompted by new data from the National Joint Registry for England and Wales that showed the ASR devices have a five year revision rate of roughly 12.5 percent, a rate that is double the industry average.
By effectively admitting it manufactured two defective products, DePuy set the stage for hundreds of lawsuits that have since followed. And although they are similar, not all of the allegations made by plaintiffs against the company are identical, nor do they have the same legal grounds. Three distinct charges against DePuy have emerged in the last few months. The first accuses the company of failing to adequately test and research the implants. A second claims that DePuy failed to issue a recall when it knew about problems with the ASR devices. A third charge alleges that DePuy attempted to deceive patients about compensation for out-of-pocket expenses related to the recall.
The first of these charges, that DePuy did not adequately test and research the ASR devices, is based on product liability laws. These laws provide protection for consumers by holding manufacturers, distributors, suppliers, retailers, and others along the “chain of distribution” of a product liable for injuries those products cause. (Liable in this sense means legally responsible). There are three major types of product liability claims: manufacturing defects, design defects, and failure to warn (also called marketing defects). By claiming that DePuy failed to properly test and research the ASRs, claimants are invoking the design defect theory of product liability. (Note that this is not an instance of a manufacturing defect, because the ASRs were produced according to specification…only the specification in this case was the problem.)
The second charge, that DePuy failed to issue a recall when they knew about ASR deficiencies, is also supported by product liability laws. In this case, the legal justification comes from the failure to warn provision of product liability. There is considerable evidence that DePuy knew about the high revision rate associated with the ASRs for years but failed to issue a recall. It follows logically that had patients known about the ASR defects, they either would have chosen another brand of implant, or would have become aware sooner of the source of their pain, weakness, and other side effects, and taken remedial action sooner.
A recent class action lawsuit filed against DePuy stems from an altogether different charge against the orthopedic manufacturer. The class action suit was filed on September 30 in Ohio and alleges that DePuy deceived patients in regards to reimbursement for medical costs related to the ASR recall. According to the charges, DePuy misled patients into believing that by signing medical releases that grants the company access to their medical records and providing extracted hip implants to DePuy, patients would receive compensation for their losses. DePuy, on the other hand, said it will reimburse patients only for costs that the company deems to be reasonable (a standard DePuy alone is to decide). Furthermore, patients not only risk receiving no compensation at all, but by releasing access to their medical records and handing over their removed hip implant, they may be giving up the means to hold DePuy financially accountable through legal action. If the court determines that the alleged deceptive practices by DePuy did in fact occur, the company could be found guilty of fraud.
Patients who are uncertain about what brand their hip replacement is should contact their orthopedic surgeon or the hospital where the hip replacement surgery was performed. If, after confirming you were implanted with an ASR, you wish to take legal action, your next step should be to speak with an attorney who can explain your rights and which of the legal theories in the lawsuits described above best applies to your circumstances.