Did the FDA Know About DePuy's Recalled Hip Implants' Defects?

Did the FDA Know About DePuy's Recalled Hip Implants' Defects

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The Food and Drug Administration is tasked with ensuring that products sold to the public conform to certain minimum safety requirements, whether it's something as benign as chewing gum or as crucial as medical implants. The purpose of regulations is to prevent lawsuits, which are more expensive and do not benefit harmed consumers because people are better off uninjured than in court. Thus, the question becomes, what did the FDA know about DePuy's metal-on-metal hip implants before the recall?

Answer: Not much. We know that DePuy sent the ASR Acetabular System and the ASR Hip Resurfacing System to the market without undergoing clinical testing. It did this by using a regulatory loophole, the "510(k) process," that allows manufacturers to claim that their products are "substantially equivalent" to ones already approved and on the market. Somehow, DePuy was able to do this by claiming its products, which used a novel technology, still met the "substantially equivalent" requirements. Even worse, these hip implants were similar to ones that had also never been clinically tested, going back close to four decades when the regulatory process was first implemented.

Beyond this, we also know that there is no medical implant registry in the United States as there are in Europe (Great Britain in particular), and Australia. These registries served as an early warning system to health officials and doctors that something was wrong with the implant. These systems were so successful that DePuy phased the hip implants out of the Australian market long before the recall.

By contrast, neither the FDA, nor any private organization maintains a registry anyone can rely on. Instead the FDA tracks the number of complaints a product receives. As complaints mount, inquiries begin. Last March, the New York Times reported that by the end of 2009, the FDA had received slightly more than 300 complaints for DePuy's ASR hip implants. Of them, 90% of the complainants had to undergo revision surgery. The implants only entered the market in 2003, meaning many hip implant recipients or orthopedists chose not to send product complaints because they believed nothing was wrong with the hip implants. DePuy also claimed that problems resulted from surgeons improperly implanting the devices, which would further confuse recipients as to whether the company was responsible for their harm due to poor product design.

Because the FDA improperly regulated the defective hip implants DePuy sent to the market, many recipients have been harmed, and now require relief. One of the best options for them is to file a lawsuit against DePuy. If you are one of those affected, then you should contact the Rottenstein Law Group for a free initial consultation.

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