DePuy Recall Leads to Bipartisan Senate Bill

The DePuy hip replacement recall, which began in August 2010, was unprecedented. It was so newsworthy that on December 14, 2011, the New York Times reported that three U.S. senators proposed a new bill affecting medical device regulations as a response.

More Implant Monitoring

The three senators, Herb Kohl (D-WI), Richard Blumenthal (D-CT), and Charles E. Grassley (R-IA) proposed a bill that would allow the U.S. Food and Drug Administration (FDA) to require device manufacturers to monitor their implants in recipients if they went through the 510(k) premarket approval process (510(k) process). Loopholes in the 510(k) process are in part responsible for the recall. It allowed DePuy to claim that the recalled ASR XL Acetabular System and ASR Hip Resurfacing System were “substantially similar” to artificial hip replacements that were already on the market to forgo clinical trials. DePuy was able to do this even though the ASR hips were novel metal-on-metal designs. Worse, the hip replacements with which DePuy claimed the ASR were similar had themselves been cleared through the 510(k) process, and the chain of approvals go back to devices that were grandfathered when the regulation was adopted.

“There is clearly a need for scrutiny once products are implanted or used on patients,” Senator Blumenthal said.

President Obama Takes No Position

FDA spokeswoman, Karen Riley, stated that the Obama administration had taken no position. The Times added that legislators have proposed a “wave” of medical device industry-friendly bills that would further “streamline” FDA regulations, allowing more product clearances.

What the bill does not do is alter the 510(k) process itself, even though the medical community’s Institute of Medicine called for its reform in publication last summer. Nor does the bill speak towards the creation of a national joint registry, which is currently ongoing. Instead, it merely requires monitoring by manufacturers. Hopefully, this will deter them from clearing implants without testing them.

RLG Advocates for Those Injured by ASR Devices

If you received an ASR device and believe it injured you, it is important to know that the amount of compensation from a hip replacement lawsuit might be greater than what you might receive going through DePuy’s claims process. The Rottenstein Law Group’s DePuy hip recall lawyers are offering free consultations to ASR recipients. Simply click on this link or call 1-877-619-5087 and an attorney will reach out to you as soon as possible.

For more information on the DePuy recall, download this free brochure.