The limitations of the U.S. Food and Drug Administration’s (FDA’s) medical device approval process explains the enormity of the DePuy ASR hip recall. DePuy Orthopaedics’ ASR XL Acetabular System and ASR Hip Resurfacing System both received FDA approval through the 510(k) premarket approval process (510(k) process), which allows medical device manufacturers to claim their new products are “substantially equivalent” to preexisting ones to avoid subjecting their devices to more rigorous clinical trials. The problem is that the preexisting products often received approval through the same process, and the “device lineage” goes back to an old, untested product. One problem within this already broken medical device approvals process is that sometimes the preexisting device turns out to have dangerous flaws that subsequent manufacturers do not bother to correct, injuring even more patients. Now, the U.S. Congress appears interested in remedying this aspect of the 510(k) process.
Future Models Wouldn’t ‘Repeat Same Flaw’ under the Bill
On February 2, 2012, Bloomberg‘s Web site reported that House Democrat Edward Markey (MA) sponsored a bill that would prevent medical device manufacturers from claiming their new products are “substantially equivalent” to existing, approved problematic devices. Specifically, the bill came about not because of the DePuy hip recall but because of a 1999 recall of vaginal mesh manufactured by Boston Scientific. Despite the numerous injuries Boston Scientific’s mesh caused women, subsequent manufacturers still used it to help their newer meshes through the 510(k) process. As a result, many women were injured.
If passed into law, the bill would permit the FDA to deny 510(k) premarket approval if the manufacturer of the preexisting device(s) had recalled their product or if the FDA was in the process of deciding to remove it. Manufacturers would also have to demonstrate how their new devices differed from troubled ones, and importantly, they would have to report to Congress if any devices in their current products’ “device lineages” had been recalled.
When asked to comment on the bill, Representative Markey said, “If an automobile is recalled for a major safety problem, we wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies.” “The bill ensures that devices do not mimic the mistakes made by other products.”
RLG Represents People Injured by Defective Medical Devices
The benefit of the proposed changes to the medical device approvals process would be to require any medical device manufacturers that based their products on the recalled DePuy ASR devices to show how their proposed products differ. While it might prevent injuries from metal-on-metal devices in the future, unfortunately it does nothing for those who have already suffered an injury. If you received a recalled ASR implant, it’s important to know that the amount of compensation from a DePuy lawsuit might be greater than what the company will pay you through its recall reimbursement program. A lawsuit can allow a plaintiff to recover medical expenses, lost income, transportation expenses, and damages for pain and suffering. For a free consultation with a hip replacement from the Rottenstein Law Group, click on this link or call 1-877-619-5087.
If you would like more information on the ASR recall, download this free brochure.