A recent Bloomberg article, reported that House Democrat Edward Markey (MA) has sponsored a bill that would prevent manufacturers from asserting that their new medical devices are “substantially equivalent” to existing, approved devices, under certain circumstances. While the bill was apparently developed as a result of a 1999 recall of vaginal mesh manufactured by Boston Scientific, it is particularly relevant given the recent litigation over the 2010 recall of the DePuy Orthopaedics’ ASR hip replacement devices.
The ASR device was approved for U.S. marketing through the 510(k) premarket approval process, which permits the manufacturers to claim their new products are “substantially equivalent” to preexisting ones. If successful, the manufacturers are able to avoid exposing their devices to more thorough clinical trials, which can often take years and can further delay introduction to the market. However, many times, the immediately preexisting device was also approved in the same manner, so that the lineage originates at an old, untested device.
The new bill would allow the Food and Drug Administration (FDA) to deny a manufacturers ability to claim its device is “substantially equivalent” to a preexisting device if the preexisting device was recalled or if the FDA was in the process of deciding to remove it. The manufacturers would also be required to demonstrate the difference between their new device and the problematic device as well as advise Congress if any device in the product’s lineage had been recalled.
In support of the bill, Representative Markey commented, “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.” He further opined that the bill ensures “that devices do not mimic the mistakes made by other products.”
At this time, it is unclear whether the bill will garner the necessary support of Congress and President Obama to become law.
If you have had a hip replacement, which used the DePuy ASR or Pinnacle devices, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against the DePuy manufacturers.