On January 14, 2016, the U.S. Court of Appeals for Fourth Circuit issued a ruling in favor of transvaginal mesh injury victims in Cisson v. C.R. Bard, Inc. The decision is not just a victory for the plaintiff in this case and other victims of transvaginal mesh with pending lawsuits, there are more than 70,000, but a victory for anyone who has been injured by a defective medical device that was cleared by the U.S. Food and Drug Administration’s 510(k) process.
Originally, a jury ruled in favor of transvaginal mesh injury victims, Donna and Don Cisson awarding them $2 million, including $1,750,000 in punitive damages in their lawsuit against the device maker Bard.
In the appeal, Bard claimed that, during trial, it should have been able to use the fact that the mesh was cleared through the FDA’s 510(k) process as evidence that the device was safe. The district court had not allowed the device maker to admit evidence regarding 510(k) compliance.
The Fourth Circuit agreed with the district court’s decision not to allow Bard’s 510(k) compliance to be used as evidence, and affirmed the original judgement.
Why This is Important to Victims of Defective Medical Devices
The FDA’s 510(k) process is an expedited clearance process that allows medical devices to go to market without extensive safety testing. Instead, the device maker needs only to show that the new device is substantially similar to an approved device, which is called a predicate device. If the predicate device is found to be defective and recalled, subsequent devices that were based on the recalled device’s approval are not affected. They remain on the market.
Compliance with the 510(k) process does not show that a device is safe, but rather that the device maker was able to avoid the rigorous, expensive, and lengthy process normally required to prove device safety.
To put this in perspective, a 2011 study found that 71% of high risk medical devices recalled from 2005 through 2009 had been cleared through the 510(k) process. Furthermore, when the Institute of Medicine (IOM) reviewed the 510(k) process, at the request of the FDA, it found the process to be so flawed that it should be scrapped entirely and replaced with a new process.
If Bard’s appeal had been successful, it would have opened the door for device makers to misleadingly use 510(k) clearance as evidence of safety in future product liability cases.
If you have been harmed by transvaginal mesh or another defective medical device, please talk to an experienced defective medical device attorney right away to learn more about your rights.