In 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that medical device manufacturers may not be held liable through product liability lawsuits involving devices that were approved by the FDA under the more stringent testing requirements of PMA, which is known as preemption.
Following increasing reports of problems with metal-on-metal hip replacements in recent years, the FDA has been pushing to requiring manufacturers to put their devies through PMA process. Most metal-on-metal hip designs were introduced under the FDA’s controversial 510(k) approval process, which allowed manufacturers to gain approval without conducting rigorous testing by establishing that the design of their device was a “substantial equivalent” to a previously approved design.
However, the American Association for Justice is now warning that there may be hidden dangers in the FDA’s recent push to require metal-on-metal hip makers to put their devices through more extensive testing process, indicating that if metal-on-metal hip replacement systems are reclassified as approved through the FDA’s PMA process, it may block plaintiffs from obtaining a recovery through hip replacement lawsuits pending nationwide.
The advocacy group is urging the FDA to take steps to avoid this injustice for consumers who have suffered complications caused by metal-on-metal hip implants, including loosening of components that often results in early failure of the device and the need for risky revision surgery.
“We can envision a manufacturer seeking to gain retroactive immunity if a device is ultimately approved through a PMA, even though that would be chronologically absurd and terribly wrong,” the AAJ President Mary Alice McLarty wrote in a letter to the FDA (PDF). “Therefore we request language that makes it explicit that such an argument would have no footing.”
Metal-on-Metal Hip Poisoning ConcernsThe FDA has increased scrutiny of metal-on-metal hips in response to increasing concerns about the effects of metallic debris that may be released as the metal parts rub against each other, potentially causing tissue damage and metal blood poisoning, also known as metallosis.
In January, the FDA released new guidance for metal-on-metal hip replacements that called for them to go through the PMA process. The agency told doctors that metal-on-metal hip replacement systems should only be used if other artificial hip implants were not appropriate, and called on manufacturers to prove that their implants were safe enough to stay on the market.
Thousands of individuals throughout the United States are currently pursuing product liability lawsuits against the makers of metal-on-metal hip replacement systems, including the recalled DePuy ASR hip, Depuy Pinnacle metal hip, Biomet M2A Magnum Hip and Wright Conserve Cup System.
The complaints all involve similar allegations that the manufacturers failed to adequately research the design or warn about the risk of problems before introducing the products. However, AAJ is raising concerns that these lawsuits may be preempted if the FDA now approves the devices under the PMA process.