Hearing Aid Lawsuit Dismissed Due to High Court Pre-emption RulingApr 11, 2008 | Parker Waichman LLP
A recently-dismissed lawsuit against the maker of a defective hearing aid provides a window into the a recent US Supreme Court decision will affect people injured by defective medical devices. That decision gave medical device makers protection from state product liability lawsuits in cases where a device has been approved by the Food & Drug Administration (FDA). Because of that decision, the Arkansas Supreme Court on Thursday reinstated the dismissal of a lawsuit filed against Soundtec, a maker of hearing aids, by a man who claimed he suffered ear damage after having a hearing device implanted in his right ear in 2002.
In February, the US Supreme Court ruled in favor of medical device makers that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims. Medtronic, which had brought the case before the Supreme Court, and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.
Eight members of the Supreme Court agreed. In his majority opinion, Justice Antonin Scalia wrote that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the FDA has the responsibility for evaluating the risks and benefits of a new device. Justice Scalia wrote that state tort law amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions.
While the US Supreme Court ruling will nullify some medical device product liability lawsuits currently making their way through state courts, it is unclear how great an affect it will really have, because most medical devices on the market today went through a different approval process than the one at issue in this case.
One lawsuit the ruling apparently did nullify was Gary Depain's claim against Soundtec. In 2004, Soundtec successfully argued federal law pre-empted state law in the matter, and the state court therefore had no jurisdiction. Despain's attorneys appealed, and the Arkansas Supreme Court agreed in February that federal law did not pre-empt state law. Despain's lawsuit was returned to the lower court for trail. But less than two weeks later, the US Supreme Court handed down the pre-emption decision. Soundtec's lawyers asked the Arkansas Supreme Court to reconsider its earlier decision, and the panel reinstated the dismissal, citing the High Court decision in doing so.
The lawyer representing Despains said in February his client remains unemployed and disabled from the device, which caused severe ringing in his ear and later was removed. Gary Despain worked at Franklin Electric Co., where welding machines produced electromagnetic fields that aggravated the problem.