A lawsuit against the makers of a cochlear implant can go forward, a federal judge in Texas has ruled, because a Supreme Court decision that gave medical device makers protection from product liability lawsuits does not apply to this case. In her opinion, US District Court Judge Barbara Lynn wrote that preemption was not warranted in the case because “plaintiffs’ strict liability claims are predicated solely on violations of federal law.”
In February, the Supreme Court ruled in favor of medical device makers in Riegel vs. Medtronic, Inc., granting them protection from product liability lawsuits involving devices that had been approved by the Food & Drug Administration (FDA). Before the High Court, Medtronic had successfully argued 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 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.
In their lawsuit filed last September against Advanced Bionics and Astro Seal, Scott and Pamela Purcel blamed the companies’ cochlear implants for injuries their son received. The Purcels’ suit centers around a single component of the HiRes90k — a feed-thru manufactured by Astro Seal — that was used to connect the device’s internal electrical circuitry to external components. Advanced Bionics issued a voluntary recall of all nonimplanted HiRes90k devices containing Astro Seal feed-thrus in September 2004 because moisture could get into the internal circuitry, which could cause the device to fail.
The Purcels’ lawsuit alleges that Advanced Bionics violated federal law when it made the defective cochlear implant. That allegation grew out of an administrative claim filed against Advanced Bionics by the FDA last November. The claim, which was amended in March, accused the company of using components from an unapproved supplier. The company settled with the FDA in July by agreeing to pay a $1.1 million fine, the maximum the FDA can impose on an individual or company. As part of the settlement, Jeffery Greiner, Advanced Bionics’ president and co-CEO, also agreed to pay a $75,000 fine.
Because the plaintiffs’ claims involve violations of federal law, the judge wrote that lawsuit does not impose requirements that are additional, or different from, those imposed by the Medical Device Amendments of 1976. As such the lawsuit is not covered by the Supreme Court’s ruling in Medtronic vs. Riegel, the judge ruled.
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