Federal preemption of medical device liability lawsuits has been a volatile issue in recent years, with the courts typically preempting product liability lawsuits citing violations of individual state safety standards. However, in Bausch v. Stryker Corporation, et al., No. 09-3434, the issue was whether a product defect claim citing federal safety standard violations was also preempted by that product having federal approval. While a Chicago federal district court had dismissed Ms. Bausch’s claim, that decision was recently overturned by the United States Court of Appeals for the Seventh Circuit. That Court of Appeals decision permitted Mr. Bausch to pursue his claim in federal court.
The case facts of the Bausch medical device lawsuit involve a hip replacement 56 year-old Margaret Bausch underwent, during which she received a Trident brand ceramic-on-ceramic hip replacement system manufactured by Stryker Corporation. The prosthetic hip device ended up failing and required an additional surgery to have it removed.
The specific type of prosthetic hip Ms. Bausch received was approved for sale in the U.S. by the Food and Drug Administration (FDA), but was later recalled due to a failure to comply with federal standards. In her Chicago medical device lawsuit, Bausch’s attorneys cited Stryker’s failure to comply with federal standards during the manufacturing process of its prosthetic hip devices.
The defendant manufacturers filed a motion to dismiss the Chicago product liability lawsuit, citing prior federal preemption cases. The judge ruled in favor of the defendants’ motion to dismiss, holding that plaintiff’s common law claim for damages was preempted by federal law since the medical device was FDA-approved. Prosthetic hip implants like the one at issue in Bausch are classified as “Class III Medical Devices” under the federal Food, Drug and Cosmetics Act and are subject to a rigorous premarket approval process.
When reviewing the district court’s decision in Bausch, the Court of Appeals referred to the precedent set by the U.S. Supreme Court prior ruling in Riegel v. Medtronic Inc.. Specifically, the Court of Appeals noted that in Riegel, the Supreme Court held that medical device lawsuits brought under state law against medical device manufacturers who obtain the full federal “premarket approval” are preempted by section 360k(a) of the Medical Devices Act. This preemption is based on the assumption that the product defect claim is based on violations of state law requirements that are either stricter or just different than federal requirements regulating the devices.
Therefore while Riegel barred product defect claims based on state safety violations, it did not specifically deal with preemption of state-filed claims based on violations of federal standards. In its opinion, the Court of Appeals stated that “the idea that Congress would have granted civil immunity to medical device manufacturers for their violations of federal law that hurt patients is, to say the least, counter-intuitive.”
The Court of Appeals reversed the district court’s dismissal of Ms. Bausch’s Chicago product liability claim and opined that the defendant’s motion had stretched the Supreme Court’s decision in Riegel beyond the boundaries that were intended. The Supreme Court had meant to preempt medical device lawsuits based on violations of state standards, not federal manufacturing standards. In all other federal preemption lawsuits the federal standards had been met, whereas in Bausch the product defect claims were based on violations of federal, not state, standards.
Bausch will be remanded to Chicago’s district court for further handling. The plaintiff still needs to prove issues of causation and liability; the point is that at least now she has earned the right to seek justice in a court of law.
Kreisman Law Offices has been handling successfully complex Illinois medical device claims andIllinois product defect cases for more than 35 years in and around Chicago, including Mount Prospect, Arlington Heights, Skokie, and South Holland.
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