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.