On February 3, 2016, Corin Group PLC and Corin USA Limited (Corin) prevailed in a lawsuit alleging injuries from Corin’s hip resurfacing system, the Cormet, a Class III medical device approved by the U.S. Food and Drug Administration (Swisher v. Stryker Corporation, et al.).

After full discovery, Corin filed motions for summary judgment and to exclude the plaintiff’s sole liability expert, metallurgist Charles Powell. The U.S. District Court for the Western District of Oklahoma excluded the relevant opinions of Powell and granted summary judgment in favor of Corin on all claims, holding, according to Corin, that there was no evidence of the purported defect in the device nor any evidence of medical causation for the plaintiff’s alleged injuries

The company challenged Powell on Daubert grounds. The Supreme Court has determined that the general standards for a Daubert challenge to expert testimony requires the trial judge to ensure “that any and all scientific testimony or evidence is not only relevant, but reliable.”

Corin claimed that Powell’s prior experience and training were substantially in areas other than medical devices. “The limited experience he does have with medical devices did not involve Class III devices such as the Cormet system. He has no experience or training with respect to the FDA approval process at issue here. He does not have the necessary expertise to express an expert opinion about the nature of the approval process or what the FDA may have viewed as complying, or not complying, with the standards of ASTM F-75. In particular, he does not have the expertise to identify those things that the FDA may have viewed as ‘inherent’ in the ASTM standard. As a result, Mr. Powell lacks the necessary qualifications to express [such] opinions.”

The Court agreed, saying that Powell’s testimonial theory was inventive, “but it wholly lacks a reliable basis in light of the explicit nature of the ASTM F-75 standard and the nature of the process that it is a part of.”

Read More – Source: Corin Wins Summary Judgement in Metal-on-Metal Hip Suit | Orthopedics This Week

by: Walter Eisner