CORIN WINS SUMMARY JUDGEMENT IN METAL-ON-METAL HIP SUIT (Orthopedics This Week)
Rack one up in the win column for a metal-on-metal hip manufacturer.
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.”
A spokesperson for Crowell & Moring LLP, the company’s law firm, told OTW that the firm believe this case is important to our readers because the Cormet is one of only three metal on metal hip devices fully approved by the FDA under the Premarket Approval (PMA) process for sale in the U.S. Furthermore, any claims regarding the design or other FDA-approved aspects of the device are expressly preempted by the Medical Device Amendments to the Federal Food, Drug and Cosmetics Act.
“Traditionally, courts have dismissed claims regarding the Cormet at the pleading stage, but some plaintiffs have attempted to sidestep preemption by alleging, without a factual basis, that Corin violated some FDA statute or regulation that caused the alleged injury. That was the path taken by the plaintiff in this case, which was the first case against Corin to avoid complete dismissal at the pleadings stage.”
Finally, the spokesperson said the Court’s rulings demonstrated that after full discovery, “Corin’s device was manufactured exactly as intended and that the allegations used to avoid preemption at the pleadings stage were without merit.”