U.S. District Judge Excludes FDA 510(k) Evidence in Medical Device MDL
In an MDL regarding the safety of certain medical devices, the U.S. District Court for the Southern District of West Virginia granted the plaintiffs’ motion in limine to exclude FDA 510(k) evidence related to the FDA’s pre-market notification process on the grounds that the process does not go to the safety or efficacy of medical devices and because of the potential to mislead and confuse the jury. U.S. District Judge Joseph R. Goodwin considered the motion under Illinois law, where a plaintiff must prove that a product is “unreasonably dangerous” under either the consumer expectation test or the risk-utility test to recover on product liability claims. The court explained that the safety of the product at issue is the focus of either test and clearance to market under the 501(k) process does not relate to safety or the efficacy of a product. The court noted that for evidence of compliance with a federal regulation to potentially be relevant in such a case, the regulation must relate to the safety or efficacy of the product; evidence of compliance with any federal regulation is not enough.
