From the National Law Review: FDA Proposal to Regulate Laboratory Developed Tests Raises Legal Liability Questions for Labs

FDA Proposal to Regulate Laboratory Developed Tests Raises Legal Liability Questions for Labs

"The American Society of Human Genetics contends in its comment to the FDA that legal liability for labs will expand with FDA regulation, subjecting labs to the same tort liability as medical device manufacturers.  It is true that some jurisdictions apply strict liability schemes to manufacturers of medical devices.  However, other courts have expressly rejected the application of strict liability to medical device manufacturers, as they have to prescription drug manufacturers. See, for example, Terrell v. Davol, 2014 U.S. Dist. LEXIS 103695 (E.D. Pa. July 30, 2014), where the court found that Pennsylvania, which already barred strict liability claims against drug manufacturers, also prohibited such claims against device manufacturers."