As we’ve pointed out elsewhere, particularly in our duty to test cheat sheet, most states do not recognize any sort of separate negligence or strict liability claim for “duty to test” or “failure to test” separate and apart from the more usual sort of product liability claims involving the design and warnings of products.  So defendants looking to file motions to dismiss against testing-based counts of their opponents’ complaints could do worse than to check out our cheat sheet.

Manufacturers of FDA pre-market approved medical devices, however, have a second option.  They can also go after testing-based claims on preemption, because claims that manufacturers of such devices should have done more or different testing than the FDA considers necessary for approval are either “different from or in addition to” the FDA’s PMA criteria.  Indeed, the seminal express preemption case, Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), recognized that express preemption under 21 U.S.C. §360k(a) extends to “tort law, applied by juries under a negligence or strict-liability standard,” such as state tort claims alleging “negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of [a PMA device],” id. at 320, although the dismissed testing claims were not separately discussed by the Supreme Court in Riegel.Continue Reading PMA Preemption of Negligent Testing Claims