Missouri Federal Court Finds Injury Claims Preempted By FDCA’s Medical Device Amendments

The defendant manufacturer of a medical device was sued after complications arose from a surgery in which the medical device had been used in an “off-label” manner.  The plaintiff’s suit asserted claims for “(1) manufacturing defect, (2) design defect, (3) failure to warn, (4) negligence, (5) strict liability (excluding design defect), (6) breach of express warranty, (7) fraudulent misrepresentation and fraud in the inducement, (8) fraud by concealment, (9) misrepresentation, (10) negligence per se, and (11) violations of the Missouri Merchandising Practices Act.”  Ruling on a motion to dismiss earlier this week, the U.S. District Court for the Western District of Missouri concluded that the plaintiff’s manufacturing and design defect, failure to warn, negligence, and strict liability claims were preempted by the Medical Device Amendments (“MDA”) to the Federal Food, Drug and Cosmetic Act (“FDCA”).  The court explained that the MDA established requirements for the manufacture, design, and labeling of the medical device in question and that the plaintiff’s claims would have imposed additional requirements on the defendant.  Thus, the claims were expressly preempted.  Further, the plaintiff’s negligence per se and negligent marketing claims were impliedly preempted because they only existed by virtue of the standards of care imposed on the defendant manufacturer by the MDA.  The court also dismissed all but one of the plaintiff’s remaining claims (a claim under the Missouri Merchandising Practices Act) for failure to plead sufficient facts and for failure to plead with particularity under Rule 9(b).