June 27, 2019

Tenth Circuit: Tort Claims Against Medical Supplier Preempted by Medical Devices Amendments to FDCA

The Tenth Circuit Court of Appeals issued its opinion in Caplinger v. Medtronic, Inc. on Tuesday, April 21, 2015.

Patricia Caplinger had a bone stimulator device implanted in a non-approved fashion after the Medtronic company representative encouraged her surgeon to implant it using the “off-label” approach. She suffered adverse consequences from the implantation and discovered the company knew of the risks of using the device in the way the representative had encouraged her surgeon to try. Ms. Caplinger alleged Medtronic was liable under a number of state tort theories, but the district court held the claims were either insufficiently pleaded or preempted. Ms. Caplinger appealed.

The Tenth Circuit first noted that § 360k(a) of the Medical Devices Amendments (MDA) to the Federal Food, Drug, and Cosmetics Act (FDCA) preempts “any requirement” imposed by states on manufacturers of medical equipment that differs from or adds to those found in the FDCA. Although the expansive preemption language seems to foreclose any state tort suits, Supreme Court precedent allows some tort claims. Addressing Ms. Caplinger’s claims for strict products liability, breach of warranty, negligent misrepresentation, and negligence, the Tenth Circuit found the MDA preempted all her claims. In her complaint, Ms. Caplinger failed to identify any parallel federal statutes to the state regulations. The Tenth Circuit upheld the district court’s judgment as a matter of law in favor of Ms. Caplinger. The Tenth Circuit similarly disregarded Ms. Caplinger’s argument that the off-label use contemplated by her suit insulated her claims for preemption.

The Tenth Circuit affirmed the district court. Judge Lucero wrote a thoughtful and detailed concurrence.

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