Tennessee Trial Court Holds Claims Preempted Notwithstanding Alleged Off-Label Use Of A Medical Device

Published date02 September 2021
Subject MatterConsumer Protection, Litigation, Mediation & Arbitration, Food, Drugs, Healthcare, Life Sciences, Product Liability & Safety, Trials & Appeals & Compensation, Personal Injury, Biotechnology & Nanotechnology
Law FirmWinston & Strawn LLP
AuthorAndrew Tauber

Today we discuss Sherrod v. Smith & Nephew, Inc., 2021 Tenn. Cir. LEXIS 74 (Tenn. Cir. Ct. 2021), a recent Tennessee trial court decision granting the defendant device manufacturer summary judgment on preemption grounds. Notwithstanding one quibble, there is much to like about the decision.

The plaintiff, who asserted a plethora of product-liability and consumer-protection claims, alleged that he was injured after undergoing two total hip replacements. He alleged that each surgery involved a hip implant that comprised four parts. One of those parts-an acetabular cup approved as a component of the Birmingham Hip Resurfacing (BHR) System-was a Class III device that had received premarket approval from the FDA. The remaining parts were Class II devices that had received 510(k) clearance.

The court granted the defendant manufacturer's motion for summary judgment on preemption grounds.

The court began its analysis with a discussion of 21 U.S.C. ' 360k(a), which-as readers of this blog surely know-expressly preempts any state-law claim that would impose any requirement on a medical device that is "different from, or in addition to," the federal requirements imposed on the device. Citing Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the court stated that claims implicating Class III devices with premarket approval are subject to preemption under ' 360k(a) but that devices with 510(k) clearance are not.

That brings us to our quibble, which is actually a point of considerable recurring frustration. Even if Lohr had been correctly decided at the time (which it was not), the decision is by now clearly outdated given intervening changes to the 510(k) process. Nonetheless, courts continue to mechanically recite its holding as if nothing has changed in the past quarter-century.

Fortunately, and correctly, the Sharrod court found Riegel, not Lohr, controlling on the facts presented.

The plaintiff argued that his claims were not subject to preemption under ' 360k(a), both because his hip implant was "a hybrid device" comprising four components, three of which had not received premarket approval, and because the component that had received premarket approval had been used in an off-label manner (i.e., in a manner not indicated on its FDA-approved label).

The court rejected each of the arguments.

First, citing 21 U.S.C. ' 396, which expressly allows doctors to use approved devices as they deem appropriate, and various...

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