Lawyer Commentary Mondaq United States Tennessee Trial Court Holds Claims Preempted Notwithstanding Alleged Off-Label Use Of A Medical Device

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

Document Cited Authorities (6) Cited in Related

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...

Experience vLex's unparalleled legal AI

Access millions of documents and let Vincent AI power your research, drafting, and document analysis — all in one platform.

Start a free trial

Start Your 3-day Free Trial of vLex and Vincent AI, Your Precision-Engineered Legal Assistant

  • Access comprehensive legal content with no limitations across vLex's unparalleled global legal database

  • Build stronger arguments with verified citations and CERT citator that tracks case history and precedential strength

  • Transform your legal research from hours to minutes with Vincent AI's intelligent search and analysis capabilities

  • Elevate your practice by focusing your expertise where it matters most while Vincent handles the heavy lifting

vLex

Start Your 3-day Free Trial of vLex and Vincent AI, Your Precision-Engineered Legal Assistant

  • Access comprehensive legal content with no limitations across vLex's unparalleled global legal database

  • Build stronger arguments with verified citations and CERT citator that tracks case history and precedential strength

  • Transform your legal research from hours to minutes with Vincent AI's intelligent search and analysis capabilities

  • Elevate your practice by focusing your expertise where it matters most while Vincent handles the heavy lifting

vLex

Start Your 3-day Free Trial of vLex and Vincent AI, Your Precision-Engineered Legal Assistant

  • Access comprehensive legal content with no limitations across vLex's unparalleled global legal database

  • Build stronger arguments with verified citations and CERT citator that tracks case history and precedential strength

  • Transform your legal research from hours to minutes with Vincent AI's intelligent search and analysis capabilities

  • Elevate your practice by focusing your expertise where it matters most while Vincent handles the heavy lifting

vLex

Start Your 3-day Free Trial of vLex and Vincent AI, Your Precision-Engineered Legal Assistant

  • Access comprehensive legal content with no limitations across vLex's unparalleled global legal database

  • Build stronger arguments with verified citations and CERT citator that tracks case history and precedential strength

  • Transform your legal research from hours to minutes with Vincent AI's intelligent search and analysis capabilities

  • Elevate your practice by focusing your expertise where it matters most while Vincent handles the heavy lifting

vLex