In Brooks v. Mentor Worldwide, 985 F.3d 1272 (2021), the U.S. Court of Appeals for the Tenth Circuit waded into the “legal quagmire” facing parties who plead state-law claims for failure of a medical device and attempt to avoid preemption under the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetics Act (FDCA). Id. at 1276. Holding that plaintiffs failed to thread the needle, the circuit court affirmed the dismissal of their product liability claims.
In 1976, Congress passed the MDA, in which it regulated the safety and effectiveness of medical devices. Id. at 1276. The device at issue in Brooks, the “MemoryGel” silicone breast implant, was a Class III device. See id. at 1277. Such devices are subject to the strictest requirements, including a premarket approval (PMA) process administered by the FDA that consumes an average of over 1,200 hours and may last years. Id. Among other things, the PMA review includes warning and labeling. Id. The FDA can also impose post-approval reporting requirement on manufactures and can revoke approval based on new or existing data. Id.
Plaintiffs’ Allegations and the District Court’s Rulings
This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
To view this content, please continue to their sites.
LexisNexis® and Bloomberg Law are third party online distributors of the broad collection of current and archived versions of ALM's legal news publications. LexisNexis® and Bloomberg Law customers are able to access and use ALM's content, including content from the National Law Journal, The American Lawyer, Legaltech News, The New York Law Journal, and Corporate Counsel, as well as other sources of legal information.
For questions call 1-877-256-2472 or contact us at [email protected]