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.
![10th Circuit Spotlight]()
Background on the MDA
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.
