Stryker alleged that the Cormet hip resurfacing system was defective and required replacement surgery. However, the court agreed with Corin that the Medical Device Amendments Act wholly pre-empts this type of claim, due to the FDA's program of review and approval of the device and its warnings.
(In July 2011, Stryker announced it would cease distribution of the Cormet hip resurfacing system because it “no longer fits within Stryker’s long-term product strategy.”)
Preemption is a legal doctrine that means federal law displaces overlapping or related state law. Preemption can be either express or implied. In the context of a Class III medical device (such as DePuy hip replacement system) the applicable federal law is the Medical Device Amendments of 1976. (Most devices, such as Class I and Class II, were marketed after the FDA found them to be “substantially equivalent” to those devices already on the market before the Medical Device Amendments of 1976.)
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In Riegel v. Medtronic, Inc., the Supreme Court held that the 510(k) process does not place “requirements” on a device; “substantial equivalence” is not a safety requirement but an exemption from it. In other words, without a federal requirement there can be no preemption of state law tort claims.
The FDA approved the Cormet hip resurfacing system in 2007 (see below) through a process that found the product was safe and effective for its intended use—similar to how DePuy took advantage of the 5012(k) process to get its hip replacement system FDA-approved. The FDA also reviewed and approved the warnings and labels used with the Cormet hip resurfacing system.