Academic journal article Defense Counsel Journal

Negligent Manufacture Claim Not Preempted by MDA

Academic journal article Defense Counsel Journal

Negligent Manufacture Claim Not Preempted by MDA

Article excerpt

Claims that the hip stem in a hip prosthesis was negligently manufactured because it was not in accordance with Food and Drug Administration standards survived a federal preemption defense in the Seventh Circuit, but counts based on strict liability and breach of implied warranty were held preempted by the Medical Device Amendments of 1976 (MDA).

The MDA's preemption provision at issue was 21 U.S.C. 360k(1), which preempts any state requirement "which is different from, or in addition to, any requirement applicable" to the device under federal law or regulation.

The plaintiff had his arthritic right hip replaced in 1985 with a device designed and manufactured by Osteonics Corp. In 1992, he slipped and fell, and the hip stem fractured. He sued in the federal district court in Indiana under Indiana law, claiming that the device was defective and unreasonably dangerous for its intended use because it was subject to corrosion and weakness. The trial court granted Osteonics summary judgment on all the claims on its contention that the action was preempted by the MDA and that the plaintiff had not offered enough to defeat summary judgment.

The FDA had authorized Osteonics to manufacture the stem as a Class III device under an investigational device exemption, which allows a manufacturer of an experimental device to obtain FDA approval with a less rigorous review than usual in order to encourage experimentation leading to new developments. …

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