13 февр. 2012 г.

Stryker Hip Suit Isn't Completely Preempted, 5th Circuit Rules

Federal law regulating medical devices doesn't completely preempt the claims of a plaintiff who alleged that a hip replacement product malfunctioned and caused him injury, the 5th Circuit has ruled.

The plaintiff underwent surgery involving the implantation of a Trident hip replacement system in his left hip. The Trident system is manufactured by Stryker Corp. The plaintiff later experienced loosening in the joint which required a surgical revision of his hip replacement.

The plaintiff filed a product liability suit, alleging that contamination of the shell of the Stryker device during the manufacturing process prevented bonding with his bone.

Stryker argued that the plaintiff's state-law claims were completely preempted by the Medical Device Amendments to the Food, Drug, and Cosmetics Act.

The court agreed that the plaintiff's breach of express warranty claims were completely preempted, as well as his claims for strict liability, design defect and negligence insofar as they were premised on failure to warn or a marketing defect.

However, the court concluded that there was no preemption of the plaintiff's strict liability and negligence claims to the extent they were based on manufacturing defects arising from a violation of Stryker's manufacturing practices or those approved by the U.S. Food and Drug Administration.

The court concluded that those claims were "parallel claims" permitted under Riegel v. Medtronic (552 U.S. 312). (See "State law claims over medical devices are preempted," Lawyers USA, March 10, 2008.)

"We ... hold that if a plaintiff pleads that a manufacturer of a Class III medical device failed to comply with either the specific processes and procedures that were approved by the FDA or the [FDA's Current Good Manufacturing Practices] themselves and that this failure caused the injury, the plaintiff will have pleaded a parallel claim," the court said.

The court similarly concluded that there was no preemption of the plaintiff's claims for breach of implied warranty.

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