Justice Joseph Maltese
In a product liability and medical malpractice action, defendant Medtronic Inc. moved to dismiss plaintiffs’ complaint by asserting that the pleadings fail to state a viable cause of action because those claims are expressly preempted by the 1976 Medical Device Amendments of the Federal Food Drug and Cosmetics Act. Plaintiff Messner sued Medtronic, the manufacturer of the "Mosaic Porcine Heart Valve" that was placed into his chest, the surgeon who selected and used the valve, and others, alleging that the valve should not have been placed into commerce and sold to the public with an "anterior dehiscence" and "hole" in its leaflet. The court, among other things, denied Medtronic’s motion to dismiss plaintiffs’ claims for negligent manufacture and inspection of the valve that produced a manufacturing defect, specifically a hole in one of the leaflets that was a deviation from the FDA-approved design and federal safety requirements and regulations.
