Supreme Court Decision Protects Manufacturers

Medical device manufacturers rejoiced in late February when the United States Supreme Court issued a decision affirming that plaintiffs injured by medical devices that have received pre-market approval from the Food and Drug Administration (FDA) cannot maintain product liability suits against the manufacturers. The recent 8-1 decision made clear that federal law preempts conflicting state requirements that can arise from lawsuits alleging defects in medical devices the federal government has already determined are “safe and effective.” A fractured 1996 Supreme Court decision, Medtronic, Inc. v. Lohr, 518 U.S. 470, had led the federal circuit courts around the nation to arrive at sometimes conflicting decisions on the issue of federal preemption of suits alleging medical devices were defective.

In 1976, Congress enacted the Medical Device Amendments (MDA) which allowed the FDA to regulate medical devices. The MDA assigns each medical device into one of three "classes." The class of the device determines the process by which the device is regulated. Class III devices, including breast implants, prosthetic hips, stents, etc., are subjected to the most rigorous safety evaluations by the FDA.

Pre-market approval (PMA) is a process whereby Class III medical devices are closely scrutinized by the FDA. The agency reviews the medical device’s design, labeling, and manufacturing specifications. The FDA spends an average of 1,200 hours reviewing a manufacturer’s materials before either approving or disapproving the device. Only if the FDA is satisfied that it has received “reasonable assurances” of a device’s “safety and effectiveness” will the product be granted pre-market approval for sale to the public.

It is this rigorous review and approval by a federal governmental agency, combined with a Congressional act, which bars the conflicting state common law claims of plaintiffs such as the one in Riegel v. Medtronic, Inc., the case recently decided by the Supreme Court. The balloon catheter at issue in that case received pre-market approval from the FDA in 1994. Two years later, a catheter burst while being inserted into Mr. Riegel during an angioplasty. His products liability lawsuit against the manufacturer alleged that the device was designed, labeled and manufactured in a manner that violated New York common law. The Supreme Court affirmed the dismissal of the plaintiff’s lawsuit based on preemption.

The MDA contains an explicit preemption provision which prohibits any state requirement which is different from, or in addition to, any federal requirement which relates to the safety or effectiveness of the device. 21 U.S.C. § 360k(a). Pre-market approval imposes specific federal requirements applicable to a particular device. After FDA approval, a manufacturer can only make the device in conformance with the federal requirements established in the PMA, and not according to alternative designs, labeling, or manufacturing processes that plaintiffs in any civil action might suggest. In this manner, state common law tort suits could lead to damage awards that would impose state “requirements” which conflict with federal requirements established via pre-market approval. Permitting state juries to impose liability on the manufacturer of an approved device would disrupt the federal scheme whereby the FDA has the responsibility to determine which devices are safe and effective. For this reason, such claims are preempted and dismissed.

This recent Supreme Court decision will be an effective defense for those attorneys, like us, defending manufacturers of medical devices that have received PMA approval. However, not all lawsuits against medical device manufacturers are affected. Claims that a device was manufactured in violation of PMA specifications would not be barred, nor would suits against products that received FDA approval because they were “substantially equivalent” to devices on the market before the 1976 Amendments, as in Medtronic, Inc. v. Lohr, because those products were not subjected to as rigorous a review.

The Supreme Court in its next term will decide whether drugs, like medical devices, pre-empt personal injury lawsuits. Medical devices are regulated under a separate law than drugs. Whereas the Medical Device Amendments of 1976 contain an express preemption provision, the law governing drugs does not. The Bush administration has argued that pre-emption is implicit in the structure of the statute.

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