The Food and Drug Administration has proposed a regulation that would virtually eliminate any argument that the Medical Device Amendments Act of 1976 (MDA) preempts state common law causes of action for product liability. The new rule would not only expose manufacturers to more lawsuits, it would deny consumers access to some life-saving or life-enhancing products.
Published last month in the Federal Register (62 Fed. Reg. 65384), the proposed interpretive rule would restate the Supreme Court's 1996 opinion in Medtronic v. Lohr, where the Court held that an FDA finding of "substantial equivalence" during the process of premarket notification does not preempt state common law claims for design or manufacturing defects. It also expressly extends the Court's holding to devices that undergo the more rigorous premarket approval (PMA) and investigational device exemption (IDE) processes.
Under the MDA, certain devices, including those that "present a potential unreasonable risk of illness or injury" require FDA approval before they can be introduced to the market. During the premarket approval process, the manufacturer must show the product is safe.
Congress created two exemptions from the premarket approval process: the Investigational Device Exemption for the purpose of collecting scientific data on devices that have passed certain safety standards, and the premarket notification process for devices that are "substantially equivalent" to ones that were on the market when the MDA took effect.
The MDA also preempts states from imposing any requirement that is "different from, or in addition to, any requirement applicable . . . to the device," and that "relates to the safety or effectiveness of the device."
An existing FDA regulation provides that preemption occurs only where FDA has established "specific counterpart regulations" or "other specific requirements applicable to a particular device," which result in state requirements "different from, or in addition to" the FDA requirements. In Medtronic, the Supreme Court relied on that regulation to hold approval under the premarket notification process did not preempt state action. In a complicated ruling that included written opinions from six different Justices, the Court reasoned that the premarket notification process was not a method for reviewing a device's safety; rather, if the original device was unreasonably unsafe, a substantially equivalent device would be, too. Further, the Court said neither the premarket notification process nor the generally applicable law of negligence and product liability applied by the state court was a specific regulation of a specific device.
By all but eliminating preemption with respect to devices given pre-market notification, the FDA's most common method of approval, the Medtronic holding placed a severe limitation on the preemption defense. The opinion did not, however, close the door on preemption entirely.
Indeed, cases after Medtronic illustrated the viability of preemption. For example, the California Court of Appeal held that the MDA still preempts state common law claims concerning a device that has gone through the full premarket approval process -- unless the claim is based on a violation of federal standards. Steele v. Collagen Corp., 54 Cal. App. 4th 1474 (1997). And another court held that an IDE preempts a strict liability claim, since the FDA must have found that the device's benefits outweighed its risks. Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090, 1099 (6th Cir. 1997).
Because lower courts could not form a uniform consensus, however, the FDA proposed its new rule, which re-emphasizes the Medtronic holding that preemption of common law duties occurs only if the FDA has "imposed . . . a specific substantive requirement applicable to a particular device," and the state law presents a "requirement . . . different from, or in addition to" the FDA requirement.
But the proposed regulation goes on to expand the Medtronic holding by stating that neither the issuance of an IDE nor premarket approval constitutes a specific FDA requirement that would preempt state action. Most significantly, the proposed regulation would eliminate manufacturers' arguments that the premarket approval and IDE processes, being much more rigorous and involving reviews for the safety of products, should result in preemption of state common law claims.
Thus, a manufacturer could do everything that the federal government required of it, but still face a suit alleging it should have done more. Even if the manufacturer proves at trial that its medical device was safe, it will have had to bear the expense and adverse publicity of a lawsuit.
The FDA should be encourage to recognize that the premarket approval process is the most efficient and effective way to ensure that medical products are safe and effective, and that ad hoc regulation by juries will increase the cost of these products and ultimately harm consumers. The FDA's Documents Management Branch will accept written comments regarding the proposed rule until February 10, 1998.
This Alert was prepared by our Product Liability Group.