When Does Federal Law Preempt State Law In Tort Cases? Last Week's Supreme Court Decision Offers Some Guidance

Last week, the Supreme Court decided the first of a series of cases involving federal preemption and tort law that will occupy their attention over the next two terms. The outcome of the case resolved last week, Riegel v. Medtronic, Inc., was never really in doubt, but, as I will explain, the decision holds some clues about the Court will approach preemption in upcoming cases that are likely to prove far more difficult.

The Facts, Issues, and Judicial Outcomes In Riegel

The key legal issue in Riegel was whether the federal Medical Devices Amendments of 1976 (MDA) completely preempted the New York tort claims brought by Charles Riegel and his wife. The MDA expressly prohibits a state from establishing or continuing in effect "any requirement - which is different from, or in addition to, any requirement applicable" under the MDA.

Riegel had suffered severe and permanent injuries when a medical device manufactured by Medtronic, Inc., the Evergreen Balloon Catheter, burst when it was inserted by Riegel's doctor during a coronary angioplasty.

Riegel's doctor had inflated the catheter to ten atmospheres of pressure, even though the product's "rated pressure" was only eight atmospheres. Despite the doctor's apparent error, Riegel also sued Medtronic, alleging a host of state common law products liability claims, including negligence in the design, testing, inspection, distribution, labeling, marketing and sale of the catheter.

The federal district court in which the suit was brought granted summary judgment for Medtronic, on the ground that the state tort claims were preempted by the MDA. The U.S. Court of Appeals for the Second Circuit affirmed the grant. Last week, moreover, the Supreme Court, 8-1, affirmed the Second Circuit's decision.

Why the Supreme Court's Decision Was Expected by Court Observers

Despite this string of court losses, Riegel did have at least some basis for his attempt to sue Medtronic under New York products liability law. After all, in 1996, in Medtronic, Inc. v. Lohr, the Supreme Court has held that the MDA did not preempt state tort claims brought against Medtronic. In that case, the plaintiff had suffered severe injury when one of the metal leads on her pacemaker failed. The Supreme Court held that many of the state law claims brought against Medtronic, including claims of design defect and inadequate warning, did not conflict with the MDA's express preemption clause.

Still, no one was surprised when Medtronic won preemption ten years later in the Riegel case -- for two reasons.

First, Lohr involved a very different part of the MDA. The pacemaker in Lohr was "approved" by the FDA under a process that might be described as "approval lite": A "grandfathering" clause in the MDA permits manufacturers to submit to the FDA devices that are equivalent to devices that had been on the market prior to the passage of the MDA in 1976. The pacemaker in Lohr was just such a device. Thus, it was not subjected to the FDA's rigorous testing protocol.

Lohr represented a type of preemption case that was, in theory, supposed to wither away as time passed. From the perspective of statutory interpretation, it made little sense that the pacemaker in Lohr had been subjected to any FDA requirements at all, since it had been approved by the FDA as a result of a "grandfathering clause" that had been inserted into the MDA for political reasons. From the perspective of policy, it made sense for state tort law to continue to be in force against the pacemaker, since that was the only body of law that which constrained its manufacturer in any way, in light the fact that under the MDA, the pacemaker was already grandfathered in.

The second reason why Riegel could be distinguished from Lohr follows from the first reason: Riegel involved a device that had been approved through MDA's rigorous approval process. Practically every aspect of the Evergreen Balloon Catheter had been considered by the FDA before it received premarket approval as a new Class III device.

Court observers also had other strong indications that the Supreme Court might not decide Riegel as it had Lohr. Between 1996 and last week, the question of whether manufacturers of Class III devices that received premarket approval from the FDA could still be held liable under state tort law was one that the Supreme Court had never answered, although the Justices had hinted at the answer to this question in Lohr. But in the meantime, various federal appellate courts had been considering this question, and by the time the United States Supreme Court decided to review Riegel, the Third, Fifth, Sixth, Seventh and Eighth Circuits had all joined the Second in recommending complete preemption for this class of devices.

Furthermore, in the intervening years since Lohr was decided, the Supreme Court had become decidedly much more inclined to find preemption. The "presumption against preemption" that the Court cited time and again in Lohr has, over the years, become the exception that proves the rule. Now, more often than not, the Court has noted the presumption only to find that it does not apply in the cases before it, and to decide that federal law does indeed preempt state law in a given case.

Justice Scalia's Opinion in Riegel, and Justice Stevens's Separate Concurrence

The Riegel opinion, written by Justice Scalia, fully reflects these changes in recent Court preemption doctrine. In the opinion, Scalia recites the differences between the kind of approval that products in Lohr and Riegel received, and notes that it is hard to say that, after 1200 hours of testing by the FDA and constant feedback between the agency and the manufacturer, that the FDA did not impose "requirements" for everything from design to warning to manufacturing - leading the preemption clause of the MDA to very broadly apply to all of Riegel's claims. Scalia's recitation of the facts is so compelling that it is easy to see why seven other justices voted that state law was preempted.

But there was a concurrence in Riegel that bears noting. Justice Stevens wrote separately to insist that the preemption doctrine that is being developed by the Court should not be misunderstood by Court observers. Stevens agrees with Scalia that state common law judgments in products liability can count as "requirements" imposed by the states, under the language of the MDA's preemption clause, just as much as a regulation written by a state legislature can count as a "requirement." Stevens, in underscoring this point, seems to be reminding Scalia (or maybe those whom Scalia is now influencing) that it was Stevens who first developed this line of analysis in the 1992 case Cipollone v. Liggett Group, and later in Lohr, whose plurality opinion he authored.

In the concurrence, Stevens seems to be telling Scalia that the theory of preemption that Stevens had developed extends only to cases of express preemption--that is, in cases where Congress has clearly stated that it wants to supplant state law, including state common law. Stevens notes that the MDA extends further than its authors probably intended (which is the basis of Justice Ginsburg's lone dissent) but deems this an occupational hazard of drafting statutory language: Sometimes, Congress will sweep more broadly than it intended.

What Riegel Suggests About the Future of Preemption at the Court

The Court will be facing a number of difficult implied preemption cases over the next two terms, and Riegel may be a clue as to where the battle lines will be drawn.

Stevens seems to be saying to the younger conservative wing of the Court (led by Scalia) that he will fight any attempt to preempt state tort law through implied preemption. The questions, however, is how many of the eight votes for preemption in Riegel Stevens will be able to muster in the next few cases.