Preemption: Riegel v. Medtronic

With the United States Supreme Court’s recent decision in Riegel v. Medtronic, — U.S. —, 128 S. Ct. 999 (2008), the High Court certainly seems to have come one sizable step closer to abiding the Bush Administration’s backdoor tort reform agenda and eliminating consumer lawsuits for harmful products. Post-Riegel, a consumer injured by a product that happens to have been the subject of federal regulatory oversight or approval prior to its having reached the marketplace, will find it difficult to get out from the ever-growing shadow of preemption.

To be sure, the Court’s holding in Riegel is fairly narrow. Indeed, the Court passed on the viability of only a limited class of lawsuits: those involving injuries caused by medical devices that were subject of the FDA’s “pre-market approval” process under the Medical Device Act (“MDA”), which the High Court found to be a “rigorous” one. And, of course, the holding is limited in that it represents an interpretation of the MDA’s express preemption provision, and hence, will not be controlling on questions of preemption arising where there has been no express Congressional intent to preempt. Moreover, only State claims that do not “parallel” the MDA’s requirements are nullified by the federal statute’s express preemption clause.

However, Riegel can, and likely will, reach farther than pre-market-approval medical devices. Consider, for instance, the following passage from Justice Scalia’s majority opinion, made in the context of determining whether State tort claims fit the definition of “requirements” under the express preemption clause:

[I]n the context of this legislation excluding common-law duties from the scope of pre-emption would make little sense. State tort law that requires a manufacturer’s catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect. Indeed, one would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation.

Id. at —, 1008.

So, while Riegel is not a death toll for all products liability law, it is certainly a dark day when the United States Supreme Court begins out loud to question the time-honored value of the jury system in adjudicating the rights of the injured. Whether the Court will halt at this pronouncement – made in this very narrow factual and regulatory context – or go further remains to be seen.