Yesterday the United States Supreme Court dealt a significant blow to the Plaintiffs’ Bar’s ability to pursue tort claims involving medical devices cleared by pre-market approval (“PMA”) application. In an 8 to 1 opinion authored by Justice Scalia, the Court handed down their first opinion in a trilogy of FDA preemption cases currently before the Court. In Riegel v. Medtronic, Inc., No. 06-179 2008 WL 440744 (U.S.), the Court held that state common law claims were preempted by the Medical Device Amendments of 1976. The opinion of the court has been long awaited and may provide a glimpse into the Court’s stance on two other significant upcoming preemption cases, Levine v. Wyeth and Warner Lambert v. Kent.
In Riegel, plaintiffs allege that a Medtronic catheter, a Class III device marketed under a PMA, ruptured in Charles Riegel’s coronary artery, causing injury. The Riegels alleged that the catheter was designed, labeled and manufactured in a manner that that violated New York common law. The issue presented was whether the preemption clause enacted in the Medical Device Amendments of 1976, 21 U.S.C. §360k, (“MDA”) bars state common law claims that challenge the safety and effectiveness of a medical device given pre-market approval by the Food and Drug Administration (“FDA”).
In its decision handed down February 20, 2008, the U. S. Supreme Court upheld the Second Circuit, which in turn had affirmed the District Court, which held that the plaintiffs’ claims of strict liability, breach of implied warranty and negligence were preempted.
Under the express preemption clause of the MDA, a state may not “establish or continue in effect with respect to a device any requirement . . . (1) which is different from or in addition to, any requirement applicable under [federal law] to the device and . . . (2) which relates to the safety or effectiveness of the device or to any other matter including the requirement applicable to the device under” relevant federal law. 21 U.S.C. § 360(k)(a).
For the first time since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Court examined the detailed, extensive scrutiny that FDA gives to medical devices marketed under PMAs. The Court discussed in some detail the extensive documentation that the agency evaluates before approving a device and the extensive time spent on review of each application (1,200 hours on average). As part of the PMA process, FDA is required to assess the risks and benefits of the device and to determine that, as designed and labeled, there is a reasonable assurance of safety and effectiveness. Significantly, the Court addressed the fact that, once a device has received PMA, the manufacturer may not, without FDA permission, make “changes in designs, specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness. §360(e)(d)(6)(A)(i).” Any change must be submitted to and approved by FDA before it can lawfully be made.
The Court was deliberate in its effort to distinguish its opinion in Riegel from its previous opinion in Lohr. In Lohr, the Court found that federal manufacturing and labeling requirements applicable to most medical devices did not preempt the common law claims of negligence and strict liability. The distinguishing factor, according to the Court, between Riegel and Lohr was the “device specific requirements” or PMA applicable to the Medtronic catheter in Riegel versus the 510k “substantial equivalence” review in the Medtronic model 4011 pacemaker lead at issue in Lohr.
The Court relied heavily on 21 C.F.R. § 808.1(d), which provides that state requirements are preempted only when FDA “has established specific counterpart regulations or there are other specific requirements applicable to a particular device” under federal law. The device marketed under PMA must be manufactured under those specifications presented and approved in the PMA application The plaintiffs’ common law claims were based upon state “requirements” that were “different from or in addition to” federal ones related to safety and effectiveness. The Court noted that the plaintiffs’ suit depended upon the “continu[ing]. . .effect” of New York’s general tort duties “with respect to” the catheter. Compare 21 C.F.R. § 801.1(d)(1), providing that MDA preemption does not extend to “[s]tate or local requirements of general applicability [whose] purpose . . . relates to other products in addition to devices . . . or to unfair trade practices in which the requirements are not limited to devices.”
The Court affirmed its confidence in the FDA as the regulating body in the best position to determine the safety and effectiveness of medical devices. Because this case involved common-law claims, a decision in favor of the plaintiffs would have essentially usurped FDA’s role and placed this function in the hands of a jury. The Court noted that a jury is not in a position to conduct a cost-benefit analysis similar to that done by the “experts” at the FDA.
Finally, the Court addressed the argument that it is difficult to believe that Congress intended preemption clauses such as the one at issue in Riegel to remove all judicial recourse for consumers injured by FDA approved devices. The Court responded to this query with a resounding yes: “. . . this is exactly what a pre-emption clause for medical devices does by its terms. The operation of a law enacted by Congress need not be seconded by a committee report on pain of judicial nullification.” Riegel at p.7 of slip opinion.
A similar issue — whether the Food, Drug and Cosmetics Act (FDCA), 21 U.S.C. §§ 301 et seq., including the NDA process, preempts state law claims for failure to warn or failure to provide adequate warnings for FDA-approved prescription drug labeling — is currently before the Court. Levine v. Wyeth No. 2004-384. In her dissenting opinion in Riegel rejecting preemption based on the MDA, Justice Ginsburg may have provided a preview of how she may view the issues in Levine. She wrote that the process for approving a new drug application is at least as rigorous as PMA for medical devices, but courts have overwhelmingly held that FDA approval of new drugs does not preempt state tort suits.
Plaintiffs and manufacturers alike will continue to wait with keen anticipation for the Court to decide the remaining two cases in the FDA preemption trilogy.