Feb. 25, 2008
Jill Jacobson of Bowman and Brooke LLP is the co-author of this article.
In Riegel v. Medtronic, Inc. , the Supreme Court considered whether the preemption clause enacted in the Medical Device Amendments of 1976 (MDA) bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration (“FDA”). In answering this question, the Court held that such claims were indeed preempted, distinguishing its 1996 decision in Medtronic, Inc. v. Lohr and potentially nullifying hundreds of suits currently pending against device manufacturers that are premised on state common-law claims.
Section 360 of the MDA contains an express preemption clause, which was at the heart of the decision in Riegel. That clause states:
[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
The Supreme Court thus conducted a two-step analysis. First, the Court determined whether the FDA had established “requirements applicable to Medtronic’s catheter.” If so, the Court reasoned, then it must take a second step to determine whether the requirements that would be established under the Riegel’s tort law claims would be “different from, or in addition to” those established requirements.
The device at issue in Riegel was a Medtronic heart catheter, a Class III device that received premarket approval from the FDA in 1994. The Court explained that the premarket approval process under §360k is a rigorous one, in which the safety and effectiveness of the device is thoroughly reviewed. This premarket review, the Court reasoned, established device-specific “requirements,” as that term is used in the Act.
The Court further determined that, if allowed to proceed, the Riegel’s negligence and strict liability claims could establish requirements that were “different from, or in addition to” the requirements established by the FDA. Thus, the Court held that those claims were preempted.
The Court’s answer to this second question turned on its interpretation of the term “requirements.” Specifically, the Court defined the “critical issue” as “whether [the state-law] tort duties constitute ‘requirements’ under the MDA.” In finding that such tort duties did constitute “requirements,” the Court stated “common-law liability is ‘premised on the existence of a legal duty,’ and a tort judgment therefore establishes that a defendant has violated a state-law obligation.” (Citing Cipollone v. Liggett Group, Inc. )The Court then made a fairly sweeping statement, noting that “Congress is entitled to know what meaning this Court will assign to terms regularly used in its enactments,” and holding that “[a]bsent other indication, reference to a State’s ‘requirements’ includes its common-law duties.” Theoretically, then, any preemption clause containing the word “requirement” could be found to preempt state common-law claims.
The Court did not completely eviscerate the remedies available for plaintiffs injured by medical devices, leaving open the possibility of claims based on violations of the federal regulations. In her dissent, Justice Ginsburg also noted the possibility of bringing claims based on defects coming to light only after the device has received premarket approval.
Riegel continues a history of the Court finding preemption in products liability cases. For instance, in Cipollone, the Court held that the Public Health Cigarette Smoking Act of 1969 preempted certain common-law actions based on advertising or promotion of cigarettes whose packages were labeled in accordance with federal law. In Geier v. American Honda Motor Co., the Court held that the National Highway Traffic Safety Administration’s Federal Motor Vehicle Safety Standards preempted a plaintiffs’ claim that her Honda Accord was defective for not having an airbag when the federal standards specifically provided Honda with a choice of restraint systems to install. In Bates v. Dow Agrosciences LLC, the Court held common-law actions to be preempted by the preclusion in the Federal Insecticide, Fungicide, and Rodenticide Act against certain States imposing requirements for labeling or packaging that were in addition to or different from the acts's requirements.
Any trend in favor of preemption may be due to the Court’s perception of the ability and, perhaps, the propriety of a civil jury, which evaluates a product on only a single-case basis, to regulate safety for the general public at large. Writing for the majority, Justice Scalia contrasted a civil jury with an agency such as the FDA, which must balance a medical device’s costs and benefits on a broader scale. He wrote, “[a] jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.”
Justice Scalia’s comment, as well as the Court’s finding of preemption despite, as Justice Ginsburg’s dissent points out, longstanding precedent establishing a presumption against finding preemption, may also provide insight into how this Court will decide preemption issues going forward. The Court’s next opportunity to address these issues will be in Levine v. Wyeth , a case from the Vermont Supreme Court for which cert has been granted. In Levine, the court will address the preemptive effect of the Food, Drug and Cosmetics Act on state law “failure to warn” product liability claims involving prescription drug labeling. There is currently a split among state and federal courts on this issue, with several courts holding that such claims are preempted, and several holding that they are not. See, e.g., Colacicco v. Apotex, Inc., (E.D. Pa. 2006) (holding such claims preempted); Desiano v. Warner-Lambert & Co., (2d Cir. 2006) (holding such claims not preempted).
In the meantime, some Congressional Democrats, including Senator Edward Kennedy (D-MA), are calling for Congress to craft legislation to overturn Riegel. Shortly after the Court handed its ruling, Senator Kennedy issued the following statement: “In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, FDA approval will become a green light for shoddy practices by manufacturers.”
To say the least, it will be interesting to see whether the Supreme Court’s trend in favor of finding preemption continues, and what, if anything, Congress will do in response.
