The United States Supreme Court recently issued two significant opinions dealing with federal preemption. Reigel v. Medtronic and Rowe v. New Hampshire. These cases demonstrate a significant interest in preemption issues by the Supreme Court.
One of those cases deals with preemption in the area of medical devices. In Reigel, the Court shielded makers of medical devices (such as implantable defibrillators) from tort liability where the devices received pre-market approval from the Federal Drug Administration. There, the Court affirmed the dismissal of a lawsuit on preemption grounds that had been brought by a patient injured during an angioplasty procedure when the balloon catheter being used to dilate his coronary artery burst. The device had received F.D.A. approval two years before the patient's procedure.
The medical device statute at issue contains a broad preemption provision that prevents states from imposing any additional requirements on manufacturers other than those imposed by the F.D.A. Justice Scalia wrote that state tort laws, by imposing duties of care on manufacturers, constituted a prohibited additional requirement on manufacturers and preempted claims made under those laws with regard to devices with pre-approval from the F.D.A.
This 8-to-1 decision, with Justice Ginsberg dissenting, was a victory for manufacturers as well as the Bush Administration which had long sought to preempt state law tort claimsvia federal preemption provisions and doctrines. Specifically, since 2004, the Administration had sought to staunch the tide of state court claims against medical device manufacturers by arguing that pre-market approval from the F.D.A. should bar most state tort damages claims.
The Administration will continue its efforts in this area by taking a similar preemption stand in another F.D.A. case which the Court has already accepted for next term. In that case, the argument is that the F.D.A.'s approval of a drug (as opposed to a device) preempts personal injury suits founded on state laws.
Continuing with the preemption theme, this week the Court heard another F.D.A. preemption case dealing with the issue of whether a state cause of action is preempted when it is based on the claim that a drug maker fraudulently misrepresented or withheld information from the F.D.A. during the approval process for a drug (there, the diabetes drug, Rezulin). Although the Administration supports the manufacturer in that case (Warner-Lambert), this type of state tort claim may prove to be the line-in-the-sand beyond which the Court will not allow claims to be preempted for two reasons. First, the statute at issue in the Warner-Lambert case does not contain a preemption clause, even though the manufacturer and the Administration argue that preemption is implicit in the structure of the statute. Second, even in Riegel, the Court refused to preempt claims in which a plaintiff argues that a device was not made according to the F.D.A.'s pre-approved requirements. Thus, the Court may be amenable to arguments that preemption does not apply where the approval process is tainted by fraudulent information provided to the F.D.A. from the manufacturer.