On February 20, in an 8-1 decision, the United States Supreme Court held that state common law tort claims against medical device manufacturers are preempted by FDA’s approval under the Premarket Approval (PMA) process. The decision dramatically enhances the regulatory compliance defense for Class III medical devices that receive Premarket Approval (PMA) from the Food and Drug Administration (FDA).
The case, Riegel v. Medtronic,[1] involved allegations that a Medtronic catheter was designed, labeled, and manufactured in violation of New York common law. The catheter was PMA-approved in 1994 by the FDA as a Class III device.
Express preemption of state tort claims by FDA requirements
Section 360k(a) of the Medical Device Amendments of 1976 (MDA) expressly preempts state requirements that “are different from or in addition to” FDA’s device safety or effectiveness requirements under the Federal Food, Drug and Cosmetic Act (FFDCA).[2] Noting that FDA premarket review of a PMA application “is federal safety review,” the Court found that the PMA approval process “imposes ‘requirements’” on Medtronic. Op. at 9 (emphasis original). Observing that “New York’s tort duties constitute ‘requirements’ under the MDA” that are expressly preempted by section 360k(a), the Court concluded “that common-law causes of action for negligence and strict liability do impose ‘requirement[s]’ and would be pre-empted by federal requirements specific to a medical device.” Op. at 10.
The Court also stated that section 360k(a) “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements”. Op. at 17. In an observation of particular significance to questions of preemption by requirements established under other federal laws, the Court observed that “[a]bsent other indication, reference to a State’s ‘requirements’ includes its common-law duties”. Op. at 11.
Implications for prescription drugs, other FDA-regulated products
In past cases asserting preemption based on FDA regulation, the FDA had historically taken the position that state tort law and premarket approval operated independently, and that state tort claims provided a significant additional layer of consumer protection. More recently, the FDA changed its stance, filing briefs in support of manufacturers, including Medtronic. In addition, in the preamble to its 2006 final prescription drug labeling rule, the FDA outlined its rationale that FDA regulation of prescription drugs should preempt state tort claims.[3] Through these recent actions, FDA has argued that state lawsuits would compel manufacturers to make product or label changes different from, or beyond, what the agency requires.
For the medical device industry, the Riegel decision may not only improve its litigation environment, but also prompt heightened congressional scrutiny of the rigor of FDA’s regulation of medical devices. It is also possible that interest will increase in legislative amendments to the FFDCA that would respond to, or reverse, the decision.
The Riegel decision does not directly address preemption of state tort claims on the basis of FDA requirements for prescription drugs and food and color additives. While the Court observed, “It has not been established (as the dissent assumes) that no tort lawsuits are pre-empted by drug or additive approval under the FDCA”, it also indicated “if, as the dissent believes, Congress wanted the two [drug and device] regimes to be alike; Congress could have applied the pre-emption clause to the entire FDCA. It did not do so, but instead wrote a pre-emption clause that applies only to medical devices.” Op. at 13-14.
It is also notable that Justice Ginsberg stated in her dissent that, while courts have “overwhelmingly held that FDA approval of a new drug application does not preempt state tort suits”, “[t]he process for approving new drugs is at least as rigorous as the premarket approval process for medical devices.” Ginsberg, dissenting, at 11.
Other pending Supreme Court cases
Riegel is the first of three significant preemption cases on the Supreme Court docket this term. Warner-Lambert v. Kent raises the question of whether there is implied preemption of an exemption to the Michigan “FDA shield” statute that requires a court determination of fraud-on-the-FDA. [4] A third case, Wyeth v. Levine, addresses whether FDA’s approval of prescription drugs under the New Drug Approval (NDA) process, particularly its labeling, preempts state law claims for failure to warn and other challenges to safety or efficacy.[5] In the immediate aftermath of Riegel and with Warner-Lambert v. Kent due to be argued on Monday, February 25, these additional cases will be closely watched because of their significance to FDA-regulated, life science industries.
1.
No. 06-179, 2008 WL 440744 (US).
3. “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” 71 Fed. Reg. 3922 (Jan. 24, 2006) (to be codified at 21 C.F.R. Parts 201, 314, and 601).
4. Warner-Lambert v Kent, --- S.Ct. ---, 2007 WL 1420397 (US), 75 USLW 3923 (Sep 25, 2007).
5. Wyeth v. Levine, --- S.Ct. ---, 75 USLW 3500, 76 USLW 3018 (U.S.Vt. Jan 18, 2008) (NO. 06-1249).