Supreme Court to Hear Case Involving Scope of the Preemption Provision of the Medical Device Amendments

July 8, 2007

On June 25, 2007, the Supreme Court agreed to hear Riegel v. Medtronic, Inc., which concerns whether the FDC Act preempts state tort claims regarding medical devices that entered the market pursuant to the Premarket Approval (“PMA”) process.  In 1996, the Supreme Court held in Medtronic, Inc. v. Lohr that certain state tort claims involving medical devices cleared under the premarket notification (i.e., 510(k)) process are not preempted. 

In Riegel, the U.S. Court of Appeals for the Second Circuit joined a majority of circuits (i.e., the Third, Fifth, Sixth, Seventh, and Eighth Circuits) that have addressed this issue in holding that state tort claims regarding PMA-approved devices are preempted by the FDC Act.  Specifically, the Second Circuit decided that claims alleging liability despite adherence to the standards on which the PMA device was approved are preempted, but claims that are based on a manufacturer’s departure from such standards are not preempted. 

Charles Riegel and his wife sued Medtronic for injuries allegedly suffered by Mr. Riegel when a balloon catheter manufactured by Medtronic ruptured during an angioplasty operation.  The suit raised several state common law causes of action, including negligence, strict liability, and breach of warranty.  The trial court and the Second Circuit addressed the scope of FDC Act § 521, which states, in relevant part: 

[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 Act 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 Act.

The Second Circuit reasoned that because devices approved through the PMA process are subject to the standards set forth in their approved applications, such devices are subject to “a requirement applicable to the device under [the FDC Act].”  The court further held that the claims for strict liability, breach of warranty, and negligent design, testing, inspection, distribution, labeling, marketing, and sale would (if successful) impose state “requirements” that differed from, or added to, the PMA-approved standards for the device.  In contrast, the court held that the negligent manufacturing claim was not preempted to the extent that it was based on the allegation that the particular catheter used during Mr. Riegel’s angioplasty had not been manufactured in accordance with the PMA-approved standards.

The Second Circuit emphasized that the scope of its decision is “actually quite limited,” because many Class III medical devices (i.e., those medical devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury) enter the market through the 510(k) process rather than the PMA process (that is, those Class III medical devices that are substantially equivalent to devices legally marketed before the enactment of the Medical Device Amendments on May 28, 1976, and for which a regulation calling for PMA has not been published).  In addition, the Second Circuit did not hold that all state tort claims as to PMA-approved devices are preempted; rather, only claims that allege liability despite the adherence of the device to standards set forth in the PMA are preempted.  The Supreme Court is expected to hear the case in the fall. 

Riegel is the first of two preemption cases the Court may hear.  The second case, Wyeth v. Levine, concerns whether prescription drug labeling preempts state law product liability claims.  FDA asserted in the preamble to its January 2006 final rule (page 3934) on prescription drug labeling that “FDA approval of labeling under the [FDC Act] . . . preempts conflicting or contrary State law.”  The Supreme Court has not yet decided whether to hear the case and has requested the Solicitor General’s views. 

In a recent development, on July 3, 2007, the U.S. District Court for the Eastern District of Louisiana issued an order in ongoing VIOXX (rofecoxib) product liability litigation denying Merck’s motion for summary judgment on federal preemption grounds.  With respect to FDA’s January 2006 position on preemption, the court stated:

FDA’s current position on preemption is neither entitled to the deference suggested in Chevron, nor to the deference espoused in Auer.  The FDA’s current views on preemption were not promulgated pursuant to its rulemaking authority, nor do they seek to clarify any ambiguity in the FDA regulations.  Rather, the FDA added these views at the end of the rulemaking process in a preamble to the 2006 Final Rule, that is, “through the back door.”  Moreover, the FDA’s preemption statements in the preamble actually conflict with statements made in the original notice of proposed rulemaking out of which the 2006 Final Rule grew. At best, the preamble merely offers an opinion on the viability of the plaintiffs’ state-law claims given the existence of the federal regulatory scheme as a whole; it does not purport to interpret any specific statutory or regulatory provision, nor is it a regulation itself. (citations omitted).


By Brian J. Wesoloski

Categories: Medical Devices