January 24, 2011
May state law place a higher standard of care upon manufacturers of medical devices than that imposed upon them by the FCDA? On January 21, 2011, the Indiana Court of Appeals held that they cannot in
McGookin v. Guidant Corp., Case No. 71A04-1001-CT-101, despite the United States Supreme Court's decision in
Wyeth v. Levine, 129 S. Ct. 1187, --- U.S. --- (2009).
less..
In this case, a newborn was diagnosed with a heart defect, was given a Guidant pacemaker, and tragically passed away at the age of fourteen months. An action for failure to warn was brought against Guidant. In other words, the complaint challenged labeling expressly approved by the FDA. Guidant moved for summary judgment, arguing that the claims were preempted by federal law. Because the label had been preapproved by the Food and Drug Administration, however, and Guidant was not required to include the additional warnings, the trial court held that any state law-based failure-to-warn claims were preempted by federal law.
On appeal, the plaintiffs argued that their failure to warn claims were not, in fact, preempted and that state law could impose higher duties upon manufacturers of medical devices than federal law. The dispute, therefore, centered on the express preemption provision of the Medical Device Act (MDA),
21 U.S.C. § 360k(a), which expressly prohibits any state law that establishes any requirement which either is different from, or in addition to, any requirement applicable under this chapter to the device or relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device.
In
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the United States Supreme Court held that tort claims under New York law were preempted by the MDA's preemption provision. The next year, the United States Supreme Court issued its decision in
Wyeth, in which it held that state law failure-to-warn claims against drug manufacturers were not preempted by federal law; federal law created a floor, but not a ceiling. In
Cook v. Ford Motor Co., 913 N.E.2d 311 (Ind. Ct.
App. 2009),
trans. denied, the Indiana Court of Appeals, relying on
Wyeth, recognized that
the National Traffic and Motor Vehicle Safety Act did not preempt state law claims.
The plaintiffs argued that
Cook establishes that the
Wyeth rule can be applied to regulatory schemes aside from just the FDCA. While the Court did not disagree with this principal, it held it did not apply to claims under the MDA.
The MDA and Riegel could not be clearer that federal law broadly preempts any claim that would allow a jury to impose a standard of care different from or in addition to the FDA's specific federal requirements. Here, the Appellants seek to do precisely that. Neither Wyeth nor Cook apply to the MDA or in any way circumvent the plain statutory language of the MDA's preemption clause or the United States Supreme Court's interpretation thereof in Riegel. The Appellants herein do not allege that Guidant violated federal requirements. Instead, they contend that Guidant should be liable for its failure to add warnings that are permitted, but not required, by federal law. We cannot imagine a plainer example of an attempt to impose a standard of care in addition to the FDA's specific federal requirements.
The lesson here is clear - when a federal statute expressly preempts state law claims, Indiana's courts will respect that legislative decision. Do not expect a failure-to-warn claim regarding a medical device to survive in Indiana's courts.
Lessons:
- Any failure-to-warn claim regarding a medical device, which seeks to impose a greater burden than that imposed by federal law, is preempted.
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