Alerts and Updates
Federal Preemption Impacts Medical Device and Pharmaceutical Litigation
June 16, 2006
Continuing a trend limiting suits available to plaintiffs alleging personal injury from medical devices and pharmaceuticals, two recent decisions have upheld federal preemption of state law-based claims.
The Second Circuit has now joined at least five others in concluding that a PMA-approved medical device manufacturer was immune from a suit brought on behalf of a man who died when a balloon catheter inserted to open a clogged coronary artery burst as a result of overinflation.
In another decision, finding persuasive the FDA's interpretation of the preemptive scope of its regulatory powers, and giving effect to a controversial preamble to its new drug labeling regulations, Eastern District of Pennsylvania District Judge Michael M. Baylson dismissed a case brought by a plaintiff whose wife committed suicide while on an antidepression drug.
In Riegel v. Medtronic, Inc., 2006 U.S. App. LEXIS 12181 (2nd Cir. May 16, 2006), plaintiffs Charles and Donna Riegel filed suit against Medtronic, Inc. ("Medtronic"), the manufacturer of the Evergreen Balloon Catheter ("catheter"), after the catheter burst inside Mr. Reigel's coronary artery during a coronary angioplasty. The catheter was designed for use during angioplasties to open a patient's clogged arteries by inserting the catheter into the blocked vessel, inflating it, and then deflating and removing the device. Plaintiffs filed suit against Medtronic in the Northern District of New York after the catheter inserted in Mr. Riegel's artery burst as a result of being inflated beyond the recommended pressure. The burst caused a complete heart block and required Mr. Riegel to undergo emergency coronary bypass surgery, which he did not survive.
Medtronic moved for summary judgment on the ground that the plaintiffs' state common law claims were preempted. The District Court granted Medtronic's motion with respect to plaintiffs' strict liability, breach of implied warranty and negligence claims, but not the claim for negligent manufacturing. The District Court held that all but the last of these claims were preempted by the Medical Device Amendments to the Food, Drug and Cosmetics Act ("FDCA"), 21 U.S.C. § 360k(a).
The Second Circuit agreed with the District Court and affirmed the grant of summary judgment in Medtronic's favor. Taking guidance from Medtronic v. Lohr, 518 U.S. 470 (1996) and several other circuit courts that have addressed similar issues, the Court used a two-step process in reaching its decision. First, it determined that the catheter, as a PMA-approved device, was subject to device-specific federal requirements. Second, the Court analyzed the plaintiffs' tort claims and concluded that they conflicted with those requirements. Based on the FDA's rigorous premarket approval process under Section 360k(a) of the FDCA, the Second Circuit concluded that all of the plaintiffs' claims but its negligent manufacturing claim were preempted.
In Colacicco v. Apotex, 2006 U.S. Dist. LEXIS 34127 (E.D. Pa. May 25, 2006), the District Court held that failure-to-warn claims against two pharmaceutical companies were preempted by the FDA's broad authority over drug labeling. The plaintiff, Joseph Colacicco, filed suit against GlaxoSmithKline, the manufacturer of the antidepressant Paxil, and Apotex, the manufacturer of the generic equivalent of Paxil, after plaintiff's wife committed suicide while taking the generic version for depression. The plaintiff claimed that at the time of his wife's death, the defendants' FDA-approved label failed to warn the decedent or her doctor of the risk of suicide.
The defendants moved to dismiss the case, arguing that the FDA's pervasive authority over prescription pharmaceuticals preempted the plaintiff's claims. The District Court agreed with the defendants and held that plaintiff's failure-to-warn claims were impliedly preempted.
In reaching its decision, the Court considered an amicus brief filed by the FDA as well as the preamble to new drug labeling regulations issued in 2006 ("Preemption Preamble"). The FDA asserted that prior to the decedent's death in October 2003, the FDA specifically and repeatedly rejected claims that adult use of antidepression drugs increased the risk of suicide. The FDA said that any warnings regarding a possible association between suicide and Paxil and/or its generic equivalent would have been false or misleading and in violation of the FDA's regulations.
The District Court agreed with the FDA and the defendants. In addition to deferring to the FDA's preemption position, the Court relied on the Preemption Preamble in support of its decision. The Preemption Preamble states that "whether it be in the old or new format, [the FDCA] preempts conflicting or contrary state law," including, as the District Court concluded, state failure-to-warn claims. The Court found that although the FDA's position with respect to preemption has not been entirely consistent, "there is no longer any justification for not giving deference to an agency's interpretation of law merely because it is not the agency's longstanding position."
Notably, the Court rejected the argument that generic manufacturers could add additional warnings to the product labeling previously approved for the brand name drug without FDA approval. The District Court deferred to the FDA's interpretation of its regulations that a generic manufacturer operating under an FDA abbreviated new drug application ("ANDA") must provide labeling and warnings identical to that of the brand name drug, and may not add a warning or caution to the label without prior approval from the FDA.
While certain to be appealed to the Third Circuit, the Eastern District's decision is the first of which we are aware to explicitly recognize the Preemption Preamble as a basis for the preemption of state law-based failure-to-warn claims.
For Further Information
For more information about this Alert, please contact Alan Klein, James J. Ferrelli, Carrie Edinger Kehner, one of the other members of our Product Liability Litigation Practice Group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.
