In Mullin v. Guidant Corporation, 114 Conn. App. 279 (2009), the Connecticut Appellate Court issued its first decision on federal preemption under the Medical Device Amendments of 1976, 21 U.S.C. § 360c, et seq. ("MDA"), since the U.S. Supreme Court decided Riegel v. Medtronic, Inc., __U.S.__, 128 S. Ct. 999 (2008).
The result was hardly a shock - the Appellate Court followed Riegel and held that the MDA expressly preempts Plaintiffs' state tort law claims.
In 1999, Leslie Mullin suffered from cardiac arrest, respiratory distress and, ultimately, ventricular fibrillation arrest. At the recommendation of her physician, Mullin was implanted with a Ventak Mini IV Model 1973 cardioverter defibrillator, manufactured by Guidant Corporation. At the time, Mullin was in her early thirties. After the implant malfunctioned and reverted to a "failsafe" mode, it was replaced with a different model. Guidant bore the costs of the new implant and the replacement procedure. Nevertheless, Mullin and her husband asserted a two-count complaint against Guidant, alleging violations of the Connecticut Product Liability Act ("CPLA") in Count One; and alleging certain emotional distress, loss of consortium, and fiscal expense claims on behalf of Mullin's husband in Count Two.
Guidant filed for summary judgment on December 14, 2007, arguing in part that Plaintiffs' claims were preempted by federal law as set forth in the MDA. The trial court agreed that the MDA preempted Plaintiffs' claims. Rather than enter judgment in favor of Guidant, however, the court dismissed Plaintiffs' complaint for lack of subject matter jurisdiction.
Plaintiffs appealed and, on May 12, 2009, the Appellate Court determined that the MDA did indeed preempt the Plaintiffs' state law claims, but rejected the trial court's conclusion that such preemption deprived the court of subject matter jurisdiction. Specifically, the Appellate Court concluded that "[b]ecause a preemption defense may be waived but jurisdiction defect may never be waived...the MDA's preemptive effect does not implicate our courts' subject matter jurisdiction."
Turning to the primary issue of federal preemption, the Appellate Court in Mullin held that "the tort claims raised in the plaintiffs' complaint are preempted by federal law," in light of the precedent set by the U.S. Supreme Court in Riegel v. Medtronic, Inc. In Riegel, the Court determined that express preemption clause contained in the MDA "bars common law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration (FDA)." In relevant part, the MDA's preemption clause provides that:
[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 chapter to a device, and (2) which relates to the safety or effectiveness of the device or any other matter included in a requirement applicable to the device under this chapter.
Relying on § 360k and the fact that the MDA provided "a regime of detailed federal oversight" of medical devices, the Court in Riegel found that state tort laws that impose higher or different safety standards on medical devices disrupt the federal scheme and are, therefore, preempted. The Connecticut Appellate Court in Mullin followed suit and held that Plaintiffs' CPLA claims relating to the allegedly defective nature of Mullin's cardioverter defibrillator were preempted in their entirety by federal law.
At first blush, the Court's decision in Mullin appears to be an unremarkable endorsement of Riegel, but Mullin is notable in two respects: First, the Court held that Riegel and its federal preemption analysis is applicable to state statutory claims, as well as common law claims. The Appellate Court noted: "Although the present case involves, at least in part, statutory claims rather than common law claims...this is a distinction without a difference," and Riegel,"is binding on our decision." Second, the Mullin Court recognized that even under Riegel, a plaintiff would be entitled to maintain state law claims for alleged violations of FDA regulations, which "parallel", rather than differ from or add to, the regulations under federal law. The Mullins failed to allege such "parallel" claims, and, as a result, the Appellate Court found that their claims were preempted. Nevertheless, Riegel, and now Mullin, leave open the possibility that state law claims challenging the safety or effectiveness of a medical device could withstand a preemption challenge if they are carefully crafted as violations of FDA regulations. An allegation, for instance, that a manufacturer failed to adhere to the FDA approved manufacturing process is the type of claim that would likely fall outside the preemptive scope of the MDA.
Manufacturers should expect a rise in such claims and should be prepared to vigorously challenge attempts by plaintiffs to plead around Riegel and Mullin to avoid federal preemption.