Court Opinion

ID: 9640955
Source: CourtListenerOpinion
Date Created: 2023-08-22 17:19:39.045506+00
Date Added: 2024-06-11T18:10:34.076194
License: Public Domain

Tom Glaze, Justice. On February 7, 2008, this court handed down its opinion reversing the circuit court’s grant of summary judgment to appellee Soundtec, Inc.; in that opinion, we held that the Medical Device Amendment (MDA) to the federal Food, Drug, and Cosmetic Act did not preempt a state-law tort claim filed against the manufacturer of a medical device. Despain v. Bradburn, 07-714 (Feb. 7, 2008). Less than two weeks later, on February 20, 2008, the United States Supreme Court decided the case of Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). In Riegel, the Supreme Court held precisely the opposite — that is, the Court determined that claims against manufacturers of medical devices are preempted by the MDA. In so holding, the Court noted first that the MDA expressly preempts only those state requirements that are “different from, or in addition to, any requirement applicable to [a medical] device” under federal law. Thus, the question was whether a device approved under the MDA’s premarket approval (PMA) procedure was subject to specific requirements, and, if so, whether common-law claims based upon state requirements with respect to the device are “different from, or in addition to,” the federal ones, and that relate to safety and effectiveness. Riegel, 128 S. Ct. at 1006. The Court concluded that the PMA process does, in fact, “impose[ ] ‘requirements’ under the MDA,” and those requirements are device-specific. Id. at 1007. The Court noted that, “[ujnlike general labeling duties, premarket approval is specific to individual devices . . . [and] is focused on safety[.]” Id. Moreover, the Court pointed out that the Food and Drug Administration (FDA) “requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.” Id. The Court then considered whether “tort duties” also constitute “requirements” under the MDA that are “’different from, or in addition to’ federal requirements and that ‘relatef ] to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device.’ ” Id. In holding that they are, the Court wrote as follows: Congress is entitled to know what meaning this Court will assign to terms regularly used in its enactments. Absent other indication, reference to a State’s “requirements” includes its common-law duties. As the plurality opinion said in Cipollone [v. Liggett Group, Inc., 505 U.S. 504 (1992)], common-law ¿ability is “premised on the existence of a legal duty,” and a tort judgment therefore establishes that the defendant has violated a state-law obligation. Id. at 522. And while the common-law remedy is limited to damages, a liability award “can be, indeed is designed to be a potent method of governing conduct and controlling policy.” Id. at 521. In the present case, there is nothing to contradict this normal meaning. To the contrary, in the context of this legislation excluding common-law duties from the scope of preemption would make little sense. State tort law that requires a manufacturer’s [medical devices] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect. Indeed, one would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation. Id. at 1108. Following the Supreme Court’s opinion, Soundtec filed its petition for rehearing, urging that the high court’s interpretation of federal law is binding upon this court. See, e.g., Harper v. Virginia Dep’t of Taxation, 509 U.S. 86 (1993) (holding that, when the Supreme Court “applies a rule of federal law to the parties before it, that rule is the controlling interpretation of federal law, and must be given full retroactive effect in all cases still open on direct review”); Rivers v. Roadway Express, Inc., 511 U.S. 298 (1994) (a “judicial construction [by the Supreme Court] of a statute is an authoritative statement of what the statute meant before, as well as after, the decision of the case giving rise to that construction”).  The basis of our earlier, unanimous opinion in this case was that the trial court erred in granting Soundtec’s motion for summary judgment on the basis of federal preemption, because Soundtec did not provide evidence of any device-specific requirements related to the hearing device at issue. We further noted that we found nothing in the Despains’ complaint that “would require a specific change in the way the hearing device was manufactured,” and so their state common-law tort claim did not constitute a device-specific requirement that would be subject to preemption under the MDA. However, in light of the Supreme Court’s conclusion in Riegel, supra, that state-law tort claims are, in fact, preempted by the MDA, we are compelled to grant Soundtec’s petition for rehearing and issue this substituted opinion whereby we affirm the trial court’s order granting Soundtec’s motion for summary judgment.1  Hannah, C.J., and Brown, J., concur.   In our original opinion, we also held that the trial court erred in concluding that summary judgment was appropriate based on the “learned intermediary doctrine.” However, because the Despains’ complaint is now barred on federal preemption grounds, it is unnecessary to discuss this issue.