Court Opinion

ID: 9710570
Source: CourtListenerOpinion
Date Created: 2023-08-26 04:12:06.759838+00
Date Added: 2024-06-11T18:22:57.868987
License: Public Domain

JUSTICE ZWICK, dissenting: I dissent. The United States Supreme Court has spoken directly on this point in Medtronic, Inc. v. Lohr, 518 U.S. 470, 135 L. Ed. 2d 700, 116 S. Ct. 2240 (1996), and this court, in a case involving virtually identical facts to those presented here, found no preemption of state common law causes of action. See Kernats v. Smith Industries Medical Systems, Inc., 283 Ill. App. 3d 455, 669 N.E.2d 1300 (1996). Accordingly, I would reverse the finding of preemption and the entry of summary judgment in favor of the defendant. The majority acknowledges that when considering a preemption question, we must begin with the assumption that the historic police powers of the states are not to be superseded by a federal law unless that was the clear and manifest purpose of Congress. Kernats, 283 Ill. App. 3d at 460, citing Medtronic, Inc., 518 U.S. at 485, 135 L. Ed. 2d at 715, 116 S. Ct. at 2250; Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 120 L. Ed. 2d 407, 422, 112 S. Ct. 2608, 2617 (1992). This approach recognizes the “historic primacy of state regulation of matters of health and safety.” Medtronic, Inc., 518 U.S. at 485, 135 L. Ed. 2d at 715, 116 S. Ct. at 2250. Writing separately, Justice Stevens found it “unpersuasive” and “implausible” that Congress would have intended to preclude state courts from affording state consumers any protection from injuries resulting from a defective medical device. Medtronic, Inc., 518 U.S. at 487, 135 L. Ed. 2d at 716, 116 S. Ct. at 2251 (opinion of Stevens, J.). Such an interpretation would have barred most, if not all, relief for persons injured by defective medical devices. Medtronic, Inc., 518 U.S. at 487, 135 L. Ed. 2d at 716, 116 S. Ct. at 2251 (opinion of Stevens, J.). Justice Stevens correctly observed that the MDA was primarily concerned with the problem of specific, conflicting state statutes and regulations rather than the general duties enforced by common law actions. Medtronic, Inc., 518 U.S. at 489, 135 L. Ed. 2d at 718, 116 S. Ct. at 2252 (opinion of Stevens, J.). Justice Stevens further noted that preemption of all state common law causes of action would have the “perverse effect of granting complete immunity from design defect liability to an entire industry that, in the judgment of Congress, needed more stringent regulation in order ‘to provide for the safety and effectiveness of medical devices intended for human use.’ ” Medtronic, Inc., 518 U.S. at 487, 135 L. Ed. 2d at 716-17, 116 S. Ct. at 2251 (opinion of Stevens, J.). Justice Stevens concluded that Congress did not intend for the MDA to provide a sweeping preemption of traditional common law remedies against manufacturers and distributors of defective devices. Medtronic, Inc., 518 U.S. at 491, 135 L. Ed. 2d at 719, 116 S. Ct. at 2253 (opinion of Stevens, J.). Such a sweeping interpretation would require far greater interference with state legal remedies, producing a serious intrusion into state sovereignty while simultaneously wiping out the possibility of remedy for injured persons. Medtronic, Inc., 518 U.S. at 488-89, 135 L. Ed. 2d at 717-18, 116 S. Ct. at 2252 (opinion of Stevens, J.). Like Justice Stevens, I do not believe that Congress “clearly signaled its intent to deprive States of any role in protecting consumers from the dangers inherent in many medical devices.” Medtronic, Inc., 518 U.S. at 489, 135 L. Ed. 2d at 718, 116 S. Ct. at 2252 (opinion of Stevens, J.). In construing the preemption provision contained in section 360k(a), the Supreme Court held the MDA dictates that preemption occur only where there is a conflict between a specific state requirement and a federal requirement applicable to the same device. Medtronic, Inc., 518 U.S. at 498-99, 135 L. Ed. 2d at 723-24, 116 S. Ct. at 2257. Thus, the Supreme Court defined a two-part inquiry to decide the preemption issue. First, the “specific” federal requirements must be reviewed; if found “applicable to the device” in question, the requirements will preempt state law only if they are “specific counterpart regulations” or “specific” to a “particular device.” Medtronic, Inc., 518 U.S. at 500, 135 L. Ed. 2d at 725, 116 S. Ct. at 2257. Second, the “particular” state requirements must be examined. In order to be preempted, state requirements must, “with respect to” medical devices, be “different from, or in addition to” federal requirements, and relate “to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device.” Medtronic, Inc., 518 U.S. at 500, 135 L. Ed. 2d at 724, 116 S. Ct. at 2257. State requirements of “general applicability” are not preempted except where they have “the effect of establishing a substantive requirement for a specific device.” 21 C.F.R § 808.1(d)(6)(ii) (1995); Medtronic, Inc., 518 U.S. at 499, 135 L. Ed. 2d at 724, 116 S. Ct. at 2257. In Kernats, the court employed this analysis to claims arising from use of a class III device and determined that the PMA process is a specific federal requirement. Kernats, 283 Ill. App. 3d at 465. The court then examined the second prong of the analysis: whether the corresponding state requirement was “specifically developed ‘with respect to’ medical devices.” Kernats, 283 Ill. App. 3d at 465, citing Medtronic, Inc., 518 U.S. at 501, 135 L. Ed. 2d at 725, 116 S. Ct. at 2258. The court concluded that the plaintiffs’ claims based on defective design and inadequate testing allege that defendant defectively designed and failed to adequately test the device. Although these allegations related to the specific medical device at issue, they emanated from general duties applicable to every manufacturer; the legal duty owed to the plaintiffs was the general duty of every manufacturer to use due care to avoid foreseeable dangers in its products. Kernats, 283 Ill. App. 3d at 465-66, citing Medtronic, Inc., 518 U.S. at 501, 135 L. Ed. 2d at 725, 116 S. Ct. at 2258. The court concluded that the plaintiffs’ common law tort claims, based upon general liability principles, were not preempted by the MDA. Upon consideration of the plaintiffs’ claims for breach of implied warranties of merchantability and fitness, the court noted that the FDA regulations specifically provide, as an example of a permissible general requirement, that the Uniform Commercial Code warranty of fitness is not preempted. Kernats, 283 Ill. App. 3d at 466-67, citing 21 C.F.R. § 808.1(d)(1) (1995); Medtronic, 518 U.S. at 497, 135 L. Ed. 2d at 724, 116 S. Ct. at 2257. Because these state requirements are clearly of “general applicability,” and not “specifically developed ‘with respect to’ medical devices,” they do not fall within the purview of section 360k. Therefore, those claims were not preempted by the MDA. In my view, the State of Illinois has an obligation to protect the rights of its citizens to recover for injuries caused by defectively manufactured goods, of whatever type, and we are obligated to follow the precedent defined by the United States Supreme Court and to adhere to the prior holdings of this court where they control the issues at hand. I would, therefore, reverse the finding of preemption by the trial court.