The opinion of the court was delivered by: Justice Heiple
-Agenda 29-September 1999.
The issue in this case is whether section 360k of the Medical Device Amendments of 1976 (MDA) (21 U.S.C. §360k (1994)) to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301 et seq. (1994)) preempts plaintiff's state common law claims for breach of warranty and defective design and construction against Telectronics Pacing Systems, Inc. (TPSI), the distributor of two allegedly defective pacemakers. The circuit court of Cook County held that section 360k preempts plaintiff's claims and granted summary judgment in favor of TPSI. The appellate court affirmed. 302 Ill. App. 3d 175. We reverse, and hold that the Food and Drug Administration's premarket approval of a Class III medical device does not create a specific federal requirement within the meaning of section 360k of the MDA which preempts plaintiff's state common law claims.
Plaintiff was diagnosed with coronary heart disease. To treat this condition, doctors implanted into plaintiff's body a model 8222 pacemaker distributed in the United States by TPSI. Plaintiff alleges that this pacemaker malfunctioned, and his doctors were forced to replace it with a model 1230 TPSI pacemaker. Plaintiff alleges that he had to undergo surgery a second time to remove the model 1230 pacemaker after it too failed to function properly. Plaintiff filed a complaint against, among others, TPSI alleging state common law claims for breach of warranty and defective design and manufacture of the two pacemakers. The trial court granted TPSI's motion for summary judgment, holding section 360k of the MDA preempts plaintiff's claims. The appellate court affirmed. This court granted plaintiff's petition for leave to appeal. 177 Ill. 2d R. 315.
The sole issue in this case is whether the MDA preempts plaintiff's state common law claims. Even when a federal statute such as the MDA contains an express preemption provision, the starting point for our analysis is the presumption that " `the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.' " Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 135 L. Ed. 2d 700, 715, 116 S. Ct. 2240, 2250 (1996), quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 91 L. Ed. 1447, 1459, 67 S. Ct. 1146, 1152 (1947). Such a presumption, the United States Supreme Court has noted, is "consistent with both federalism concerns and the historic primacy of state regulation of matters of health and safety." Lohr, 518 U.S. at 485, 135 L. Ed. 2d at 715, 116 S. Ct. at 2250. As always, the purpose of Congress is the "ultimate touchstone" of preemption analysis. Busch v. Graphic Color Corp., 169 Ill. 2d 325, 334 (1996), quoting Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 120 L. Ed. 2d 407, 422, 112 S. Ct. 2608, 2617 (1992).
Section 360k(a) of the MDA provides:
"[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 the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." 21 U.S.C. §360k(a) (1994).
This provision, however, is highly ambiguous. Lohr, 518 U.S. at 505, 135 L. Ed. 2d at 728, 116 S. Ct. at 2260 (Breyer, J., Concurring in part and Concurring in the judgment). Section 360k clearly states "that federal requirements may pre-empt state requirements, but it says next to nothing about just when, where, or how they may do so." Lohr, 518 U.S. at 505, 135 L. Ed. 2d at 728, 116 S. Ct. at 2260 (Breyer, J., Concurring in part and Concurring in the judgment). Fortunately, in Lohr, the United States Supreme Court developed a standard for determining whether section 360k of the MDA preempts state common law claims. In order for a federal "requirement" to have preemptive effect under section 360k, the Lohr Court held, it must be a specific requirement which applies to a particular device and focuses on the safety and effectiveness of that device. Lohr, 518 U.S. at 498, 135 L. Ed. 2d at 723, 116 S. Ct. at 2256. Accord Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1372 (11th Cir. 1999); Mitchell v. Collagen Corp., 126 F.3d 902, 909-10 (7th Cir. 1997).
In Lohr, the Supreme Court held that section 360k of the MDA does not preempt state common law claims against the manufacturer of an allegedly defective pacemaker for negligent design, manufacture and assembly as well as strict products liability. Lohr, 518 U.S. at 492-502, 135 L. Ed. 2d at 719-26, 116 S. Ct. at 2253-58. The Lohr Court's analysis, however, was limited to a pacemaker which had received FDA approval for marketing under a grandfather provision in the MDA which requires only that the manufacturer demonstrate that its medical device is "substantially equivalent" to a medical device that was on the market prior to the adoption of the MDA in 1976. 21 U.S.C. §360e(b)(1)(B) (1994). TPSI's pacemakers, however, did not receive approval from the FDA under this section of the MDA. The holding in Lohr, therefore, does not definitively resolve whether the MDA preempts plaintiff's claims in this case.
In order to determine whether section 360k preempts plaintiff's claims in this case, we must examine the process by which the FDA approved TPSI's request to market its pacemakers. The MDA classifies medical devices into three categories based on the risk they pose to the public. Class III medical devices are devices which are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health" or "present a potential unreasonable risk of illness or injury." 21 U.S.C. §360c(a)(1)(C)(ii) (1994). The FDA classifies pacemakers as Class III devices. 21 C.F.R. §870.3610(b) (1995). Before a manufacturer can market a Class III medical device which is not "substantially equivalent" to a medical device on the market prior to the enactment of the MDA, the manufacturer must provide the FDA with a "reasonable assurance of the [device's] safety and effectiveness." 21 U.S.C. §360c(a)(1)(C)(i) (1994). This "premarket approval" process is a rigorous one. A manufacturer seeking premarket approval must submit to the FDA detailed information regarding the safety and effectiveness of the device, and the FDA spends an average of 1,200 hours reviewing each submission for premarket approval. Lohr, 518 U.S. at 477, 135 L. Ed. 2d at 710-11, 116 S. Ct. at 2246-47. Both of TPSI's pacemakers implanted in plaintiff's body received premarket approval from the FDA.
TPSI argues that the FDA's premarket approval of both pacemakers implanted in plaintiff's body constitute federal requirements which preempt plaintiff's state common law claims. As stated above, in order for a federal requirement to have preemptive effect under section 360k, it must be a specific requirement which applies to a particular device and focuses on the safety and effectiveness of that device. The premarket approval process unquestionably focuses on the safety and effectiveness of a particular Class III medical device; therefore our ...