The opinion of the court was delivered by: Justice Greiman
Appeal from the Circuit Court of Cook County.
The Honorable Defendant-Appellee. Gary L. Brownfield, Judge Presiding.
Plaintiff Harold Weiland brought suit against defendant Telectronics Pacing Systems, Inc., alleging claims for breach of warranty and product liability regarding two pacemakers implanted into his body. The circuit court granted summary judgment to the defendant on the claims because it determined that those claims were preempted by the Medical Device Amendments of 1976 (MDA) (21 U.S.C.A. §§360c through 360k (West Supp. 1998)) to the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C.A. §301 et seq. (West Supp. 1998)). Plaintiff appealed.
For the reasons that follow, we affirm.
On July 26, 1993, plaintiff filed a third amended complaint against Telectronics Proprietary, Ltd. (TPL), Telectronics Pacing Systems, Inc. (TPSI), and Alexian Brothers Medical Center, Inc. (Alexian), alleging breach of warranty and product liability claims against each defendant and loss of consortium for plaintiff's wife. According to the complaint, prior to January 1991, plaintiff suffered from a heart ailment. He sought treatment from Alexian and was diagnosed with heart disease. In January 1991, a pacemaker, model 8222, was surgically implanted into plaintiff. The pacemaker was designed and manufactured by TPL and sold to its distributor, TPSI, which in turn sold it to Alexian. Plaintiff alleged that the pacemaker malfunctioned, causing him to suffer various physical problems as well as general mental and psychological distress. The pacemaker was removed and a new pacemaker, model 1230, was implanted. This pacemaker was also manufactured by TPL, sold to TPSI, and resold to Alexian.
Plaintiff alleged that TPSI impliedly warranted that the pacemakers were merchantable and fit for the particular purpose for which they were intended and that they failed to meet those warranties. He further alleged that the two pacemakers were defective in design and construction, the defective condition existed at the time they left TPSI's possession, and the pacemakers were defective when they were sold to Alexian and, ultimately, to plaintiff. Plaintiff claimed that as a result of the defect he suffered adverse cardiac reaction, mental and physical pain, and psychological strain and anguish. He underwent surgical procedures to have the pacemakers removed and replaced with related devices.
Plaintiff's complaint noted that on December 31, 1991, the Department of Health and Human Services' Food and Drug Administration issued a recall of the model 8222 pacemaker.
On October 12, 1993, TPL was dismissed from the case without prejudice. Plaintiff later stipulated to the dismissal of the claims against Alexian with prejudice.
On July 6, 1995, the circuit court granted summary judgment to TPSI on the claims against it, counts II and V of the third amended complaint. During the hearing on the motion, the court stated that it found the claims preempted by federal law "in that they seek to impose requirements on the manufacturer that relate to the safety and effectiveness of a class III device that are different from and in addition to the requirements imposed by the medical device amendment[s]."
Plaintiff now appeals this ruling, arguing that the claims are not preempted by the MDA. The matter was held in abeyance pending resolution of Haudrich v. Howmedica, Inc., 267 Ill. App. 3d 630 (1994), in the Illinois Supreme Court, pending resolution of Medtronic, Inc. v. Lohr, 518 U.S. 470, 135 L. Ed. 2d 700, 116 S. Ct. 2240 (1996), in the Supreme Court of the United States, and pending resolution of a petition for certiorari for Kernats v. Smith Industries Medical Systems, Inc., 283 Ill. App. 3d 455 (1996), appeal denied, 169 Ill. 2d 569 (1996), cert. denied, --- U.S. ---, 139 L. Ed. 2d 631, 118 S. Ct. 684 (1998). The Illinois Supreme Court decided Haudrich without reaching the issue of whether the Medical Device Amendments of 1976 preempted state claims. See Haudrich v. Howmedica, Inc., 169 Ill. 2d 525 (1996) (preemption issue waived by failure to raise to court below). The Supreme Court's decision in Medtronic and this court's ruling in Kernats are discussed below.
Summary judgment is appropriate where the pleadings, affidavits, depositions, and admissions on file show there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Busch v. Graphic Color Corp., 169 Ill. 2d 325, 333 (1996). The standard of review is de novo. Busch, 169 Ill. 2d at 333.
The outcome of this case involves the interpretation of the MDA as well as several decisions interpreting the MDA, including Medtronic, Inc. v. Lohr, 518 U.S. 470, 135 L. Ed. 2d 700, 116 S. Ct 2240 (1996); Kernats v. Smith Industries Medical Systems, Inc., 283 Ill. App. 3d 455 (1996), appeal denied, 169 Ill. 2d 569 (1996), cert. denied, --- U.S. -- -, 139 L. Ed. 2d 631, 118 S. Ct. 684 (1998), and Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997), cert. denied, --- U.S. ---, 140 L. Ed. 2d 467, 118 S. Ct. 1300 (1998).
Plaintiff contends the circuit court erred in determining that the MDA preempted his claims for breach of implied warranty and product liability, and relies on this court's opinion in Kernats, which appears on point with regard to the preemption of his claims. Defendant argues, however, that this court should reconsider Kernats because it misconstrued the United States Supreme Court decision in Medtronic and, in light of subsequent federal decisions, hold these claims preempted by the MDA.
The MDA classifies medical devices into three categories based on the risk they pose to the public. See 21 U.S.C.A. §360c (West Supp. 1998); see generally Medtronic, 518 U.S. at 476-77, 135 L. Ed. 2d at 710, 116 S. Ct. at 2246; Kernats, 283 Ill. App. 3d at 459-60. Class III devices, which are at issue here, present "a potential unreasonable risk of illness or injury" and are subject to the most stringent MDA controls. 21 U.S.C.A. §360c(a)(1)(C) (West Supp. 1998). To market a class III device, a manufacturer must provide the FDA with a "reasonable assurance" that the device is both safe and effective. 21 U.S.C.A. §360e(d)(2) (West Supp. 1998). Manufacturers must obtain premarket approval (PMA) through a rigorous process that requires them to submit detailed information regarding the safety and efficacy of their medical devices. See Medtronic, 518 U.S. at 477, 135 L. Ed. 2d at 710-11, 116 S. Ct. at 2246-47.
Exceptions to the PMA requirement allow some class III devices to reach the marketplace without PMA review. A "grandfather" provision allows pre-1976 medical devices to remain on the market until such time as the FDA initiates and completes the requisite PMA. See 21 U.S.C.A. §360e(b)(1)(A) (West Supp. 1998); 21 C.F.R. §814.1(c)(1) (1998). The MDA also allows devices that are "substantially equivalent" to pre-existing devices to avoid the PMA process. See 21 U.S.C.A. §360e(b)(1)(B) (West Supp. 1998); see generally Medtronic, 518 U.S. at 478, 135 L. Ed. 2d at 711, 116 S. Ct. at 2247. Under the "substantially equivalent" exception, manufacturers must submit to a limited form of review known as "premarket notification," which allows the device to be marketed without further regulatory analysis if the FDA decides that it is "substantially equivalent" to a pre-existing device. Plaintiff does not suggest that the devices here are under the "substantial equivalent" exception.
Because the pacemakers implanted into plaintiff fall under class III, defendant was required to provide a "reasonable assurance" that the device was both safe and effective. Defendant asserts that the two pacemakers at issue here underwent the PMA review process. With this background, we must decide whether the MDA preempts plaintiff's claims.
The supremacy clause of the United States Constitution provides that the laws of the United States "shall be the supreme Law of the Land *** any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const., art. VI, cl. 2. Where state law conflicts with federal law, the state law is "'without effect.'" Busch, 169 Ill. 2d at 334, quoting Maryland v. Louisiana, 451 U.S. 725, 746, 68 L. Ed. 2d 576, 595, 101 S. Ct. 2114, 2128 (1981).
When analyzing a preemption question, there is an assumption that a federal law will not supersede the historic police powers of the states unless the purpose of Congress is clear and manifest. Kernats, 283 Ill. App. 3d at 460-61, citing Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 120 L. Ed. 2d 407, 422, 112 S. Ct. 2608, 2617 (1992); Medtronic, 518 U.S. at 485, 135 L. Ed. 2d at 715, 116 S. Ct. at 2250. Unless there is an express congressional command, state law is preempted if that law actually conflicts with federal law or if federal law so thoroughly occupies the legislative field as to make reasonable the inference that ...