Walker v. Johnson & Johnson Vision Products, Inc.

• Decision Date: 26 July 1996
• Docket Number: Docket No. 175013
• Parties: , Prod.Liab.Rep. (CCH) P 14,738 Kim WALKER, Plaintiff-Appellant, v. JOHNSON & JOHNSON VISION PRODUCTS, INC., Defendant/Third-Party Defendant/Appellee, and For Your Eyes Only, Inc., Defendant/Third-Party Plaintiff, and First Optometry Care Centers, Inc., and Dr. Irving Adler, Defendants.
• Court: Court of Appeal of Michigan — District of US

Page 679

552 N.W.2d 679

217 Mich.App. 705, Prod.Liab.Rep. (CCH) P 14,738

Kim WALKER, Plaintiff-Appellant, v. JOHNSON & JOHNSON VISION PRODUCTS, INC., Defendant/Third-Party Defendant/Appellee, and For Your Eyes Only, Inc., Defendant/Third-Party Plaintiff,

and

First Optometry Care Centers, Inc., and Dr. Irving Adler, Defendants.

Docket No. 175013.

Court of Appeals of Michigan.

Submitted March 13, 1996, at Detroit.

Decided July 26, 1996, at 9:05 a.m.

Released for Publication Sept. 13, 1996.

Kelman, Loria, Downing, Schneider & Simpson by Alan B. Posner, Detroit, for plaintiff.

Dickinson, Wright, Moon, Van Dusen & Freeman by Robert S. Krause and Robert W. Powell, Detroit, for defendant.

Before MURPHY, P.J., and RICHARD ALLEN GRIFFIN and E.R. POST, ^* JJ.

MURPHY, Presiding Judge.

Plaintiff filed suit against Johnson & Johnson Vision Products, Inc. ¹ when she suffered permanent injury to her right eye after using contact lenses manufactured by defendant. The trial court found that plaintiff's claims against defendant were preempted by the Medical Device Amendments of 1976 (MDA), 21 U.S.C. § 360c et seq., to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., and granted defendant's motion for summary disposition pursuant to MCR 2.116(C)(4) (the court lacks subject-matter jurisdiction). Plaintiff appeals. We reverse and remand for trial.

Plaintiff alleged that she developed a corneal ulcer and suffered permanent injury to her right eye after using Vistakon Acuvue, etafilcon A, hydrophilic disposable contact lenses (Acuvue contact lenses), a product manufactured by defendant. Plaintiff's second amended complaint contained claims against defendant for negligent design and manufacture of the contact lenses, negligent failure to warn of the dangers associated with the use of the contact lenses, and breach of warranty. ² Defendant moved for summary disposition pursuant to MCR 2.116(C)(4), arguing that Acuvue contact lenses are regulated as Class III medical devices under the MDA and that plaintiff's claims against defendant were expressly preempted by § 360k(a), 21 U.S.C. § 360k(a). The trial court granted defendant's motion, holding that § 360k(a) preempted plaintiff's claims.

This Court reviews de novo a trial court's grant or denial of summary disposition. Bitar v. Wakim, 211 Mich.App. 617, 619, 536 N.W.2d 583 (1995). When reviewing a motion for summary disposition under MCR 2.116(C)(4), we must determine whether the pleadings demonstrate that the defendant was entitled to judgment as a matter of law or whether the affidavits and other proofs show that there was no genuine issue of material fact. Bitar, supra, 619-620, 536 N.W.2d 583.

The issue in this case is whether § 360k(a) preempts plaintiff's negligent design and manufacture, negligent failure to warn, and breach of implied warranty claims against defendant. The majority of federal and state courts considering this issue have held that § 360k(a) preempts most or all state products liability claims against the manufacturer of a Class III medical device. See, e.g., Mitchell v. Collagen Corp., 67 F.3d 1268 (C.A.7, 1995); Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392 (C.A.4, 1995); Mendes v. Medtronic, Inc., 18 F.3d 13 (C.A.1, 1994); Stamps v. Collagen Corp., 984 F.2d 1416 (C.A.5, 1993); Stefl v. Medtronic, Inc., 916 S.W.2d 879 (Mo.App., 1996); Ambrosio v. Barnes-Hind, Inc., 211 A.D.2d 70, 625 N.Y.S.2d 740 (1995). The United States District Courts for the Eastern and Western Districts of Michigan have both adopted the majority position. Strong v. Telectronics Pacing Systems, Inc., 891 F.Supp. 401 (W.D.Mich., 1994), rev'd on other grounds 78 F.3d 256 (C.A.6, 1996); Kemp v. Pfizer, Inc., 835 F.Supp. 1015 (E.D.Mich., 1993). Recently, the Sixth Circuit Court of Appeals adopted the majority position. Martin v. Telectronics Pacing Systems, Inc., 70 F.3d 39 (C.A.6, 1995).

Until now, no Michigan appellate state court has addressed in a published decision the preemptive effect of § 360k(a) in regard to state products liability claims against manufacturers of Class III medical devices. After much consideration, we reject the reasoning of Martin as well as the rest of the federal and state cases that have held that § 360k(a) preempts most or all state products liability claims against manufacturers of Class III medical devices. Instead, we are persuaded by the minority view, which rejects the view that § 360k(a) provides blanket preemption of all state law claims against manufacturers of Class III medical devices. Kennedy v. Collagen Corp., 67 F.3d 1453 (C.A.9, 1995); Ministry of Health, Province of Ontario v. Shiley Inc., 858 F.Supp. 1426 (C.D.Cal., 1994); Larsen v. Pacesetter Systems, Inc., 74 Haw. 1, 837 P.2d 1273 (1992), amended 74 Haw. 650, 843 P.2d 144 (1992); Haudrich v. Howmedica, Inc., 267 Ill.App.3d 630, 204 Ill.Dec. 744, 642 N.E.2d 206 (1994). We therefore adopt the minority position. In particular, we find the analysis and reasoning of the Ninth Circuit Court of Appeals in Kennedy to be persuasive.

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. Pursuant to the Supremacy Clause, Congress may preempt state law. Louisiana Public Service Comm. v. Federal Communications Comm., 476 U.S. 355, 368, 106 S.Ct. 1890, 1898, 90 L.Ed.2d 369 (1986). "Consideration of issues arising under the Supremacy Clause 'start[s] with the assumption that the historic police powers of the States [are] not to be superseded by ... Federal Act unless that [is] the clear and manifest purpose of Congress.' " Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407 (1992), quoting Rice v. Santa Fe Elevator Corp, 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947). Congressional intent is the touchstone of any preemption analysis. Cipollone, supra, at 516, 112 S.Ct. at 2617. Congressional intent may be explicitly stated in the language of a statute or implicitly contained in its structure and purpose. Id. In the absence of an express preemption clause, state law is preempted if the state law actually conflicts with federal law or if federal law so thoroughly occupies a legislative field that it can be reasonably inferred that Congress did not intend the states to supplement it. Id. If the statute contains an express preemption clause, the plain wording of the preemption clause must be examined because it contains the best evidence of Congress' preemptive intent. CSX Transportation, Inc. v. Easterwood, 507 U.S. 658, 664, 113 S.Ct. 1732, 1737-1738, 123 L.Ed.2d 387 (1993). The question to be answered in instances of express preemption is the extent to which Congress intended to preempt state law. Cipollone, supra, at 517, 112 S.Ct. at 2617-2618; Kennedy, supra, at 1456.

There is a strong presumption against preemption. Cipollone, supra, at 523, 112 S.Ct. at 2621. This presumption is particularly strong when the regulations in question relate to health and safety, which have historically been matters of local concern, and when preemption would preclude state remedies where no federal remedy exists. Ministry of Health, supra, at 1432.

The MDA was enacted in response to concerns regarding the safety of the Dalkon Shield and other medical devices, such as heart valves and pacemakers. Id., at 1434. The purpose of the MDA was to protect consumers from "increasingly complex devices which pose serious risk if inadequately tested or improperly designed or used." Id., quoting S.Rep. No. 94-33, 94th Cong., 2d Sess. (1976), reprinted in 1976 U.S.Code Cong. & Admin.News 1070, 1075. In introducing the legislation, Senator Edward Kennedy stated: "The purpose of this legislation is to protect the health and safety of the American people ... the legislation is written so that the benefit of the doubt is always given to the consumer. After all it is the consumer who pays with his health and his life for medical device malfunctions." Id., quoting 121 Cong.Rec. 59, 10688 (1975). The MDA was also written to encourage the research and development of medical devices that would improve the health and longevity of American people. Id.

The MDA classifies medical devices as Class I, II, or III devices. 21 U.S.C. § 360c(a). The degree of danger posed by the medical device to the public determines its classification. Class III medical devices are the most dangerous and the most heavily regulated. The Food and Drug Administration has classified extended wear soft contact lenses as Class III medical devices. 21 CFR 886.5925. Generally, Class III devices are subject to "premarket approval to provide reasonable assurance of [their] safety and effectiveness." 21 U.S.C. § 360c(a)(1)(C). To obtain premarket approval, the manufacturer of a Class III medical device must submit a detailed application to the FDA containing, but not limited to, the following information: information regarding the safety and effectiveness of the device, the intended use of the device, the methods used to manufacture the device, copies of proposed labeling for the device, and any other information requested by the FDA. 21 U.S.C. § 360e(c)(1)(A)-(G); 21 CFR 814.20(b)(1)-(12). The FDA refers each application to a panel that prepares a report and recommendation. 21 U.S.C. § 360e(c)(2). The FDA must either accept or reject the application within 180 days after receiving the application. 21 U.S.C. § 360e(d)(1)(A). Defendant submitted an application for premarket approval of Acuvue contact lenses. The FDA approved the application, subject to additional FDA "conditions of approval." There is no indication from the record that defendant failed to comply with the FDA's additional approval conditions.

The MDA contains an express preemption provision which provides as follows:

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