Walker v. Johnson & Johnson Vision Products, Inc
Walker v. Johnson & Johnson Vision Products, Inc
Opinion of the Court
Plaintiff filed suit against Johnson & Johnson Vision Products, Inc.,*
This Court reviews de novo a trial court’s grant or denial of summary disposition. Bitar v Wakim, 211 Mich App 617, 619; 536 NW2d 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.
The issue in this case is whether § 360k(a) preempts plaintiff’s negligent design and manufacture, negligent failure to warn, and breach of implied war
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 m 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 HI 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 in medical devices. Kennedy v Collagen Corp, 67 F3d 1453 (CA 9, 1995); Ministry of Health, Province of
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.” US Const, art VI, cl 2. Pursuant to the Supremacy Clause, Congress may preempt state law. Louisiana Public Service Comm v Federal Communications Comm, 476 US 355, 368; 106 S Ct 1890; 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under the Supremacy Clause ‘start[s] with the assumption that the historic police powers of the States [are] not to be superseded by .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 US 504, 516; 112 S Ct 2608; 120 L Ed 2d 407 (1992), quoting Rice v Santa Fe Elevator Corp, 331 US 218, 230; 67 S Ct 1146; 91 L Ed 1447 (1947). Congressional intent is the touchstone of any preemption analysis. Cipollone, supra, 516. 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.
There is a strong presumption against preemption. Cipollone, supra, 523. 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, 1432.
The mda was enacted in response to concerns regarding the safety of the Daikon Shield and other medical devices, such as heart valves and pacemakers. Id., 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 US Code Cong & Admin News 1074. 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 devel
The mda classifies medical devices as Class I, n, or m devices. 21 USC 360c(a). The degree of danger posed by the medical device to the public determines its classification. Class m 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 in medical devices. 21 CFR 886.5925. Generally, Class in devices are subject to “premarket approval to provide reasonable assurance of [their] safety and effectiveness.” 21 USC 360c(a)(l)(C). To obtain premarket approval, the manufacturer of a Class m 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 USC 360e(c)(l)(A)-(G); 21 CFR 814.20(b) (1)-(12). The FDA refers each application to a panel that prepares a report and recommendation. 21 USC 360e(c)(2). The FDA must either accept or reject the application within 180 days after receiving the application. 21 USC 360e(d)(l)(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:
*713 Except as provided in subsection (b)[3 ] of this section, no 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 USC 360k(a).]
Whether Congress intended to preempt state law products liability actions is unclear from the express language of the preemption clause. If a statute is silent or ambiguous regarding congressional intent, a court may look to an agency’s regulations for guidance in interpreting congressional intent. Chevron, USA, Inc v Natural Resources Defense Council, Inc, 467 US 837, 843; 104 S Ct 2778; 81 L Ed 2d 694 (1984). The court should defer to a federal agency’s construction of the statute unless the agency’s interpretation is unreasonable. Id., 844. Because the FDA is the agency that implements the mda, we must consider its interpretation of the preemption clause of the mda. The FDA interprets the preemption clause as follows:
State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements. [21 CFR 808.1(d) (emphasis added).]
it makes little sense to hold that the fda’s premarket approval process qualifies as a ‘specific requirement applicable to a particular device.’ 21 CFR 808.1(d) (emphasis added). All class III devices are required to obtain premarket approval before being sold in interstate commerce. 21 USC 360e; 21 CFR 814.1. The fact that the premarket approval process involves specific requirements, see 21 CFR 814, 820, must not be confused with the premarket approval requirement itself acting as a specific requirement. [Id., 1459.]
The conclusion that the premarket approval process satisfies the requirement that there be a specific requirement applicable to a particular device is also inconsistent with cases that have analyzed the preemption issue with regard to Class n medical devices:
In Class ii cases courts have consistently focussed [sic] both on the specificity of the federal requirement and the particularity of the device. . . . [0]ther courts have required*715 less overall specificity under § 808.1(d) for Class III devices than for Class H devices. They have required particularity in the preemption analysis of Class n devices, but have ignored the word ‘particular’ in the preemption analysis of Class hi devices.
Such distinctions between Class n and Class III devices make little sense. Congress enacted the mda to ensure that safe and effective medical devices were introduced into the market. HR Conf Rep No 1090. There is no reason for a court’s preemption analysis to change depending on the class of device in issue. [Id., 1458-1459.]
Moreover, it is the burden of the party arguing in favor of preemption to show that Congress intended to preempt state law, Silkwood v Kerr-McGee Corp, 464 US 238, 255; 104 S Ct 615; 78 L Ed 2d 443 (1984), and defendant has failed to show that there are any “specific requirements” that are uniquely applicable to disposable soft contact lenses. We find the court’s reasoning in Kennedy to be persuasive and reject defendant’s argument that the premarket approval process constitutes a specific requirement applicable to a particular device. “The federal law requiring the premarket approval of Class m devices was not enacted in order to free manufacturers from the everyday burdens of the marketplace after they are permitted to enter it. Premarket approval is supposed to benefit consumers, not create a rose garden, free from liability, for manufacturers.” Kennedy, supra, 1459-1460.
While our rejection of the conclusion that § 360k(a) provides for blanket preemption of all state products liability claims is a departure from the majority position, we believe that our holding is consistent with congressional intent. Because Congress enacted the mda to protect consumers, it would be entirely con
Accepting defendant’s interpretation of Congress’ intent in enacting § 360k(a) would result in the elimination of any remedy for a consumer injured by a Class m medical device and would effectively immunize manufacturers of Class m medical devices from claims brought by consumers injured by such devices. This was not the result Congress intended when it enacted § 360k(a). “The legislative history of the [Medical Device] Amendments shows an intent to protect consumers from medical device injuries, rather than leave them without a remedy.” Ministry of Health, supra, 1440. We decline to interpret the mda as immunizing manufacturers of Class m medical devices from claims brought by consumers injured by such devices and providing for blanket preemption of all state products liability claims against such manufacturers in the absence of more specific statutory language. “If the intent of Congress were to nullify an entire body of state consumer protection law, and leave the victims without a remedy, it would have specifically said so.” Id.
Reading the mda’s preemption provision in the manner advocated by the defendant would result in consumers of Class m devices being left without recourse for any harm suffered. Such a result flies in the face of the congressional intent behind the mda legislation: consumer protection.
Courts that have held that § 360k(a) preempts state products liability actions against manufacturers of Class m devices have also failed to consider the meaning of the words “general applicability” as used in the context of 21 CFR 808.1(d)(1). Id., 1458. 21 CFR 808.1(d) provides, in relevant part:
There are other State or local requirements that affect devices that are not preempted by section 521(a) of the act [21 USC 360k(a)] because they are not ‘requirements applicable to a device’ within the meaning of section 521(a) of the act. The following are examples of State or local requirements that are not regarded as preempted by section 521 of the act:
*718 (1) Section 521(a) does not preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices. [Emphasis added.]
State common law is a law of general applicability. Kennedy, supra, 1459. Furthermore, plaintiffs breach of implied warranty claim arises under the Uniform Commercial Code, MCL 440.2314, 440.2315; MSA 19.2314, 19.2315, and the UCC is specifically included in 21 CFR 808.1(d)(1) as an example of a law of general applicability. Thus, 21 CFR 808.1(d)(1) also supports our conclusion that plaintiffs negligent design and manufacture, negligent failure to warn, and breach of implied warranty claims are not preempted.
Defendant argues that plaintiffs failure to warn claim is preempted because it would impose a requirement that is “different from, or in addition to” the requirements imposed under the mda. We disagree. According to plaintiff, defendant failed to include in or on the sealed contact lens dispensing box a warning of the risk of corneal ulcer associated with the use of Acuvue contact lenses. The mda contains labeling requirements that are applicable to all medical devices regulated by the MDA. 21 USC 352(f) requires medical devices to have a label with “adequate directions for use,” but provides that when such directions are “not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement.” The FDA has promulgated a regulation providing for an exemption from the labeling require
Plaintiff argues that the danger of increased risk of corneal ulcer was not commonly known when plaintiff was prescribed Acuvue contact lenses and that defendant therefore was required to include a warning in the package. Plaintiffs failure to warn claim is not based on state law. Plaintiffs failure to warn claim is actually a claim that defendant negligently failed to comply with the labeling requirements of the mda as well as the labeling requirements of the applicable FDA regulation. 21 CFR 808.1(d)(2) specifically states that § 360k(a) “does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.” In Ministry of Health, supra, 1439, the court stated that “the MDA would not preempt claims that the manufacturer negligently failed to comply with the fda’s regulations, since a finding of wrongdoing would merely impose those regulations already imposed by the statute, and would not be ‘different from or in addition to’ those imposed by the MDA.” Thus, to the extent that plaintiff’s failure to warn claim is based on defendant’s failure to comply with the mda and 21 CFR 801.109, plaintiff’s failure to warn claim merely seeks to enforce the federal standard established by the mda and the appropriate FDA regulation and is therefore not preempted.
Defendant also contends that 21 CFR 808.1(b) supports its argument that plaintiff’s claims are pre
Finally, defendant argues that the United States Supreme Court’s decision in Cipollone supports its argument that plaintiff’s claims are preempted. Cipollone involved an analysis of the preemptive effect of the Federal Cigarette Labeling and Advertising Act of 1965, and its successor, the Public Health Cigarette Smoking Act of 1969, 15 USC 1331 et seq. In contrast, the instant case involves the preemptive effect of § 360k(a) of the mda and its accompanying regulations. The statutes in Cipollone were applicable to a particular product, whereas the mda applies to medical devices generally as opposed to a specific medical device. While the language of the preemption clauses in the respective statutes is similar, it is not identical, and we conclude that the language of the mda, the legislative history, and the fda regulations reveal that Congress did not intend to preempt state products liability claims against manufacturers of Class in medical devices.
After our preparation of this opinion, but prior to its release, the United States Supreme Court decided
In sum, we conclude that § 360k(a), considered in conjunction with 21 USC 360h(d) and the applicable FDA regulations, supports a finding that Congress did not intend to preempt plaintiff’s negligent design and manufacture, negligent failure to warn, and breach of implied warranty claims against defendant. The Supreme Court’s holding in Lohr supports our holding in this case. Accordingly, we conclude that the trial court erred in granting defendant’s motion for summary disposition pursuant to MCR 2.116(C)(4).
Reversed and remanded. We retain no jurisdiction.
Plaintiff also filed suit against Dr. Irving Adler, First Optometry Care Centers, Inc., and For Your Eyes Only, Inc. However, these defendants are not parties to this appeal because the trial court entered an order dismissing plaintiff’s cause of action against them pursuant to the parties’ stipulation for dismissal.
Because plaintiff’s complaint does not allege that defendant breached any express warranties, we will assume that plaintiff’s breach of warranty claim is a claim for breach of an implied warranty of merchantability, MCL 440.2314; MSA 19.2314, or a claim for breach of an implied warranty that the contact lenses were fit for a particular purpose, MCL 440.2315; MSA 19.2315.
Subsection b permits a state to apply for an exemption from the preemption of subsection a and is not at issue in this case.
Concurring Opinion
(concurring). I concur in the result. In my view, Medtronic, Inc v Lohr, 518 US _; 116 S Ct
Reference
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- Walker v. Johnson & Johnson Vision Products, Inc.
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