Lead Opinion
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,
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 HI mеdical device. See, e.g., Mitchell v Collagen Corp,
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,
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
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 thе 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, 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 mediсal 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 аnd 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
The MDA contains an express preemption provision which provides as follows:
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,
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 аny 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).]
Defendant argues that the premarket approval process is a “specific requirement[] applicable to a particular device.” We cannot agree. While most federal and state courts that have considered similar arguments have concluded that the premarket approval process satisfies the fda’s preemption rule and preempts state common-law claims, we agree with the court in Kennedy that these courts have failed to consider whether Class m medical devices as a group can constitute a “particular device” within the FDA’s understanding of that term. Kennedy, supra, 1458. If the premarket approval process constitutes a specific requirement applicable to a particular device, then manufacturers of Class m medical devices would be immune from state products liability claims. However,
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 less overall specificity under § 808.1(d) for Class III devices than for Class H devices. They have required particularityin 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 werе 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,
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 contrary to Congress’ intent to interpret the mda as providing for blanket preemption of state products liability claims against manufacturers of Class ni medical devices. Moreover, Congress included in the mda a provision stating that “[c]ompliance with an order issued under this section shall not relieve any person from liability under Federal or State law.” 21 USC 360h(d). Congress’ inclusion of such a provision in the mda is evidence that Congress intended to preserve state products liability claims against manufacturers of Clаss m medical devices rather than to preempt such claims.
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.
In light of the purpose of the MDA of protecting consumers from unsafe medical devices, the fact that Congress did not provide any federal remedy in the MDA is also compelling evidence that Congress did not intend to provide for blanket preemption of state products liability claims against the manufacturers of Class m medical devices. Congress’ silence regarding whether it intended to preempt state products liability claims by enacting the MDA “takes on added significance in light of Congress’ failure to provide any federal remedy for persons injured by such conduct. It is difficult to believe that Congress would, without comment, remove all means of judicial recourse for those injured by illegal conduct.” Silkwood, supra, 251. As the court noted in Kennedy, supra, 1459:
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 hаrm suffered. Such a result flies inthe 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:
(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 tо 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 requirement of 21 USC 352(f) for “prescription devices” if certain conditions are met. 21 CFR 801.109. One of the conditions is that the medical device must be one “for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device.” 21 CFR 801.109(c).
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 еqual 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 preerupted. In 21 CFR 808.1(b), the FDA states that “no State or political subdivision of a State may establish or continue in effect any requirement with respect to a medical device intended for human use having the force and effect of law (whether established by statute, ordinance, regulation, or court decision).” To the extent that the FDA’s inclusion of the words “court decision” suggests that the fda interprets § 360k(a) as preempting plaintiff’s claims, the fda regulation contradicts congressional intent as well as every other fda regulation interpreting § 360k(a) and is not based on a permissible construction of the statute. Chevron, supra, 842.
Finally, defendant argues that the United States Supreme Court’s decision in Cipollone supports its argument that plaintiff’s
After our preparation of this opinion, but prior to its release, the United States Supreme Court decided Medtronic, Inc v Lohr,
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.
Notes
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 warrаnty 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.
Concurrence Opinion
(concurring). I concur in the result. In my view, Medtronic, Inc v Lohr,