Preemption of State Tort Claims Under the Medical Device Amendments

Publication year1995
24 Colo.Law. 2217
Colorado Lawyer

1995, September, Pg. 2217. Preemption of State Tort Claims Under The Medical Device Amendments


Vol. 24, No. 9, Pg. 2217

Preemption of State Tort Claims Under The Medical Device Amendments

by Stephen D. Harris

The federal Food and Drug Administration ("FDA") has been regulating medical devices under the aegis of the Medical Device Amendments ("MDA") to the federal Food, Drug and Cosmetic Act ("FDCA") since 1976. The MDA attempts to strike a balance between protecting public health and encouraging the development of new medical devices by providing uniform regulatory requirements designed to ensure safety and effectiveness. The MDA also has become a potent mechanism used to bar state products liability and tort claims.

The Food, Drug and Cosmetic Act

The FDCA was amended in 1976, when Congress expanded the reach of the Act to include all medical devices via passage of the MDA.(fn1) The FDA is charged with administering its provisions and authorized to promulgate implementing regulations.(fn2)

Classification Scheme

According to the MDA, a medical device receives one of three regulatory classifications, depending on the level of regulation or control deemed necessary to provide reasonable assurance of the safety and effectiveness of that device.(fn3) All classes of devices are subject to minimal regulation under the MDA's so-called "general controls," which relate primarily to reporting and recordkeeping and require adequate labeling and good manufacturing practices.(fn4) Because class I devices generally pose little or no threat to public health and safety,(fn5) they are usually regulated only by the general controls. Examples of class I medical devices include ice bags, elastic bandages and tongue depressors.(fn6)

By comparison, all class II devices are or eventually will be subject to "special controls." These may include specific performance standards,(fn7) postmarket surveillance, patient registries, recommendations or guidelines.(fn8) Standard mercury thermometers and hypodermic needles are regulated by the FDA as class II devices.(fn9)

Class III devices are defined as those that support or sustain human life, are of substantial importance in preventing impairment of human health or are implanted in the human body, and in addition present a potential, unreasonable risk of illness or injury.(fn10) Before a class III device may be marketed, the FDA must find that it is "substantially equivalent" to a device existing prior to May 28, 1976 (the effective date of the MDA),(fn11) or grant premarket approval ("PMA") after significant scientific review.(fn12) Class III devices also are subject to extensive post-approval regulation.(fn13) Many components of pacemakers are class III devices.(fn14)

In addition, certain devices may qualify for an "investigational device exemption" ("IDE"). The IDE process is designed to encourage innovation and experimentation in the development of medical devices.(fn15)

Preemption Scheme

The MDA contains an express preemption provision in 21 U.S.C. § 360k(a), which specifically provides that no state or political subdivision 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.

The FDA construed the scope of this statute in 21 C.F.R. § 808.1, specifically identifying "statutes, regulations, court decisions and ordinances" as state requirements subject to preemption by federal law.(fn16) The FDA also determined that [s]tate or local regulations are preempted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act....(fn17)

In 1990 and 1992, Congress enacted amendments to the MDA, while leaving § 808.1 intact, suggesting that the regulation is consistent with congressional intent regarding MDA preemption.(fn18) An overwhelming majority of courts have ruled that the regulation is a reasonable interpretation of congressional intent.(fn19)

Apparently, only the Ninth Circuit and the District of Colorado view § 808.1 as requiring device specificity.(fn20) The First, Third, Fifth, Eighth and Eleventh Circuits have adopted the position that preemption is triggered when a requirement applies specifically to a particular device or when a general requirement is applied


to a particular device.(fn21) The Eleventh Circuit has recognized that "preemption-triggering requirements should, in some way, be restricted by nature to a particular process, procedure or device and should not be completely open-ended."(fn22)

Further evidence of a congressional intent not to preempt state tort claims can be derived from the MDA's Savings Clause, which plainly contemplates that a manufacturer of a device subject to MDA regulation may, in some circumstances, be liable under state law:

Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided him under such order shall be taken into account.(fn23)

Manufacturers have argued that § 360h(d) may refer only to state statutory and tort laws for which an exemption has been obtained pursuant to the procedures set forth at 21 U.S.C. § 360k(b), but the courts have generally been unwilling to adopt this reasoning.
Preemption of State Tort Claims

Preemption doctrine originates in the U.S. Constitution. According to the Supremacy Clause, the laws of the United States "shall be the supreme Law of the Land; and the judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any state to the contrary notwithstanding."(fn24) State laws that conflict with federal laws and regulations,(fn25) therefore, are preempted. Since 1992, the lower federal courts have looked to Cipollone v. Liggett Group, Inc. for guidance with respect to federal preemption of state law.(fn26) The FDA and the courts have universally agreed that state tort claims may be preempted by the MDA and its corresponding regulations.(fn27)

Nonetheless, courts have recognized a strong presumption against preemption: "[I]t must be initially presumed that Congress did not intend to displace state law."(fn28) This is especially true with respect to areas historically entrusted to state control. "[T]he historic police powers of the States [are] not to be superseded by [a] Federal Act unless that was the clear and manifest purpose of Congress."(fn29) The presumption against preemption is equally strong with respect to tort cases where no federal remedy exists.(fn30) Accordingly, the party claiming preemption bears the burden of proof and must demonstrate an unmistakable Congressional intent to preempt.(fn31)

"The FDA and the courts have universally agreed that state tort claims may be preempted by the MDA and its corresponding regulations."

Congressional intent is the touchstone of preemption analysis.(fn32) State law may be preempted either expressly, where Congress has specifically provided for such preemption, or implicitly, "where the scheme of federal regulation is sufficiently comprehensive to make reasonable the inference that Congress 'left no room' for supplementary state regulation."(fn33) In Cipollone, the Supreme Court stated that

[w]hen Congress has considered the issue of preemption and has included in the enacted legislation a provision explicitly addressing that issue, and when that provision provides a "reliable indicium of congressional intent with respect to state authority," there is no need to infer congressional intent to preempt state laws from the substantive provisions of the legislation.(fn34)

As the Fifth Circuit has recognized, "the fact that Congress included [§ 360k] in the MDA implies that matters beyond its reach are not preempted."(fn35) The cases interpreting the preemption provision of the MDA have generally applied a two-part test in resolving preemption claims: (1) the court identifies what federal requirements are applicable to the particular device in question; and (2) the court analyzes each of the plaintiff's claims to determine whether or not it imposes a requirement that is "different from, or in addition to" the federal requirements.(fn36)

Requirements Applicable To a Particular Device

The MDA itself makes no distinctions as to preemptive effect based on device classification, yet...

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