Medical device manufacturers who seek to dispose of meritless claims at the initial pleading stage have long relied upon the doctrine of federal regulatory preemption. This doctrine is embodied by 21 U.S.C. § 360k(a), the express preemption provision of the 1976 Medical Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”).1 The FDCA granted the United States Food and Drug Administration (“FDA”) jurisdiction over medical devices, and the MDA extended the process of premarket approval (“PMA”) to Class III devices, “the most stringent regulatory category for medical devices.”2 Class III devices “may enter the market only if the [FDA] reviews their design, labeling, and manufacturing specifications and determines that those specifications provide a reasonable assurance of safety and effectiveness.”3 The closely-scrutinized nature of this process ensures that Class III devices that comport with PMA requirements—which are ongoing in nature—remain safe and effective for human use.4 Given this “regime of detailed federal oversight,”5 21 U.S.C. § 360k(a) mandates that states may not establish any requirement “different from, or in addition to” a federal requirement that relates “to the safety or effectiveness” of a medical device.6 Section 360k(a) expressly preempts all state law claims directed at medical devices that have successfully completed the PMA process unless those claims explicitly parallel federal requirements, in other words. Manufacturers are thus safeguarded against state standards that are more rigorous than federal ones.
Litigants who seek to assert preemption under Section 360k(a) face a deceptively perilous legal landscape, however. Courts have construed the scope of the so-called “parallel claim” exception inconsistently, interpreting and applying this seemingly straightforward statutory carve-out in radically different ways. While some courts have permitted imprecisely-drawn allegations that would otherwise face preemption to survive challenges at the pleading stage, others have applied the standard articulated in Bell Atlantic Corp. v. Twombly7 and Ashcroft v. Iqbal8 and required plaintiffs to set forth facts sufficient to support such allegations.9 Many courts, including the Supreme Court of the United States and the United States Court of Appeals for the First Circuit, have yet to squarely address the question of the requisite level of pleading specificity applicable in the context of medical device preemption.
In light of this conflicting authority, how can medical device manufacturers protect themselves from lawsuits that are plainly preempted by Section 360k(a)? Can plaintiffs who claim injury related to a medical device survive 12(b)(6) motions by asserting allegations that might not in and of themselves pass muster under Twombly and Iqbal? Answers to these questions require an analysis of both the regulatory and jurisprudential framework of federal medical device preemption and the divergent approaches to pleading standards adopted by federal Circuit Courts of Appeals. Preemption can be a powerful tool for medical device manufacturers, allowing them to dispose of meritless claims at the pleading stage and avoid the costly burdens of discovery and trial. Whether civil defense attorneys can rely upon this doctrine to function as it was intended depends upon an understanding of the interactions between plausibility pleading standards and the permissible scope of the parallel claim exception.
Prior to the enactment of the MDA, the regulation of medical devices in the United States largely fell under the mantle of state control.10 The federal government did not require medical devices to undergo safety or effectiveness review prior to entering the stream of commerce, and did not authorize any control over the introduction of new medical devices.11 In response to these conditions, in which “complex devices proliferated and some failed,” the MDA implemented an integrated regulatory system while sweeping back authority from conflicting state-level schemes.12
Under the MDA, medical devices are classified according to the level of danger they pose.13 Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury.14 Because the level of risk associated with Class III devices is higher, they are subject to the most rigorous level of FDA scrutiny.15 Only when the FDA has received “reasonable assurance” that the device is safe and effective under the conditions of its use included on the label and that the proposed labeling is neither false nor misleading can the agency approve a PMA application.16 Once a device receives PMA approval, the FDA’s oversight responsibilities persist. Device manufacturers are forbidden from making “changes in design, specifications, manufacturing processes, labeling, or any other attribute[] that would affect safety or effectiveness” without permission from the FDA.17
The roots of federal medical device preemption lie in the Supremacy Clause of the United States Constitution, under which “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.”18 Recognizing the “undu[e] burden[]” imposed by potentially conflicting state-level regulations, Congress adopted a general “prohibition on non-Federal regulation” of medical devices by incorporating the express preemption clause into the MDA.19 That provision—21 U.S.C. § 360k(a)—expressly preempts any claim that imposes a state law “requirement” with respect to a medical device that is “different from, or in addition to” any federal requirement imposed by the FDA.20 Under the express preemption clause of the MDA:
(a) Except as provided in subsection (b)521 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 and effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.22
Section 360e of the MDA provides two exceptions to the requirement that Class III devices must undergo PMA review. The first exception permits “predicate” devices—those that were already on the market prior to the MDA’s enactment in 1976—to remain on the market while the FDA completes the PMA process; the second applies to devices that are “substantially equivalent” to Class I, II, or III devices that were approved by the FDA prior to 1976.23
In seeking to exploit perceived gaps in the framework of federal preemption, plaintiffs often resort to allegations that medical device manufacturers’ supposed violations of state law amount to agency fraud.24 These “fraud on the FDA” lawsuits were for the most part put to rest by Buckman Co. v. Plaintiffs’ Legal Comm., in which the Supreme Court of the United States held that “the plaintiffs’ state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, [the MDA and FDCA].”25 This conflict “stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against [it], and that this authority is used by the [FDA] to achieve a somewhat delicate balance of statutory objectives”; moreover, “[p]olicing fraud against federal agencies is hardly ‘a field which the States have traditionally occupied.’”26 Under Buckman, even if a state tort claim is not expressly preempted, it might be implicitly preempted. Because the FDA conducts a “time-consuming inquiry into the risks and efficacy of each device”27 that receives PMA approval, a finding that such a device breached an implied warranty, for example, would run counter to the FDA’s determination that the device was safe and effective for human use, and would thus “[a]lter[] the balance struck by the FDA” by imposing a state law requirement “to protect safety to a greater degree” than the FDA had determined to be appropriate.28 “[A] state law claim is impliedly preempted under the FDCA if the conclusion that the state law has been violated is based solely on a violation of the FDCA rather than on some independent state law duty.”29
Medtronic v. Lohr involved a medical device that did not receive premarket approval, but rather completed the less exacting process of substantial equivalence review.30 The device at issue in Lohr underwent a process “known as the § 510(k) process,” which involves the “review of devices for substantial equivalence” whereby a “new device need not undergo premarket approval if the FDA finds it is ‘substantially equivalent’ to another device exempt from premarket approval.”31 Lohr holds that state-level tort claims against manufacturers of medical devices that have received § 510(k) clearance are not preempted, because the substantial equivalence review process, without more, does not constitute a requirement that “relates to the safety or effectiveness of the device” since it is focused on equivalence, not safety.32 While paving the way for the broader preemption analysis outlined in Riegel v. Medtronic, Lohr does not provide much in the way of protection for medical device manufacturers who wish to dispose of inadequate claims.
In Riegel v. Medtronic, the Supreme Court held that because PMA-approved medical devices are subject to device-specific requirements imposed by the FDA, 21 U.S.C. § 360k(a) preempts state common law claims that: (i) are addressed to the design...
