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)5

²¹

• 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, manufacture, and labeling of medical devices; and (ii) present requirements that are “different from, or in addition to, any requirement applicable” under federal law.³³ Riegel imposes a two-prong test on courts conducting preemption analyses: first, “whether the Federal Government has established requirements applicable to” the device at issue; and, if so, “whether the [plaintiff’s] common-law claims are based upon [state law] requirements with respect to the device that are ‘different from, or in addition to,’ the federal ones, and that relate to safety and effectiveness.”³⁴ The parallel claim exception mandates that only claims “premised on the breach of a state-law duty that is the same as a duty imposed under the [FDCA] (or one of its implementing regulations)” can circumvent preemption under 21 U.S.C. § 360k(a).³⁵ As such, the MDA “does not prevent a State from providing a damages remedy for claims premised on the violation of FDA regulation” where “the state duties in such a case parallel, rather than add to, federal requirements.”³⁶

That Riegel—and, to a lesser extent, Buckman and Lohr—allow courts to realize the legislative intent undergirding the MDA is clear. More problematic for medical device manufactures and civil defense attorneys is how federal courts have interpreted and applied the language of Section 360k(a) in seemingly incongruous ways.

In Riegel, the Supreme Court affirmed the broad preemptive power of 21 U.S.C. § 360k(a) and clarified that individuals who allege injury as a result of medical devices can initiate lawsuits based upon state law claims that “parallel” applicable FDA requirements.³⁷ The Supreme Court failed to define the scope of the parallel claim exception with any precision, however, and as a result, “the contours of the [] exception . . . are as-yet ill-defined.”³⁸ Lower courts have thus adopted conflicting interpretations. At the heart of this split lies the question of the degree of particularity with which a plaintiff alleging injuries tied to a medical device must state his or her allegations. The crux of this question is often whether (and how) plaintiffs allege violations of federal requirements.

Federal Courts of Appeals are divided on the question. The Eighth and Eleventh Circuits have held that 21 U.S.C. § 360k(a) preempts state law claims that are based upon generalized federal requirements applicable to all medical devices.³⁹ “[C]ourts across the country have applied Section 360k(a) broadly, preempting all manner of claims from strict products liability and negligence, to breach of warranty, to failure to warn and manufacturing- and design-defect, to negligence per se.”⁴⁰ In Wolicki-Gables v. Arrow Int’l, for example, the United States Court of Appeals for the Eleventh Circuit found that the district court “did not err in concluding that [the plaintiffs’] state common law claims were preempted” by the MDA, because the “allegations do not set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged.”⁴¹ The court reasoned that a plaintiff must “specifically state[]” a parallel claim to survive preemption under Section 360k(a); to plead a parallel claim plausibly, a complaint must allege a specific problem with a medical device “‘that can be linked to the [plaintiff’s] injury,’” and cannot merely contend that this problem was caused by a failure to satisfy generalized FDA requirements.⁴² Plaintiffs must instead plead facts “pointing to specific PMA requirements that have been violated.”⁴³ A lower pleading threshold would permit plaintiffs to assert and maintain state law claims that are explicitly preempted by Section 360k(a) simply by “‘incant[ing] the magic words’” that a manufacturer “‘violated FDA regulations.’”⁴⁴ While Wolicki-Gables does not cite to Twombly or Iqbal, it comports with their mandate that a plaintiff must plead a “cognizable link” connecting his or her allegations to a set of facts that renders those allegations plausible.⁴⁵

The Fifth, Sixth, Seventh, and Ninth Circuits have held, in contrast, that such claims are not expressly preempted under Section 360k(a) and Riegel.⁴⁶ These cases provide varying answers regarding the level of contextual detail necessary to state a parallel claim successfully. In Bausch v. Stryker Corp., for example, the United States Court of Appeals for the Seventh Circuit held that a complaint setting forth allegations that the defendant “violated federal law” in manufacturing a hip replacement system was not expressly preempted by Section 360k(a), despite the fact that the complaint failed to allege specific violations of federal law.⁴⁷ Because the plaintiff included in the complaint a litany of factual details that corroborated her claims of injury, however, she pled a “cognizable link” between the device and her injuries. These details include the facts that the manufacturer had received complaints that the device was failing after implant; that a batch of the device’s components was recalled due to “dimensional anomalies”; that the FDA issued an inspection report noting “numerous deficiencies [in the device’s] manufacturing and inspection processes”; and that six days before the plaintiff’s surgery, the FDA issued a warning letter stating that the device was “adulterated due to manufacturing methods . . . not in conformity with industry and regulatory standards.”⁴⁸ The United States Court of Appeals for the Fifth Circuit reached a similar conclusion in a case involving the same defendant, in which a plaintiff who received a hip replacement alleged that he was injured by manufacturing defects resulting from violations of federal regulations about which the defendant had received a formal warning letter from the FDA.⁴⁹ In both of these cases, courts found that plaintiffs pled parallel claims with enough specificity to overcome preemption under 21 U.S.C. § 360k(a) in part because their state law claims were rendered plausible by the factual context they introduced into their complaints.

Although the pleading at issue in Bausch is relatively rich in contextual detail—which should afford medical device manufacturers faced with facially-deficient complaints some relief—it nevertheless sets a dangerous precedent. The Seventh Circuit held that plaintiffs alleging injuries as a result of PMA devices should in essence be afforded a special dispensation exempting them from the plausibility pleading standard established by Twombly and Iqbal. The court focused upon the supposed difficulties of obtaining factual information about PMA devices, given the confidential nature of the PMA process: for a plaintiff “to plead with any more detail that her claims were ‘based entirely on a specific defect [] that existed outside the knowledge and regulations of the FDA,’ she would need access to the confidential materials in the [PMA] application setting forth the medical device’s specifications.”⁵⁰ Because some of the PMA materials are confidential, and there is “no public access to complete versions of these documents,” the court suggested that complaints containing conclusory allegations about Class III devices can nevertheless survive 12(b)(6) motions.⁵¹

Lack of access to information does not nullify a plaintiff’s pleading obligations, however, and civil defense attorneys should bear in mind that plaintiffs who are “armed with nothing more than conclusions” remain subject to Twombly and Iqbal.⁵² Despite the precedent established by Bausch, “the majority of courts who have addressed the pleading standards in this context” have held that “Plaintiffs cannot simply incant the magic words [that the defendant] violated FDA regulations in order to avoid [express] preemption.”⁵³

In the absence of a clear and uniform pleading standard, it is imperative that civil defense attorneys who are confronted with a complaint that alleges injuries tied to a medical device consider whether the doctrines of implied or express preemption (or both) can be used to eliminate some or all of these claims at the motion to dismiss stage. To that end, civil defense attorneys should bear in mind the following questions and issues:

• Is the complaint vulnerable to implied preemption, express preemption, or both? Taken together, “Riegel and Buckman create a narrow gap through which a plaintiff’s state law claim must fit if it is to escape express or implied preemption.”⁵⁴ In order to avoid dismissal, a “plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by §360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA ([because] such a claim would be impliedly preempted under Buckman).”⁵⁵ In other words, for a state law claim to survive preemption under this framework, it “must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the FDCA.”⁵⁶ “[T]he plaintiff’s state-law claim must ‘parallel[] a federal-law duty under the MDA’ but also exist [in state law] ‘independent[ly]’ of the MDA.”⁵⁷ Drafting a complaint that toes this line can be difficult. One or more causes of action can often be dismissed under these theories.

• Jurisdiction. Have federal district courts and Circuit Courts of Appeals ruled definitively on the issue of pleading standards for parallel claims in the context of medical device preemption? Keep in mind that even ostensibly bad precedent (such as Bausch v. Stryker) is not always as bad as it seems, particularly when the relevant complaints are compared on a granular level.

• To that end, comparing the complaint that you will be moving to dismiss against the complaint(s) at issue in the precedent that controls in your jurisdiction can help you sort the wheat from the chaff. Does the pleading in your case cite to violations of specific regulations, or does it allege more generalized violations (e.g., “FDA regulations,” “PMA requirements”)? What level of corroborating detail does the complaint in your case contain (e.g., does it cite to a warning letter or product recall, adverse event reports, physician letters, etc.)? If not, it likely does not satisfy the requirements of Twombly and Iqbal, so in addition to asserting claims that are preempted under the MDA and/or the FDCA, it fails to state a claim.

• Finally, it is useful to center Twombly and Iqbal in your analysis when drafting a 12(b)(6) motion, in view of the interconnectedness of plausibility pleading analyses with preemption analyses. A strong motion to dismiss may go far in ridding you of meritless claims at the pleading stage, even if those claims are not plainly preempted.