The Massachusetts Supreme Judicial Court recently addressed the question of what pleading standard is required in Massachusetts to allege parallel state law claims involving medical devices to avoid preemption under the federal law regulating medical devices. The Court’s decision sheds light on the lack of consensus among state and federal courts on this issue, which may impact the time and resources that litigants and the courts expend on claims that may later prove to be meritless.
As background, the Food and Drug Administration (“FDA”) must approve or clear medical devices before they can be marketed or sold to the public. The approval process employed depends upon the category of the medical device. Under the Medical Device Amendments of 1976 (the “MDA”) to the Federal Food, Drug, and Cosmetic Act (the “FDCA”), devices are separated into three categories depending on the potential risks they present: Class I, Class II, and Class III. Class I devices “are those that present no unreasonable risk of illness or injury and therefore require only general manufacturing controls; Class II devices are those possessing a greater potential dangerousness and thus warranting more stringent controls; Class III devices ‘presen[t] a potential unreasonable risk of illness or injury’ and therefore incur the FDA’s strictest regulation.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 343-44 (2001) (citation omitted); see also 21 U.S.C. § 360c. Class III devices include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators, among other devices. Riegel v. Medronic, 552 U.S. 312, 316 (2008).
Minus certain exceptions, a Class III device typically undergoes a review process and receives what is termed premarket approval (“PMA”) before it can be advertised and sold to the public. The PMA process “requires the applicant to demonstrate a ‘reasonable assurance’ that the device is both ‘safe . . . [and] effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.’” Buckman Co., 531 U.S. at 343-45 (citation omitted). The application for PMA must include, among other things, “full reports of all information . . . concerning investigations which have been made to show whether or not such device is safe and effective; . . . a full statement of the components, ingredients, and properties and of the principle or principles of operation, of such device; . . . [and] a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device . . . .” 21 U.S.C. § 360e.
Once the FDA grants premarket approval for a device, it retains certain control over the device. For instance, pursuant to the Supremacy Clause of the United States Constitution, particular claims that a litigant brings against a device will be barred because the FDA already imposed requirements on the device in order to clear it. Specifically, the MDA bars state law claims if they are either expressly or impliedly preempted by the MDA. A state law claim is expressly preempted by the MDA if: (1) the Federal government has established requirements applicable to the device, and (2) Plaintiff’s claims are different from or in addition to the requirements that the federal government imposes on the device and are related to the safety or effectiveness of the device “or to any other matter included in a requirement applicable to the device under [21 U.S.C. § 360k].” See 21 U.S.C. § 360k(a); Riegel, 552 U.S. at 316. If the device has received premarket approval, then courts answer the first question in the affirmative. See e.g., Riegel, 552 U.S. at 322-23. As to the second question, if the state law claims do not impose requirements different from or in addition to the federal law, then the state law claims are thought to “parallel” rather than add to federal requirements and therefore can proceed. Further, a state law claim is impliedly preempted if it seeks to privately enforce a duty that is held by the FDA; this typically arises when a litigant alleges that the defendant defrauded the FDA without any connection to a state law claim. Therefore, under the MDA, Plaintiffs only have a “narrow gap” for state law claims against a device that received FDA approval or clearance: to avoid preemption, a Plaintiff must sue for an action that violates a federal requirement but does not impose more or different requirements than the federal law (to avoid express preemption), but cannot sue solely because the conduct complained of violated that federal requirement (to avoid implied preemption). Typically, claims such as strict liability-design defect and strict liability-failure to warn, among others, are found to be preempted.
Recent Opinion from the Massachusetts Supreme Judicial Court
The issue of preemption of state law claims involving a medical device recently arose in the Massachusetts Supreme Judicial Court case, Dunn v. Genzyme Corporation, 486 Mass. 713, 716 (2021). In Dunn, Plaintiff received two injections of Synvisc-One—a medical gel-like substance that relieves knee pain. See id. Synvisc-One is categorized as a Class III device that received premarket approval. See id. After receiving the injections, Plaintiff experienced negative side effects and commenced an action against Genzyme Corporation, the manufacturer of the Synvisc-One injections, alleging that Synvisc-One was “negligently manufactured, designed, distributed, and sold by [Genzyme], and . . . failed to contain appropriate and significant warnings related to its use.” Id. Plaintiff sought monetary damages based on four state law claims: (1) failure to warn, (2) breach of warranty, (3) negligence, and (4) products liability, and later amended her complaint to add a fifth claim under the Massachusetts Consumer Protection Act. See id. Genzyme filed a motion to dismiss pursuant to Mass. R. Civ. P. 12 (b)(6) on the basis that Plaintiff’s assertions were not only preempted by federal law, but also failed to satisfy the state law pleading standards. Id. at 716-17. The Superior Court denied Genzyme’s motion to dismiss; it held that Plaintiff’s complaint was sufficiently pled under state law, and was not preempted by federal law. See id. at 717. Genzyme appealed, and the Appellate Court granted interlocutory review. See id. The Supreme Judicial Court of Massachusetts then took up the case sua sponte before the intermediate Appellate Court heard it. See id.
The Massachusetts Supreme Judicial Court considered whether Plaintiff’s claims were expressly preempted by the MDA and applied the two-step inquiry as outlined in Riegel. See id. at 718-20. As to the first question—whether the Federal government has established requirements applicable to the device—the Court answered in the affirmative because the product was a Class III device that received premarket approval. See id. at 719. As to the second question—whether Plaintiff’s claims were different from or in addition to the requirements that the federal government imposes on the device—the Court held the state law claims did not impose additional or different requirements and therefore the state law claims were parallel to the federal law. See id. at 719-20. Significantly, the court addressed the pleading standard required to demonstrate that the state law claims were parallel, and applied the typical notice-pleading standard of Massachusetts Rule 8. See id. at 719-22. In denying a heightened pleading standard, the court held, “[w]e will not require plaintiffs who are asserting parallel State law claims to plead specific facts, such as the precise Federal regulations purportedly violated or the precise relationship between State and Federal requirements, to meet our ordinary, notice-pleading standard. ‘Although the complaint would be stronger with such detail, we do not believe the absence of those details shows a failure to comply’ with the requirements.” Id. at 719-20. To note, although the court held that the claims were not preempted, it dismissed the claims for failure to state a claim based on failure to adequately plead causation.
Other Court Holdings and Analysis
The pleading standard required to avoid preemption for products liability claims involving medical devices has been a contentious issue with no clear agreement among federal and state courts. At one end of the spectrum, the 11th Circuit in Wolicki-Gables held, “‘[t]o properly allege parallel claims, the complaint must set forth facts’ pointing to specific PMA requirements that have been violated.” Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) (emphasis added) (“Plaintiffs cannot simply incant the magic words ‘[Appellees] violated FDA regulations’ in order to avoid preemption.”). On the other end of the spectrum is the 7th Circuit, which applied the typical notice pleading standard and held, “[t]he federal standard of notice pleading applies, so long as the plaintiff alleges facts sufficient to meet the new ‘plausibility’ standard applied in Iqbal and Twombly.” Bausch v. Stryker Corp., 630 F.3d 546, 558 (7th Cir. 2010) (“Defendants object that the original complaint does not specify the precise defect or the specific federal regulatory requirements that were allegedly violated. Although the complaint would be stronger with such detail, we do not believe the absence of those details shows a failure to comply with Rule 8 of the Federal Rules of Civil Procedure or can support a dismissal under Rule 12(b)(6).”). Courts have subsequently decided cases in between the two spectrums. See e.g., Bass v. Stryker Corp., 669 F.3d 501, 513 (5th Cir. 2012). In this recent decision, the Dunn court seems to be in line with the 7th Circuit in applying the plaintiff-friendly notice pleading standard. Presently, there has been no United States Supreme Court decision addressing this issue.
The conflict regarding what pleading standard is required to allege parallel claims in the context of medical devices will affect how far claims can proceed in a case. If plaintiffs are permitted to make vague allegations without specifying which federal requirement is implicated, then meritless claims may proceed past the Rule 12 stage of litigation and litigants and the court will expend numerous resources only to find out later that the claims would be preempted. Further, by side-stepping preemption at the Rule 12 stage, Plaintiffs may have more time to potentially find more creative ways to get around preemption by the time motions for summary judgment come around. On the contrary, requiring plaintiffs to satisfy a heightened pleading standard may overburden common citizens by mandating that they identify and understand federal requirements in order to bring a state law claim. The Massachusetts Supreme Judicial Court’s recent decision in Dunn is another example to demonstrate that the United States Supreme Court should address this issue to reach a consensus among the courts.