Parallel Preemption, Plausibility, And The Pleading Puzzle: Massachusetts Marks Its Ground As To Medical Device Preemption Pleading Requirements

The Supreme Judicial Court in Dunn v. Genzyme (SJC-12904) (January 29, 2021) staked Massachusetts’ ground amidst the differing views as to the level of sufficiency needed for pleading state product liability law claims pertaining to medical devices to survive preemption under the Medical Device Amendments (MDA), 21 U.S.C. §§ 360c et seq., of the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (“MDA”). A unanimous SJC refused to impose any type of “heightened” obligation including any mandate that the applicable federal requirement be identified but nonetheless proceeded to find the complaint devoid of sufficient factual allegations particularly as to causality to survive a motion to dismiss.

The claimant had suffered an allegedly adverse reaction after knee injections with Synvisc-One used to treat patients suffering pain due to osteoarthritis of the knee. The product is intended to supplement the body’s fluid or lubricant in the knee joint. Synivisc-One is a Class III medicaldevice subject to premarket approval under the MDA and was otherwise approved by the FDA in 2009.  The immediate side effects alleged by the claimant included “pain and swelling” of both knees, “difficulty walking, hip bursitis and systemic pseudo-septic acute arthritis.” The side effects were likewise alleged to have caused the claimant to fall several times resulting in a meniscus tear and a fracture in her neck.

The action was commenced in the Superior Court and, through an amended complaint, asserted state law-based claims for failure to warn; breach of warranty; negligence; product liability; and violation of G.L. c. 93A. The manufacturer moved to dismiss stating the amended complaint was insufficient to state a claim and to survive federal preemption under the MDA. A judge of the Superior Court denied the motion with the Supreme Judicial Court transferring the matter for its consideration after the manufacturer’s petition for interlocutory review was granted by the Appeals Court.

The Supreme Judicial Court recognized that the inquiry was essentially two-fold: (1) whether the state claims survived MDA preemption; and (2) if so, whether the claims satisfy the applicable pleading requirements under Rule 12(b)(6), and particularly, the “plausibility” standard adopted in Iannacchino v. Ford Motor Co., 451 Mass. 623, 636 (2008).

As to the issue of preemption, the Supreme Judicial Court started its analysis with the express terms of the MDA which provides for preemption of state requirements pertaining to a medical device that are “different from, or in addition to, any requirement applicable . . . to the device” under Federal law. 21 U.S.C. § 360k(a)(1). Although “the gap” permitting escape from express and implied preemption under the MDA is a “narrow” one, the Supreme Judicial Court applied the test identified by the United States Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008) which ruled that state-based claim will survive MDA preemption so long as the claims “parallel” the federal requirements or, stated differently, where the state claims are based on, or coextensive with, violations of Federal statutes and regulations.

In addressing the “parallel” inquiry, the Supreme Judicial Court had to stake Massachusetts’ position amidst the differing views as to the level of specificity needed to survive preemption at the motion to dismiss stage. It noted that both federal court decisions as well as decisions of the Superior Court were not uniform. The range of views include those which hold that the claimant is not required to specify the federal requirement allegedly violated (see Bausch v. Stryker, 630 F. 3d 546 (7th Cir. 2010) to those that hold that the claimant must specify both the federal requirement and the medical device defect. Wolicki-Gables v. Arrow International, 634 F.3d 1296 (11th Cir. 2011). Between these extremes are certain “tweeners” in which there appears to be the obligation to specify as least the federal requirement or the defect. Funk v. Stryker, 631 F. 3d 777 (5th Cir. 2011). Neither the Supreme Court nor the First Circuit have yet to address the issue.

The Supreme Judicial Court proceeded to reject the view that a claimant had to plead or identify the specific federal regulatory requirement or specification. It rejected the manufacturer’s argument that the amended complaint needed to reference or identify what premarket approval requirements (“PMA”) were violated or how violated in order to state a viable, non-preempted claim. The SJC found that such a pleading obligation was not required as it would extend beyond the notice pleading requirements and be akin to imposing a heightened burden applicable to a fraud claim. As such, the Supreme Judicial Court held that it would “decline to require that plaintiffs asserting State common-law claims regarding MDA-regulated medical devices plead these parallel claims in greater specificity than otherwise would be required under the plausibility standard set forth in Iannacchino.”

The Supreme Judicial Court went on to hold, however, that the amended complaint otherwise did not meet the plausibility standard. The Court identified the salient allegations as including that the “reasonably foreseeable use of Synvisc-One involved significant dangers not readily obvious to the ordinary user of the product”; Synvisc-One had “dangerous propensities that were  known or reasonably knowable to [the manufacturer] at the time of its manufacture and distribution of Synvisc-One”; Synvisc-One posed “known or reasonably knowable dangers”; or, alternatively, that the “Synvisc-One that was ultimately injected into [claimant] was adulterated and defectively manufactured, distributed, marketed, and sold.” It found the fundamental deficiency to be that these allegations were conclusory and that there was a clear lack of “factual” allegations particularly as to the causality between the manufacturer’s allegedly tortious conduct and the claimant’s injuries. Unlike other cases where causation was found to have been sufficiently alleged as to an MDA device, the Court stated that the amended complaint contained “no facts regulatory, medical, or otherwise — that connect [the manufacturer’s] actions with the purported harm.”

The decision is notable in several respects. The “parallel” exception to MDA preemption requires that the state claim or requirement be identical to, or at least include, the federal requirement which, in this instance, would be PMA specifications. Similarly, for a state law failure to warn claim to escape MDA preemption it would at least have to plead the deviation from the product’s warning or FDA approved label. As such, to eliminate the need to identify the federal requirement in the amended complaint allows the specter of allowing a claim to proceed without identifying the “wrong” committed by the manufacturer and opens the door for allowing burdensome and costly discovery for what is essentially an unspecified wrongdoing. The SJC’s analogy to “fraud” claims and the specificity required for such claims can be deemed a reach as the identification of the fundamental federal requirement is not the same as the heightened burden applicable to fraud claims. Indeed, the heightened burden on fraud claims is largely historically based including their disfavor at common law and as they constitute a serious attack (bordering on a charge of criminal like conduct) on character with basic fairness mandating that the defendant be provided the who, what, where, when and how in the initial pleading. Identifying the federal requirement is arguably simply requiring the pleading of a fundamental factual element needed for any viable claim.

At the same time, PMA requirements are not publicly available. Since a plaintiff cannot allege that which he/she does not know imposing such a burden merits pause. Similarly, the goal of tort law is to protect the interests of injured consumers with the goal of MDA preemption to insulate manufacturers from any a higher or different standard than the federal government applies. As such, a more lenient pleading standard does not necessarily undercut federal preemption but delay its resolution until after discovery.

The Supreme Judicial Court’s decision in Dunn carves a space between the opposing interests. While it rejected any requirement to plead the specific federal requirements violated it otherwise reaffirmed the teeth of the plausibility standard noting the necessity of pleading “facts” and not “labels or conclusions” including as to the fundamental element of causation. Of note, the Court did not differentiate a medical device claim premised on FDA standards for “Current Good Manufacturing Practices” which are publicly available and part of the federal standards, and PMA product specific specifications which are not. A more precise delineation including an analysis of each separate state claim may have been more helpful and informing. The Supreme Judicial, nonetheless, held fast to the plausibility standard and the need for the pleading of facts, not labels or conclusions. Indeed, while the Court did not require identification of the specific federal standard violated, the failure to do so made it incumbent that the claimant otherwise factually allege, within the context-specific task underlying the plausibility inquiry, a cognizable link between the product defect and the injury. Absent identification of the federal regulatory requirement or any equivalent facts demonstrating causality beyond mere possibility, the Amended Complaint failed the plausibility inquiry. 

The Amended Complaint in Dunn will now serve as the benchmark for future cases in the quest to separate the wheat from the chaff as to pleading state product liability claims based on FDA regulated medical devices in the face of a challenge of preemption and/or plausibility on a motion to dismiss. Although any future MDA related complaint under Massachusetts law does not have to identify the specific or general federal requirements at issue, the failure to do so may make it more difficult to sufficiently allege a viable claim.