February 24, 2021

The Massachusetts Supreme Court held in it opinion filed on January 29, 2021 in a defective medical device case that “the complaint does not proffer sufficient factual assertions that plausibly establish causality between Genzyme’s purportedly tortious activities and Dunn’s injuries. Rather, the complaint seems to imply that the temporal proximity between the injections of Synvisc-One and Dunn’s injuries alone is sufficient to establish the necessary element of causality … While all of the plaintiff’s State law claims here properly parallel the Federal requirements, none of them is sufficiently pleaded.”

Synvisc-One is manufactured by Genzyme Corporation (Genzyme) and is a Class III medical device subject to premarket approval under the MDA. Synvisc-One was approved by the FDA in 2009 for the treatment of pain associated with osteoarthritis of the knee in patients who have failed to respond to other treatments.

The Massachusetts Supreme Court stated, “We are asked in this case involving claims of personal injury and product liability against the manufacturer of a medical device to decide whether Federal law preempts the plaintiff’s State law claims because the device is regulated 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. State law claims survive preemption under the MDA so long as these claims parallel, rather than supplement, Federal requirements. See Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008). Under this standard, plaintiffs need not specify the precise defect in the medical device nor the specific Federal regulatory requirement allegedly violated in order to survive a motion to dismiss. No heightened pleading standard is required. Rather, we conclude that plaintiffs asserting parallel State law claims may do so with no greater degree of specificity than otherwise required under Iannacchino v. Ford Motor Co., 451 Mass. 623, 636 (2008).”

Iannacchino set forth a plausibility standard: “while a complaint need not include “detailed factual allegations[,] a plaintiff’s obligation to provide the grounds of his [or her] entitle[ment] to relief requires more than labels and conclusions” … plaintiffs asserting parallel State-law claims based upon a violation of FDA regulations must articulate only “factual allegations plausibly suggesting (not merely consistent with) an entitlement to relief.””

“We 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.”

In the case it was deciding, the Massachusetts Supreme Court held: “None of Dunn’s claims meets this standard. Dunn asserts 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 [Genzyme] 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 [Dunn] was adulterated and defectively manufactured, distributed, marketed, and sold” by Genzyme. No factual allegations are, however, provided upon which to ground these “labels and conclusions.””

Source Dunn vs. Genzyme Corporation, SJC-12904.

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