Massachusetts’ highest court issued an  interesting decision regarding pleading requirements and the causation element in a device case  See Dunn v. Genzyme Corp., No. SJC-12904 (Sup. Jud. Ct. Mass. 1/29/21). Plaintiff Dunn received two injections of Synvisc-One, one in each knee. Synvisc-One 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.  When she experienced alleged side effects, she sued, focusing on an alleged failure to warn.

We won’t spend any time in this post on the first issue for the court: whether Federal law preempted the plaintiff’s State law claims because the device is regulated under the Medical Device Amendments (MDA), 21 U.S.C. §§ 360c et.  The court found the State law claims survived preemption under the MDA as these claims parallel, rather than supplement, federal requirements. See Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008). More  interesting is the conclusion that, although parallel, none of the claims were sufficiently pleaded to survive the manufacturer’s motion to dismiss. Accordingly, the lower court’s decision denying the manufacturer’s motion to dismiss was reversed.

There is some disparity in views among the few courts that have examined the level of specificity necessary to plead State law claims in order to survive preemption under the MDA. Compare Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) (“A plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue” ), with Bausch v. Stryker Corp., 630 F.3d 546, 560-561 (7th Cir. 2010), cert. denied 565 U.S. 976 (2011) (declining to require that plaintiffs “specify the precise defect or specific  federal regulatory requirements that were allegedly violated”).

Here, of course, we are talking about pleading under state rules, and the court declined 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 under state law. See Iannacchino v. Ford Motor Co., 451 Mass. 623, 636 (2008). Cf. Bass v. Stryker Corp., 669 F.3d 501, 509 (5th Cir. 2012).

But none of Dunn’s claims met this traditional standard. Dunn asserted 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. These were labels and conclusions however, and no factual allegations were provided upon which to ground these “labels and conclusions.” Iannacchino, 451 Mass. at 636, quoting Twombly, 550 U.S. at 555.

Thus, there were insufficient facts in the complaint plausibly to suggest an entitlement to relief. Fundamentally, the complaint did not proffer sufficient factual assertions that plausibly established causality between the purportedly tortious activities and Dunn’s injuries. Rather, the complaint sought to imply that the temporal proximity between the injections of Synvisc-One and Dunn’s injuries alone was sufficient to establish the necessary element of causality. The court contrasted cases cited by plaintiff, as her complaint invoked no such facts – regulatory, medical, or otherwise — that connected Genzyme’s actions with the purported harm.  While the lower court had emphasized the purported disparity between the information available to Dunn and to Genzyme, a lack of access to information at the pleading stage does not nullify a plaintiff’s pleading obligations.