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Lab., 833 F. App’x 947, 950 (3d Circ. 2020) the court affirmed the district court’s dismissal of the complaint, reasoning that “[a]bsent reference to actual premarket approval requirements, the [plaintiffs] do not plausibly allege that Abbott abridged a state-law duty that neither adds to nor differs from the federal premarket approval requirements.” See also Otis-Wisher v. Medtronic, Inc., 616 F. App’x 433, 434 (2d Cir. 2015) (“To the extent her claim for strict liability manufacturing defect is not preempted . . . her assertion of a manufacturing defect is wholly conclusory and, therefore, must be dismissed for failure to state a plausible claim grounded in fact . . . .”); Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 777 (3d Cir. 2018) (reversing dismissal of negligence claims where plaintiff plausibly alleged that defendant published
“false or misleading” advertising in violation FDA statute, relied upon by plaintiff’s surgeon, and causing injuries). These cases are notable in that while they reached different outcomes, each decision required the plaintiffs to point to a specific federal law or regulation that the defendant violated, suggesting that the Seventh Circuit’s decision in Bausch could be considered to be somewhat of an outlier, which leads us to further discuss Dunn v. Genzyme Corp., 486 Mass. 713, 2021 WL 298551 (January 29, 2021) (slip op.).
Dunn v. Genzyme Corporation
In Dunn, Massachusetts’ highest court agreed with Bausch and held that a plaintiff need not plead
the specific federal statute or regulation violated to state a parallel claim, yet nonetheless dismissed the complaint, finding that the plaintiff had not plausibly stated a claim. 2021 WL 298551, at *4 (“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.”).
To alleviate the symptoms of osteoarthritis in her knees, the plaintiff in Dunn received an injection
of Genyzme’s Synvisc-One, a Class III medical device subject to FDA pre-market approval under the MDA. Id. at *2. Immediately after receiving the injections, the plaintiff allegedly experienced adverse side effects—“‘pain and swelling in her knees, difficulty walking, hip bursitis and systemic pseudoseptic acute arthritis.’” Id. (quoting the complaint). Plaintiff evidently fell several times allegedly because of
the side effects and broke her neck during one of the falls. Id. Genzyme moved to dismiss plaintiff’s complaint, arguing that the Massachusetts product liability claims were preempted and failed to meet the Massachusetts plausibility pleading standard, which mirrors the federal Twombly standard. Id.; Iannacchino v. Ford Motor Co., 451 Mass. 623, 636 (2008) (adopting Twombly standard under Mass. R. Civ. P.). The trial court denied the motion to dismiss, citing the Bausch decision and the informational disparities between plaintiffs and medical device manufacturers prior to discovery. 2021 WL 29855, at *3. The trial court reasoned that the complaint was sufficient, “given the amount of information to which [the plaintiff ] had access.” Id.
The Massachusetts Supreme Judicial Court reversed, agreeing with Genzyme that a lack of access to information at the pleading stage does not relieve a plaintiff of its obligation to plead a plausible claim. Id. at *6. The court held that “[n]o heightened pleading standard is required,” rather, “plaintiffs asserting parallel State law claims may do so with no greater degree of specificity than otherwise required under the [plausibility standard].” Id. at *1, *5 (distinguishing fraud cases). The court further held that while the plaintiff had not specified the precise product defect at issue or the federal regulatory requirement that was violated, that was not what was fatal to the claims at issue, it was the lack of plausibility of her claims. Id. at *1. In essence, the court found that plaintiff’s “bare bones” complaint merely alleged a temporal
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