We’ve bashed the horrible decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), more times than we care to count. This time we’re taking a look precedent contrary to Bausch’s statement that “[t]here are no special pleading requirements for product liability claims.” Id. at 558. While that is true as a platitude, the fact of the matter is that TwIqbal does not recognize legal conclusions such as “X violated the FDCA” unless they are supported by facts that plausibly establish the purported violation. Plaintiffs “cannot simply incant the magic words [defendant] violated FDA regulations in order to avoid preemption.” Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206, 1224 (W.D. Okla. 2013), aff’d, 784 F.3d 1335 (10th Cir. 2015)
Thus, in the specific context of allegations of “parallel” claims that seek to evade preemption, most courts have recognized that “[p]arallel claims must be specifically stated in the initial pleadings.” Wolicki-Gables v. Arrow International, 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. To properly allege parallel claims, the complaint must set forth facts pointing to specific PMA requirements that have been violated. . . . [A]n allegation that the manufacturing processes for the device and certain of their components did not satisfy the [FDA’s] Pre-Market Approval standards for the devices is insufficient to satisfy the requisite elements of a parallel claim . . . if the complaint fails to “provide any factual detail to substantiate that crucial allegation.
Id. (citations and quotation marks omitted). Under TwIqbal, “[t]o avoid having his claims preempted, a plaintiff must carefully plead a claim that implicates the safety or effectiveness of a [PMA] medical device.” Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1327 (11th Cir. 2017). Therefore, plaintiffs asserting parallel claims are subject to a “heightened pleading standard.” Irizarry v. Abbott Laboratories, 833 Fed. Appx. 947, 950 (3d Cir. 2020).
That’s why, “[b]ecause of the potential for preemption, courts have required greater specificity in pleading parallel claims.” Chiasson v. Medtronic Inc., 2016 WL 4191837 at *4 (E.D. La. Aug. 9, 2016).
When facing MDA preemption, a plausible cause of action requires, among other things, a showing that the alleged violation of state law parallels a violation of federal law. This additional step requires some greater specificity in the pleadings.
White v. Stryker Corp., 818 F. Supp.2d 1032, 1037 (W.D. Ky. 2011). “[V]ague allegations that Defendant violated ‘accepted standards for medical device risk management,’ are insufficient to meet the pleading requirement because Plaintiff does not specify what the ‘accepted standards’ are nor that the FDA imposed them.” Gallego v. Tandem Diabetes Care, Inc., 776 F. Supp.3d 119, 135 (E.D.N.Y. 2025).
To state a parallel claim and avoid preemption . . ., a plaintiff must identify state law that parallels a federal regulation or federal requirement that applies to the medical device at issue. The plaintiff must also allege that the defendant violated that federal regulation or federal requirement. And, the plaintiff must set forth factual allegations regarding how the medical device at issue violated the federal regulation” or federal requirement and link the alleged violation to plaintiff‘s alleged injury.
Reynolds v. Medtronic, Inc., 2021 WL 1854968, at *7 (S.D. Ohio May 10, 2021) (citations and quotation marks omitted). “A plaintiff must bolster her legal claims with factual evidence about how the medical device at issue violated the federal regulation.” Mories v. Boston Scientific Corp., 494 F. Supp.3d 461, 471 (S.D. Ohio 2020). A complaint that does “not set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged” does not state a claim. Yosowitz v. Covidien LP, 182 F. Supp.3d 683, 692 (S.D. Tex. 2016) (citation and quotation marks omitted).
Because medical device preemption turns on the sufficiency of purported violations of parallel PMA or other device-specific federal requirements, “[f]air notice of the basis of Plaintiff’s claims may be particularly important in the case of a medical device to which the Medical Device Amendments to the [FDCA] apply because federal law preempts state law requirements.” Warmoth v. Medtronic, Inc., 2023 WL 3938464, at *1 (W.D. Okla. June 9, 2023) (citation and quotation marks omitted). “To elude FDCA preemption, ‘parallel’ claims must be pled with sufficient specificity regarding how a device deviated from its PMA specifications.” Harris v. Medtronic, Inc., 729 F. Supp.3d 869, 882 (D. Minn. 2024). “Parallel claims require a high degree of specificity about what actions or inactions by a defendant violated federal law.” Ford v. St. Jude Medical, LLC, 2024 WL 4267981 at *3 (M.D. Pa. Sept. 23, 2024).
According to the pleading standards set forth in [TwIqbal], however, Plaintiff‘s broad references to federal regulations are insufficient to establish the duty element of a negligence state law claim which would parallel a violation of federal law. . . . Courts within the Third Circuit closely adhere to the pleading standards set forth in [TwIqbal]. . . . In the context of MDA preemption, [TwIqbal] make a plaintiff’s job more difficult than it would be in a typical product liability case.
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This Court requires a greater level of specificity in pleading a parallel claim, rather than allowing claims premised on violations of general regulations to go forward merely because plaintiffs will supplement their pleadings at trial.
Gross v. Stryker Corp., 858 F. Supp.2d 466, 494-96 (W.D. Pa. 2012) (finding Bausch “unpersuasive”) (citations and quotation marks omitted). Accord Smith v. ZOLL Medical Corp., 505 F. Supp.3d 787, 796 (W.D. Tenn. 2020) (agreeing that pleading parallel claims “is more difficult than it would be in a typical product liability case”) (citation and quotation marks omitted).
We’re not the only ones bashing Bausch. Many courts have also done so.