The latest protection win in Dains v. Bayer HealthCare LLC, 2022 WL 16572021 (N.D.N.Y. Nov. 1, 2022), demonstrates why many plaintiff-side counsel are well-advised to steer away from instances involving PMA medical units. Between federal preemption and TwIqbal, not one of many plaintiff’s “seventeen individually enumerated causes of motion” escaped the defendant’s movement to dismiss. Id. at *3.
This specific litigation, involving a everlasting contraception machine, appears to be winding down, and Dains is an effective instance of why that’s. Taking over any Class III PMA machine defendant requires being ready for categorical FDCA preemption, and the plaintiff in Dains was not. She made quite a lot of allegations about this or that purported violation of the FDCA, however couldn’t get the items to suit collectively sufficient to suit by way of the “slender hole” between categorical medical machine preemption and implied Buckman preemption of personal FDCA enforcement makes an attempt. 2022 WL 16572021, at *4.
On the outset, plaintiff’s tried home-run ball curved foul. She claimed that the defendant’s supposed FDCA-related sins one way or the other invalidated the PMA altogether – making categorical preemption magically disappear. Two issues, first she didn’t plead something concerning the claimed “conditional premarket approval.” Id. at *4. Second, the declare was legally meritless:
Plaintiff’s grievance doesn’t allege that the FDA has withdrawn [the device’s] premarket approval, and she or he supplies no authority to help her assertion that the “FDCA and MDA are clear that the failure to adjust to situations of approval will invalidate [it].” On the contrary, the FDA has “authority and discretion” to withdraw premarket approval from a tool “if there’s a violation of situations.”
Id. at *4 n.6 (citations omitted).
Her particular person claims fared no higher. The grievance did “not allege that the warnings Defendants supplied deviated in any means from the language and warnings that the FDA accepted. Id. at *5. That was a “crucial prerequisite to keep away from categorical preemption.” Id. Nor may she declare that defendants “had been required to offer any warning or instruction past the labeling the FDA accepted.” Id. (emphasis unique). Bye-bye warning claims.
The identical reality – compliance with FDA-approved warnings – likewise preempted her misrepresentation claims, each negligent and intentional (often referred to as “fraud”). Id. at *5-6. “With out an allegation of a selected assertion which violated FDA-approved statements for the . . . machine, Plaintiff’s misrepresentation claims are preempted.” Id. at *6. Merely, slapping the title “misrepresentation” on a warning declare didn’t change the preempted consequence. Not solely that, however the allegations failed the specificity necessities of Rule 9(b). “Plaintiff’s imprecise allegations that Defendants misrepresented the security of and dangers related to the . . . machine fail to fulfill the Rule 9(b) commonplace, as she affords no particulars about exact statements that had been made, by whom, or when.” Id.
The courtroom averted deciding the extra fascinating query of whether or not New York permitted failure-to-report-based warning claims (the nice weight of authority is that NY doesn’t), however nonetheless dinged the plaintiff on causation, which as our 50-state survey additionally particulars, virtually at all times defeats any such declare. Though plaintiff alleged that the FDA discovered reporting violations (as did a P-side citizen petition to the FDA) – the FDCA didn’t make any related modifications to the product’s warnings through the related time interval:
Given the FDA’s consciousness of the alleged deficiencies in Defendants’ reporting previous to Plaintiff’s implantation, Plaintiff has didn’t plausibly allege that any failure to report brought about her accidents . . . the place the FDA grew to become conscious of those hostile occasions . . . earlier than the plaintiff’s process . . . however didn’t require [defendants] to take any motion to additional warn physicians or sufferers past the warnings already in place.
Id. at *7 (citations and citation marks omitted). Like many claims that the opposite aspect goals up as preemption dodges, “failure to report” is sort of at all times a awful declare, factually.
The design and manufacturing defect claims suffered from the identical fundamental drawback because the warning claims – plaintiff’s allegation of “no information . . . supporting [her] conclusory conclusion” that the machine’s design was “violative” of relevant FDA laws. Id. Thus, “[p]laintiff has not plausibly alleged information suggesting that Defendants deviated from the FDA-approved design . . ., a crucial prerequisite to avoiding categorical preemption.” Id. Ditto for manufacturing. Id. at *8 (“no information alleged from which it might be plausibly inferred that there was any defect within the manufacturing course of”).
One other preemption dodge declare, “negligent coaching,” didn’t dodge effectively sufficient and in addition fell to precise preemption. “Plaintiff has not alleged that Defendants deviated in any means from the coaching necessities imposed by the FDA.” Id. at *8. It was additionally a awful declare from a causation standpoint:
The grievance doesn’t include any factual allegations . . . that Defendants had been negligent within the coaching of the physician who implanted Plaintiff’s . . . machine, that her physician’s coaching affected the correct implantation of the machine, or that any such error is causally associated to the alleged accidents she suffers.
Id.
Of the remaining flotsam and jetsam of plaintiff’s 17-count grievance: (1) guarantee claims had been barred by the statute of limitations; (2) client fraud claims weren’t “client oriented” as a result of that purported “unfair and misleading” practices had been directed in opposition to both the FDA or the medical neighborhood; and (3) “negligence, negligence per se, and constructive fraud claims” didn’t allege causation past mere “conclusory assertions.” Id. at *9-10.
Lastly, for the reason that plaintiff went zero for seventeen along with her first grievance, Dains was understandably skeptical of her boilerplate request to amend. Plaintiff due to this fact needed to display that there was any “there there”:
If Plaintiff seeks depart to file an amended grievance, she should file a letter temporary no more than 15 pages lengthy, together with a proposed amended grievance which has proposed insertions and deletions recognized. . . . Plaintiff’s response to the movement to dismiss failed to deal with the relevant preemption regulation. Any letter temporary should element how the proposed pleading cures the deficiencies the Courtroom has recognized and should deal with relevant preemption regulation.
2022 WL 16572021, at *10.
As King George mentioned in “Hamilton” – “good luck.”
