Preemption and Pleading Ship Plaintiff Packing

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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 circumstances involving PMA medical gadgets.  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 system, appears to be winding down, and Dains is an effective instance of why that’s.  Taking over any Class III PMA system defendant requires being ready for specific FDCA preemption, and the plaintiff in Dains was not.  She made numerous allegations about this or that purported violation of the FDCA, however couldn’t get the items to suit collectively sufficient to suit via the “slim hole” between specific medical system 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 someway invalidated the PMA altogether – making specific preemption magically disappear.  Two issues, first she didn’t plead something in regards to the claimed “conditional premarket approval.”  Id. at *4.  Second, the declare was legally meritless:

Plaintiff’s criticism doesn’t allege that the FDA has withdrawn [the device’s] premarket approval, and he or she gives no authority to help her assertion that the “FDCA and MDA are clear that the failure to adjust to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 criticism did “not allege that the warnings Defendants offered deviated in any method from the language and warnings that the FDA authorized.  Id. at *5.  That was a “vital prerequisite to keep away from specific preemption.”  Id.  Nor might she declare that defendants “had been required to offer any warning or instruction past the labeling the FDA authorized.”  Id. (emphasis authentic).  Bye-bye warning claims.

The identical reality – compliance with FDA-approved warnings – likewise preempted her misrepresentation claims, each negligent and intentional (often known as “fraud”).  Id. at *5-6.  “With out an allegation of a particular assertion which violated FDA-approved statements for the . . . system, Plaintiff’s misrepresentation claims are preempted.”  Id. at *6.  Merely, slapping the title “misrepresentation” on a warning declare didn’t change the preempted outcome.  Not solely that, however the allegations failed the specificity necessities of Rule 9(b).  “Plaintiff’s imprecise allegations that Defendants misrepresented the protection of and dangers related to the . . . system fail to fulfill the Rule 9(b) customary, as she gives no particulars about exact statements that had been made, by whom, or when.”  Id.

The courtroom prevented deciding the extra attention-grabbing 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 this kind of declare.  Although 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 in the course of the related time interval:

Given the FDA’s consciousness of the alleged deficiencies in Defendants’ reporting previous to Plaintiff’s implantation, Plaintiff has did not plausibly allege that any failure to report brought on 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 desires 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 downside because the warning claims – plaintiff’s allegation of “no details . . . supporting [her] conclusory conclusion” that the system’s design was “violative” of relevant FDA rules.  Id.  Thus, “[p]laintiff has not plausibly alleged details suggesting that Defendants deviated from the FDA-approved design . . ., a vital prerequisite to avoiding specific preemption.”  Id.  Ditto for manufacturing.  Id. at *8 (“no details 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 nicely sufficient and likewise fell to precise preemption.  “Plaintiff has not alleged that Defendants deviated in any method from the coaching necessities imposed by the FDA.”  Id. at *8.  It was additionally a awful declare from a causation standpoint:

The criticism doesn’t include any factual allegations . . . that Defendants had been negligent within the coaching of the physician who implanted Plaintiff’s . . . system, that her physician’s coaching affected the right implantation of the system, or that any such error is causally associated to the alleged accidents she suffers.


Of the remaining flotsam and jetsam of plaintiff’s 17-count criticism:  (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 towards both the FDA or the medical neighborhood; and (3) “negligence, negligence per se, and constructive fraud claims” did not allege causation past mere “conclusory assertions.”  Id. at *9-10.

Lastly, because the plaintiff went zero for seventeen along with her first criticism, Dains was understandably skeptical of her boilerplate request to amend.  Plaintiff subsequently needed to show that there was any “there there”:

If Plaintiff seeks depart to file an amended criticism, she should file a letter temporary no more than 15 pages lengthy, together with a proposed amended criticism which has proposed insertions and deletions recognized. . . .  Plaintiff’s response to the movement to dismiss failed to handle the relevant preemption regulation.  Any letter temporary should element how the proposed pleading cures the deficiencies the Courtroom has recognized and should tackle relevant preemption regulation.

2022 WL 16572021, at *10.

As King George mentioned in “Hamilton” – “good luck.”

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