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The recent defense 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 cases involving PMA medical devices.  Between federal preemption and TwIqbal, not one of the plaintiff’s “seventeen separately enumerated causes of action” escaped the defendant’s motion to dismiss.  Id. at *3.

This particular litigation, involving a permanent birth control device, seems to be winding down, and Dains is a good example of why that is.  Taking on any Class III PMA device defendant requires being prepared for express FDCA preemption, and the plaintiff in Dains was not.  She made a lot of allegations about this or that purported violation of the FDCA, but couldn’t get the pieces to fit together enough to fit through the “narrow gap” between express medical device preemption and implied Buckman preemption of private FDCA enforcement attempts.  2022 WL 16572021, at *4.

At the outset, plaintiff’s attempted home-run ball curved foul.  She claimed that the defendant’s supposed FDCA-related sins somehow invalidated the PMA altogether – making express preemption magically disappear.  Two problems, first she didn’t plead anything about the claimed “conditional premarket approval.”  Id. at *4.  Second, the claim was legally meritless:

Plaintiff’s complaint does not allege that the FDA has withdrawn [the device’s] premarket approval, and she provides no authority to support her assertion that the “FDCA and MDA are clear that the failure to comply with conditions of approval will invalidate [it].” To the contrary, the FDA has “authority and discretion” to withdraw premarket approval from a device “if there is a violation of conditions.”

Id. at *4 n.6 (citations omitted).

Her individual claims fared no better.  The complaint did “not allege that the warnings Defendants provided deviated in any way from the language and warnings that the FDA approved.  Id. at *5.  That was a “necessary prerequisite to avoid express preemption.”  Id.  Nor could she claim that defendants “were required to give any warning or instruction beyond the labeling the FDA approved.”  Id. (emphasis original).  Bye-bye warning claims.

The same fact – compliance with FDA-approved warnings – likewise preempted her misrepresentation claims, both negligent and intentional (usually called “fraud”).  Id. at *5-6.  “Without an allegation of a specific statement which violated FDA-approved statements for the . . . device, Plaintiff’s misrepresentation claims are preempted.”  Id. at *6.  Simply, slapping the title “misrepresentation” on a warning claim did not change the preempted result.  Not only that, but the allegations failed the specificity requirements of Rule 9(b).  “Plaintiff’s vague allegations that Defendants misrepresented the safety of and risks associated with the . . . device fail to satisfy the Rule 9(b) standard, as she offers no details about precise statements that were made, by whom, or when.”  Id.

The court avoided deciding the more interesting question of whether New York permitted failure-to-report-based warning claims (the great weight of authority is that NY doesn’t), but still dinged the plaintiff on causation, which as our 50-state survey also details, almost always defeats this type of claim.  Even though plaintiff alleged that the FDA found reporting violations (as did a P-side citizen petition to the FDA) – the FDCA did not make any relevant changes to the product’s warnings during the relevant time period:

Given the FDA’s awareness of the alleged deficiencies in Defendants’ reporting prior to Plaintiff’s implantation, Plaintiff has failed to plausibly allege that any failure to report caused her injuries . . . where the FDA became aware of these adverse events . . . before the plaintiff’s procedure . . . but did not require [defendants] to take any action to further warn physicians or patients beyond the warnings already in place.

Id. at *7 (citations and quotation marks omitted).  Like many claims that the other side dreams up as preemption dodges, “failure to report” is almost always a lousy claim, factually.

The design and manufacturing defect claims suffered from the same basic problem as the warning claims – plaintiff’s allegation of “no facts . . . supporting [her] conclusory conclusion” that the device’s design was “violative” of applicable FDA regulations.  Id.  Thus, “[p]laintiff has not plausibly alleged facts suggesting that Defendants deviated from the FDA-approved design . . ., a necessary prerequisite to avoiding express preemption.”  Id.  Ditto for manufacturing.  Id. at *8 (“no facts alleged from which it could be plausibly inferred that there was any defect in the manufacturing process”).

Another preemption dodge claim, “negligent training,” didn’t dodge well enough and also fell to express preemption.  “Plaintiff has not alleged that Defendants deviated in any way from the training requirements imposed by the FDA.”  Id. at *8.  It was also a lousy claim from a causation standpoint:

The complaint does not contain any factual allegations . . . that Defendants were negligent in the training of the doctor who implanted Plaintiff’s . . . device, that her doctor’s training affected the proper implantation of the device, or that any such error is causally related to the alleged injuries she suffers.


Of the remaining flotsam and jetsam of plaintiff’s 17-count complaint:  (1) warranty claims were barred by the statute of limitations; (2) consumer fraud claims were not “consumer oriented” because that purported “unfair and deceptive” practices were directed against either the FDA or the medical community; and (3) “negligence, negligence per se, and constructive fraud claims” failed to allege causation beyond mere “conclusory assertions.”  Id. at *9-10.

Finally, since the plaintiff went zero for seventeen with her first complaint, Dains was understandably skeptical of her boilerplate request to amend.  Plaintiff therefore had to demonstrate that there was any “there there”:

If Plaintiff seeks leave to file an amended complaint, she must file a letter brief not more than 15 pages long, along with a proposed amended complaint which has proposed insertions and deletions identified. . . .  Plaintiff’s response to the motion to dismiss failed to address the applicable preemption law.  Any letter brief must detail how the proposed pleading cures the deficiencies the Court has identified and must address applicable preemption law.

2022 WL 16572021, at *10.

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