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Not long ago, an EPL (evil plaintiff lawyer) relayed to us that, based on reading our posts, another EPL had assumed we had a particular political view.  As we laughed at the notion, we pondered the issues of assumption and incomplete information.  Much like the old quip about what happens when you assume, many assumptions are not just wrong, they can be really wrong.  The incidence of incorrect assumptions seems to increase with the less information the assumer has and, we posit, a tendency to not seek out information.  In terms of politics, we tend not to air our views too openly, but there have certainly been clues.  (While we use plural pronouns, we do not all have the same views about law, grammar, or punctuation, let alone politics.)  It is true that we tend not to discuss many of the cases that grab headlines in the lay press and when we do, like last week’s post on Bostock, we focus on the legal principles applicable to our sweet spot rather than simply cheering (out loud).  Similarly, were we to discuss a recent decision on a certain (current) member of Congress versus a fictitious heifer, we would probably ruminate on the role of social media in product liability litigation, the Sullivan decision, or the reluctance of most judges to deter frivolous litigation through cost-shifting sanctions.  Even though we have scoresheets, we care less about who wins than we do about underlying legal principles, rigorous legal analysis, and maintaining the proper roles for various players in our complicated federal system and Constitutional republic—concepts one might lump under the banner of “the rule of law.”  Why else would we note when a decision in favor of a drug or device manufacturer applied the wrong analysis or point out typographical errors in published decisions?  Either we are believers in process or we are just kindof jerky.  Maybe both.  Lacking access to our internal editing and banter, the readers will just have make assumptions on incomplete information.

That was all a highly contrived device to get to the English v. Bayer Corp., — F. Supp. 3d. –, 2020 WL 3454877 (W.D.N.Y. June 25, 2020), decision.  We have posted on a number of Essure decisions from various federal courts, most of which have found broad preemption of claims against the manufacturer of this PMA contraceptive device, like this one.  English involved three separate plaintiffs lumped together and dismissed together on what the court labeled preemption.  We will start with our assumptions and incomplete information, with dashes of misdirection and foreshadowing.  We do not know why these three plaintiffs were together in a single case filed in 2019, but we do know their devices were implanted between 2009 and 2011, that one of them had sued before, and that the complaint did not offer any specifics on which of a laundry list of alleged possibility injuries they suffered.  From this, we assume these plaintiffs had no significant injuries, their claims were time-barred, and they were brought in the hope of resolution without much effort, as sometimes happens with the later cases thrown into an MDL.  Those assumptions, correct or not, do not affect our read of the decision or, as far as we can tell, the decision itself.

Rather than assert design defect claims—which are usually easy pickings with PMA preemption—the plaintiffs mostly asserted the sort of atypical claims that some courts have let slip past both Riegel express preemption and Buckman implied preemption.  Our view about the near mythical status of such “parallel claims” has been voiced a number of times, like here and here.  After recapping the basic legal framework, the court noted

[M]ultiple federal and state courts nationwide have previously dismissed, on express and/or implied preemption grounds, claims involving the Essure device which are nearly identical to those asserted by plaintiffs. The Court finds no reason to depart from this consistent and well-settled precedent.

Id. at *2 (citations omitted).  The court then walked through the asserted claims.  What the court did not note was that the decisions it cited (and we omitted above), including one applying New York law, had been issued before this case was brought.

First up was the purported “negligent training” claim, which was predictably a mishmash of allegations apparently not focused on the doctors who treated these plaintiffs.  The court started looking at whether the asserted claim sought to “impose obligations beyond those mandated by the FDA” without first looking at whether the asserted claim was cognizable under state law.  New York does not have a failure to train claim against medical device manufacturers, so the court concluded there could be no parallel claim to get past express preemption.  Id. at *3.  The simpler route is that a 12(b)(6) motion is for “failure to state a claim on which relief can be granted,” which means the lack of any recognized state law claim (or any right of action under federal law) should end the inquiry before preemption.  A little Erie restraint can be thrown in for good measure.  The result is the same, but, like we said before, we care about process.

Next up was the purported claims for failing to report adverse events to FDA.  New York did not recognize such a claim.  Id.  If this was a just a step to arguing that the warnings should have been changed because of the adverse events that were allegedly not reported, then it was expressly preempted.  Calling it by another name—negligent risk management—did not save the claim based on the same alleged conduct. Id.

The remaining claims for misrepresentation and breach of express warranty were treated together.  Quoting the decision we discussed here, the court started with the principle that express preemption applies to any claim, however denominated, “based on written or oral statements whose content falls within the parameters of FDA-approved labeling.”  Id. at * 4 (citation omitted).  Plaintiffs did not allege “any statements by defendants that substantively stray beyond those approved by the FDA.”  Id.  It was unclear whether the court took this failing as an indication that plaintiffs did not actually advance these claims or that whatever they were pushing was not going to be a parallel claim.  Either way, they were dismissed:

In sum, plaintiffs’ attempts to distinguish their claims to bring them outside of the scope of the preemption provisions of the Medical Device Amendments to the FDCA, or otherwise to state plausible parallel claims under the laws of New York State, are unavailing.


With the dismissal of all asserted claims, two issues were left.  First, the plaintiffs sought leave to amend.  As we have noted before, plaintiffs tend to get more than one strike when it comes to 12(b)(6) dismissals, even when preemption is the driving force for the dismissal.  Perhaps these plaintiffs assumed they would get another shot at pleading non-preempted claims.  They did not submit the redlined proposed amended complaint required by local rules, but the court considered the merits anyway.  The merits showed amendment would be moot because it just added a new claim based on the same factual allegations and added other “extraneous” factual allegations cut and pasted from another case’s complaint.  Id. at *5.  Again, maybe the plaintiffs assumed the court would not read the complaint find references that gave away the cutting and pasted.  If so, then they were wrong.  We would note that the decisions the court cited finding preemption of similar claims (and the one it cited that did not) were all decided before this case was filed, so it would make sense that plaintiffs did not get more chances to plead New York claims that were not preempted.

The last issue was also one of timing.  As mentioned above, one plaintiff had sued before and had her case dismissed. Defendants sought costs under Fed. R. Civ. P. 41(d), a provision that seems to be raised prior to a voluntary dismissal more often than it results in a ruling on the merits.  Although the plaintiff indigence meant she did not have to pay the defendants’ costs of defending her claims in English, the discussion was instructive.  This plaintiff suggested “that she or her attorney failed to adequately investigate her claims before filing the 2018 lawsuit”—also after the cited preemption decisions—“and that she later decided she preferred to litigate in a forum with the opportunity for multidistrict litigation.”  Id. at *6.  This betrayed a number of incorrect assumptions and apparent lack of diligence in trying to gain important information.  It also revealed the thinking that an MDL proceeding—and there was not one here—allows legal defects in plaintiff’s case to escape notice until some group settlement can take place.  Ultimately, the result in English does little to deter that model of litigation, at least as long as 41(d) only allows the imposition of costs against plaintiffs and not their lawyers.  Not to get too political.