[Drug and Device Law] Be Careful What You Ask For



            This post is from the non-Reed Smith side of the blog only.

            That’s an admonition that plaintiffs in Cales v. Medtronic, Inc. should have heeded.  Last November, they became another of the many InFuse plaintiffs to have the bulk of their claims dismissed with prejudice on the grounds of preemption, with non-preempted claims dismissed without prejudice for failure to plead with sufficient particularity.  See Cales v. Medtronic, Inc., 2014 WL 6600018 (Ky. Cir. Ct. Nov. 21, 2014).  Rather than spending their time drafting a well-pleaded amended complaint for their remaining causes of action, plaintiffs moved for reconsideration.  Cales v. Medtronic, Inc., No. 14-CI-1774, slip op. (Ky. Cir. Ct. Jul. 1, 2015).  Not only was their motion denied -- the court found a few other things that had slipped through the cracks that should have been dismissed as well.  In other words, plaintiffs aren’t any better off for their motion; in fact, their worse.

            The crux of plaintiffs’ motion for reconsideration is that the court applied the federal TwIqbal standard of pleading rather than Kentucky’s “notice” pleading standard.  It turns out that plaintiffs’ complaint was so poorly crafted that the error was harmless – plaintiffs’ complaint failed even the less-demanding requirements. 

            But plaintiffs’ complaint wasn’t the only thing poorly crafted.  So too were plaintiffs’ arguments on reconsideration.  The court spends pages of its decision admonishing plaintiffs for “selectively cherry-pick[ing] quotes from a number of unpublished appellate decisions and out-of-context dictum to support their argument that merely pleading bald, legal conclusions satisfies Kentucky’s liberal pleading standard.”  Cales, slip op. at 5.  Challenging plaintiffs’ “Frankenstein-esque construction of notice pleading,” id. at 7, the court is clear that notice pleading does not “relieve [plaintiffs] of a responsibility to produce some factual basis to support the elements of their various claims.”  Id. 

            While plaintiffs’ argument seemed to be full of incomplete quotes and allusions, in sum their position was that “so long as the defendant is given notice of the claim, it does not matter whether the Complaint includes facts or conclusory allegations.”  Id. at 7n.6.  But what do unsupported allegations give a defendant notice of?  Nothing.  So agreed the court.  Neither the court nor the defendant should have to “imaginatively conjure up” a provable factual scenario.  While on a motion to dismiss material facts are to be construed as true – there must be some material facts (court can’t “liberally construe nonexistent facts”).  Id. at 8.  Nor does sheer volume save the day:

It would be antithetical for this Court to allow Plaintiffs to proceed solely based on the fact that somewhere in their 965 paragraph Complaint they “surely” must have alleged enough “facts which could be proved” to eschew Defendant’s Motion to Dismiss. 

Id. at 8-9.  Same issue, but we couldn’t leave this quote out:

[I]t is not the Court’s job to endlessly sift through Plaintiffs’ Complaint, which includes by reference, thousands of pages of irrelevant information that is wholly irrelevant to various claims.  Plaintiffs seemingly sought to obfuscate their claims’ lack of merit by barraging the court with voluminous paperwork, and oft-repeated, misconstrued legal analysis, with the misguided hope that the Court will respond in Pavlovian fashion.

Id. at 9n.7.  “Particularity and prolixity are not synonymous.”  Id. at 9.  This is good stuff.  The kind we can see slipping into our own briefs.

            Even better, the court got specific.  Footnote 7 goes on in some detail about all the various allegations that plaintiffs seek to incorporate by reference even though not relevant to the particular cause of action – a lack of clarity the court would not overlook.  The opinion also notes plaintiffs’ misplaced reliance on many, many events that post-date plaintiffs’ alleged injury.  We see this approach all the time – throw in anything and everything and hope something sticks.  This time the court wasn’t interested. 

            Moving on to applying the proper notice pleading standards to the non-preempted remaining claims, the court found that both plaintiffs’ fraud and breach of express warranty claims missed the mark completely.  Kentucky, like federal courts, requires fraud to be pleaded with particularity.  Id. at 10.  Plaintiffs, however, argued that under federal law that standard is “relaxed” “when the necessary information is under the exclusive control of the defendant.”  Id.  The court was not amused that after moving for reconsideration on the ground that the court improperly applied the federal pleading standard, plaintiffs urged application of a “federal interpretation of a federal rule.”  Id.  Not only was there no support for plaintiffs’ position under Kentucky law, but the court pointed to the amount of publicly available information cited in plaintiffs’ complaint as evidence that the information is not within the “exclusive control” of the defendant.  Id. at 10-11.  Finally, because plaintiffs “have not alleged with any modicum of specificity the contents of the misrepresentations, why the misrepresentations were false, or that Plaintiffs’ physician relied upon any specific misrepresentations,” the fraud claims remained dismissed.        Id. at 12.

            As for breach of express warranty, the court got directly to the point – “Plaintiffs’ Complaint does not identify any warranty that Medtronic allegedly made, let alone breached.”  Id. at 14. 

            Plaintiffs also alleged that the court improperly dismissed their negligent misrepresentation claim as the same as failure to warn and therefore preempted.  Id. at 14.  Once again, plaintiffs got less than they were hoping for.  Under Kentucky law, a negligent misrepresentation claim requires “an affirmative false statement; a mere omission will not do.”  Id.  So, the court reasoned that the portion of plaintiffs’ negligent misrepresentation claim that was based on “omitted material information” is in fact failure to warn in disguise and therefore preempted.  Id. at 15.  To the extent plaintiffs were alleging negligent misrepresentation based on an affirmative misstatement – Kentucky has not recognized such a claim outside the context of pecuniary loss.  The cause of action has not been adopted for economic loss or physical harm and therefore, plaintiffs’ claim was dismissed this time as having no basis in Kentucky law.  Id. at 15-16. 

            Finally, there is the additional ruling that plaintiffs hadn’t bargained for when they sought reconsideration.  The court had dismissed as preempted plaintiffs’ failure to warn claims based on off-label promotion and based on alleged failure to submit adverse event reports.  But, in the original decision, the court inadvertently allowed plaintiffs to amend their complaint on this claim.  While this probably would have been caught on its own when plaintiffs filed their amended complaint – having sought reconsideration, this portion of the decision was reconsidered too.  No leave to amend on failure to warn.  Id. at 3.

            So, plaintiffs went in hoping to resurrect their fraud, breach of express warranty and negligent misrepresentation claims.  They came out with a second dismissal of negligent misrepresentation on new grounds; re-dismissal of fraud and breach of express warranty with a lengthy opinion on just how lacking the court found both their argument and their complaint; and a dismissal with prejudice on failure to warn that wasn’t on the table.  You know that fun, old chestnut “there’s no harm in asking.”  Well, sometimes there is.   


--
Posted By Michelle Yeary to Drug and Device Law at 7/07/2015 03:57:00 PM

--
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To post to this group, send email to drug-and-device-law@googlegroups.com
To unsubscribe from this group, send email to drug-and-device-law-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/drug-and-device-law?hl=en
---
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To unsubscribe from this group and stop receiving emails from it, send an email to drug-and-device-law+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.

No comments:

Post a Comment