Monday, December 09, 2013

Court in Hip Implant Litigation Finds Complaint Lacking Despite Allegations of Recall and FDA Adulteration Finding

Today’s case comes with a lesson: don’t be easily discouraged from filing your TwIqbal motion.  Consider it carefully, even if your case is part of a mass tort with a challenging background, including product recalls and FDA investigations.  In fact, under those circumstances, it may be more important to scrutinize the plaintiff’s allegations.  A filing frenzy can occur in such mass torts, at times spitting out complaints with no merit. 

So take the time to break down the complaints.  Separate legal conclusions from factual allegations.  Look for alleged facts that identify the product used by the plaintiff, the actual defect in its manufacture or design, or what was missing from or misleading about the warning.  You’ll find that many times these allegations are missing.  There is a tendency for complaints in mass torts to lean on the big picture – e.g., the recall or the FDA investigation – while offering few if any facts about the particular plaintiff.  When you see a complaint like this, get your TwIqbal motion ready.  It can win.

It did in Bertini v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS (E.D.N.Y. July 15, 2013).  One of the plaintiffs in Bertini had hip replacement surgery involving an R3 liner manufactured by the defendant.  Id. at *2.  He had problems after the procedure and eventually needed revision surgery.  Id. at *2-3.  The complaint alleged that his doctor determined that the R3 liner had loosened after the procedure, that the product was subject to a recall by the defendant for this very problem, and that the FDA deemed R3 liners generally to be adulterated after the FDA found cGMP violations during a plant inspection.  That’s usually a good start for a plaintiff’s story, a very good one. 

But the factual allegations stopped there.  There was no end to the story. 

The complaint did almost nothing to allege a failure to warn claim.  It alleged neither what the warning was nor what it should have been: “plaintiffs plead no facts related to any specific warnings or how these warnings were inadequate.”  Id. at *8.  Such pleading can’t satisfy FRCP 8(a) and TwIqbal. 

There were similar factual gaps in plaintiffs’ design and manufacturing defect allegations.  The plaintiffs didn’t connect the FDA’s conclusions to the R3 liner used in plaintiff: “they fail to show how the vague allegation that defendant’s plant was ‘adulterated’ is in any way connected to a design or manufacturing defect.”  Id.  Also, simply alleging that plaintiff’s R3 liner “loosened” and that defendant recalled R3 liners for this reason isn’t enough to state a defect claim.  There must at least be facts that identify the defect:
Plaintiffs essentially pled only that the device is defective because it loosened but . . .  the mere fact that the device did not perform as intended is not by itself indicative of a flaw in the manufacturing or design processes.  Similarly, merely alleging that the device was recalled due to this performance issue does not suffice to plausibly show that the device itself was defective.  Without further alleging facts as to whether it was feasible to design the R3 liner in a safer manner, or how the R3 liner deviated from its intended design, the fact that the R3 liner loosened and was recalled for the same issue is “merely consistent with’ [defendant’s] liability” and “stops short of the line between possibility and plausibility of ‘entitlement to relief.”
Id. at *8-9.  (quoting Iqbal and Twombly).

As to design defect, plaintiffs failed to not only identify a particular defect but to plead anything other than conclusory language on whether there was a safer design for the product: “Plaintiffs fail to plead any facts to plausibly suggest that it was feasible to design the R3 liner used in their case in a safer manner.”  Id. at *9.  As to manufacturing defect, plaintiff alleged no actual facts on how the product should have been manufactured or how it deviated from that process.  Id. at *10.  The court similarly dismissed plaintiffs’ warranty and negligence claims as lacking in factual allegations and impermissibly relying on boilerplate allegations.  Id. at *12-14.

The court did one other nice thing in its opinion.  It refused to follow Bausch, a decision that we’ve criticized here before.  Id. at *10-12  The court explained that other courts have criticized Bausch’s reasoning that a court may excuse a plaintiff’s failure to identify a design defect in its complaint because the plaintiff may not have an opportunity to learn of the defect, if any, until discovery.  The Bertini court criticized this as contrary to TwIqbal’s purpose, which is to avoid the use of discovery as a fishing expedition to find claims. 

So don’t let the big story in a big mass tort discourage you from moving to dismiss a complaint.  Look at the smaller story in the complaint – the plaintiff, the product and its warnings.  If the smaller story isn’t there, that’s where you’ll get your dismissal.

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