Friday, May 30, 2014

There Are Still Lipitor Rhabdo Cases?

Imagine our surprise at learning that people are still filing cases alleging rhabdomyolysis resulting from Lipitor use.  Lipitor is the best known prescription drug ever (except maybe for Viagra), and the association between rhabdomyolysis and statins is one of the most warned-of drug risks in history.  Every doctor knows about it, and litigation involving another statin, Baycol, resulted in what was then the largest MDL that the JPML had ever created. 
 
The upshot is that any plaintiff pursuing failure-to-warn claims involving rhabdomyolysis and Lipitor faces a very steep uphill battle, and such was the case in Miller v. Pfizer Inc., No. 4:13-cv-01687, 2014 U.S. Dist. LEXIS 70297 (N.D. Ala. May 22, 2014).  The plaintiff allegedly took Lipitor samples for his high cholesterol and allegedly experienced muscle pain and weakness—sometimes signs of rhabdo.  Id. at *3.  The problem for the plaintiff is that Lipitor’s labeling says flat out that Lipitor “like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness.”  Id.  The label also stated that “Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with Lipitor.”  Id. 
 
Based on these warnings, the district court granted the manufacturer’s motion for judgment on the pleadings, which is the obvious and correct result.  So why is this case interesting?  Well, for a few reasons.  First, this was a motion for judgment on the pleadings under Rule 12(c), not a motion for summary judgment.  We have at times scratched our heads at the strategic decision to move on the pleadings and eschew the opportunity to submit evidence, such as the labeling itself or evidence that the prescriber (and sometimes the plaintiff himself or herself) fully understood the relevant risks.   On the one hand, moving on the pleadings holds the promise of a quick strike and the avoidance of expensive discovery.  On the other, a challenge to the pleadings admits the truth of the plaintiff’s factual allegations, and courts are usually (and disappointingly) amenable to granting leave to amend.  A motion for summary judgment avoids these pitfalls, but has its own issues, e.g., the plaintiff gets to submit evidence, too.  We don’t know how it will work out in Miller because the court granted (sigh) leave to amend, but given the nature of these warned-of risks, we don’t blame the defendant for trying to nip this lawsuit in the bud. 
Which leads to the second reason why Miller is interesting.  The defendant moved for judgment on the pleadings, but did not rely only on the pleadings.  It supported its motion also with the Lipitor labeling, which the district court accepted under the “incorporation by reference doctrine.”  Id. at **4-5.  As the district court explained, “[T]he court may consider a document attached to [the motion] without converting the motion into one for summary judgment if the attached document is (1) central to the plaintiff’s claim and (2) undisputed,” which means “the authenticity of the document is not challenged.”  Id. at *5.  This was a good move.  We have usually thought of “incorporation by reference” more narrowly, such as where a complaint alleges breach of contract and actually refers to the contract.  But when reading the district court’s recitation of the rule, it makes perfect sense that a complaint alleging inadequate drug warnings has “incorporated by reference” the drug labeling.  We have often sought judicial notice of FDA-approved labeling, usually with success, but we’re going to add “incorporation by reference” to the Drug and Device Law toolbox.
Third, the Miller order is interesting and useful also because the district court held the plaintiff to an appropriately rigorous TwIqbal standard, resulting in the dismissal of every claim, ranging from failure to warn to design defect to negligence to breach of warranty and so on.  It is not as though the plaintiff pretended that the rhabdomyolysis and myopathy warnings did not exist.  Rather, the plaintiff argued “that although the Lipitor label ‘contains language on myopathy and related injuries . . . that very same label is inadequate in relaying the full weight of such risks.’”  Id. at *6.  That, however, was not good enough because
With any pleading, the complaint must contain more than “a formulaic recitation of the elements of a cause of action” and cannot be based merely upon “labels or conclusions” or “naked assertions” without supporting factual allegations.  Twombly, 550 U.S. at 555, 557.  As applied in this situation, a mere statement that a warning is “inadequate” without facts supporting this assertion is insufficient.
Id. at *8.  We will repeat that last part because we like it so much:  Under Twombly, “a mere statement that a warning is ‘inadequate’ without facts supporting this assertion is insufficient.”  Amen.  Every plaintiff should have to meet this standard, and the plaintiff in Miller did not because the complaint stated that the warnings were inadequate, but did “not explain why they were inadequate” and did not “provide any factual support for an allegation that the necessary warnings were present but inadequate.”  Id. at *9 (emphasis in original).  Moreover, because all of the plaintiff’s claims (under the Alabama Extended Manufacturer’s Liability Doctrine) relied in some fashion on an alleged failure to warn, the plaintiff’s failure to explain why Lipitor’s warnings were inadequate led the district court to dismiss the entire complaint.
So for now, the decision to move for judgment on the pleadings seems like a good one, but it remains to be seen what result the defendant ultimately will receive.  Leave to amend is one of the aforementioned pitfalls with challenging the pleadings, and it is one over which we have often expressed our frustration.  As we said at the outset, cases alleging rhabdomyolysis resulting from Lipitor use should not exist, and having successfully placed the content of Lipitor’s warnings before the court, we do not see what else the defendant should have to do to end this case.  We fear unnecessary and expensive discovery will ensue.  As the district court observed, “most—if not all—of the cases that Defendant cited to the court in their briefs involved the court deciding the issue at the summary judgment stage, not at the motion to dismiss stage.”  Id. at *10.  Stay tuned.   

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