Wednesday, August 29, 2012

More Mensing, More Mensa

This makes two Wednesdays in a row where we have the pleasure of discussing courts that applied Mensing in a clear-headed manner.  To review the bidding:  the Supreme Court decided in Mensing that claims against generic drug manufacturers for failing to disclose risks are preempted because generic manufacturers are powerless to deviate from the FDA-approved brand label.  That straightforward rule has not prevented plaintiffs from pursuing some clever, though mostly not-so-clever, paths around preemption.  We cannot blame plaintiffs for their efforts, but we certainly can blame those courts that reward such efforts. 

Last week we reviewed the Truddle case, where a Mississippi federal judge followed Mensing and bounced claims against a generic manufacturer.  This week, we have a well-reasoned, well-written opinion from the Eastern District of Louisiana in Jacobsen v. Wyeth LLC, No. 2:2010 cv 00823, 2012 U.S. Dist. LEXIS 116887 (E.D. La August 20, 2012).  Is common sense suddenly breaking out all across the land?  What next?  Will telephone customer service center operators stop asking us for our account number after we have just punched it in?  Will the Phillies drop Jimmy Rollins (with an on-base percentage under .300) from the lead-off spot?  Will the Republican and Democratic conventions quit with the phony "spontaneous" floor celebrations?  Doubtless we are hoping for too much.  But cases like Jacobsen give rise to optimism. 

In Jacobsen, the plaintiff claimed injuries from metoclopramide, the generic form of brand-name drug Reglan.  The plaintiff alleged that the defendants were liable for their alleged failure to monitor the drug, because the design was unreasonably dangerous, because (big surprise) the defendants failed to warn of certain risks, and because the drug did not conform to an express warranty.  The generic defendants moved to dismiss the case in its entirety on the ground of Mensing preemption.  The plaintiff sought to evade preemption with a series of arguments that have secured purchase in some courts.  Perhaps as the crystalline logic of Truddle, Jacobsen, and, indeed, Mensing itself, prevails, those few courts buying the plaintiff arguments will be exposed as the rogues that they are.  The plaintiff's arguments in Jacobsen were rejected efficiently and elegantly:

* Failure to Monitor

The only point of monitoring is if it would "necessarily result in warnings to patients and physicians."  2012 U.S. Dist. LEXIS 116887 at *36.  Mensing precludes warnings claims.  Accordingly, the monitoring claim is gone.  (And, as Marcellus says in Pulp Fiction, it better "stay gone.")

* Design Defect

The only alternative design suggested by the plaintiffs was "unit of use" packaging, which would limit the amount of drug dispensed and which would provide warning information directly to the patient.  There is that W-word again.  Moreover, if you are talking about packaging, you are ineluctably talking about failure to warn.  As Blofeld would say, "Goodbye Mr. Bond!"  As David Spade would say, "Buh bye."  Or, as an Article III judge would say, "Dismissed."

* Failure to Warn

As in many other cases, the plaintiffs argued that the generic manufacturer should have worked toward changing the label, engaged in non-label communications (including Dear Doctor letters), or even gone so far as to withdraw the drug from the market.  But Mensing explicitly forecloses the first option, the majority of the judges in Mensing made reasonably clear that the second option is a no-go, and the underlying logic of Mensing rules out the third.  The Jacobsen court observes that "[t]o require a generic manufacturer to remove a drug from the market would repudiate the label approved by the FDA."  Id. at * 42.  That reasoning is unanswerable, and should drive errors like the Bartlett opinion into the dustbin of history. The plaintiff in Jacobsen offered another argument that some courts have smiled upon - that the generic manufacturer did not update its label as fast as it should have.  But that argument in Jacobsen was merely a post hac rationalization to keep the case alive.  The claim was nowhere in the complaint, nor had the plaintiff ever moved to amend the complaint.  Some courts either hate preemption or love plaintiffs so much that they would have permitted a tardy amendment.  Not the Jacobsen court.  

* Express Warranty

Claims for express warranty often seem like afterthoughts lobbed into complaints, almost as a matter of rote.  It looks like that here.  The plaintiff's complaint never identified any express warranties by the defendants "beyond the allegedly false statements contained in the package insert."  Id. at *45.  "Specifically, Plaintiff has not alleged that Defendants advertised their products, detailed their products to doctors, or made any other forms of communication regarding the drug."  Id.  To make matters worse for the plaintiff, her opposition to the summary judgment motion asserted that the defendants "never provided Plaintiff or her physicians with ANY warning or other information with respect to metoclopramide."  Id.   That fact is presumably a bad thing, right?  Well, it is really bad for the plaintiff's warranty claim.   It refutes it.

The reasoning in Jacobsen is so clear and compelling that it makes all the usual plaintiff maneuverings around Mensing seem utterly specious.  The plaintiff's arguments in Jacobsen were rightly greeted with dismissal.  We would like to see that become commonplace.  Maybe in the not-too-distant future, as cases like Truddle and Jacobsen build up momentum, plaintiff efforts to circumvent Mensing will be greeted with more and more dismissals ... and yawns.  As a current book on the science of sleep (Dreamland) reminds us, yawns are contagious.    


2 comments:

Sarah Lovequist said...

A correct application of Mensing as described with a quote from Pulp Fiction - no better way to begin Hump Day! Thank you for spreading your optimism.

neil jonson said...

Thumbs up guys your doing a truly terrific job.
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