The plaintiffs in the Whitener v. Pliva case danced through the Mensing raindrops for quite some time, using off-label promotion allegations to avoid preemption.  But, no matter however inventively they articulated their claim, it was still a claim that the manufacturer didn’t warn about risks of the drug, in this instance, off-label risks.  And a claim that the manufacturer should have warned about those risks triggersMensing implied conflict preemption.  Yet the Whitenerplaintiffs had a history of surviving Mensing preemption, even if just barely.

Their off-label allegations survived the defense’s first motion to dismiss because the court handed them the opportunity to fix theirpleadings.  Whitener, v. PLIVA, Inc., 2011 WL 6056546 (E.D. La. Dec. 6, 2011).  The next time around, the court found their off-label allegations to be sufficient to survive a motion to dismiss.  The court was concerned about the defense’s argument, particularly with “permitting a generic defendant to violate federal law by actively and aggressively promising a drug for a purpose not contemplated by the label approved by the FDA while also hiding behind an inability to provide warnings connected to that off-label use because it cannot change the approved label.”  Whitener v. PLIVA, Inc., 2012 WL 3948797, at *4 (E.D. La. Sept. 10, 2012).  While the court may have been concerned with the defense’s argument, Bexis became uber-concerned with the court’s ruling, particularly its conflation of the express-preemption concept of a “parallel violation” and the implied-preemption basis for Mensing.  Finally, everything – well, everything but that particular piece of reasoning – got fixed at summary judgment, when the court granted judgment against the off-label claim for lack of proximate causation.  The alleged off-label promotion hadn’t influenced the doctor.  Whitener v. Pliva, Inc., 2014 U.S. Dist. LEXIS 41121(E.D. La. March 27, 2014).  We were at least satisfied with the outcome, if not all of the reasoning.  While avoiding the Mensing raindrops, plaintiffs couldn’t avoid the reality of the prescribing doctor independently exercising his own medical judgment. 

Plaintiffs tried their luck with the Fifth Circuit and just recently lost there too.  On Thursday, the Fifth Circuit affirmed summary judgment against plaintiff.  It did so in all respects, which is to say that it was still a little unsatisfying. The court did not invoke Mensing preemption.  But that may have been a little too much to expect given that the court had such an easy basis on which to affirm – the prescribing doctor’s testimony and proximate causation.  So we won’t lament a good decision for not being great.

In fact, setting aside our remorse about the Mensing ruling, the proximate causation victory is quite a good one.  We’ve seen a number of cases in our careers that are carried through summary judgment and to trial based on marketing evidence that had nothing to do with the prescriber. Plaintiffs would offer up sales rep training materials, alleged ghost writing, dinner or lunch presentations, call notes, emails and more.  They would never connect that evidence to the prescribing doctor, and yet courts would allow this evidence at trial, and use it as a basis to deny summary judgment, presumably based on the notion that it had an atmospheric effect that the prescriber somehow breathed in. 

The Whitener court, and now the Fifth Circuit, didn’t allow that.  Plaintiff’s prescriber, a Dr. McCrossen, prescribed the drug based on his clinical experience, not marketing, and marketing evidence suddenly became irrelevant:

In his deposition, Dr. McCrossen testified at length as to why he prescribed metoclopramide to treat Mrs. Whitener’s morning sickness.  This testimony is unequivocal: he prescribed metoclopramide to Mrs. Whitener not because any defendant suggested that he do so, but because, in his “clinical experience,” metoclopramide “works good to control nausea and vomiting associated with pregnancy.”  Indeed, Dr. McCrossen’s testimony makes clear that he could nothave been directly influenced by the defendants to promote metoclopramide to pregnant women.  He testified that he had never had any contact with the defendants or their representatives with regard to metoclopramide; that “[n]o one ha[d] specifically talked to [him] from a company about Reglan or Metoclopramide”; and that samples of the drug were never left at his office or, to his knowledge, provided to anyone else in his practice.  Thus, the record is clear that it was Dr. McCrossen’s “clinical . . . judgment” and “experience” and not any promotional activities on the part of the defendants-that led him to prescribe metoclopramide to Mrs. Whitener.

Id. at *10. 

Although it we would have liked to see the off-label claimMensing-ed, we know from way too much experience ourselves that the connection between marketing evidence and the prescriber comes up at almost every trial.  And, in that way, Whitener is much more helpful than disappointing.