This post comes from only the Cozen O’Connor side of the blog.
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 triggers Mensing implied conflict preemption. Yet the Whitener plaintiffs 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 their pleadings. 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.
Continue Reading The Next Best Thing to Mensing Preemption: Winning for Lack of Connection between Marketing and the Prescriber