Happy Birthday LEXIS/NEXIS, whose legal research service went up on this date back in 1973.  There’s no doubt that LEXIS/NEXIS has made our professional lives considerably easier.  We’ve long since given up our campaign to persuade young lawyers to venture beyond computerized research.  What’s the point of suggesting that lawyers occasionally cuddle up with digests or ALRs when we’ll inevitably be greeted with blank looks? Such legal texts have been exiled from too many modern law offices.  Pity.  Be that as it may, we are grateful for all the information, insight, and, every once in a while, merriment we’ve received from LEXIS/NEXIS over the years, just as we are grateful to Marvin Gaye and Leon Russell (also with birthdays on April 2) for a very different sort of information, insight, and merriment — all ready on instant notice to pulse forth from our iPod.

It’s LEXIS/NEXIS’s birthday, so by all rights we should be the one bearing gifts.  Instead, we get this gift from LEXIS/NEXIS: Whitener v. Pliva, Inc., 2014 U.S. Distr. LEXIS 41121(E.D. La. March 27, 2014), where the court halts an effort by generic plaintiffs to make an off-label end-run around Mensing preemption.  The plaintiffs alleged injuries from metoclopramide, the generic form of Reglan.  They sued both the manufacturer of the generic metoclopramide, which had been used in this case, and the manufacturer of the brand name Reglan, which had not.  The original complaint was dismissed on preemption grounds.  The plaintiffs tried again.  (We have written about the preemption rulings in Whitener before.)  After the amended complaint was filed, the pharmaceutical entities filed a joint motion to dismiss.  According to the defendants, the amended complaint persisted in asserting a failure-to-warn theory that was preempted by Mensing.  In response, the plaintiffs argued that the defendants violated federal regulations by promoting metoclopramide for off-label use and by failing to warn of the risks associated with that off-label use.  That is a somewhat creative argument.  It was also, at least temporarily, successful.

The court denied the motion to dismiss, holding that the plaintiffs “ha[d] (barely) pleaded enough facts to raise a reasonable expectation that discovery will reveal evidence of such conduct.” Whitener, 2014 U.S. Dist. LEXIS 41121 at *3.  The court believed that the application of Mensing to a straight failure to warn claim was easy enough, but the “harder question…is whether the Mensing analysis changes if a generic defendant actively promises the drug for off-label use in violation of federal law.  [T]here is something troubling about 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.”  Id. at *4.   We find the court’s refusal to dismiss the case “troubling.”  But there’s always summary judgment.

True to form, the defendants filed for summary judgment.  Sounds like we’re in for an interesting preemption analysis, doesn’t it?  Not really.  The court’s opinion dodges the preemption question and holds that any off-label promotion was non-causal as a matter of law.  The court closely reviewed the prescriber’s deposition, and concluded that it was “clear that his decision to prescribe the drug to Ms. Whitener was made independently of any alleged conduct by the pharmaceutical entities.”  Id. at *16.  The doctor testified “unambiguously that his decision to prescribe the drug to Ms. Whitener was only based on his own experience.”  Id. The plaintiffs argued that the prescriber’s deposition was “misinterpreted or that his statements have been taken out of context.”  Id. at *17.  During oral argument, the court “perused the entire deposition and sees no reason to consider the designation provided as exhibits to the papers as aberrations or misrepresentations.”  Id. at *17-18.  That quote reminds us of Judge Keller in C.D. Cal., who liked to remind lawyers that the word “perused” is often misused to suggest some sort of casual or careless review, when in fact it denotes an especially careful reading.

The prescriber also testified that it did not matter that metoclopramide had not been approved by the FDA for use in treating pregnant women, because “I don’t rely on the FDA to make those decisions” and “[i]t’s a clinical decision and a professional decision based on guidelines from the people that practice my sort of medicine.”  Instead, what matters is that he use “a medication that helps a problem.”  Id. at *18.  Just so.  Most doctors will say that.  Consequently, the generic manufacturer gets out on lack of warning causation.  Mensing preemption remained just off-stage. It’s still a win.

It’s also a win for the manufacturer of the brand name drug, because under Louisiana’s product liability law, “recovery is not available against a manufacturer if the manufacturer did not produce the offending product.  Accordingly, a drug manufacturer may not be held liable where a plaintiff has not been injured from ingesting another drug manufacturer’s drug.”  Further, even if the Louisiana product liability statute did not apply, under Louisiana law “there is no duty of care owned by name-brand manufacturers to consumers of generic products.”  Id. at *20.  The dreaded Conte doctrine makes no inroads in the Pelican State.  (As shown in our Conte Scorecard, this is not the first time that Conte has been chased out of the bayou.)  It’s not quite the classic pro-Mensing/anti-Conte two-fer, but it’s a good result nonetheless.  Because of LEXIS/NEXIS, that result showed up conveniently on our computer screen.  We didn’t have to hear it through the grapevine.  It’s a good start to the day.  Now back to the iPod.  “Delta Lady” is cued up.