United States: A One-Two Punch Case With An Off-Label Twist

Last Updated: July 22 2016
Article by Eric Alexander

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense.  For more important stuff, we find qualifiers like "vague" and "fuzzy" being applied more often to our own characterization of what we think we recall.  (We can only imagine how different things will be should be advance to the current age of McConnell, Bexis, or Weil.)  Buried somewhere between esoteric and important would be the question of whether we have seen a certain issue before in cases that have been the subject of past posts.  With a caveat about our memory, supplemented by a less than exhaustive search of prior posts, we thought we could present a decision addressing an issue we have never talked about before—and we have talked about a boatload of issues through the years.  (No, "boatload" was not our first choice, but we try to keep it clean here.)

The silly Conte case popularized the idea that a company that developed and brought a drug to the market could be liable for injuries allegedly caused by a generic version of the drug sold by a competitor. Conte was itself a reaction to the realization, even before Mensing and Bartlett, that most traditional product liability theories against the makers of generic drugs would be preempted.  When plaintiffs have tried to sue both the manufacturers of the generic drug they took and the company that "innovated" the drug and a single decision rejected the claims against both sets of defendants, we have called that a one-two punch.  Because plaintiff lawyers are stubborn in their pursuit of ways to pin liability on defendants with money—or get far enough along in the case to take some of that money to go away—we have described a number of varieties of these one-two punch cases. Just skimming our scoresheets on these issues should give some idea of that variety.

While off-label promotion allegations feature prominently in a range of cases involving prescription drugs, we have not seen them much in innovator liability or generic drug cases.  That might be because NDA holders tend not to do much promotion at all on their drug once generic drugs have entered the market and ANDA holders tend not to promote their generic drugs much at all, especially when there are multiple generics available.  This is not a matter of on-label or off-label promotion as much as it is of economics.  So, when we saw that Perdue v. Wyeth Pharms., Inc., No. 4:15-CV-208-FL, slip op. (E.D.N.C. July 20, 2016), delivered a one-two punch in a case where both the branded manufacturer and three generic manufacturers were alleged to have promoted off-label, we thought we might have a chance to talk about something novel.  We were wrong.  We wrote about another case last year Twice.  Involving the same drug as in Perdue.  One post even talked about elephants, known not just for their girth but for their memories.  Oh, the irony.  But that will not stop us from talking about the good result in Perdue.

Perdue involved allegations about a prescription anti-arrhythmic drug approved in 1985 for ventricular fibrillation and ventricular tachycardia, but allegedly promoted for the off-label use of atrial fibrillation.  When the generics entered the market in 1998, they also allegedly promoted the drug for atrial fibrillation.  They also allegedly failed to provide their distributors with the mandated medication guides and generally failed to warn of certain risks of the drug, which were not really specified but presumably are pulmonary in nature.  Plaintiff alleged that her decedent was prescribed the drug in 2006 for her allegedly non-life threatening atrial fibrillation, she received three manufacturers' generic drugs from the pharmacy but no medication guide, she was unaware of the risks of the drug, and she ultimately died of unspecified pulmonary problems in 2013 in the age of 82.  Of course, her estate sued all four manufacturers and offered scattershot allegations focused, if we can use that word here, on atrial fibrillation patients.

First up for us is the branded manufacturer's motion to dismiss.  The court did not need to look closely at the allegations of off-label promotion or any other allegation about what the defendant did with its own drug, because the plaintiff was not alleged to have taken the branded defendant's drug.  Established North Carolina law says "a defendant may not be held liable for injuries allegedly caused by the use of another's product."  Citing two of the many cases rejecting innovator liability, there was no reason why this rule should be different for "claims brought by plaintiffs against brand-name drug manufacturers where plaintiffs have only ingested generic drugs."  No need to mention Conte or the relatively few cases that followed it to decide to dismiss the claims against this defendant.  Our only gripe is that the dismissal was without prejudice.  Plaintiff did not lose because of a pleading issue that could be fixed.  She lost because she alleged the decedent used only the generic drugs of three manufacturers, presumably after doing enough investigation to determine if the branded drug was ever dispensed.

As to the generic manufacturers, plaintiff offered some ridiculous vague (no risk identified) and overbroad (well beyond the learned intermediary) failure to warn allegations and apparently abandoned them in response to the motion.  They were preempted under Mensing anyway.

The claims against the generic manufacturers for off-label promotion were preempted under Buckman, but they also could have been dismissed for failing to state a claim under North Carolina law.  The analysis is essentially the same.  Plaintiff alleged that the drugs were promoted for off-label use in violation of various provisions of the FDCA.  Of note, plaintiff's allegations look like they sought to impose liability for truthful statements that pertained to off-label uses, which is a bit of a First Amendment problem, but that is for another day and case.  North Carolina law does not impose any duty against promoting drugs for off-label uses.  Nor does it allow a federal law without a private right of action like the FDCA to be the predicate for negligence per se.  So, there is no cause of action under state law.  We also suspect there would be no proximate cause between truthful promotion for off-label use—distinct from failing to warn of risks—and the decedent's injuries after receiving a prescription for an off-label use from a physician exercising independent medical judgment.  Again, that is for another day and case, and there is still Buckman.  Because North Carolina law did not provide any basis for recovery, the plaintiff was asserting a claim that "exists solely by virtue of the FDCA regulations regarding off-label promotion," which is exactly what Buckman said creates implied preemption, specifically the obstacle variety.  The court looked to a number of device cases where off-label promotion allegations—largely offered to try to get around express preemption—were impliedly preempted under Buckman.  Other than introducing the inapplicable concept of parallel claims, these cases were worth following.

Plaintiff's last claim also ran smack into Buckman. North Carolina law does not impose any duty regarding getting Medication Guides to distributors so that, eventually, pharmacies might hand them out to patient filling prescriptions.  Such a requirement comes solely from the FDCA and its regulations, which the plaintiff made pretty clear through the complaint's allegations.  That means "plaintiff's claims based upon failure to provide a medication guide are preempted under Buckman."  This claim, like the rest of them against the generic manufacturers, was dismissed with prejudice.  We may or may not remember Perdue in another year, but we will add it to the relevant scoresheet and survey post so our readers—y'all as you all would be called in the Eastern District of North Carolina—will not need to rely on our fading memory.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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