United States: Off-Label Marketing Case Tossed

Last Updated: October 3 2017
Article by Eric Alexander

Implied Preemption. Off-label promotion. TwIqbal. They make up a core of our posts, yet we never seem to tire of them. Maybe our readers, especially interlopers from the other side of the v., tire of reading about them, but we can often find a wrinkle in a case that merits our huzzahs or inspires a rant. Today's case falls into the praiseworthy category, as the court dismissed a complaint predicated on violations of the FDCA in spite of sympathetic allegations that might have carried the day with some other courts. Markland v. Insys Therapeutics, Inc., — F. Supp. 3d –, 2017 WL 4102300 (M.D. Fla. Sept. 15, 2017), involved the alleged death of a patient as a result of respiratory distress from the defendant's sublingual spray prescription painkiller drug, which she had started the day before. Rather than offer the typical product liability claims under Florida law, perhaps because the labeling had extensive warnings on respiratory distress, plaintiff asserted only a claim for negligent marketing. Calling it "negligent marketing" does not really identify what duty was allegedly breached, whether state law recognizes a claim for such a breach, and such a claim would be preempted. The allegedly actionable conduct in Markland was promoting the drug for off-label use, like the chronic back pain of plaintiff's decedent, as opposed to the approved indication for breakthrough pain with cancer. While we do not know the merits, there were many allegations about off-label promotion, which seem to tie to the conduct at issue in well-publicized federal and state investigations.

Defendants moved to dismiss on various grounds, the most relevant of which (for our purposes) were that there was no claim under Florida law for this conduct and it would be impliedly preempted under Buckman anyway. These had been hot topics recently in some Florida state and federal cases we have discussed, like Mink ( here and here) and Wolicki-Gables, but those dealt with PMA devices and the additional issue of express preemption. Here, with a prescription drug marketed under an NDA approval, there is no express preemption to navigate, but the plaintiff still had to walk a narrow path to state a claim that would not be impliedly preempted. As we have said before, we think the appropriate order of analysis here would be the determine if there was a cognizable state law claim asserted and then determine if it was preempted, but the Markland court did not separate out its analysis. It also did not weigh in on whether the allegations here were of truthful off-label promotion that might implicate First Amendment protection. Instead, it assumed that the off-label promotion alleged violated the FDCA's prohibition on misbranding. 2017 WL 4102300, *6 & n.4.

The court could take this approach because the plaintiff's claim was so squarely focused on alleged violations of the FDCA. Since Buckman, plaintiffs tend to be a bit cagier in making it look like their claims were not predicated on violations of the FDCA or fraud on the FDA. The Markland plaintiff, however, labeled the defendant's alleged conduct as violating the FDCA, "federal law," and "requirements imposed by the FDA regarding the condition that this drug should be utilized to treat cancer patients with breakthrough cancer pain." Id. at *9. "Hence, [the claim], while framed in the language of negligence, appears to derive from [defendant's] alleged off-label promotion of [the drug]" and "the very concepts of off-label use and off-label marketing are born out of the FDCA." Id. This was well phrased, as was the later statement that "it is only because of the existence of the FDCA's restrictions on off-label marketing that Mr. Markland claims [defendant's] actions were improper or otherwise violated a duty." Id.

This is the recipe for implied preemption under Buckman. It also means there is no negligence claim under Florida law, "which bars plaintiffs from using state negligence actions to seek recovery for FDCA violations." Id. at 10 (citing negligence per se cases). Of course, Buckman recognized that the FDCA does not provide for a private right of action, and preempts claims with FDCA violations as "critical element[s]," which should prevent such piggybacking. So, plaintiff's case was done and could not be revived by amending the complaint. In other words, there was no need for a second and third strike before judgment could be entered. This was so despite the Court's expression of compassion:

The Court does not question for a moment the grievous nature of Carolyn Markland's death, nor the deep sadness Mr. Markland must face on a daily basis as a result of his wife's untimely passing. Nonetheless, the Court must act within the bounds of the law.

Id. at *11. This a good lesson, especially for courts sitting in diversity, that the law should not be expanded to allow for recovery by sympathetic who cannot make their case under accepted tort theories.

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

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