We’ve written about the Actimmune off-label marketing litigation before (here and here). Hey, we even named a prior Actimmune decision Honorable Mention in our Top Cases of 2009 post. And now, it seems the Actimmune litigation has finally met its demise. You can get more detail about the backstory from our prior posts, but here’s the quick synopsis: the plaintiffs filed consumer and third-party payor (TPP) class actions against InterMune and others, alleging that the defendants illegally marketed the drug Actimmune off-label for treatment of idiopathic pulmonary fibrosis (IPF), a nasty lung disease, when Actimmune was ineffective to treat IPF. Originally, the plaintiffs raised a host of fraud-based claims, which the court blew out for failure to plead with particularity. In a bit of deja vu, the plaintiffs took another hack at stating a viable claim, but the court dismissed all fraud-based claims with prejudice.

Which brings us to take three. This time, the plaintiffs tried to state a claim under California’s Unfair Competition Law (UCL), and the TPP plaintiffs also tried to assert a claim under Missouri’s Merchandising Practices Act (MMPA). Again, the court dismissed all claims. With prejudice. See In re: Actimmune Marketing Litig., 2010 U.S. Dist. LEXIS 90480 (N.D. Cal. Sept. 1, 2010). See ya, Actimmune litigation.

Taking apart the UCL claim, the court noted that the plaintiffs had one more shot to plead a non-fraud UCL claim, under the UCL’s “unlawful” and “unfair” prongs. Id. at *16. But the plaintiffs failed to plead such a claim consistent with their TwIqbal obligations. The plaintiffs pointed to alleged off-label marketing as “evidence” that the defendants’ conduct was “unlawful” under the UCL. Id. at *17. Unfortunately for the plaintiffs, they forgot that it is not enough to allege unlawful conduct “in the air” – you also have to establish that the alleged violation caused harm. Id. at *18 (statute requires showing of injury “as a result of” the alleged violation). And here’s the best part: the UCL’s causation element requires proof of “actual reliance.” Id. at *24-25. In other words, “the ‘as a result of’ language places the burden on plaintiffs to establish that they actually relied upon the representations delivered through defendants’ off-label marketing.” Id. at *23.

In this case, involving doctors as “learned intermediaries,” the consumer plaintiffs’ complaint was inadequate because the plaintiffs “fail[ed] to allege that their doctors believed that Actimmune was an effective treatment for IPF ‘as a result of’ defendants’ off-label promotion of Actimmune.” Id. at *30-31. Instead, the plaintiffs simply pled that their doctors prescribed Actimmune “in substantial part because of defendants’ unfair and unlawful marketing.” Id. at *31 (quoting Third Amended Complaint). The court dismissed these allegations as “merely formulaic recitations of the elements of the cause of action.” Id. at *31-32. The TPP complaint fared no better; although it alleged that doctors relied on information received from the defendants when making prescribing decisions, “the complaint fails entirely to allege that the information was disseminated through defendants’ unlawful behavior, i.e., off-label marketing. In fact, the complaint avers exactly the opposite: that the pulmonologists received information about Actimmune’s efficacy in treating IPF through perfectly legitimate channels of communication.” Id. at *32 (legitimate channels include participating in clinical trials and consulting for InterMune on IPF issues).

This is a significant decision entrenching the requirement that plaintiffs show “actual reliance” when making out UCL claims in California, and taking a look at those causation/reliance allegations through the appropriate TwIqbal lens. But we’d be remiss if we finished without mentioning many of the court’s ancillary rulings, which are equally helpful:

(1) The plaintiffs could not state a UCL unlawful-prong claim based on an alleged violation of the False Claims Act, because the plaintiffs did not “allege a single fact connecting their alleged injury in paying for Actimmune to treat IPF to the submission of allegedly false claims to government payors.” Id. at *34.

(2) Nor could the plaintiffs state a claim under the UCL’s “unfair” prong. The plaintiffs’ complaint of “unfair” practices amounted to nothing more than a complaint that the defendants “knew that Actimmune was ineffective in treating IPF, but nonetheless represented to doctors and patients suffering from IPF that Actimmune could effectively treat IPF.” Id. at *35. That’s a fraud-based claim dressed up as an “unfair” practices claim, and that’s a no-go, consistent with the court’s prior order knocking out all fraud-based claims. Id.

(3) Finally, the TPPs lacked standing to state a claim under the MMPA, because that statute is limited to claims made by a plaintiff who purchased for his or her own “personal, family, or household purposes.” Id. at *38. In other words, no TPP claims.

So what’s the end result? Actimmune marketing litigation dismissed with prejudice, the plaintiffs’ motion to amend (again) denied. Strike three.