Here's the second case that was sent to us by our readers. It is a favorable decision on one of our many pet peeves, off-label promotion, In re Celexa & Lexapro Marketing & Sales Practices Litigation, 2014 WL 3908126 (D. Mass. Aug. 8, 2014). On this one, the congratulations belong to Debevoise for winning it, and our thanks to J. Robert Abraham for being so kind as to send us a copy of the decision. In C&L (the official title is too much of a mouthful) the defendant was sued under the California unfair competition statute (“UCL”) for “restitution” of co-payment the plaintiffs paid for Celexa. The case was initially brought as a class action (most UCL cases these days are), but certification had been denied earlier because of the predominance of individualized issues. Among other things, C&Ldemonstrates the correctness of that determination, since the reliance facts were quite peculiar.
Other than the peculiar UCL damages (personal injury is not recoverable), C&L reads like a learned intermediary rule warning causation case and applies largely the same principles.
Of most significance to us, the plaintiff also moved for summary judgment, claiming that a guilty plea by the defendant established liability as a matter of law. The court rejected the plaintiff’s arguments.
First, C&L rejected the plaintiff’s attempt to distinguish between the UCL’s “fraud” and “unlawful” prongs with respect to the element of reliance:
California courts rejected that very argument . . ., however, and have clarified that the reliance requirement applies both to claims that expressly invoke the “fraud” prong of the UCL and claims that are asserted under the “unlawful” prong but that are based upon misrepresentations or false statements.
2014 WL 3908126, at *6 (citation omitted).
Second, C&L held that the guilty plea did not ipso facto establish liability under the UCL. The guilty plea was merely to “distributing a misbranded drug” under the FDCA – in other words, to off-label promotion. Id. at *7. Mere off-label promotion did not establish that “deceptive and misleading statements and omissions” were made, as the UCL requires:
Plaintiff is incorrect about the extent of [defendant’s] admissions. [Defendant] did not admit to making false or misleading statements in its plea allocution by its general counsel. Moreover,false or deceptive conduct was not an element of the strict liability misdemeanor to which Forest pled guilty and promotion of a drug for off-label use is not inherently false or misleading.
Id. (emphasis added). For this proposition, C&L cited one of our favorite cases: United States v. Caronia, 703 F.3d 149, 165 (2d Cir. 2012) (“[P]romotion of off-label drug use is not in and of itself false or misleading.”).
That meant that the plaintiff had to prove either actual reliance or that the alleged misrepresentations were material as a matter of law. Plaintiff failed on both counts. Typically, he had no evidence of actual reliance, and materiality was for the jury. 2014 WL 3908126, at *7. “Reasonable physicians” would not necessarily find “material” what the Department of Justice, the FDA, the New York Times, or even the defendant itself did. Id. at *8. Plaintiff’s own prescribers certainly did not:
[The first prescriber] testified that it makes no difference to him whether a drug is approved for a certain use by the FDA and that he continues to prescribe [the drug] to pediatric patients for whom he believes the drug might be effective despite his awareness of the negative . . . Study and the fact that [the drug] does not have a pediatric indication. [The second prescriber] provided similar testimony.
Id. So the plaintiff’s motion for summary judgment was denied.
Third, the defendant was entitled to summary judgment against the off-label promotion-based UCL claim. Plaintiff was allowed to get away with exposure (to the promotion) evidence that was, according to the court, “very weak.” 2014 WL 3908126, at *8. There was no need to go there because the reliance evidence was even worse. “[T]he issue of whether or not [minor plaintiff’s] treating physicians were exposed to misrepresentations is moot because the record establishes conclusively that the physicians did not rely.” Id. at *9.
Both prescribers testified that they didn’t care about the indications in the FDA-approved label. They prescribed off label because it worked for their patients:
[B]oth doctors testified under oath that they do not attach much if any importance to the fact that a drug does not have an “indication” for the purpose for which it is prescribed, i.e. the FDA has not approved it for a specific use such as use by children or adolescents. [The first prescriber] prescribed [the drug] to “hundreds” of children, including [minor plaintiff], and testified that he believed [the drug] was effective for [him]. His testimony is supported by the fact that he investigated whether . . . a different SSRI, would be more effective but concluded, based upon [plaintiff’s] self-reported symptoms, that [defendant’s drug] was more effective.
2014 WL 3908126, at *9. The second prescriber
would “possibly, but not necessarily” give weight to the FDA's rejection of an application for a particular indication, he continued to prescribe [the drug] for use by children even after learning about the [purportedly suppressed] Study and the fact that the FDA rejected the application.
Ouch. It’s tough for a plaintiff to win when the prescribers’ testimony is that good for the defense. Such testimony “establishes conclusively that [minor plaintiff’s] treating physicians did not rely.” Id. The plaintiff could not prevail under the UCL with an off-label promotion claim without evidence that such promotion caused the prescriber to prescribe the drug for this particular plaintiff. Obviously, there’s no way, even in California, that a class action could apply to claims so intimately tied to the decisions of individual physicians.
Fourth, there was no “injury in fact” with respect to any prescriptions written for generic versions of the defendant’s drug:
A plaintiff is entitled to restitution only with respect to money or property that was lost by the plaintiff and acquired by the defendant. Plaintiff has submitted no evidence to support a finding that the money he spent on generic citalopram inured to the benefit of [the defendant innovator manufacturer].
2014 WL 3908126, at *10. The infamous Conte decision only dealt with duties to warn and did “not alter the basic requirement that a plaintiff who asserts a claim for restitution under the UCL show that the defendant received the money or property that he lost.” Id. (emphasis original).
So the result in C&L is just how we like it. Plaintiff loses; defense wins.
Once again, thanks again to our correspondents in the defense community for letting us know of these decisions. Keep those defense wins coming!