United States: Off-Label Marketing MDL Winds Down With Some Summary Judgment

Last Updated: February 15 2018
Article by Eric Alexander

We have written extensively on the travesty of the Neurontin trilogy (like here and here) and noted how the plaintiffs' efforts to fit cases based on alleged off-label promotion of the prescription SSRIs Celexa and Lexapro into the same rubric have not been as successful. Today's case addresses what we understand to be some of the last few cases in the MDL. In re Celexa & Lexapro Mktg. & Sales Practs. Litig., MDL No. 09-02067-NMG, 2018 U.S. Dist. LEXIS 13579 (D. Mass. Jan. 26, 2018). This summary judgment decision addresses three cases, one by a third party payor on behalf of a purported class and two by parents of former pediatric users. As always, we reserve the right to focus on the parts we want and to make gratuitous statements about how these cases exemplify much of what is wrong with civil RICO and consumer fraud cases over prescription drugs.

A little background on the litigation and these cases should help. The allegations centered on the claim that the manufacturer of these drugs had caused economic injury to the plaintiffs by promoting the use of the drugs for pediatric patients when they were only approved for adult use. To dispose of the plaintiffs' cases, the court did not have to resolve whether the manufacturer engaged in such promotion, let alone whether any promotion was untruthful—which we think it would need to be to impose liability consistent with the First Amendment. Celexa was approved to treat depression in adults in 1998 and an application to treat depression in adolescents was filed in 2002. FDA denied that application based on a lack of efficacy in one of the two clinical studies. Lexapro was approved to treat depression in adults in 2002 and an application to treat depression in adolescents was filed in 2008 and approved a year later. The Celexa label always stated that "safety and effectiveness in pediatric patients have not been established" and, starting in 2005, described the results of certain pediatric trials. The Lexapro label had similar language until the pediatric indication was added. The first individual plaintiff sued over the prescription, purchase, and intermittent use of Celexa by a thirteen year old depressed patient in 2002-2003. The second individual plaintiff sued over the prescription, purchase, and use of Celexa and later Lexapro by an eight to fifteen year old autistic patient from 2003 to 2010. The TPP plaintiff sued over prescriptions paid for a relatively small number of Celexa prescriptions for pediatric beneficiaries from 1999 to 2004 and for a somewhat larger number of Lexapro prescriptions for pediatric beneficiaries between 2012 and 2015, but also claimed to represent a nationwide class of payors. The plaintiffs asserted a mix of federal civil RICO and state consumer fraud claims and, skipping some procedural history, the court entertained summary judgment motions.

The consideration of the RICO requirements of injury and causation resolved all issues. For those of you who know RICO or have just followed along with some of our posts, RICO requires an injury to "business or property" as a matter of standing. Relying on the Neurontin cases, these plaintiffs claimed that they had been injured because they paid for drugs that were not effective for the indications for which they were prescribed. They claimed, however, that any payment for an off-label prescription was an injury because they contended that FDA had somehow been defrauded in connection with the applications for pediatric indications. 2018 U.S. Dist. LEXIS 13579, *19. If you are following along, then you might wonder how this theory could apply to Celexa prescriptions or the earlier prescriptions of either drug. First things first, though, as the Celexa court had to unpack the Neurontin rulings to see if they supported plaintiffs' relaxed standard. They did not, so plaintiffs had to prove lack of efficacy. The TPP and second plaintiff could not: "[T]he FDA in this case approved the drug for use in adolescents. There is no conclusive or even strongly suggestive evidence of inefficacy in this case and plaintiff have presented no evidence as to the inefficacy for [the second plaintiff] or for any of [the TPP's] plan members." Id. at *22. As one might expect with prescriptions over the eight years, the second individual plaintiff's prescribing physician testified that the drugs had been effective with the patient's autism. The TPP's evidence resembled what we have seen in other cases—no proof from physicians for the plan beneficiaries and the plan still pays for pediatric prescriptions for both drugs, contrary to the allegations in the case.

Plaintiffs' attempted end run was that they had experts who would say FDA was somehow defrauded about efficacy for pediatric use—presumably just for Lexapro, as FDA rejected the only application for a pediatric indication for Celexa, and not for autism, as that was not an indication for either drug. As the court noted, and we will let the Neurontin characterizations lie, plaintiffs' "fraud theory is a tenuous attempt to shoehorn the facts of this case into the facts of Neurontin, where there were no positive, or even equivocal, clinical trials for the indications at issue." Id. at *25. Here, FDA "determined that two clinical studies were positive" and "FDA is the exclusive judge of safety and efficacy and a court should not question that judgment unless new information not considered by the FDA develops." Id. (internal quotes and citation omitted). Keep in mind that RICO is federal, so there is no preemption. Not too shabby. And summary judgment for the manufacturer on two of the plaintiffs.

On the remaining plaintiff, the first individual, the manufacturer challenged causation. In part because we think the analysis was somewhat confused, we will skip to what mattered and probably applies to other plaintiffs with similar claims. The prescribing physician's testimony did not support reliance on a sales representative's discussion of Celexa at all. Id. at *30. While he did acknowledge a possibility of some unrecalled exposure to off-label promotion, this is not enough to avoid summary judgment on an issue for which the plaintiff bears the burden of proof. "A mere possibility that the doctor could have, at some point, encountered off-label promotion, although he has no memory of it, does not rise to the level of a disputed material fact." Id. at **30-31. That sounds like what courts are supposed to say when evaluating a summary judgment motion on proximate cause for failure to warn with a prescription medical product. The court here called this "but-for causation," but we will not quibble. Summary judgment was awarded to the manufacturer on the last plaintiff's RICO claim and the analysis on RICO determined the result of the various consumer fraud claims. Like we said up front, this was all without reaching whether the manufacturer did anything wrong with its promotion.

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

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