Debevoise & Plimpton LLP secured a victory following almost nine years of litigation in the Celexa and Lexapro Marketing and Sales Practices multidistrict litigation (MDL). The United State District Court for the District of Massachusetts granted summary judgment in Allergan’s favor and dismissed all claims of the remaining plaintiffs. This avoids a jury trial that had been scheduled to begin March 12.
Plaintiffs allege that Forest Laboratories, an Allergan subsidiary, fraudulently marketed the antidepressants Celexa and Lexapro for off-label pediatric use and misrepresented the drugs’ efficacy for pediatric patients by manipulating study data and deceiving the FDA into approving the drugs for the treatment of adolescent depression. On the heels of a government investigation into Forest’s marketing practices and the Company’s plea to a misdemeanor relating to off-label promotion, the first complaint in this MDL was filed in March 2009. Since then, the Debevoise team has defeated motions to certify nine classes asserting claims under RICO, all 50 states’ consumer protection laws, and common law. Debevoise also obtained dismissal of several claims under Rule 12(b)(6) and on statute-of-limitations grounds, and we obtained a significant ruling from the First Circuit clarifying the law on federal preemption of state law claims against drug manufacturers.
In the ruling, Judge Gorton dismissed all federal and state law claims of two consumers and a third-party payor, including for lack of RICO standing. The Court held that plaintiffs failed to establish a concrete injury because they failed to present evidence that the drugs were ineffective for their own children or plan members. Rather than submitting such evidence, Plaintiffs argued that they had raised a genuine dispute of material fact as to whether the drugs are generally ineffective for all patients by purportedly showing that Forest manipulated the results of a negative study to make it look positive and rigged another study. However, the FDA had concluded that both studies are positive and approved Lexapro for adolescent depression on that basis. Judge Gorton refused to allow Plaintiffs to second-guess the FDA’s efficacy determinations in the absence of new evidence not previously considered by the FDA, which Plaintiffs failed to adduce.
The team was led by partner Edwin G. Schallert and counsel Kristin D. Kiehn, and includes associates J. Robert Abraham, Noelle E. Lyle, Danielle E. Thorne, Ryan Kocse and Jane Chung and Litigation Case Manager Robert Tebbenkamp. A number of other lawyers (past and present) have had a significant role over the years, including Andrew J. Ceresney, Kate Kochendorfer Smith, Bethany Davis Knoll, Claire Martirosian, David Noland, Jehan Pernas, Kristin Bryan, David Imamura and Josh Roberts, among others. Many others have contributed, including Alex Ginsberg and Nathan Richards.
Debevoise & Plimpton LLP is a premier law firm with market-leading practices, a global perspective and strong New York roots. We deliver effective solutions to our clients’ most important legal challenges, applying clear commercial judgment and a distinctively collaborative approach.