In Re Celexa & Lexapro Marketing & Sales Practices Litigation

751 F. Supp. 2d 277, 2010 U.S. Dist. LEXIS 120258, 2010 WL 4644429
CourtDistrict Court, D. Massachusetts
DecidedNovember 10, 2010
DocketMDL 09-02067-NMG
StatusPublished
Cited by5 cases

This text of 751 F. Supp. 2d 277 (In Re Celexa & Lexapro Marketing & Sales Practices Litigation) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Celexa & Lexapro Marketing & Sales Practices Litigation, 751 F. Supp. 2d 277, 2010 U.S. Dist. LEXIS 120258, 2010 WL 4644429 (D. Mass. 2010).

Opinion

MEMORANDUM & ORDER

GORTON, J.

Plaintiffs Scott A. Wilcox (“Wilcox”), Angela Jaeckel, et al. (“Jaeckel”), Martha Palumbo, et al. (“Palumbo”), Municipal Reinsurance Health Insurance Fund, et al. (“Municipal Reinsurance”) and New Mexico UFCW Union’s and Employers’ Health Welfare Trust Fund, et al. (“NM UFCW”) have brought suit against Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. (“Forest”). Before the Court are motions to dismiss filed by the defendants on three grounds: lack of subject matter jurisdiction pursuant to Fed.R.Civ.P. 12(b)(1), failure to state a claim upon which relief can be granted pursuant to Fed. R.Civ.P. 12(b)(6), and failure to plead fraud allegations with particularity pursuant to Fed.R.Civ.P. 9(b).

I. Background

A. Factual Background

This collection of lawsuits arises out of Forest’s marketing and sales of two related anti-depressant drugs: Celexa and Lexapro. In the interest of brevity, Celexa and citalopram (the trade name for Celexa), along with any generic equivalents manufactured by Forest, will be referred to collectively as “Celexa”. The following facts are as alleged in the plaintiffs’ complaints.

The crux of the allegations is that from about 2001 to 2005, Forest illegally promoted the drugs for off-label use in pediatric and adolescent patients. The Food and Drug Administration (“FDA”), however, had only approved the drugs for use in adult patients and, with respect to Celexa, the FDA had specifically denied approval for pediatric use.

In September, 1999, Forest submitted protocols to the FDA for two double-blind, placebo-controlled studies on the pediatric use of Celexa. The first was conducted in Europe by Lundbeck (“the Lundbeck study”) and the other at the University of Texas by Karen Wagner (“the Wagner study”). In mid-2001, Forest executives received the results of the two studies. The Wagner study indicated that Celexa was more effective than a placebo in treating pediatric depression. The Lundbeck study indicated that Celexa was no more effective than a placebo and that it caused more suicidal ideation compared to the patients taking a placebo. Forest submitted the results of the two studies to the FDA in April, 2002, seeking a six-month extension of patent exclusivity. In September, 2002, the FDA denied Forest’s application for a pediatric indication for Celexa, finding that the Lundbeck study “is a clearly negative study that provides no support for the efficacy of Celexa in pediatric patients with [major depressive disorder].”

With respect to Forest’s marketing scheme, the plaintiffs allege that from *284 mid-2001 through at least 2005, Forest 1) misled physicians by promoting the results of the positive Wagner study while failing to disclose the results of the contemporaneous Lundbeck study and 2) illegally paid various kickbacks to physicians to induce them to prescribe the drugs.

The plaintiffs allege that, for three years, Forest failed to disclose the negative Lundbeck study to its thousands of sales representatives, pediatric specialists whom it hired to give promotional speeches on Celexa, its Executive Advisory Board which was responsible for conveying information to sales personnel, its Professional Affairs Department, which disseminates information to physicians, or its pediatric researchers, including Dr. Wagner.

During those three years, Forest allegedly engaged in an aggressive marketing campaign for Celexa in which the Wagner study was highly publicized and the Lundbeck study was never mentioned. Dr. Wagner, allegedly ignorant of the Lundbeck study, gave presentations to various professional groups on the findings of her study. Forest also allegedly caused news stories about the Wagner data to be disseminated in national and local media and held 20 Continuing Medical Education (“CME”) teleconferences addressing the Wagner study results.

The plaintiffs maintain that Forest’s failure to disclose the Lundbeck study results to the above-named groups and individuals caused those people to make false or misleading statements about Celexa to the public, physicians and patients. For example, in June, 2004, The American Journal of Psychiatry published an article by Dr. Wagner in which she discussed her placebo-controlled trial on pediatric use of Celexa but did not mention the Lundbeck study.

On June 21, 2004, the New York Times published an article revealing the negative results of the Lundbeck study and observing that the article published by Dr. Wagner failed to mention the Lundbeck study. Three days later, Forest issued a press release acknowledging that the Lundbeck study and another double-blind study of the drug Lexapro did not show efficacy in comparison to placebo.

In early 2005, Forest changed the Celexa label to include a black-box warning required pursuant to a public health advisory issued by the FDA on March 22, 2004. The warning stated that the safety and effectiveness of the drug in the pediatric population had not been established and that

[t]wo placebo-controlled trials in 407 pediatric patients with [major depressive disorder] have been conducted with Celexa, and the data were not sufficient to support a claim for use in pediatric patients.

In 2007, the Celexa label was modified again to state that, in placebo-controlled selective serotonin reuptake inhibitor (“SSRI”) trials in both children and adults,

[t]here was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied.

In addition to the allegedly misleading statements concerning the safety and efficacy of Celexa for pediatric use, the plaintiffs also assert that Forest illegally induced physicians to prescribe Celexa through a system of kickbacks, such as honoraria for participation in advisory boards, restaurant gift certificates, lavish entertainment and research grants. The advisory boards, which were allegedly held between 2001 and 2005, consisted of physicians who received monetary compensation to give feedback on the marketing of Celexa. The plaintiffs claim that the payment for being on such an advisory board *285 was intended as an incentive for physicians to write more prescriptions for Celexa.

The plaintiffs also allege that Forest induced physicians to prescribe Celexa through “preceptorships” which were an ostensible training opportunity where Forest sales representatives would interview physicians about how Celexa was used in practice. Physicians allegedly received up to $1,000 for participation.

1. Qui Tam Suits

In 2003 and 2005, two qui tam law suits were filed against Forest in this district by Christopher Gobble (Civil Action No. 03-10395-NMG) and Joseph Piacentile (Civil Action No. 05-10201-NMG).

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751 F. Supp. 2d 277, 2010 U.S. Dist. LEXIS 120258, 2010 WL 4644429, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-celexa-lexapro-marketing-sales-practices-litigation-mad-2010.