United States District Court, D. Massachusetts
In re: CELEXA AND LEXAPRO MARKETING AND SALES PRACTICES LITIGATION MDL No. 09-2067-NMG
FOREST LABORATORIES, INC. and FOREST PHARMACEUTICALS, INC., Defendants. MARLENE T. LOCONTE and DELANA S. KIOSSOVSKI, on behalf of themselves and all persons similarly situated, Plaintiffs,
MEMORANDUM & ORDER
NATHANIEL M. GORTON, District Judge.
This case arises out of the marketing and sales of the related anti-depressant drugs Celexa and Lexapro by defendants Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. ("defendants" or, collectively, "Forest"). Plaintiffs Marlene T. LoConte ("LoConte") and Delana S. Kiossovski ("Kiossovski"), consumers who purchased Celexa or Lexapro for their minor children, allege that defendants violated the Racketeer Influenced and Corrupt Organizations Act ("RICO") and were unjustly enriched by misrepresenting and concealing material information about the efficacy of those drugs in treating major depressive disorder ("MDD") in pediatric patients. LoConte and Kiossovski advance additional state law claims under the Massachusetts Consumer Protection Act, M.G.L. c. 93A ("Chapter 93A") and the Washington Consumer Protection Act ("CPA"), respectively.
Pending before the Court are defendants' request for judicial notice and motion to dismiss plaintiffs' complaint. For the reasons that follow, the request for judicial notice will be allowed and the motion to dismiss will be allowed, in part, and denied, in part.
Celexa and Lexapro are closely-related selective serotonin reuptake inhibitor antidepressants. Forest obtained the approval of the Food and Drug Administration ("FDA") to market Celexa (citalopram) for adult use in 1998 and to market Lexapro for adult use in 2002. It later sought to market both drugs for use in treating MDD in children and adolescents.
A. FDA approval process
In order to obtain FDA approval to market Celexa and Lexapro as effective for pediatric and adolescent use, Forest was required to make a sufficient showing to the FDA that the drugs would be more effective than placebos in treating MDD in pediatric or adolescent patients. The FDA typically requires parties to submit at least two "positive" placebo-controlled clinical trials supporting such use.
Drug studies are deemed "positive" if they show statistically significant improvements for patients who are administered a drug rather than a placebo. In contrast, a "negative" study is one that indicates no statistically significant difference in outcomes between patients who are administered the drug and those who receive a placebo.
Drug manufacturers submit the results of such trials to the FDA as part of "new drug applications" ("NDAs"). Through an NDA, a manufacturer may also request FDA approval of use of the drug to treat a specific condition which is known as an "indication." A manufacturer may only market and sell the drug for an approved indication.
B. Clinical studies and FDA approval of an adolescent indication for Lexapro
Forest arranged for researchers to conduct four double-blind, placebo-controlled studies on the efficacy of Celexa and Lexapro in treating pediatric and adolescent depression. The first two studies, which examined the efficacy of Celexa, were completed in 2001. Of those studies, Celexa Study 18 ("Wagner Study") produced positive results whereas Celexa Study 94404 ("Lundbeck Study") produced negative results.
Forest submitted the results of the two Celexa studies to the FDA in a supplemental NDA in 2002. The FDA denied Forest's application for a pediatric indication for Celexa after finding that the Lundbeck Study was a clearly negative study.
Two studies of Lexapro's efficacy produced similar results to the earlier Celexa studies. Lexapro Study 15, which was completed in 2004, produced negative results, whereas Lexapro Study 32 was positive.
Celexa's FDA-approved label was revised in February, 2005 to include a description of the Wagner Study and Lundbeck Study. Lexapro's FDA-approved label was revised at the same time to describe Lexapro's negative pediatric study. Both labels added an explicit statement that data were not sufficient at that time to support an indication for use in pediatric patients.
In 2008, Forest submitted the results of the Lexapro studies and the earlier Celexa studies to the FDA in a supplemental NDA. Based on 1) the fact that Celexa Study 18 and Lexapro Study 32 were both positive for efficacy in adolescents and 2) the chemical similarities between Celexa and Lexapro, the FDA permitted Forest to revise its Lexapro label in March, 2009 and market Lexapro as safe and effective in treating MDD in adolescents. Forest never obtained FDA approval to market Celexa for such use.
C. Alleged misrepresentations by Forest
Plaintiffs allege that Forest engaged in a comprehensive program to mislead consumers and healthcare professionals into believing that Celexa and Lexapro were clinically effective in treating MDD in children. The crux of their theory is that Forest deprived consumers of the ability to make an informed decision about whether to purchase or prescribe Celexa or Lexapro for their children by withholding information about the negative efficacy studies and engaging in an aggressive marketing campaign designed to mislead consumers and physicians about the efficacy of Celexa.
D. United States' qui tam complaint
In February, 2009, the United States Department of Justice unsealed its qui tam complaint against Forest ("government's qui tam complaint") alleging off-label pediatric promotion and concealment of the Lundbeck Study.
Following the unsealing of the government's qui tam complaint, several national class actions were filed including 1) New Mexico UFCW Union's and Employers' Health and Welfare Trust Fund v. Forest Labs, Inc. et al., No. 09-cv-11524-NMG (filed Mar. 13, 2009) ("March, 2009 RICO action"), which alleged causes of action under civil RICO and various state consumer protection statutes on behalf of a putative class of TPPs and 2) Anson v. Forest Labs, Inc. et al., No. 09-cv-11539-NMG (filed June 9, 2009) ("Anson action"), which asserted civil RICO and consumer fraud claims on behalf of a nationwide consumer class.
In September, 2010, Forest pled guilty to several violations of the Food, Drug and Cosmetic Act and agreed to pay $313 million and to cease and desist its pattern of misconduct.
E. Procedural history
Plaintiffs are consumers whose minor children were prescribed Celexa or Lexapro. LoConte paid $1, 476 for Lexapro prescriptions for her fourteen-year-old son from November, 2004 until at least 2010. Kiossovski paid $60 for Celexa prescriptions for her twelve-year-old daughter between July, 2001 and March, 2002 when her daughter was hospitalized due to worsening depression and the emergence of suicidal ideation.
Plaintiffs filed their complaint in August, 2014 asserting claims under RICO (Counts I and II), Massachusetts Consumer Protection Act (Count III), Washington Consumer Protection Act (Count IV) and the common law for unjust enrichment (Count V). Defendants made a request for judicial notice and moved to dismiss the case in December, 2014. A hearing was held on the pending motion to dismiss in June, 2015.
II. Defendants' request for judicial notice
Under Federal Rule of Evidence 201(b)
[t]he court may judicially notice a fact that is not subject to reasonable dispute because it: (1) is generally known within the trial court's territorial jurisdiction; or (2) can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.
Fed. R. Evid. 201(b). Moreover, the Court
must take judicial notice if a party requests it and the court is supplied with the ...