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In re Celexa and Lexapro Marketing and Sales Practices Litigation

United States District Court, D. Massachusetts

December 12, 2014

In re: CELEXA AND LEXAPRO MARKETING AND SALES PRACTICES LITIGATION;
v.
FOREST LABORATORIES, INC. and FOREST PHARMACEUTICALS, INC., Defendants. PAINTERS AND ALLIED TRADES DISTRICT COUNCIL 82 HEALTH CARE FUND, Plaintiff, ALLIED SERVICES DIVISION WELFARE FUND and NEW MEXICO UFCW UNION'S AND EMPLOYER'S HEALTH AND WELFARE TRUST FUND, Plaintiffs,
v.
FOREST LABORATORIES, INC. and FOREST PHARMACEUTICALS, INC., Defendants

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[Copyrighted Material Omitted]

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For In Re: Celexa and Lexapro Marketing and Sales Practices Litigation (1:09-md-02067-NMG): Christopher L. Coffin, Pendley, Baudin & Coffin, LLP, New Orleans, LA.

For Martha Palumbo, Individually and on behalf of all other persons similarly situated (09-11532), Peter Palumbo, Individually and on behalf of all other persons similarly situated (09-11532), Consolidated Plaintiffs (1:09-md-02067-NMG): Harris L. Pogust, LEAD ATTORNEY, Cuneo, Pogust & Mason LLP, Conshohocken, PA; Nicholas R. Rockforte, LEAD ATTORNEY, PRO HAC VICE, Pendley, Baudin & Coffin, LLP, Plaquemine, LA; Patrick W. Pendley, LEAD ATTORNEY, Pendley, Baudin & Coffin, LLP, Plaquemine, LA; Christopher L. Coffin, Pendley, Baudin & Coffin, LLP, New Orleans, LA; Michael L. Baum, Baum, Hedlund, Aristei & Goldman, P.C., Los Angeles, CA; Robert Brent Wisner, Baum Hedlund Aristei and Goldman PC, Los Angeles, CA.

For Jayne Ehrlich, Individually and on behalf of all other persons similarly situated (09-11532), Consolidated Plaintiff (1:09-md-02067-NMG): Harris L. Pogust, LEAD ATTORNEY, Cuneo, Pogust & Mason LLP, Conshohocken, PA; Patrick W. Pendley, LEAD ATTORNEY, Pendley, Baudin & Coffin, LLP, Plaquemine, LA; Christopher L. Coffin, Pendley, Baudin & Coffin, LLP, New Orleans, LA.

For Anna Murret, Individually and on behalf of all other persons similarly situated (09-11532), Consolidated Plaintiff (1:09-md-02067-NMG): Harris L. Pogust, LEAD ATTORNEY, Cuneo, Pogust & Mason LLP, Conshohocken, PA; Nicholas R. Rockforte, LEAD ATTORNEY, PRO HAC VICE, Pendley, Baudin & Coffin, LLP, Plaquemine, LA; Patrick W. Pendley, LEAD ATTORNEY, Pendley, Baudin & Coffin, LLP, Plaquemine, LA; Christopher L. Coffin, Pendley, Baudin & Coffin, LLP, New Orleans, LA.

For Universal Care, Inc., (09-11518), Consolidated Plaintiff (1:09-md-02067-NMG): Douglas R. Sprong, LEAD ATTORNEY, KOREIN TILLERY, LLC, St. Louis, MO; Roger D. Drake, LEAD ATTORNEY, Baum, Hedlund, Aristei & Goldman, P.C., Los Angeles, CA; Michael L. Baum, PRO HAC VICE, Baum, Hedlund, Aristei & Goldman, P.C., Los Angeles, CA.

For Angela Jaeckel, (09-11518), Melvin M. Fullmer, On behalf of themselves and all others similarly situated (09-11518), Consolidated Plaintiffs (1:09-md-02067-NMG): Douglas R. Sprong, LEAD ATTORNEY, KOREIN TILLERY, LLC, St. Louis, MO; Nicholas R. Rockforte, LEAD ATTORNEY, PRO HAC VICE, Pendley, Baudin & Coffin, LLP, Plaquemine, LA; Christopher L. Coffin, Pendley, Baudin & Coffin, LLP, New Orleans, LA; Michael L. Baum, Baum, Hedlund, Aristei & Goldman, P.C., Los Angeles, CA; Robert Brent Wisner, Baum Hedlund Aristei and Goldman PC, Los Angeles, CA.

For New Mexico UFCW Union's and Employer's Health and Welfare Trust Fund, on behalf of itself and all others similarly situated (09-11524), Consolidated Plaintiff (1:09-md-02067-NMG): David R. Buchanan, LEAD ATTORNEY, PRO HAC VICE, Seeger Weiss LLP, New York, NY; Douglas R. Plymale, James R. Dugan, II, LEAD ATTORNEYS, The Dugan Law Firm, New Orleans, LA; Justin Bloom, LEAD ATTORNEY, Justin Bloom, Esq., New York, NY; Shane Youtz, LEAD ATTORNEY, Youtz and Valdez, P.C., Albuquerque, NM; Adam M. Stewart, Thomas G. Shapiro, Shapiro Haber & Urmy LLP, Seaport East, Boston, MA; David B. Franco, The Dugan Law Firm, APLC, New Orleans, LA.

For Allied Services Division Welfare Fund, on behalf of itself and all others similarly situated (09-11524), Consolidated Plaintiff (1:09-md-02067-NMG): David R. Buchanan, LEAD ATTORNEY, PRO HAC VICE, Seeger Weiss LLP, New York, NY; Douglas R. Plymale, James R. Dugan, II, LEAD ATTORNEYS, The Dugan Law Firm, New Orleans, LA; Adam M. Stewart, Thomas G. Shapiro, Shapiro Haber & Urmy LLP, Seaport East, Boston, MA; David B. Franco, The Dugan Law Firm, APLC, New Orleans, LA.

For Municipal Reinsurance Health Insurance Fund, Consolidated Plaintiff (1:09-md-02067-NMG): Thomas M. Sobol, Hagens Berman Sobol Shapiro LLP, Cambridge, MA.

For Ruth Dunham, Consolidated Plaintiff (1:09-md-02067-NMG): Christopher L. Coffin, Pendley, Baudin & Coffin, LLP, New Orleans, LA.

For Tanya Shippy, Consolidated Plaintiff (1:09-md-02067-NMG): Christopher L. Coffin, Pendley, Baudin & Coffin, LLP, New Orleans, LA; Robert Brent Wisner, Baum Hedlund Aristei and Goldman PC, Los Angeles, CA.

For Painters and Allied Trades District Council 82 Heath Care Fund, Plaintiff (1:09-md-02067-NMG): Christopher L. Coffin, Pendley, Baudin & Coffin, LLP, New Orleans, LA.

For Forest Laboratories Inc., Forest Pharmaceuticals, Inc., Consolidated Defendants (1:09-md-02067-NMG): Cicely I. Lubben, Sandra J. Wunderlich, LEAD ATTORNEYS, Stinson, Morrison et al. - St. Louis, Clayton, MO; Danielle E. Kasten, Kristin D. Kiehn, Steven S. Michaels, LEAD ATTORNEYS, PRO HAC VICE, Debevoise & Plimpton LLP, New York, NY; Edwin G. Schallert, LEAD ATTORNEY, Debevoise & Plimpton, New York, NY; J. Robert Abraham, LEAD ATTORNEY, Debevoise & Plimpton LLP, New York, NY; William F. Benson, Sugarman, Rogers, Barshak & Cohen, P.C., Boston, MA.

For Warner Lambert Company, (09-11524), Consolidated Defendant (1:09-md-02067-NMG): Barbara Wrubel, LEAD ATTORNEY, Skadden, Arps, Slate, Meagher & Flom LLP, New York, NY; Mark S. Cheffo, LEAD ATTORNEY, PRO HAC VICE, Quinn Emanuel Urquhart & Sullivan, LLP, New York City, NY.

For Natalie Luster, Interested Party (1:09-md-02067-NMG): Alex Lumaghi, Douglas P. Dowd, LEAD ATTORNEYS, PRO HAC VICE, Dowd & Dowd, P.C., St. Louis, MO; Christopher J. Quinn, John J. Driscoll, LEAD ATTORNEYS, PRO HAC VICE, The Driscoll Firm, P.C, St. Louis, MO; William T. Dowd, LEAD ATTORNEY, PRO HAC VICE, DOWD AND DOWD, St. Louis, MO; Ryan P. McManus, Hemenway & Barnes, Boston, MA.

For Painters and Allied Trades District Council 82 Health Care Fund, Plaintiff (1:13-cv-13113-NMG): Shawn M. Raiter, LEAD ATTORNEY, Larson & King, St.Paul, MN; T Joseph Snodgrass, Larson King, LLP, St Paul, MN.

For Forest Pharmaceuticals, Inc., Forest Laboratories Inc., Defendants (1:13-cv-13113-NMG): Edwin G. Schallert, Debevoise & Plimpton, New York, NY; William F. Benson, Sugarman, Rogers, Barshak & Cohen, P.C., Boston, MA.

For Allied Services Division Welfare Fund, on behalf of themselves and all others similarly situated, New Mexico UFCW Union's and Employers' Health and Welfare Trust Fund, on behalf of themselves and all others similarly situated, Plaintiffs (1:14-cv-10784-NMG): David B. Franco, LEAD ATTORNEY, PRO HAC VICE, The Dugan Law Firm, APLC, New Orleans, LA; Douglas R. Plymale, James R. Dugan, II, LEAD ATTORNEYS, PRO HAC VICE, The Dugan Law Firm, New Orleans, LA; Thomas G. Shapiro, Shapiro Haber & Urmy LLP, Seaport East, Boston, MA.

For Forest Laboratories, Inc., Forest Pharmaceuticals, Inc., Defendants (1:14-cv-10784-NMG): Edwin G. Schallert, LEAD ATTORNEY, Debevoise & Plimpton, New York, NY; William F. Benson, Sugarman, Rogers, Barshak & Cohen, P.C., Boston, MA.

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MEMORANDUM & ORDER

Nathaniel M. Gorton, United States District Judge.

These two cases arise 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" ). Plaintiff Painters and Allied Trades District Council 82 Health Care Fund (" Painters" ) and plaintiffs Allied Services Division Welfare Fund and New Mexico UFCW Union's and Employers' Health and Welfare Trust Fund (" Allied Services/NM UFCW" ) are health and benefit funds providing benefits to covered members and their families. They act as third-party payors (" TPPs" ) that reimburse medical expenses of plan members.

Painters alleges that defendants violated the Racketeer Influenced and Corrupt Organizations Act (" RICO" ), Minnesota Consumer Fraud Act, Minnesota Unfair Trade Practices Act and Minnesota Deceptive Trade Practices Act by misrepresenting and concealing material information about the efficacy of Celexa and Lexapro in treating major depressive disorder (" MDD" ) in pediatric patients. Allied Services/NM UFCW allege that defendants violated RICO, Illinois and New Mexico consumer protection statutes, the consumer fraud laws of 46 other states and was unjustly enriched.

Pending before the Court are defendants' motions to dismiss the Painters first amended complaint (" FAC" ) and the Allied Services/NM UFCW complaint.

I. Background

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.

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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 (" MD-18" ) 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 MD-18 and the 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 those 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. United States' qui tam complaint

In February, 2009, the United States Department of Justice unsealed its qui tam complaint against Forest (" the 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, two national class actions were filed: 1) New Mexico ...


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