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In re Celexa and Lexapro Marketing and Sales Practices Litigation

United States District Court, D. Massachusetts

June 2, 2016

In re: CELEXA AND LEXAPRO MARKETING AND SALES PRACTICES LITIGATION. MDL No. 09-02067-NMG
v.
FOREST LABORATORIES, INC. and FOREST PHARMACEUTICALS, INC., Defendants. PAINTERS AND ALLIED TRADES DISTRICT COUNCIL 82 HEALTH CARE FUND, Plaintiff,

          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"). Plaintiff Painters and Allied Trades District Council 82 Health Care Fund ("plaintiff" or "Painters") is a health and benefit fund providing benefits to covered members and their families. It acts as a third-party payor ("TPP") that reimburses the medical expenses of plan members.

         Painters alleges that defendants violated the Racketeer Influenced and Corrupt Organizations Act ("RICO"), Minnesota Consumer Fraud Act ("MCFA"), Minnesota Unfair Trade Practices Act ("MUTP") 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.

         Pending before the Court is Painters' motion to certify certain classes (Docket No. 546). For the reasons that follow, that motion will be denied.

         I. Background

         Celexa and Lexapro are closely-related selective serotonin reuptake inhibitor ("SSRI") anti-depressants. Forest obtained the approval of the Food and Drug Administration ("FDA") to market Celexa for adult use in 1998 and Lexapro for adult use in 2002. It later sought to market both drugs for 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 use, Forest had to make a sufficient showing to the FDA that the drugs would be more effective than placebos in treating MDD in pediatric patients. The FDA typically requires the submission of at least two "positive" placebo-controlled clinical trials supporting such use. A "positive" drug study shows statistically significant improvements for patients who are administered the drug rather than a placebo. A "negative" study is one that indicates no statistically significant difference in outcomes between patients who receive the drug and those who receive a placebo.

         Drug manufacturers submit the results of such trials to the FDA as part of their "new drug applications" ("NDAs"). The 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 approved indications.

         B. Clinical studies and FDA approval

         Forest conducted four double-blind, placebo-controlled studies on the efficacy of Celexa and Lexapro in treating pediatric depression. The first two studies examined the efficacy of Celexa and were completed in 2001. The 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.

         The other two studies addressed the efficacy of Lexapro. Lexapro Study 15 produced negative results but Lexapro Study 32 arguably produced positive results.

         The FDA-approved labels for both drugs prior to 2005 stated that "[s]afety and effectiveness in pediatric patients have not been established." In February, 2005, Forest revised Celexa's label to include a description of MD-18 and the Lundbeck Study and Lexapro's label to describe Lexapro's negative study.

         In 2008, Forest submitted the results of the studies to the FDA in a supplemental NDA. In March, 2009, the FDA reviewed the positive results in MD-18 and Lexapro Study 32, noted the chemical similarities between Celexa and Lexapro and approved Lexapro as safe and effective in treating MDD in adolescents. Forest did not seek similar FDA approval for Celexa.

         C. Procedural history

         Plaintiff Painters initiated this action on behalf of two putative nationwide TPP classes in November, 2013. It filed a first amended complaint in February, 2014, asserting violations of RICO (Counts I and II) and three Minnesota consumer protection statutes (Counts III, IV and V) on behalf of the two nationwide classes of TPPs and two Minnesota classes of TPPs and consumers. This Court dismissed Count V in December, 2014.

         Painters moved for class certification in February, 2016 and the Court heard oral argument in May, 2016.

         II. Motion to certify class

         Painters requests the certification of two nationwide classes:

1) the Celexa Class: All health insurance companies, third-party administrators, health maintenance organizations, self-funded health and welfare benefit plans, third-party payors and any other health benefit providers, in the United States of America and its territories, which paid or incurred costs for the purchase or reimbursement of the drug Celexa prescribed for use by an individual under 18 years of age, for purposes other than resale. Excluded from the Class are employees of Forest, including its officers and directors; the judge to which this case is assigned and his immediate family members; personnel of the Court to which this case is assigned; governmental entities and/or governmental healthcare payors; all claims reimbursed to health insurance companies, third-party administrators, health maintenance organizations, self-funded health and welfare benefit plans, third-party payors and any other health benefit providers included in the settlement class certified in In re Celexa & Lexapro Mktg. & Sales Practices Litig., No. MDL 09-2067-NMG, 2014 WL 4446464 (D. Mass. Sept. 8, 2014), except for any opt outs of these entities; and, pharmacy benefit managers; and
2) the Lexapro Class: All health insurance companies, third-party administrators, health maintenance organizations, self-funded health and welfare benefit plans, third-party payors and any other health benefit providers, in the United States of America and its territories, which paid or incurred costs for the purchase or reimbursement of the drug Lexapro prescribed for use by an individual under 18 years of age, for purposes other than resale, on or before March 19, 2009. Excluded from the Class are employees of Forest, including its officers and directors; the judge to which this case is assigned and his immediate family members; personnel of the Court to which this case is assigned; governmental entities and/or governmental healthcare payors; all claims reimbursed to health insurance companies, third-party administrators, health maintenance organizations, self-funded health and welfare benefit plans, third-party payors and any other health benefit providers included in the settlement class certified in In re Celexa & Lexapro Mktg. & Sales Practices Litig., No. MDL 09-2067-NMG, 2014 WL 4446464 (D. Mass. Sept. 8, 2014), except for any opt outs of these entities; and, pharmacy benefit managers.

         Painters also requests certification of two Minnesota subclasses: 3) the Minnesota Celexa Class which includes entities who paid or incurred costs for the purchase or reimbursement of Celexa prescribed for persons under the age of 18 for purposes other than resale in Minnesota; and 4) the Minnesota Lexapro Class which includes entities who paid or incurred costs for the purchase or reimbursement of Celexa prescribed for persons under the age of 18 for purposes other than resale, on or before March 19, 2009, in Minnesota.

         A. Class certification

         Under Fed.R.Civ.P. 23, a court may certify a proposed class only if it satisfies all of the requirements in Rule 23(a) and one of the requirements in Rule 23(b). See Smilow v. Sw. Bell Mobile Sys., Inc., 323 F.3d 32, 38 (1st Cir. 2003). Here, Painters requests the certification of a class pursuant to Rule 23(b)(3).

         Although a court must conduct a "rigorous analysis" before certifying a class, id., it should inquire into the merits of the action only "to the extent that the merits overlap the Rule 23 criteria, " In re Boston Sci. Corp. Sec. Litig., 604 F.Supp.2d 275, 281 (D. Mass. 2009)(quoting In re New Motor Vehicles Canadian Export Antitrust Litig., 522 F.3d 6, 24 (1st Cir. 2008)). If there are disputed factual or legal premises, however, the court may "probe behind the pleadings to formulate some prediction as to how specific issues will play out". In re New Motor Vehicles, 522 F.3d at 20 (citations omitted).

         Rule 23(a) contains requirements of numerosity, commonality, typicality and adequacy:

(1) the class is so numerous that joinder of all members is impracticable;
(2) there are questions of law or fact common to the class;
(3) the claims or defenses of the representative parties are typical of the claims or defenses of the class; and
(4) the representative parties will fairly and adequately protect the interests of the class.

         Fed. R. Civ. P. 23(a). Rule 23(b)(3) requires that 1) common questions of law or fact "predominate" over those affecting individual class members and 2) a class action be the "superior" method for fair and efficient adjudication. Fed.R.Civ.P. 23(b)(3).

         B. Rule 23(a) Requirements

         1. Numerosity

         With respect to numerosity, it is undisputed that the proposed classes would include "hundreds of [TPPs] nationwide and many within the State of Minnesota". Those TPPs are sufficiently numerous that joinder of all members would be impractical. See In re Relafen Antitrust Litig., 218 F.R.D. 337, 342 (D. Mass. 2003)(holding that forty class members are generally sufficient to establish numerosity).

         2. Commonality

         In assessing commonality, the court should inquire into "the capacity of a classwide proceeding to generate common answers apt to drive the resolution of the litigation." Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338, 350 (2011). The plaintiff must show that there is a common contention capable of class-wide resolution such that

determination of its truth or falsity will resolve an issue that is central to the validity of each one of the claims in one stroke.

         Id. There is sufficient commonality if the

questions that go to the heart of the elements of the cause of action... will each be answered either "yes" or "no" for the entire class [and] the answers will not vary by individual class member.

Donovan v. Philip Morris USA, Inc., 2012 WL 957633, at *21 (D. Mass. Mar. 21, 2012).

         Painters alleges that "Forest engaged in a common course of fraudulent conduct directed toward the entire class" by fraudulently promoting off-label, pediatric prescriptions of Celexa and Lexapro paid for by TPPs. Painters satisfies the commonality requirement.

         3. Typicality

         Under the typicality requirement, the injuries of the named plaintiff must arise from the same events or course of conduct and be based upon the same legal theory as the injuries and claims of the class. Swack v. Credit Suisse First Boston, 230 F.R.D. 250, 260 (D. Mass. 2005). The named plaintiff is not typical of the class if it may be ...


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