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In re Celexa and Lexapro Marketing and Sales Practices Litigation

United States District Court, D. Massachusetts

August 15, 2017

In re CELEXA AND LEXAPRO MARKETING AND SALES PRACTICES LITIGATION
v.
FOREST LABORATORIES, INC., FOREST LABORATORIES, LLC and FOREST PHARMACEUTICALS, INC., Defendants. DELANA S. KIOSSOVSKI and RENEE RAMIREZ, Plaintiffs, Civil Action No. 14-13848-NMG

          MEMORANDUM & ORDER

          NATHANIEL M. GORTON UNITED STATES DISTRICT JUDGE.

         This case arises out of the marketing and sales of the anti-depressant drugs Celexa and Lexapro by defendants Forest Laboratories, Inc., Forest Laboratories, LLC and Forest Pharmaceuticals, Inc. (collectively, “defendants” or “Forest”). Plaintiffs Delana Kiossovski and Renee Ramirez (collectively, “plaintiffs”) allege that defendants 1) engaged in a fraudulent marketing scheme designed to induce consumers to purchase Celexa and Lexapro for pediatric use in violation of the Racketeer Influenced and Corrupt Organizations Act (“RICO”), 18 U.S.C. §§ 1962(c) and (d), 2) were unjustly enriched and 3) violated the Washington Consumer Protection Act, RCW § 19.86.010 et seq. Plaintiffs' motion for class certification (Docket No. 137) is currently pending before the Court. For the reasons that follow, that motion will be denied.

         I. Background and procedural history

         Celexa and Lexapro are closely related anti-depressants. Forest obtained approval from 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 to treat pediatric major depressive disorder (“MDD”).

         A. FDA Approval Process

         To obtain FDA approval to market Celexa and Lexapro for pediatric use, Forest had to show that the drugs would be more effective than placebos in treating MDD in pediatric patients. The FDA typically requires at least two “positive” placebo-controlled clinical trials before approval. A “positive” drug study shows statistically significant improvements for patients who are administered the drug rather than a placebo while a “negative” study indicates no statistically significant difference. Drug manufacturers submit trial results to the FDA as part of their “new drug applications” (“NDAs”).

         Forest conducted four double-blind, placebo-controlled studies on the efficacy of Celexa and Lexapro in treating pediatric depression. The first two examined the efficacy of Celexa and were completed in 2001. The Celexa Study 18 (“MD-18”) produced results that the FDA determined were positive (although plaintiffs dispute that finding). On the other hand, 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 negative. The other two studies addressed the efficacy of Lexapro. Lexapro Study 15 produced negative results but Lexapro Study (“MD-32”) produced statistically significant, and therefore positive, results.

         Before 2005, the FDA-approved labels for both drugs 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 the negative study.

         In 2008, Forest submitted study results to the FDA in a supplemental NDA. The following year, the FDA reviewed the positive results in MD-18 and MD-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.

         B. Delana Kiossovski and Renee Ramirez

         The proposed class representatives both purchased Celexa and/or Lexapro for their children and both assert that they were mis-led to believe that those drugs effectively treated pediatric depression. From July, 2001 to March, 2002, Kiossovski bought Celexa for her daughter, who was then 12 years old, based upon the recommendation of her daughter's psychiatrist, Dr. Stephen Barnett. In 2002, Kiossovski's daughter attempted suicide. After that, she stopped using Celexa. Kiossovoski became aware that the efficacy of Celexa for children was unproven in 2014. From February, 2003 to April, 2004, the eight-year-old son of Ramirez used Celexa for his depression and from April, 2004 to January, 2007 he used Lexapro. His physician, Dr. Michael Saito, recommended both drugs.

         C. Procedural history

         In August, 2014, former plaintiff Marlene LoConte and Kiossovski commenced this action in the Western District of Washington by filing a complaint on behalf of themselves and putative consumer classes. They alleged that Forest fraudulently promoted the pediatric use of Celexa and Lexapro despite knowing that the drugs did not provide any clinically significant benefit over placebos in treating MDD. The case was transferred to this Court pursuant to a multi-district litigation assignment in October, 2014.

         In June, 2015, this Court 1) allowed defendants' motion to dismiss with respect to the RICO, Massachusetts Consumer Protection Act, M.G.L. c. 93A (“Chapter 93A”) and unjust enrichment claims brought by LoConte and 2) denied the motion with respect to the RICO, Washington Consumer Protection Act and unjust enrichment claims brought by Kiossovski. Plaintiffs amended the complaint in January, 2016 by replacing LoConte with Ramirez as the second putative class representative. The amended complaint raises two RICO claims by Kiossovski and Ramirez, an unjust enrichment claim by both plaintiffs and a Washington Consumer Protection Act claim by Kiossovski.

         In February, 2016, defendants moved to dismiss the amended complaint which this Court denied in June, 2016. In March, 2017, plaintiffs moved for class certification which defendants opposed. This Court convened a hearing on the motion for class certification and that motion is the subject of this memorandum and order. For the reasons that follow, it will be denied.

         II. Motion to Certify Class

         Plaintiffs request the certification of the following nationwide RICO classes and subclasses:

Damages Class. All persons, in the United States of America and its territories, who, for purposes other than resale, (1) paid or incurred costs for the drug Celexa prescribed for use by an individual under 18 years of age; and/or (2) paid or incurred costs on or before March 19, 2009, for the drug Lexapro prescribed for use by an individual under 18 years of age.

         Plaintiffs also propose the following sub-classes because there is no study demonstrating that Celexa and/or Lexapro are effective for children 12 or younger and MD-32 was not submitted to the FDA in a supplemental NDA until March, 2008:

Child Subclass. All persons, in the United States of America and its territories, who, for purposes other than resale, (1) paid or incurred costs for the drug Celexa prescribed for use by an individual under 13 years of age; and/or (2) paid or incurred costs on or before March 19, 2009, for the drug Lexapro prescribed for use by an individual under 13 years of age.
MD-32 Subclass. All persons, in the United States of America and its territories, who, for purposes other than resale, (1) paid or incurred costs for the drug Celexa prescribed for use by an individual under 18 years of age; and/or (2) paid or incurred costs on or before March 11, 2008, for the drug Lexapro prescribed for use by an individual under 18 years of age.

         Plaintiffs alternatively seek to certify a “liability-only class” that is the same as the proposed damages class under Fed.R.Civ.P. 23(c)(4). Plaintiffs also move for the designation of Kiossovski and Ramirez as class representatives and to appoint Christopher L. Coffin of Pendley, Baudin & Coffin, L.L.P. and Michael Baum of Baum, Hedlund, Aristei & Goldman, P.C., along with their respective law firms, as class counsel.

         Plaintiffs further request certification of classes of Washington residents for the unjust enrichment and Washington Consumer Protection Act claims. Kiossovski is the putative class representative for those claims.

         A. Class Certification Pursuant to Fed.R.Civ.P. 23(b)

         A court may certify a proposed class only if it satisfies all of the requirements in Fed.R.Civ.P. 23(a) and one of the requirements in Fed.R.Civ.P. 23(b). See Smilow v. Sw. Bell Mobile Sys., Inc., 323 F.3d 32, 38 (1st Cir. 2003). Here, plaintiffs seek to certify a class under 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 [as individual plaintiffs] 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 be the “superior” method for fair and efficient adjudication. Fed.R.Civ.P. 23(b)(3).

         B. Application of the Rule 23(a) Requirements

         1. ...


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