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In re Celexa and Lexapro Marketing and Sales Practices Litigation

United States District Court, D. Massachusetts

January 26, 2018

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, DELANA S. KIOSSOVSKI and RENEE RAMIREZ, Plaintiffs,
v.
FOREST LABORATORIES, INC. and FOREST PHARMACEUTICALS, INC., Defendants.

          MEMORANDUM & ORDER

          Nathaniel M. Gorton United States District Judge.

         These cases arise 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, “the Kiossovski plaintiffs”) and plaintiff Painters and Allied Trades District Council 82 Health Care Fund (“Painters”) (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, 3) violated the Washington Consumer Protection Act (Kiossovski) and 4) violated the Minnesota Consumer Fraud Act and Minnesota Unfair Trade Practices Act (Painters).

         Pending before the Court are (1) Painters' motion for partial summary judgment on Forest's statute of limitations affirmative defense (Painters) (Docket No. 662), (2) Forest's cross-motion for summary judgment on all claims (Painters) (Docket No. 676) and (3) Forest's motions for summary judgment on all claims (Painters and Kiossovski) (Docket Nos. 797 and 798). For the reasons that follow, this Court will deny as moot Painters' motion for partial summary judgment, allow, in part, and deny as moot, in part, Forest's cross motion for summary judgment and allow Forest's motions for summary judgment on all claims.[1]

         The Court heard oral argument on the pending motions on January 11, 2018.

         I. Background and procedural history

         Celexa and Lexapro are closely related selective serotonin reuptake inhibitor (“SSRI”) anti-depressants sold by Forest. 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 and Lundbeck, the Danish pharmaceutical company that developed the drugs and licensed them to 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, were completed in 2001 and were submitted to the FDA in 2002. 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 (“MD-15”) was completed in 2004 and produced negative results but Lexapro Study 32 (“MD-32”), completed in 2007, 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 ages 12-17. Forest did not seek similar FDA approval for Celexa.

         B. Delana Kiossovski and Renee Ramirez

         From July, 2001 to February, 2002, Kiossovski bought Celexa for her daughter, who was then 13 years old, based upon the recommendation of her daughter's psychiatrist, Dr. Stephen Barnett. A short time later, Kiossovski's daughter developed a rash and stopped ingesting Celexa for approximately two months. She resumed taking the medication in October, 2001. In March, 2002, Kiossovski's daughter attempted suicide. Shortly after her attempted suicide, Kiossovski's daughter was diagnosed with bipolar disorder by psychiatrist Dr. Carola Bosenberg. Dr. Bosenberg discontinued the prescription of Celexa for use by Kiossovski's daughter and prescribed other medication. Thereafter the daughter stopped using Celexa. Kiossovoski became aware in 2014 that the efficacy of Celexa for pediatric use was unproven when it was prescribed for her daughter.

         From February, 2003 to April, 2004, Ramirez purchased Celexa for her eight-year-old son and from May, 2004 to December, 2006 she bought Lexapro. Ramirez continued to fill her son's Lexapro prescriptions until March, 2010. Dr. Michael Saito, a neurologist, treated Ramirez's son from March, 2001 to September, 2010. During that time, the son was diagnosed with several disorders including autism and anxiety. Dr. Saito prescribed Celexa and Lexapro to treat symptoms of autism.

         C. Painters and Allied Trades District 82 Council Health Care Fund

         Painters is a third-party payor (“TPP”) that provides medical benefits, including prescription drug coverage, to its insured beneficiaries, who are employees of unionized commercial painting companies. Painters retains a pharmacy benefit manager (“PBM”), Prime Therapeutics (“Prime”), that administers Painters' prescription drug benefit program. Painters delegated to Prime responsibility for 1) determining which drugs to include on the approved drug formulary, 2) negotiating rebates with pharmaceutical manufacturers, and 3) imposing limitations on coverage, if necessary. A drug formulary lists medications that will be reimbursed by the insurer or TPP, in this case, Painters.

         Between January, 1999 and October, 2004, Painters reimbursed 72 Celexa prescriptions for 16 of its pediatric insureds, at a total cost of $4, 210. Between August, 2002 and January, 2015, Painters reimbursed 234 prescriptions for Lexapro for 31 of its pediatric insureds, at a total cost of $20, 262.

         D. Procedural history

         Plaintiff Painters and another TPP initiated this action in the District of Minnesota on behalf of two putative nationwide TPP classes in November, 2013. The case was transferred to this Court pursuant to a multi-district litigation assignment in December, 2013. Plaintiffs 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 putative nationwide classes of TPPs and two putative Minnesota classes of TPPs and consumers. This Court dismissed Count V and all claims brought by TPP Allied Services Division Welfare Fund and New Mexico UFCW Union's and Employers' health and Welfare Trust Fund in December, 2014.

         Painters moved for class certification in February, 2016 and that motion was denied in June, 2016. In December, 2016, the First Circuit Court of Appeals denied Painters' Fed.R.Civ.P. 23(f) petition seeking permission to appeal this Court's order denying class certification. Painters filed its second motion for class certification in February, 2017. Forest has not opposed that motion but instead sought a stay of consideration of that motion until the motions for summary judgment have been resolved.

         In August, 2014, former plaintiff Marlene LoConte and Kiossovski commenced an action in the United States District Court for the Western District of Washington 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 the action 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, the Kiossovski plaintiffs moved for class certification which defendants opposed. This Court denied the Kiossovski plaintiffs' motion for class certification in August, 2017.

         II. Motions for Summary Judgment

         A. Legal Standard

         The role of summary judgment is “to pierce the pleadings and to assess the proof in order to see whether there is a genuine need for trial.” Mesnick v. Gen. Elec. Co., 950 F.2d 816, 822 (1st Cir. 1991). The burden is on the moving party to show, through the pleadings, discovery and affidavits, “that there is no genuine dispute as to any material fact and that the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). A fact is material if it “might affect the outcome of the suit under the governing law.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A genuine issue of material fact exists where the evidence with respect to the material fact in dispute “is such that a reasonable jury could return a verdict for the nonmoving party.” Id.

         If the moving party has satisfied its burden, the burden shifts to the non-moving party to set forth specific facts showing that there is a genuine, triable issue. Celotex Corp.v.Catrett, 477 U.S. 317, 324 (1986). The Court must view the entire record in the light most favorable to the non-moving party and indulge all reasonable inferences in that party's favor. O'Connorv.Steeves, 994 F.2d 905, 907 (1st Cir. 1993). Summary judgment is appropriate if, after viewing the record in the non-moving party's favor, the Court ...


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