Painters & Allied Trades Dist. Council 82 Health Care Fund v. Forest Labs., Inc. (In re Celexa & Lexapro Mktg. & Sales Practices Litig.)

289 F. Supp. 3d 247
District Court, District of Columbia·Decided January 26, 2018·No. MDL No. 09–02067–NMG; Civil Action No. 13–13113–NMG; Civil Action No. 14–13848–NMG·Published·Cited by 2 cases

Opinion

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

*250The 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.

*251Kiossovoski 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

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Painters & Allied Trades Dist. Council 82 Health Care Fund v. Forest Labs., Inc. (In re Celexa & Lexapro Mktg. & Sales Practices Litig.), 289 F. Supp. 3d 247 (D.D.C. 2018).

289 F. Supp. 3d 247 (Painters & Allied Trades Dist. Council 82 Health Care Fund v. Forest Labs., Inc. (In re Celexa & Lexapro Mktg. & Sales Practices Litig.)) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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