Painters & Allied Trades District Council 82 Health Care Fund v. Forest Laboratories, Inc.

65 F. Supp. 3d 283
CourtDistrict Court, D. Massachusetts
DecidedDecember 12, 2014
DocketMDL No. 09-2067-NMG; Civil Action Nos. 13-13113-NMG, 14-10784-NMG
StatusPublished
Cited by6 cases

This text of 65 F. Supp. 3d 283 (Painters & Allied Trades District Council 82 Health Care Fund v. Forest Laboratories, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Painters & Allied Trades District Council 82 Health Care Fund v. Forest Laboratories, Inc., 65 F. Supp. 3d 283 (D. Mass. 2014).

Opinion

MEMORANDUM & ORDER

GORTON, 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.

[287]*287A. 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 Lexa-pro 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 (“Lund-beck 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 Lexa-pro, 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 UFCW Union’s and Employers’ Health [288]*288and Welfare Trust Fund v. Forest Labs, Inc., No. 09-cv-11524-NMG (filed Mar. 13, 2009) (“March, 2009 RICO complaint”), which alleged causes of action under civil RICO and various state consumer protection statutes on behalf of a putative class of TPPs and 2) Jaeckel, et al. v. Forest Pharm., Inc., et al., No. 09-cv-11518-NMG (filed Mar. 20, 2009) (“Jaeckel complaint”), which asserted consumer claims for fraudulent concealment and misrepresentation, among others.

D. Procedural history
1. Painters action

In November, 2013, plaintiff Painters filed a complaint on behalf of a putative nationwide TPP class. 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 a class of TPPs and consumers.

2. Allied Services/NM UFCW action

NM UFCW filed a complaint in this MDL in March, 2009, asserting RICO, consumer fraud and unjust enrichment claims on behalf of a nationwide class of TPPs. Allied Services joined as a plaintiff later that month. Allied Services/NM UFCW voluntarily dismissed the complaint in June, 2010.

In March, 2014, Allied Services/NM UFCW filed a new complaint on behalf of a putative nationwide class for alleged claims for violations of RICO (Counts I and II), Illinois and New Mexico consumer protection statutes (Counts III and IV), the consumer fraud laws of 46 other states (Count V) and unjust enrichment (Count VI).

Defendants moved to dismiss both actions in April, 2014. After extensive briefing was completed in each case, the Court held a joint hearing on the motions to dismiss in October, 2014.

II. Defendants’ motions to dismiss Painters’ first amended complaint

Plaintiff Painters alleges that defendants misrepresented and concealed material information about the efficacy of Lexa-pro in treating major depressive disorder (“MDD”) in pediatric patients.

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65 F. Supp. 3d 283, Counsel Stack Legal Research, https://law.counselstack.com/opinion/painters-allied-trades-district-council-82-health-care-fund-v-forest-mad-2014.