65 F.Supp.3d 283
D. Mass.2014Background
- Forest Laboratories marketed Celexa and Lexapro (SSRIs) and sought pediatric MDD indications; FDA typically requires two positive placebo-controlled trials for approval.
- Clinical trials: one Celexa study (MD-18) and one Lexapro study (Study 32) were positive; the Lundbeck Celexa study and Lexapro Study 15 were negative. FDA denied a pediatric Celexa indication in 2002; in 2005 labels were revised to disclose negative pediatric data; Lexapro received an adolescent indication in 2009 based on combined data.
- The DOJ unsealed a qui tam complaint in 2009 alleging off-label pediatric promotion and concealment of the Lundbeck Study; multiple putative class actions followed, including a March 2009 national RICO suit and the Jaeckel consumer class action.
- Two TPP plaintiffs sued Forest in the MDL: Painters (filed 2013 FAC asserting RICO and Minnesota consumer claims) and Allied Services/NM UFCW (filed 2014 asserting RICO, state consumer statutes, and unjust enrichment).
- Forest moved to dismiss both complaints for, inter alia, statute-of-limitations defects and failure to plead RICO and state-law elements; the court held hearings and resolved the motions by opinion dated December 12, 2014.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Accrual and SOL for RICO | Injury is payment caused by fraud; discovery in 2013; timely. | Injury was payment for ineffective drugs and was discoverable by 2005 (label changes, press). | SOL did not accrue later than March 2009 (when national RICO suit was filed); Painters’ RICO claims saved by tolling from the March 2009 RICO filing. |
| American Pipe tolling for non-identical claims | Earlier class filings (Jaeckel and others) tolled SOL for subsequent RICO claims. | Tolling applies only where earlier complaint asserted identical claims. | Jaeckel (consumer suit) did not toll RICO claims; March 2009 RICO complaint did toll Painters’ RICO claims despite later voluntary dismissal. |
| Sufficiency of RICO pleading (standing, enterprise, predicates) | Alleged payments for ineffective drugs, enterprise of Forest/subsidiaries/academics, predicate mail/wire fraud tied to off-label promotion. | Lack of injury proof, no common purpose among alleged associates, predicates not pleaded with Rule 9(b) particularity. | FAC adequately pleaded injury/standing, an association-in-fact (for now), and predicate mail/wire fraud (incorporating plea/information), so RICO claims survive dismissal. |
| State consumer-law and unjust enrichment claims (Painters and Allied Services/NM UFCW) | Plaintiffs allege deceptive promotion caused payments; seek damages. | Many state claims are time-barred or improperly pleaded; some remedies limited (e.g., MDTPA injunctive relief only). | Painters’ Minnesota claims (MCFA, MUTPA) survive for payments within six-year window; MDTPA count dismissed (statute allows injunctive relief only). Allied Services/NM UFCW state claims dismissed as time-barred or otherwise deficient; extra-state consumer claims dismissed. |
Key Cases Cited
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (standards for plausibility on a motion to dismiss)
- Ashcroft v. Iqbal, 556 U.S. 662 (pleading standards; courts need not accept legal conclusions)
- Rotella v. Wood, 528 U.S. 549 (RICO accrual: discovery of injury starts SOL)
- Sedima, S.P.R.L. v. Imrex Co., 473 U.S. 479 (elements of a §1962(c) RICO claim)
- Boyle v. United States, 556 U.S. 938 (definition and requirements for association-in-fact enterprise)
- H.J., Inc. v. Northwestern Bell Tel. Co., 492 U.S. 229 (pattern of racketeering requirement)
- American Pipe & Constr. Co. v. Utah, 414 U.S. 538 (class-action filing tolls SOL for putative class members)
- Crown, Cork & Seal Co. v. Parker, 462 U.S. 345 (American Pipe tolling extends to putative class members)
- In re Lupron Mktg. & Sales Practices Litig., 295 F. Supp. 2d 148 (statute-of-limitations typically a jury question)
- In re Neurontin Mktg. & Sales Practices Litig., 712 F.3d 21 (First Circuit discussion of American Pipe tolling and related pleading issues)