315 F.R.D. 116
D. Mass.2016Background
- Forest Laboratories marketed SSRI antidepressants Celexa and Lexapro and sought pediatric MDD indications; FDA required positive placebo-controlled trials for approval.
- Forest ran four pediatric double-blind, placebo-controlled studies: two for Celexa (one positive, one negative) and two for Lexapro (one negative, one arguably positive); FDA approved Lexapro for adolescents in 2009 but never approved Celexa for pediatric use.
- Painters and Allied Trades Dist. Council 82 Health Care Fund (a third-party payor) sued Forest under RICO and Minnesota consumer-protection statutes, alleging Forest fraudulently promoted off-label pediatric use and caused payors to reimburse ineffective prescriptions.
- Painters sought certification of nationwide RICO classes (Celexa and Lexapro) and two Minnesota statutory subclasses; class certification motion was heard after extended MDL-related proceedings.
- The court found Rule 23(a) numerosity, commonality, typicality, and adequacy satisfied but denied certification under Rule 23(b)(3), concluding common proof would not predominate on but-for causation, injury, damages, and statute-of-limitations issues; superiority also failed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Predominance of proximate causation for RICO | Forest’s marketing targeted physicians intending TPPs would pay; class-wide evidence shows directness and foreseeability | Reliance and physician-specific prescribing decisions require individualized proof that defeat predominance | Proximate causation can be shown with class-wide proof (Bridge/Neurontin line); proximate causation predominance satisfied |
| Predominance of but‑for causation | Aggregate regression (Rosenthal) linking total promotion to total sales shows increased prescriptions due to fraud; expert model suffices class-wide | Regression improperly uses total promotions/total sales as a proxy for fraudulent promotion/off‑label sales; model fundamentally flawed | Rosenthal’s proxy assumption is unjustified and fundamentally flawed; but-for causation does not meet predominance |
| Class-wide proof of injury and damages | TPPs suffered economic injury paying for additional, ineffective pediatric prescriptions; aggregate evidence of inefficacy supports class-wide injury and damages model | FDA findings and clinical trial mix require patient-specific efficacy assessments; damages depend on individualized proof | Clinical evidence is equivocal; efficacy and injury likely require individualized medical determinations, so injury and damages fail predominance |
| Statute of limitations and superiority | Class action is necessary and efficient; many TPPs could not economically litigate individually | Each TPP’s notice (and accrual) depends on its PBM and information access, producing individualized limitations inquiries; many TPPs have resources to sue individually | Limitations questions would predominate for many members; class action is not the superior method; subclasses also not certified |
Key Cases Cited
- Bridge v. Phoenix Bond & Indem. Co., 553 U.S. 639 (2008) (first-party reliance not required for proximate cause in mail‑fraud‑based RICO claims)
- Neurontin decisions: In re Neurontin Mktg. & Sales Practices Litig., 712 F.3d 21 (1st Cir. 2013) (addressing proximate and but‑for causation analyses in pharmaceutical‑marketing RICO suits)
- In re Neurontin Mktg. & Sales Practices Litig., 712 F.3d 51 (1st Cir. 2013) (evaluating aggregate econometric proof of causation)
- In re Neurontin Mktg. & Sales Practices Litig., 712 F.3d 60 (1st Cir. 2013) (discussing evidentiary and causation issues relevant to class certification)
- Wal‑Mart Stores, Inc. v. Dukes, 564 U.S. 338 (2011) (commonality requires a classwide contention that can resolve central issues in one stroke)
- Amchem Prods., Inc. v. Windsor, 521 U.S. 591 (1997) (predominance inquiry assesses whether class adjudication is sufficiently cohesive)
- Tyson Foods, Inc. v. Bouaphakeo, 136 S. Ct. 1036 (2016) (permitting representative statistical evidence for class liability when individual plaintiffs could rely on that evidence in individual actions)
- Holmes v. Securities Investor Protection Corp., 503 U.S. 258 (1992) (RICO proximate cause requires directness between misconduct and injury)
- Rotella v. Wood, 528 U.S. 549 (2000) (RICO statute of limitations runs from discovery of injury)