289 F. Supp. 3d 247
D.D.C.2018Background
- Plaintiffs (two consumer plaintiffs and Painters, a third-party payor) sued Forest Laboratories over marketing of SSRIs Celexa and Lexapro, alleging RICO, unjust enrichment, and state consumer-protection claims based on alleged fraudulent promotion of pediatric use.
- Forest had FDA approval for adult use; Lexapro was later approved for adolescent MDD based on two positive trials (MD-18 and MD-32); Celexa was not approved for pediatric MDD after one positive and one negative Celexa study.
- Plaintiffs rely on a theory that Forest corrupted or misreported clinical trials (challenging MD-18 and MD-32) and that TPPs and consumers paid for ineffective, fraudulently promoted prescriptions.
- Painters reimbursed pediatric prescriptions for Celexa and Lexapro for a limited number of beneficiaries; individual medical records and testimony for those insureds were not produced.
- Procedurally: multiple related actions consolidated in MDL. Court considered summary judgment motions by Forest and a partial summary judgment motion by Painters; class-certification efforts were denied or stayed in related rulings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| RICO standing / injury (Painters, Ramirez) | Money paid for prescriptions due to fraudulent promotion is a RICO injury; need not prove individual inefficacy if general trials show inefficacy | Plaintiffs must show injury to business or property by proving drug inefficacy for insureds or individuals; no evidence of inefficacy presented | Held for Forest: Painters and Ramirez lack RICO injury — summary judgment for Forest because plaintiffs failed to show general or individual inefficacy |
| RICO causation (Kiossovski) — but-for & proximate | Off-label promotion foreseeably led to prescription; direct reliance unnecessary; doctor could have been exposed | No evidence Dr. Barnett saw off-label promotion; hospital barred reps; mere possibility is insufficient for but-for causation | Held for Forest: no but-for causation; proximate causation disputed but but-for failure is dispositive — summary judgment for Forest as to Kiossovski |
| Washington Consumer Protection Act (Kiossovski) | WCPA claims rest on same misconduct as RICO; injured by purchase of ineffective drug | Causation and injury lacking for same reasons as RICO | Held for Forest: dismissed (claims rise and fall with RICO) |
| Minnesota consumer statutes (Painters) | Painters injured by paying for ineffective prescriptions; public interest supports claim | Painters failed to show product defect or ineffective treatment for any insured; no causal link | Held for Forest: summary judgment for Forest — Painters failed to show injury/causation |
Key Cases Cited
- Sedima, S.P.R.L. v. Imrex Co., 473 U.S. 479 (RICO requires injury to business or property)
- Holmes v. Securities Investor Protection Corp., 503 U.S. 258 (proximate causation in RICO; limiting judicial tool)
- Bridge v. Phoenix Bond & Indemnity Co., 553 U.S. 639 (direct reliance not required for private RICO claims predicated on mail or wire fraud)
- In re Neurontin Marketing & Sales Practices Litigation, 712 F.3d 21 (1st Cir.) (clinical-trial evidence of inefficacy can establish RICO injury)
- Marcus v. Forest Laboratories, 779 F.3d 34 (1st Cir.) (deference to FDA as judge of safety and efficacy absent new information)
- Maio v. Aetna, Inc., 221 F.3d 472 (3d Cir.) (no RICO recovery where health care was not shown to be compromised)
- UFCW Local 1776 v. Eli Lilly & Co., 620 F.3d 121 (2d Cir.) (TPP formulary decisions can undercut quantity-effect theories of injury)