In Re Schering Plough Corp. Intron/Temodar Consumer Class Action
678 F.3d 235
| 3rd Cir. | 2012Background
- Two putative nationwide classes sue Schering for off-label marketing and seek RICO and related state claims.
- Plaintiffs include third-party payors (Local 331 et al.) and patient-consumers led by Angela Montgomery.
- District Court dismissed for lack of standing and failure to plead causation between marketing and off-label prescribing.
- Schering allegedly promoted off-label uses and paid physicians via schemes and inducements; FDA labeling restrictions and FDCA framework are central.
- Montgomery alleges her physician prescribed off-label Rebetol/PEG-Intron therapy due to Schering marketing, causing her harm and costs.
- This court reviews standing de novo and requires Article III injury, traceability, and redressability for both Article III and RICO standing.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Local 331 has Article III standing | Local 331 asserts injury from off-label purchases traceable to Schering's conduct. | Schering contends no direct, personal injury or causation tying Local 331's payments to misconduct. | Local 331 lacks injury-in-fact traceable to Schering; dismissed. |
| Whether Montgomery has Article III standing | MAC ties Montgomery's injury to Dr. Willis's off-label prescription influenced by Schering. | Montgomery failed to allege a non-conclusory causal nexus between marketing and her prescription. | Montgomery lacks standing; district court's dismissal affirmed. |
| Whether the district court properly required a plausible nexus between alleged misconduct and injury | Plaintiffs argue substantial corroborating materials should support a causal link. | Court properly required non-conclusory facts showing causation; incorporated materials do not cure pleading gaps. | Plausible nexus not shown; standing lacking. |
| Whether the claims satisfy the RICO standing requirements (injury to business or property and proximate causation) | TPP asserted injury from payments for off-label prescriptions due to illicit marketing. | Injury not adequately pled as fairly traceable to the alleged racketeering conduct. | RICO standing not established; dismissal affirmed. |
| Whether the court should consider incorporated external documents for standing | Montgomery argues incorporated qui tam, settlement, and criminal materials bolster standing. | Court may not rely on endless external incorporations to establish standing; need direct injury linkage. | External documents cannot create standing; insufficient nexus found. |
Key Cases Cited
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (injury-in-fact requires concrete, particularized, actual or imminent injury)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (plausibility pleading standard for claims)
- Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009) (multipart test to assess pleadings for plausibility)
- Maio v. Aetna, Inc., 221 F.3d 472 (3d Cir. 2000) (two-threshold standing requirements for RICO)
- West Penn Allegheny Health Sys., Inc. v. UPMC, 627 F.3d 85 (3d Cir. 2010) (plausibility of injury-to-claim linkage in standing analysis)
- Morse v. Lower Merion Sch. Dist., 132 F.3d 902 (3d Cir. 1997) (court need not credit bald assertions in pleadings)
- Allen v. Wright, 468 U.S. 737 (1984) (standing requires injury, causation, and redressability)
- Cetel v. Kirwan Fin. Grp., Inc., 460 F.3d 494 (3d Cir. 2006) (consistency between federal and state RICO statutes)