In Re Flonase Antitrust Litigation
798 F. Supp. 2d 619
E.D. Pa.2011Background
- Flonase is a GSK nasal spray containing fluticasone propionate; Roxane, a generic competitor, challenges GSK's alleged anticompetitive conduct delaying Roxane's entry.
- Three coordinated lawsuits allege antitrust violations by GSK: direct purchasers (American Sales Co.), indirect purchasers (IBEW-NECA), and Roxane as a generic manufacturer (Roxane Labs.).
- GSK moved for summary judgment under Fed. R. Civ. P. 56 on causation, arguing Roxane would have delayed entry regardless due to FDA deficiencies and API sourcing.
- The FDA's ANDA approval process under Hatch-Waxman involves BE and chemistry (CMC) reviews; deficiency notices can delay approval for substantial issues.
- GSK petitions in 2004 allegedly influenced FDA reviews and a USP monograph that raised the bar for Roxane's FP API, affecting timing of approval.
- Roxane ultimately received FDA approval for its ANDA in February 2006, after technical deficiencies and USP-related issues were resolved.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether GSK's conduct proximately caused Roxane's delay | Roxane argues GSK's petitions foreseeably delayed FDA reviews and forced defects. | GSK contends intervening FDA actions and independent factors caused delay. | Genuine facts remain; causation not decided as matter of law. |
| Whether BE deficiency was proximately caused by GSK petitions | BE Deficiency arose from threat of litigation tied to GSK petitions. | Deficiency stemmed from FDA's standard BE methodology changes, not petitions. | Issues of proximate cause for BE deficiency must go to jury. |
| Whether Impurity deficiency was proximately caused by GSK petitions | FDA revisited chemistry due to litigation threats from GSK petitions. | Impurity concerns were standard post-2005 USP monograph adjustments. | Jury question on proximate cause remains. |
| Whether USP deficiency was proximately caused by GSK petitions | GSK pressured USP to adopt heightened standards affecting Roxane's approval path. | USP monograph changes and FDA adoption were independent actions. | Causation issues for USP deficiency are for the jury. |
| Whether Roxane's decision not to purchase USP-compliant FP severed the chain of causation | Roxane waited due to uncertainty from pending petitions, linking to GSK conduct. | Roxane's business choice could be an independent intervening cause. | Fact question; cannot resolve as law at summary judgment. |
Key Cases Cited
- In re Hydrogen Peroxide Antitrust Litig., 552 F.3d 305 (3d Cir.2008) (causation and proximate cause for antitrust damages)
- Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U.S. 100 (S. Ct. 1969) (proximate cause in antitrust context)
- In re Wellbutrin SR/Zyban Antitrust Litig., 281 F. Supp. 2d 751 (E.D. Pa. 2003) (intervening cause and foreseeability in causation)
- Allegheny Gen. Hosp. v. Philip Morris, Inc., 228 F.3d 429 (3d Cir.2000) (antitrust proximate causation and foreseeability)
- Callahan v. A.E.V., Inc., 182 F.3d 237 (3d Cir.1999) (causation as issue of fact in antitrust cases)
- Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574 (S. Ct. 1986) (standard for summary judgment and ultimate outcome)
- 2660 Woodley Rd. Joint Venture v. ITT Sheraton Corp., 369 F.3d 732 (3d Cir.2004) (proximate cause and foreseeability in antitrust context)
- Rivas v. City of Passaic, 365 F.3d 181 (3d Cir.2004) (proximate causation; jury issues in municipal liability)
- McCullough v. Zimmer, 382 F. App’x 225 (3d Cir.2010) (rejects pure but-for causation in antitrust claims)