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309 F.R.D. 107
D. Mass.
2015
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Background

  • Plaintiffs (classes of Direct Purchasers, End-Payors, and several retailers) sued AstraZeneca, Ranbaxy, Teva, and DRL alleging antitrust harm from reverse-payment settlements (pay-for-delay) involving Nexium (esomeprazole). DRL and Teva settled before trial; trial focused on AstraZeneca and Ranbaxy.
  • Central legal theory: AstraZeneca’s settlement with Ranbaxy included a no-authorized-generic (no‑AG) provision that functioned as a large non‑cash reverse payment, allegedly delaying generic entry and injuring competition and purchasers.
  • Pretrial summary-judgment practice: the court initially granted partial rulings, finding insufficient causation for Ranbaxy at summary judgment but permitting a rule-of-reason Actavis-based theory to go to jury focused on whether Ranbaxy’s exclusivity and conduct caused the alleged overcharges via a Teva partnership (the court constrained plaintiffs to that causation theory at trial).
  • At trial a jury found (1) AstraZeneca had market power, (2) the AstraZeneca‑Ranbaxy settlement involved a large unjustified payment, and (3) the settlement was unreasonably anticompetitive, but (4) the jury answered that plaintiffs did not prove the required causal “but‑for” entry (i.e., Ranbaxy would not have enabled earlier generic entry before May 27, 2014). Judgment entered for defendants.
  • Plaintiffs moved for a new trial (arguing newly relevant post‑trial FDA actions—Ranbaxy’s forfeiture of 180‑day exclusivity and Teva’s subsequent approval/launch—show a different causation theory) and sought a permanent injunction under Section 16; the court denied the new trial and denied injunctive relief as moot/no liability.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
New trial based on post‑trial FDA events / newly discovered evidence FDA’s later rescission of tentative approval and forfeiture of Ranbaxy’s exclusivity (and Teva’s approval/launch) constitute newly discovered, material evidence showing involuntary forfeiture causation that would likely change the verdict Events occurred after trial; plaintiffs could not have relied on them at trial; post‑trial developments do not show facts existing at trial or prove earlier causation Denied — post‑trial FDA actions are not newly discovered evidence that would have probably changed the verdict; the proffered chain of inference is speculative and impermissibly relies on inference‑upon‑inference
Causation theory constrained at trial (but‑for entry via Ranbaxy‑Teva partnership) Plaintiffs contend the court improperly limited them to one causation theory and prevented consideration of involuntary forfeiture theory later borne out by FDA action Defendants contend plaintiffs had notice and opportunity and were limited by the trial record and pretrial rulings; jury rejected plaintiffs’ sole proffered causation theory Court held limitation appropriate given record; jury found lack of causation under the permitted theory; later FDA action does not retroactively establish causation at the earlier time
Permanent injunction under Section 16 based on jury answers to Questions 1–3 Plaintiffs argue jury’s finding that the settlement was anticompetitive satisfies §16 standing and merits injunctive relief (including banning no‑AG clauses) Defendants argue no antitrust liability was established because plaintiffs failed to prove causation (Question 4), and the no‑AG clause is effectively unenforceable after Ranbaxy lost exclusivity Denied — court held plaintiffs failed to establish the necessary causal link for private §16 relief; injunctive request as to the AstraZeneca‑Ranbaxy no‑AG clause is moot after FDA forfeiture
Use of post‑May‑27,‑2014 evidence and judicial estoppel Plaintiffs rely on post‑May‑27 developments as relevant new evidence; defendants argue plaintiffs are estopped because they previously sought to bar post‑May‑27 evidence Defendants point to plaintiffs’ earlier in‑limine position and reliance on the May 27 cut‑off; plaintiffs respond they did not succeed in precluding post‑May‑27 evidence and that developments changed the record Court rejected judicial estoppel: plaintiffs’ in‑limine motion was denied without prejudice; later evidence did not create an estoppel and was considered but found immaterial to warrant a new trial

Key Cases Cited

  • McDonough Power Equip., Inc. v. Greenwood, 464 U.S. 548 (Sup. Ct. 1984) (litigant entitled to a fair, not a perfect, trial)
  • Federal Trade Comm’n v. Actavis, Inc., 570 U.S. 136 (Sup. Ct. 2013) (rule‑of‑reason analysis applies to reverse‑payment settlements)
  • Atl. Richfield Co. v. USA Petroleum Co., 495 U.S. 328 (Sup. Ct. 1990) (private antitrust plaintiff must prove antitrust injury)
  • Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U.S. 100 (Sup. Ct. 1969) (causation: illegality must be a material cause of the injury)
  • New Hampshire v. Maine, 532 U.S. 742 (Sup. Ct. 2001) (doctrine of judicial estoppel)
  • Sullivan v. Nat’l Football League, 34 F.3d 1091 (1st Cir. 1994) (elements and causation requirement for Section 1 Sherman Act claim)
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Case Details

Case Name: In re Nexium (Esomeprazole) Antitrust Litigation
Court Name: District Court, D. Massachusetts
Date Published: Jul 30, 2015
Citations: 309 F.R.D. 107; 2015 WL 4720033; 2015 U.S. Dist. LEXIS 99679; CIVIL ACTION NO. 12-md-02409-WGY
Docket Number: CIVIL ACTION NO. 12-md-02409-WGY
Court Abbreviation: D. Mass.
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    In re Nexium (Esomeprazole) Antitrust Litigation, 309 F.R.D. 107