421 F.Supp.3d 12
E.D. Pa.2019Background
- Plaintiffs (Direct Purchasers and End Payors) allege Reckitt engaged in a "product hop" hard-switch: introducing Suboxone film, disparaging and withdrawing Suboxone tablets, and delaying generic entry to maintain monopoly power and inflate prices.
- Reckitt launched Suboxone film (NDA approved 2010) with three years exclusivity and later patents; tablets relied on expired orphan exclusivity and faced impending generic ANDAs.
- Plaintiffs allege Reckitt: (1) ran a misleading safety campaign against tablets; (2) manipulated the SSRS/REMS process to delay generics; (3) filed a sham Citizen Petition timed to block ANDA approvals; and (4) withdrew tablets shortly before generics launched.
- Alleged effects: suppression/delay of AB-rated generic substitution, national conversion of prescriptions to film, and overpayment by class members.
- Procedural posture: court considered a Daubert challenge to plaintiffs’ damages expert (Dr. Russell Lamb) and motions for class certification by DPPs (Rule 23(b)(3)) and EPPs (Rule 23(b)(2) and 23(c)(4)). The court denied the Daubert motion, certified the DPP class under 23(b)(3), denied EPP 23(b)(2) injunctive class, and certified an EPP issues class under 23(c)(4).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of Dr. Lamb's expert opinions | Lamb's methodology reliably measures class-wide antitrust impact and aggregate damages using transaction data, analogs, and but-for scenarios. | Reckitt contends Lamb's methods are unreliable: improperly include lawful pricing effects, misuse chargebacks, fail to link hard-switch to but-for shares, employ arbitrary analogs, and ignore generic bypass. | Court denied Daubert challenge: methodology admissible; disputes go to weight, not admissibility. |
| DPP class certification under Rule 23(b)(3) (predominance, superiority) | Common proof exists for liability, impact (overcharges), and aggregate damages; Dr. Lamb provides a reliable classwide damages model. | Reckitt argues individualized issues (clinics vs wholesalers, varied purchasing behaviors, causation, and pricing legality) defeat predominance and damages can’t be classwide. | Court certified DPP class: Rule 23(a) met; common issues predominate; superiority satisfied. |
| EPP injunctive class under Rule 23(b)(2) | EPPs seek injunctive relief (e.g., corrective disclosures) to remedy ongoing effects of Reckitt’s misinformation campaign. | Reckitt argues no ongoing systemic misconduct or concrete future harm; corrective relief would not benefit all class members and is speculative. | Court declined to certify a 23(b)(2) injunctive class: EPPs failed to show a continuing or imminent injury remediable by a single injunction for all. |
| EPP issues class under Rule 23(c)(4) (liability issues only) | EPPs seek class certification for common liability issues (anticompetitive/deceptive conduct, intent, procompetitive justification) reserving impact/damages for individual proceedings. | Reckitt contends liability cannot be separated from impact; issues are not administratively ascertainable or cohesive; state-law variations and individual reliance undermine efficiencies. | Court certified a 23(c)(4) issues class for the enumerated liability questions: class is ascertainable and cohesive; common proof of defendant conduct will materially advance litigation. |
Key Cases Cited
- Daubert v. Merrell Dow Pharms., 509 U.S. 579 (expert admissibility gatekeeping standard)
- Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338 (class-certification requires rigorous analysis of commonality)
- Comcast Corp. v. Behrend, 569 U.S. 27 (damages model must be consistent with the liability theory for class certification)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (Daubert gatekeeping applies to all expert testimony)
- LePage’s Inc. v. 3M, 324 F.3d 141 (in monopolization cases court evaluates defendant’s exclusionary conduct in totality; disaggregation of damages may be unnecessary)
- In re Blood Reagents Antitrust Litig., 783 F.3d 183 (3d Cir.) (expert testimony relied upon at certification must satisfy Daubert)
- In re Hydrogen Peroxide Antitrust Litig., 552 F.3d 305 (3d Cir.) (plaintiff must show antitrust impact is capable of proof by common evidence at certification)