IN RE NAMENDA INDIRECT PURCHASER ANTITRUST LITIGATION, 1:15-cv-06549

Background

Namenda (IR and XR) are Forest/Actavis brand memantine products; IR and XR had different patents/timelines and XR was not AB-rated equivalent to IR.
Multiple generic manufacturers filed Paragraph IV ANDAs; Forest entered reverse-payment settlements that delayed generic IR market entry until July 2015.
Forest launched Namenda XR (2013) and later announced discontinuation of IR (Feb 2014) —the alleged "hard switch"—which plaintiffs say forced patients onto XR and insulated XR from generic substitution.
SBA (a third-party payor) sued on behalf of TPPs under various state antitrust and consumer-protection laws alleging two theories: pay-for-delay (reverse settlements) and hard switch; it sought class certification for TPPs reimbursing Namenda from June 1, 2012–Dec 31, 2017.
Experts for plaintiffs (Drs. Lamb and Vogt) provided market-impact and damages models estimating earlier but‑for generic entry and classwide overcharges; defendants challenged those models and moved to exclude Vogt under Daubert.
The court denied Daubert exclusion of Vogt, found Rule 23(a)/(b) largely satisfied for the pay‑for‑delay theory, certified a TPP class limited to that theory, and denied certification as to the hard‑switch theory (no subclass certified).

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Admissibility of Dr. Vogt’s damages/but‑for entry model	Vogt used standard bargaining and benchmark pricing models to estimate an earlier but‑for generic entry and classwide overcharges.	Defendants say Vogt misapplied inputs and assumptions so his opinions are unreliable.	Denied Daubert challenge; model deemed sufficiently reliable for class‑certification stage (cross‑examination allowed).
Predominance & damages for pay‑for‑delay theory	Common proof (market prices, settlements, NPA/IQVIA data) and Vogt/Lamb models show classwide injury and aggregate damages tied to the pay‑for‑delay theory.	Defendants point to rebates, Medicare cost‑sharing, brand loyalists, and PBM arrangements to argue individualized inquiries will predominate.	Predominance satisfied for pay‑for‑delay: common issues and Vogt’s damages model adequately tie damages to the liability theory; class certified for that theory.
Predominance for hard‑switch theory	Lamb contends the hard‑switch announcement materially shifted patients to XR, reducing IR base and harming TPPs reimbursing XR.	Defendants show most TPPs never reimbursed XR or reimbursed XR for patients who would have switched regardless; individualized inquiries would be required to identify injured TPPs.	Predominance not satisfied for hard‑switch across the proposed class; class (or any XR subclass) not certified under that theory.
Multi‑state claims, ascertainability, and superiority	SBA: state antitrust/consumer statutes are substantially similar or harmonized with federal/FTC standards; class membership can be identified from PBM/PBM data; class action is superior.	Defendants: variations in state law, statutes of limitations, arbitration clauses, and administrative feasibility defeat predominance/ascertainability/superiority.	Court: ascertainability met; state‑law variations do not predominate or defeat superiority; arbitration and limitations concerns not shown to be widespread obstacles.

Key Cases Cited

FTC v. Actavis, Inc., 570 U.S. 136 (2013) (reverse‑payment settlements subject to antitrust scrutiny)
Comcast Corp. v. Behrend, 569 U.S. 27 (2013) (damages model at certification must measure damages tied to the specific theory of liability)
Wal‑Mart Stores, Inc. v. Dukes, 564 U.S. 338 (2011) (commonality requirement for class certification)
Amchem Prods., Inc. v. Windsor, 521 U.S. 591 (1997) (predominance and manageability in Rule 23(b)(3) analysis)
In re Petrobras Secs., 862 F.3d 250 (2d Cir. 2017) (ascertainability requirement and objective class boundaries)
Sykes v. Mel S. Harris & Assocs., 780 F.3d 70 (2d Cir. 2015) (Rule 23 prerequisites in class certification context)