Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

In re Namenda Direct Purchaser Antitrust Litigation

United States District Court, S.D. New York

July 20, 2017

IN RE NAMENDA DIRECT PURCHASER ANTITRUST LITIGATION

          REPORT AND RECOMMENDATION

          HON. COLLEEN McMAHON, Chief Judge

         This is a putative class action asserting violations of antitrust law by defendants Forest Laboratories, LLC, Forest Laboratories, Inc., and Forest Laboratories Holdings Ltd. (together, "Forest") and Actavis pic (now known as Allergan pic) in connection with the patented Alzheimer's drugs Namenda IR and Namenda XR (brand names for memantine hydrochloride). Before me are two motions arguing that two of the Direct Purchaser Plaintiffs' experts labor under conflicts of interest and must therefore be disqualified. Forest seeks to disqualify Dr. Lon Schneider, a physician who assertedly advised Forest on its development of Alzheimer's drugs. Teva Pharmaceuticals USA, Inc. ("Teva"), which is not a party to this litigation but is a defendant in related litigation regarding the same Alzheimer's drugs at issue here, [1] seeks to disqualify Deborah Jaskot, a former Teva employee whom the plaintiffs have retained as an expert on regulatory issues in the pharmaceutical industry. I recommend denying both the defendants' motion and Teva's motion.[2]

         Background

         The plaintiffs in this action and the related litigation allege that Forest and several generic drug companies, including Teva, entered into collusive settlements of patent litigation involving Namenda in order to restrict access to the drug. As noted in an earlier opinion, in 2007 a number of generic manufacturers filed Abbreviated New Drug Applications (“ANDAs”) with the FDA for generic versions of Namenda IR in which they contended, among other things, that the Namenda patent was invalid. In re Namenda Direct Purchaser Antitrust Litigation, No. 15 Civ. 7488, 2017 WL 2226591, at *2 (S.D.N.Y. May 19, 2017). Forest later filed infringement suits against these generic manufacturers, who again argued patent invalidity. Id. Forest settled these cases, paying the generic manufacturers a cash payment and entering license agreements that allowed generic versions of Namenda IR to enter the market on a date before Namenda IR's patent expired, but “well after” the generic version of the drug could have been sold “if Forest's patent was found to be invalid.” Id. (quoting Sergeants Benevolent Association v. Actavis, Nos. 15 Civ. 6549, 15 Civ. 7488, 2016 WL 4992690, at *5 (S.D.N.Y. Sept. 13, 2016)). The Supreme Court has held that settlements like this can be anticompetitive where a so-called “reverse payment” is “large and unjustified, ” FTC v. Actavis, Inc., __ U.S. __,, 133 S.Ct. 2223, 2237 (2013), such as when the patent holder had a strong defense against claims of invalidity, see, e.g., In re Namenda, 2017 WL 2226591, at *2.

         In a related stratagem, Forest allegedly violated the Sherman Act by “attempt[ing] to force patients and physicians to switch from Namenda IR . . . to Namenda XR . . . ‘by effectively removing Namenda IR from the market before its patent exclusivity period expired and a generic substitute to the Namenda drugs became available.'” In re Namenda Direct Purchaser Antitrust Litigation, No. 15 Civ. 7488, 2017 WL 2693713, at *1 (S.D.N.Y. June 21, 2017) (quoting Sergeants Benevolent Association, 2016 WL 4992690, at *1); see generally New York v. Activis, PLC, No. 14 Civ. 7473, 2014 WL 7015198 (S.D.N.Y. Dec. 11, 2014). They accomplished this “hard switch” by introducing and promoting Namenda XR and announcing that Namenda IR would not be available after fall 2014. In re Namenda, 2017 WL 2693713, at *1.

         Here, Forest argues that Dr. Schneider must be disqualified because he received confidential information from the company when he “consulted for Forest in various capacities since at least 2003 on a variety of issues directly related to Forest's research, development, and approval of Namenda and Alzheimer's treatments.” (Memorandum in Support of Defendants' Motion to Disqualify Dr. Lon Schneider (“Def. Memo.”) at 2). Teva argues that Ms. Jaskot must be disqualified because she was privy to Teva's confidential information as a result of her twenty-three year tenure at that company, which included eight years as Vice President of U.S. Generic Regulatory Affairs. (Memorandum of Law in Support of Non-Party Teva USA's Motion to Disqualify Direct Purchaser Plaintiffs' Proposed Expert Deborah Jaskot (“Teva Memo.”) at 6).

         Analysis

         A. Legal Standard

         A federal court's power to disqualify an expert witness derives from its “duty to protect the integrity of the legal process.” Grioli v. Delta International Machinery Corp., 395 F.Supp.2d 11, 13 (E.D.N.Y. 2005) (quoting In re Ambassador Group, Inc., Litigation, 879 F.Supp. 237, 241 (E.D.N.Y. 1994)). However, a court should balance “the public interest in preserving judicial integrity and fairness . . . [against] the parties' right to the assistance of experts ‘who possess specialized knowledge' and the right of such experts to ‘pursue their professional calling.'” Hinterberger v. Catholic Health System, Inc., No. 08-CV-380, 2013 WL 2250591, at *6 (W.D.N.Y. May 21, 2013) (quoting Mays v. Reassure America Life Insurance Co., 293 F.Supp.2d 954, 957 (E.D. Ark. 2003)).

         The party seeking disqualification must make two showings. First, it must establish that it is objectively reasonable to believe that a confidential relationship existed. Gordon v. Kaleida Health, No. 08-CV-378, 2013 WL 2250506, at *5 (W.D.N.Y. May 21, 2013). “The emphasis . . . is not on whether the expert was retained per se but whether there was a relationship that would permit the litigant reasonably to expect that any communications would be maintained in confidence.” Hewlett-Packard Co. v. EMC Corp., 330 F.Supp.2d 1087, 1093 (N.D. Cal. 2004) (citing In re Ambassador Group, 879 F.Supp. at 243). Second, the moving party must demonstrate that its “confidential information was ‘actually disclosed' to the expert or consultant.” Gordon, 2013 WL 2250506, at *5 (quoting The Topps Co. v. Productos Stani Sociedad Anomina Industrial y Commercial, No. 99 Civ. 9437, 2001 WL 406193, at *1 (S.D.N.Y. April 20, 2001)). “Unlike attorney-client communications, discussions between parties or counsel and experts do not carry the presumption that confidential information was exchanged.” Hewlett-Packard, 330 F.Supp.2d at 1094 (quoting Stencel v. Fairchild Corp., 174 F.Supp.2d 1080, 1083 (C.D. Cal. 2001)). Rather, the moving party “should point to specific and unambiguous disclosures that if revealed would prejudice the party.” Id.

         Thus, “the instances of expert disqualification are rare, ” and generally “should not occur where a confidential relationship existed but no privileged information was communicated, or, alternatively, where no confidential relationship existed but privileged information was nonetheless disclosed.” Grioli, 395 F.Supp.2d at 13-14 (quoting In re Orthopedic Bone Screw Products Liability Litigation, No. MDL 1014, 1995 WL 925673, *3 (E.D. Pa. May 5, 1995)); see also Ziptronix, Inc. v. Omnivision Technologies, Inc., No. C-10-5525, 2013 WL 146413, at *1 (N.D. Cal. Jan. 14, 2013)).

         B. Dr. Schneider

         Forest bases its disqualification motion on the following documents and other evidence demonstrating the contacts between the company and Dr. Schneider:

(1) A Consulting Agreement between Dr. Schneider and Forest executed May 2, 2003, engaging Dr. Schneider to perform “[c]onsulting services for Memantine NDA” for a term of one year, with confidentiality obligations to last for an additional seven years. (Consulting Agreement dated May 2, 2003 (“May 2003 Consulting Agreement”), attached as Exh. A to Declaration of Heather K. McDevitt dated June 15, 2017 (“First McDevitt Decl.”)).
(2) A PowerPoint presentation by Dr. Schneider entitled “Memantine Efficacy in Moderate to Severe AD, ” dated September 2003, which was given at an FDA advisory meeting. (Memantine Efficacy in Moderate to Severe AD dated Sept. 2003, attached as Exh. B to First McDevitt Decl.).
(3) A Consulting Agreement between Dr. Schneider and Forest executed December 4, 2003, engaging Dr. Schneider to perform consulting services on at least one study of the efficacy of memantine for a term of one year, with confidentiality obligations to last for an additional seven years. (Consulting Agreement dated December 4, 2003 (“December 2003 Consulting Agreement”), attached as Exh. C to First McDevitt Decl.; Study No. MEM-MD-12 dated June 28, 2004, attached as Exh. D to First McDevitt Decl.; First McDevitt Decl., ¶ 8).
(4) Notes from a September 23, 2004 advisory conference call among two Forest employees, Dr. Schneider, and three other advisors regarding the “executive advisors['] [] feedback and impressions of Pfizer claims.” (Thought Leader Outreach Notes from Advisory Conference Call 9/23, 10 am, attached as ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.