United States ex rel. Kester v. Novartis Pharmaceuticals Corp.

43 F. Supp. 3d 332, 2014 U.S. Dist. LEXIS 124761, 2014 WL 4370597
District Court, S.D. New York·Decided September 3, 2014·No. No. 11 Civ. 8196(CM)·Published·Cited by 28 cases

Opinion

MEMORANDUM DECISION AND ORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS’ MOTIONS TO DISMISS

McMAHON, District Judge:

Plaintiff-relator David M. Kester (“Relator”) filed a sealed qui tam action asserting claims arising under the False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq., and related state laws. The Defendants named in the complaint include Novartis Pharmaceuticals Corporation (“Novartis”) and certain specialty pharmacies, including CVS Caremark Corporation (“Caremark”), Accredo Health Group, Inc. (“Accredo”), and Curascript, Inc. (“Curascript”) (collectively, the “Pharmacy Defendants”). The Relator alleges that Novartis and these pharmacies violated the FCA and the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b(b), in connection with a kickback scheme.

Pending before the Court are the Defendants’ motions to dismiss the Relator’s Second Amended Complaint pursuant to Rules 12(b)(1), 12(b)(6), and 9(b) of the Federal Rules of Civil Procedure. For the [339] reasons discussed below, those motions are granted in part and denied in part.1

BACKGROUND2

A. The Plaintiffs

Pursuant to the False Claims Act (“FCA”), private persons known as “rela-tors” may file qui tarn actions and recover damages on behalf of the United States. See 31 U.S.C. § 3730(b). Plaintiff Kester (“Relator”) originally filed this FCA action in November 2011 on behalf of the United States, 27 states, and the District of Columbia.

The Relator filed a Second Amended Complaint (“the Relator’s Complaint”) on January 30, 2014. He brings claims against Novartis and the Pharmacy Defendants on behalf of the United States, 26 states, and the District of Columbia. The Relator asserts claims (Counts 1a, 1b, 1c, and Id)3 under four subsections of the FCA—31 U.S.C. §§ 3729(a)(1)(A), (a)(1)(B), (a)(1)(C), and (a)(1)(G). He also asserts claims (Counts 2-28) under 27 different state law analogues of the FCA, including the parallel false claim statutes in California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nevada, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Virginia, and Wisconsin.

The United States government (“the Government”) elected to intervene as a co-plaintiff in this case. On January 8, 2014, the Government filed an Amended Complaint-in-Intervention (“the Government’s Complaint”) asserting claims against Novartis (but not the Pharmacy Defendants) under the FCA and related state laws.

Eleven states have since intervened as co-plaintiffs against Novartis alone, asserting claims under state law analogues of the FCA.

Generally, the FCA outlaws the submission of a false or fraudulent “claim” for payment (ie., a request for reimbursement) to the government. See 31 U.S.C. § 3729(a)(1). Such claims may be rendered “false” in a variety of ways. In this case, the Relator’s FCA claims are predicated on underlying violations of the Anti-Kickback Statute (“AKS”). Under the AKS, it is illegal to offer a person “remuneration” (ie., kickbacks) in order to “induce” that person to “recommend” the purchase of a drug covered by a federal health care program. 42 U.S.C. § 1320a-7b(b)(2). It is likewise illegal to receive remuneration “in return for ... recommending purchasing” such drugs. Id. at § 1320a-7b(b)(l-).

The reader is presumed to be familiar with this Court’s previous orders in this case: denying Novartis’s motion to dismiss the Government’s Complaint pursuant to Rule 9(b), see U.S. ex rel. Kester v. Novartis Pharmaceuticals Corp., No. 11 Civ. 8196(CM), 23 F.Supp.3d 242, 2014 WL 2324465 (S.D.N.Y. May 29, 2014) (“Novartis /”); granting in part and denying in part Defendants’ motions to dismiss the Relator’s Second Amended Complaint pursuant to Rule 9(b), see U.S. ex rel. Kester v. Novartis Pharm. Corp., 11 Civ. [340]*3408196(CM), 2014 WL 2619014 (S.D.N.Y. June 10, 2014) (“Novartis II”); denying Defendants’ motion for reconsideration of this Court’s order in Novartis II (“Novartis III”), see Docket No. 216; and granting in part and denying in part Novartis’s motion to dismiss the Government’s Complaint pursuant to Rules 12(b)(6) and 9(b) (“Novartis IV”), see Docket No. 227.

B. The Alleged Kickback Schemes

Defendant Novartis is a pharmaceutical company that develops, manufactures, and markets prescription drugs. It sells these drugs through various avenues, one of which is “specialty” pharmacies which sell drugs that are not available at normal retail pharmacies. See Compl.4 at ¶ 1. The Relator alleges that Novartis conducted five illegal kickback schemes involving drugs covered by federal health care programs, and that the Pharmacy Defendants participated in those schemes.

The Relator, David M. Kester, is a former sales employee of Novartis who discovered that Novartis was engaging in practices that allegedly violated the AKS and the FCA. See id. at ¶¶ 15-16. According to the Relator, Novartis realized that certain pharmacies had influence over doctors or patients. So beginning in January 2007 it decided to “leverage” these pharmacies’ influence—it offered them kickbacks in the form of rebates, discounts, and patient referrals to induce them to “recommend” its drugs to doctors or patients. Id. at ¶ 2.

The Relator’s Complaint contains a detailed description of the mechanics of the kickback schemes. It alleges that Novartis gave the pharmacies several types of remuneration: “first category rebates,” which were volume-based rebates of about 1-3% of all sales of Novartis drugs; “see-ond category rebates,” which were performance-based payments depending on quantity sold or market share; and patient referrals, which Novartis controlled through its exclusive distribution networks. See id. at ¶¶ 63-65.

When a new patient received a prescription for a specialty medication manufactured by Novartis, the patient would contact a Novartis call center (or “reimbursement hub”). Id. at ¶ 57. The reimbursement hub would then steer the patient to one of the specialty pharmacies in its exclusive drug distribution networks. See id. at ¶¶ 58, 65. One of these reimbursement hubs was operated by a Care-mark subsidiary, Theracom, LLC. See id. at ¶ 59.

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United States ex rel. Kester v. Novartis Pharmaceuticals Corp., 43 F. Supp. 3d 332, 2014 U.S. Dist. LEXIS 124761, 2014 WL 4370597 (S.D.N.Y. 2014).

43 F. Supp. 3d 332 (United States ex rel. Kester v. Novartis Pharmaceuticals Corp.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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