United States ex rel. Dickson v. Bristol-Myers Squibb Co. (In re Plavix Mktg., Sales Practice & Prods. Liab. Litig. (NO. II))

332 F. Supp. 3d 927
CourtDistrict Court, D. New Jersey
DecidedJune 27, 2017
DocketMDL DOCKET NO. 2418; Civil Action No. 13-1039 (FLW)(LHG)
StatusPublished
Cited by10 cases

This text of 332 F. Supp. 3d 927 (United States ex rel. Dickson v. Bristol-Myers Squibb Co. (In re Plavix Mktg., Sales Practice & Prods. Liab. Litig. (NO. II))) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States ex rel. Dickson v. Bristol-Myers Squibb Co. (In re Plavix Mktg., Sales Practice & Prods. Liab. Litig. (NO. II)), 332 F. Supp. 3d 927 (D.N.J. 2017).

Opinion

WOLFSON, United States District Judge:

Before the Court is the motion of Defendants Bristol-Myers Squibb Company ("BMS"), Sanofi-Aventis U.S. LLC, Sanofi U.S. Service Inc., and Sanofi-Synthelabo Inc. (collectively "Sanofi") (together with BMS, "Defendants") to dismiss the Fourth *933Amended Complaint ("4AC") of relator Elisa Dickson ("Realtor"). In the 4AC, Relator brings a qui tam action, a member case of the Multi-District Litigation, In re: Plavix Marketing, Sales Practices and Products Liability Litigation, involving the alleged wrongful marketing and sales of Plavix (clopidogrel bisulfate), a prescription blood thinner manufactured by Defendant BMS and marketed in the United States by BMS and Sanofi. Relator brings this case on behalf of the United States and seventeen states, asserting claims for violation of the federal False Claims Act ("FCA"), 31 U.S.C. §§ 3729 - 3733 (Count I); conspiracy under the FCA, 31 U.S.C. § 3729(a) (Count II); and the False Claims Acts of twenty-four (24) states (Counts III-XXVI). Defendants move to dismiss the 4AC in its entirety, and in the alternative to limit the temporal scope of Relator's state FCA claims under the laws of five states, the FCAs of which became effective after March 30, 2005.

For the reasons stated herein, the Defendants' Motion to Dismiss the 4AC is GRANTED, and Defendants' motion to restrict the retroactive application of the five state FCAs, which became effective after March 30, 2005, is denied as moot.

I. FACTUAL BACKGROUND

The relevant facts of this action, as set forth in the 4AC and taken as true by this Court, are as follows. Plavix ® (clopidogrel bisulfate) ("Plavix") is a prescription blood thinner manufactured by BMS and comarketed in the United States by Sanofi. 4AC ¶ 1. Plavix has been approved by the United States Food and Drug Administration ("FDA") and is indicated for the treatment of Acute Coronary Syndrome and for use following a recent myocardial infarction or stroke or established peripheral artery disease. Ibid.Plavix costs approximately $4.00 per pill. Aspirin, an over-the-counter blood thinner, costs approximately $0.04 per pill. Id. at ¶ 3.

Relator claims that Defendants promoted Plavix as a superior drug to aspirin for certain indicated usages, when Plavix was no more effective than aspirin for those indicated usages and cost one hundred times more. Id. at ¶ 22. More than half of state Medicaid programs contain cost-based restrictions that limit coverage under Medicaid to cost-effective treatments. Ibid. In these states, Medicaid only pays for cost-effective drugs. Ibid. Where an equally effective but cheaper treatment is available for a particular course of treatment, the more expensive drug is not cost effective and cannot be reimbursed. Ibid. In these states, cost effectiveness is not just a requirement for participation in Medicaid, it is a condition precedent to reimbursement designed to ensure that a state's Medicaid program is a good steward of taxpayer dollars. Ibid.

Relator alleges that Defendants targeted their marketing efforts, misrepresenting the effectiveness of Plavix relative to aspirin, at physicians and prescribers whose patients relied upon public assistance programs such as Medicaid. Id. at ¶ 3. Relator claims that Defendants' marketing efforts caused physicians to submit many prescriptions for Plavix in the mistaken belief that it was a cost-effective treatment. Ibid.

In order for the cost of a drug to be reimbursed under Medicaid, the drug manufacturer must have entered into, and have in effect, a rebate agreement wherein the manufacturer agrees to give the applicable government payor back a percentage of the cost of the reimbursed drug. Id. at ¶ 92. Drugs that are covered by a rebate agreement are then statutorily divided into two distinct categories: those that require prior authorization from Medicaid prior to reimbursement and those that are *934reimbursed automatically when the drug is prescribed. Ibid. Each state maintains a preferred drug list, or formulary1 , that explicitly exempts certain Medicaid-eligible drugs from a prior authorization requirement. Medicaid is obligated to provide reimbursement for the cost of a drug on a state's formulary when the drug is prescribed by a physician for an "on-label" indication. Ibid. In other words, if a drug is on a state's formulary, once an "on-label" prescription for that drug is written and the prescription is filled, the cost for that prescribed drug is automatically reimbursed by the government. No other authorizations are required. Id. at ¶ 26.

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332 F. Supp. 3d 927, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-ex-rel-dickson-v-bristol-myers-squibb-co-in-re-plavix-njd-2017.