United States ex rel. Dickson v. Bristol-Meyers Squibb Co. (In re Plavix Mktg., Sales Practices & Prods. Liab. Litig. (No. II)), MDL No. 13–2418 (FLW).

123 F.Supp.3d 584

In re PLAVIX MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION (No. II).

United States et al., ex rel. Elisa Dickson, Plaintiffs,

v.Bristol–Meyers Squibb Co., et al., Defendants.

MDL No. 13–2418 (FLW).

Civ. Action No. 13–1039 (FLW).

United States District Court, D. New Jersey.

Signed Aug. 20, 2015.

OPINION

WOLFSON, District Judge.

This qui tam action, a member case of the Multi–District Litigation, In re: Plavix Marketing, Sales Practices and Products Liability Litigation, involves the alleged wrongful marketing and sales of Plavix (clopidogrel bisulfate), a prescription blood thinner manufactured by Defendant Bristol–Myers Squibb Company ("BMS") and marketed in the United States by BMS and Defendants Sanofi–Aventis U.S. LLC, Sanofi U.S. Service Inc., and Sanofi–Synthelabo Inc. (collectively "Sanofi") (collectively "Defendants"). Relator Elisa Dickson ("Relator") brought this case on behalf of the United States and various states, asserting claims under the following statutes: (Count 1) the federal False Claims Act ("FCA"), 31 U.S.C. §§ 3729 –3733 ; (Count 2) Conspiracy under the FCA, 31 U.S.C. § 3729(a), as well as 26 separate state law claims.¹

Defendants move to dismiss the Third Amended Complaint ("TAC") on the basis that Relator's allegations—namely, that Defendants engaged in false marketing causing physicians to submit claims to Medicaid and Medicare Part D that were not "medically necessary" or "reasonable and necessary"—are insufficient to state a claim under the FCA and the state statutes. As a threshold issue, however, Defendants maintain that Relator's state and federal claims are barred by the applicable statute of limitations, and by the doctrine of public disclosure set forth in the FCA.

For the reasons expressed herein, Relator's Motion to Dismiss is GRANTED in part and DENIED in part. Specifically, the following categories of Relator's claims are dismissed: (1) federal FCA claims based on Medicare Part D; (2) federal FCA claims based on the Medicaid plans of thirty-three states, including the District of Columbia;² and (3) claims based on state formularies. The only surviving federal claims are Relator's FCA claims related to the Medicaid plans of the following states: Connecticut, Delaware, Idaho, Kansas, Maryland, Massachusetts, Mississippi, Montana, Nebraska, North Carolina, Ohio, Oklahoma, Rhode Island, South Dakota, Utah, Washington and Wyoming. Additionally, all claims arising under state law are dismissed, except for the following states: Delaware, Montana, Massachusetts, Rhode Island, Oklahoma, North Carolina, and Connecticut. Moreover, Relator has also filed a Motion for Reconsideration of this Court's previous denial of her Motion for Suggestion of Remand. For the reasons stated herein, this motion is DENIED.

BACKGROUND

I. Factual Background

The relevant facts alleged in the Third Amended Complaint, which I must take as true for the purpose of this Motion, are as follows.

Plavix, clopidogrel bisulfate, is a FDA-approved prescription blood thinner, which is marketed for the treatment of Acute Coronary Syndrome, and used by patients following the occurrence of myocardial infarction, stroke or established peripheral artery disease. See TAC at ¶ 1. While under patent, Plavix was BMS's top-selling product, with sales accounting for 30% of its gross revenue ($1.67 billion). Id. BMS and Sanofi market Plavix jointly. Id. at ¶ 2. Plavix costs approximately four dollars per pill. Id. at ¶ 3. Since 1998, the FDA has sent three letters to Sanofi involving the allegedly misleading promotion of Plavix. Id. at ¶¶ 4–14.

Relator worked in the pharmaceutical industry for twelve years, and was employed by Sanofi as a sales representative specializing in selling Plavix. Id. at ¶ 16. Relator alleges that she was instructed by Sanofi to promote Plavix as having certain characteristics that Sanofi knew were not true. Id. at ¶ 19. For example, while trial data found non-significant efficacy in stroke victims, Relator was instructed to promote Plavix as superior to aspirin in stroke patients. Id. at ¶ 20. Relator also promoted Plavix as comparably safe to aspirin, based on a study which compared Plavix to a more toxic dose of aspirin not normally prescribed today. Id. Relator further alleges that she was instructed to focus sales calls on physicians who wrote significant numbers of prescriptions submitted to government payors. Id. at ¶ 22.

In that regard, according to Relator, Defendants engaged in a comprehensive scheme to defraud federal and state governments by illegally and deceptively promoting Plavix. Id. at ¶ 23. Relator claims that Plavix is no more effective than aspirin, while being many times more expensive. Id. at ¶ 24. Thus, Relator alleges, Defendants' actions caused states to include Plavix on their Medicaid formularies for indications for which Plavix was not medically necessary. Id. Plaintiff further asserts that Medicare Part D requires prescriptions to be "reasonable and necessary" to be reimbursable, and that Medicaid requires prescriptions be "medically necessary" to be reimbursable. Id. at ¶ 26. According to Relator, Defendants' false marketing prevented physicians from making an informed decision as to Plavix's reasonable or medical necessity, and therefore caused physicians to submit numerous false claims for reimbursement to Medicaid and Medicare Part D. Id. at ¶¶ 27–28.

II. Procedural History

Relator filed the original complaint in the United States District Court for the Southern District of Illinois on March 30, 2011. First and Second Amended Complaints were filed in that court in 2011 and 2012, respectively. Defendants moved to dismiss the Second Amended Complaint in December 2012. On January 30, 2013, the Hon. David R. Herndon, U.S.D.J., denied the Motion in part, and granted it in part, dismissing only a claim on which Relator had requested a voluntary dismissal. On February 14, 2013, the case was transferred to this Court by the Judicial Panel on Multidistrict Litigation. Defendants then filed a Motion for Reconsideration before this Court on the denial of their Motion to Dismiss, on the basis that Judge Herndon's January 30 Order incorrectly assumed that a "reasonable and necessary" standard applied to Medicaid and Medicare Part D. Following a hearing on August 22, 2013, this Court granted the Motion for Reconsideration, vacated the prior denial of the Order to Dismiss with respect to the FCA claims under Medicaid and Medicare Part D, and granted the Motion to Dismiss with respect to the FCA claims under those programs. The Court granted Relator leave to amend her Complaint. Relator filed the TAC on September 20, 2013; this Motion to Dismiss followed.

DISCUSSION

I. Standard of Review

A. Rule 12(b)(6)

When considering a motion to dismiss a complaint for failure to state a claim upon which relief can be granted, pursuant to Fed.R.Civ.P. 12(b)(6), a court must accept all well-pleaded allegations in the complaint as true and view them in the light most favorable to the plaintiff. Evancho v. Fisher,

423 F.3d 347, 351 (3d Cir.2005). It is well settled that a pleading is sufficient if it contains "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed.R.Civ.P. 8(a)(2). However, "[a]lthough the Federal Rules of Civil Procedure do not require a claimant to set forth an intricately detailed description of the asserted basis for relief, they do require that the pleadings give defendant fair notice of what the plaintiff's claim is and the grounds upon which it rests." Baldwin Cnty. Welcome Ctr. v. Brown, 466 U.S. 147, 149–50 n. 3, 104 S.Ct. 1723, 80 L.Ed.2d 196 (1984) (quotation and citation omitted). A district court, in weighing a motion to dismiss, asks " ‘not whether a plaintiff will ultimately prevail but whether the claimant is entitled to offer evidence to support the claim.’ " Bell Atlantic v. Twombly, 550 U.S. 544, 583, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (quoting Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S.Ct. 1683, 40 L.Ed.2d 90 (1974) ); see also Ashcroft v. Iqbal, 556 U.S. 662, 684, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) ("Our decision in Twombly expounded the pleading standard for all civil actions.") (internal citations omitted); Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir.2009) ("Iqbal

... provides the final nail-in-the-coffin for the ‘no set of facts' standard that applied to federal complaints before Twombly ." ).

Following the Twombly/Iqbal standard, the Third Circuit applies a two-part analysis in reviewing a complaint under Rule 12(b)(6). First, a district court must accept all of the complaint's well-pleaded facts as true, but may disregard any legal conclusions. Fowler, 578 F.3d at 210. Second, a district court must determine whether the facts alleged in the complaint are sufficient to show that the plaintiff has a "plausible claim for relief." Id. A complaint must do more than allege the plaintiff's entitlement to relief. Id. However, this standard " ‘does not impose a probability requirement at the pleading stage,’ but instead ‘simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of’ the necessary element.' " Phillips v. Cnty. of Allegheny, 515 F.3d 224, 234 (3d Cir.2008) (quoting Twombly, 127 S.Ct. at 1965 ); see also Covington v. Int'l Ass'n of Approved Basketball Officials, 710 F.3d 114, 118 (3d Cir.2013) ( "[A] claimant does not have to set out in detail the facts upon which he bases his claim.... The pleading standard is not akin to a probability requirement, ... to survive a motion to dismiss, a complaint merely has to state a plausible claim for relief." (citations omitted)). Nonetheless, a court need not credit either "bald assertions" or "legal conclusions" in a complaint when deciding a motion to dismiss. In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1429–30 (3d Cir.1997). The defendant bears the burden of showing that no claim has...