United States ex rel. JKJ P'ship 2011, LLP v. Sanofi-Aventis, U.S., LLC, Inc. (In re Plavix Mktg., Sales Practices & Prods. Liab Litig.)

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IN RE PLAVIX MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION (NO. II)

UNITED STATES OF AMERICA, et al., ex rel. JKJ Partnership 2011, LLP, Plaintiffs, v. SANOFI AVENTIS, U.S., LLC, et al., Defendants.

MDL No. 2418

Civil Action No. 11-6476 (FLW)

United States District Court, D. New Jersey

October 28, 2021

NOT FOR PUBLICATION

OPINION

Freda L. Wolfson, U.S. Chief District Judge.

Before the Court is the renewed motion of Defendants Sanofi-Aventis U.S., LLC (“Sanofi”); Sanofi U.S. Services, Inc. Aventis Pharmaceuticals, Inc.; Bristol-Myers Squibb Company (“Bristol Myers”); and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership (collectively “Defendants”), to dismiss the Second Amended Complaint (“SAC”) of Relator-Plaintiff JKJ Partnership 2011, LLP (“JKJ” or “Relator”) for failure to state a claim, pursuant to Fed.R.Civ.P. 12(b)(6), and to strike Relator's discovery-supplemented allegations. For the reasons that follow, Defendants' motion to dismiss is GRANTED.

I. FACTUAL BACKGROUND AND PROCEDURAL HISTORY

A. Factual Background

On October 26, 2011, two doctors and a Sanofi sales representative formed JKJ, a Delaware Limited Partnership. JKJ was formed for the purpose of bringing the present litigation. On November 4, 2011 - nine days after it was formed - JKJ filed the original qui tam Complaint, identifying its partners anonymously as “Partner A, ” “Partner B, ” and “Partner C.” Original Compl., ¶¶ 20-24. The partners were later identified as Dr. John Venditto, Kelly Evans, and Dr. Jeffrey Stahl. In the Original Complaint, JKJ alleged, inter alia, that

the Sanofi Defendants failed to disclose material adverse efficacy data regarding Plavix®, as required by 21 C.F.R. § 314.80 (governing post-marketing reporting of adverse drug experiences), causing physicians to prescribe, and Government Programs to reimburse, Plavix® for millions of patients who were genetically predisposed to experience diminished or no responsiveness to Plavix®, rendering it little more than a placebo and placing the patients at significant risk.

Id. at ¶ 5. Plavix® (clopidogrel bisulfate) (“Plavix”) is a prescription antiplatelet drug (“blood thinner”) manufactured by Bristol Myers and comarketed in the United States by Sanofi. SAC, ¶¶ 125-126. Approved by the United States Food and Drug Administration (“FDA”) in November 1997, Plavix is indicated for the treatment of Acute Coronary Syndrome and for use following a recent myocardial infarction or stroke or established peripheral artery disease. Id. at ¶ 125. Defendants marketed and sold Plavix in the United States from March 1998 until May 2012, when Plavix's patent expired. Id. at ¶ 126. During that time, Relator alleges that Plavix was among the top-selling drugs in the United States, and it was the dominant antiplatelet drug. Id. at ¶¶ 125-27.

On February 22, 2017, JKJ filed the SAC, further supporting its claim of Plavix's ineffectiveness for certain patients based on their genetic makeup. In the SAC, JKJ alleges that

Defendants promoted [Plavix] as the standard of care for all antiplatelet and antithrombotic patients-including patients who received stents-notwithstanding their knowledge that the drug had little or no effect, and was therefore medically contraindicated, for over 30% of patients. . . . Defendants knew, but concealed the fact that their blockbuster drug Plavix had no demonstrable pharmacodynamics effect for many patients who had been prescribed the drug. They also knew that these “non-responders” or “low responders” were not entirely genetically random. Individuals whose ethnic background was African-American or Asian-American had a much higher risk of non-response to Plavix than other ethnicities. . . . Defendants referred to this as the Plavix “Variability of Response” (or “VOR”) issue.

Id. at ¶¶ 1-2 (emphasis in original). Relator further alleges that beginning in 1998, Defendants knew that over 30% of patients had little or no response to Plavix (i.e., “non-responders”). Id. at ¶¶ 1-2, 131. Relator specifically claims that while Defendants knew that certain ethnic groups, such as African Americans and Asian Americans, were more likely to be non-responders, they actively concealed this information from healthcare providers, government payors and purchasers, and the FDA to avoid curbing profits from the sale of the drug. Id. at ¶¶ 2, 272, 274. In the years to follow, Relator alleges that medical researchers, including Dr. Paul A. Gurbel, discovered that “Plavix was essentially a placebo and medically unnecessary” for certain patients. Id. at ¶¶ 2, 131-32. Indeed, the SAC alleges that Dr. Gurbel “communicated regularly with Defendants about clopidogrel resistance in the late 1990s and early 2000s, ” and he received a grant from Defendants in the late 1990s to conduct the first prospective study of the antiplatelet effects of Plavix in patients undergoing stenting. Id. at ¶ 134. According to Relator, the so-called PRONTO study, revealed “the lack of response (defined as <10% inhibition of platelet aggregation) in over 30% of the patients studied.” Id.

Furthermore, Relator alleges that in 2009, Dr. Gurbel as senior author, along with principal investigator Alan R. Shuldiner, M.D., and others, co-authored a study that “conclusively identified a common variant of the CYP2C19 gene as a major factor for clopidogrel non-responders and low- responders.” Id. at ¶ 143. Put simply, according to Relator, patients' variability of response to Plavix was associated with a genetic mutation on the CYP2C19 enzyme - a genetic mutation that was more common in African Americans and Asian patients.^[1] Id.

Purportedly, in response to Dr. Gurbel's findings, and other independent studies conducted on the topic, Defendants added information about these CYP2C19 poor metabolizers to the Plavix label in May 2009. Id. ¶ 194. Specifically, the label “expressly addressed the fact that, due to polymorphisms in the CYP2C19 enzyme, not all patients taking Plavix will have adequate platelet inhibition.” Id. Relator also alleges that later in 2009, the FDA required Defendants add a “WARNINGS” section to the Plavix label, describing the potential for reduced effectiveness of the drug due to impaired CYP2C19 function. Id. at ¶ 195. One year later, in March 2010, the FDA moved the information about CYP2C19 poor metabolizers to a boxed warning. Id. at ¶ 196.

Relator claims that Defendants made affirmative misrepresentations by “systematically and deliberately promot[ing] Plavix through false and misleading advertising [and other marketing materials] that overstated efficacy, and minimized critical adverse event and risk information. Relator alleges that Defendants branded this as their ‘Expand and Protect' strategy.” Id. at ¶ 249. Indeed, Relator avers that Defendants created a logo used on Sales and Marketing material to stress and reflect this strategy. Id. According to Relator, based upon such a strategy, Defendants “protected” Plavix by selling the drug's safety and efficacy in all patients in spite of the fact that Defendants knew it was false. Id. Defendants purportedly directly contracted with government purchasers, expressly and impliedly warranting that Plavix was suitable to treat government purchasers' beneficiaries, even though Defendants knew that Plavix was not suitable for a substantial portion of those beneficiaries. Id. at ¶¶ 305-08.

B. Procedural History

As stated above, the Original Complaint was filed on November 4, 2011, by JKJ, which, at the time, consisted of Dr. John Venditto, Kelly Evans, and Dr. Jeffrey Stahl. Thereafter, the SAC was filed on February 22, 2017. The SAC asserts five counts, alleging violations of four sections of the FCA, 31 U.S.C. § 3729(a)(1)(A), (B), (C), and (G), and their state law analogues. SAC, ¶¶ 390-405. Relator alleges that: (1) Defendants submitted, or caused to be submitted, factually false claims to the Government by concealing that Plavix was defective for over thirty percent of patients; (2) Defendants' false statements or records caused healthcare providers to falsely certify (either expressly or impliedly) to government programs that Plavix was reasonable and medically necessary for non-responders, and therefore, eligible for reimbursement; (3) Defendants' false statements or records caused healthcare providers to falsely certify (either expressly or impliedly) to government programs that prescriptions for Plavix were reimbursable, even though Defendants' misrepresentations and inadequate instructions for use rendered Plavix misbranded and not FDA-approved (and therefore ineligible for reimbursement); (4) Defendants fraudulently induced government contracts by misrepresenting Plavix as effective for all patients for its approved uses and then sought payment under those contracts; and (5) Defendants knowingly concealed an obligation to pay the Government that arose out of Defendants' violations of existing corporate integrity agreements.

At some point between the filing of the Original Complaint and the filing of the SAC, however, Dr. Venditto withdrew from the JKJ partnership, and Dr. Gurbel joined the JKJ partnership to replace him. After the substitution in membership came to light, the Court, at an August 9, 2017 status conference asked the parties to brief whether JKJ was a proper relator capable of continuing the litigation. In response to the Court's inquiry, on October 11, 2017, Defendants filed a motion to dismiss, pursuant to Fed.R.Civ.P. 12(b)(1) and Fed.R.Civ.P. 12(b)(6). In part, Defendants invoked the False Claims Act's first-to-file bar. 31 U.S.C. § 3730(b)(5); see United States ex rel. JKJ P'ship 2011, LLP v. Sanofi Aventis, U.S., LLC (In re Plavix Mktg., Sales Practices & Prods. Liab. Litig. (No. II)), ...