Sergeants Benevolent Ass'n Health & Welfare Fund v. Sanofi-Aventis U.S. LLP

20 F. Supp. 3d 305, 2014 WL 1894303, 2014 U.S. Dist. LEXIS 65714
CourtDistrict Court, E.D. New York
DecidedMay 12, 2014
DocketNo. 08-CV-179 (SLT)(RER)
StatusPublished
Cited by11 cases

This text of 20 F. Supp. 3d 305 (Sergeants Benevolent Ass'n Health & Welfare Fund v. Sanofi-Aventis U.S. LLP) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Sergeants Benevolent Ass'n Health & Welfare Fund v. Sanofi-Aventis U.S. LLP, 20 F. Supp. 3d 305, 2014 WL 1894303, 2014 U.S. Dist. LEXIS 65714 (E.D.N.Y. 2014).

Opinion

MEMORANDUM AND ORDER

TOWNES, District Judge:

In January 2008, plaintiffs Sergeants Benevolent Association Health and Welfare Fund (“SBA”), New England Carpenters Health Benefits Fund (“NEC”) and Allied Services Division Welfare Fund (“ASD”) (collectively “Plaintiffs”) and others commenced this action on behalf of themselves and others similarly situated, principally alleging that defendants sanofi-aventis U.S. LLP and sanofi-aventis U.S., Inc. (collectively, “Defendants”) violated the Racketeer Influenced and Corrupt Organizations Act “(RICO”), 18 U.S.C. § 1961 et seq., and various state laws by misrepresenting the safety and efficacy of Ketek, a prescription antibiotic marketed by Defendants. In December 2011 — after this Court denied Plaintiffs’ motion to certify a nationwide class — Defendants moved for summary judgment. By order dated January 4, 2012, this Court referred the motion to Magistrate Judge Ramon E. Reyes (“Judge Reyes”) for a report and recommendation.

On September 17, 2012, Judge Reyes issued his report and recommendation (the “R & R”)—Sergeants Benev. Ass’n Health & Welfare Fund v. Sanofi-Aventis U.S., LLP, No. 08-CV-0179 (SET) (RER), 2012 WL 4336218 (E.D.N.Y. Sept. 17, 2012) (“Sergeants III”)—which recommends that Defendants’ motion for summary judgment be granted in its entirety. On October 4, 2012, Plaintiffs collectively filed objections to almost every aspect of the R & R. For the reasons set forth below, this Court, having conducted a de novo review of those portions of the R & R to which Plaintiffs object, now adopts Judge Reyes’ R & R except to the extent that it recommends limiting Plaintiffs’ cause of action for violations of various consumer protection statutes to claims brought pursuant to the laws of Plaintiffs’ home states of New York, Massachusetts and Illinois. However, Defendants are granted leave to file a second motion for summary judgment once Plaintiffs clarify the scope of their state-law claims under Counts III and IV of the Second Amended Complaint.

BACKGROUND

In setting forth the facts of this case, the R & R incorporates by reference a much more detailed statement of facts contained in Judge Reyes’ report and recommendation on Plaintiffs’ motion for class certification (the “Prior R & R”): Sergeants Benev. Ass’n Health & Welfare Fund v. Sanofi-Aventis U.S., LLP, No. 08-CV-0179 (SLT) (RER), 2011 WL 824607 (E.D.N.Y. Feb. 16, 2011) (“Sergeants I”), adopted, 2011 WL 1326365 (E.D.N.Y. Mar. 30, 2011) (“Sergeants II”). The Prior R & R itself largely relied on facts set forth in Plaintiffs’ Second Amended Complaint and Plaintiffs’ Proffer of Facts in Support of the Motion for Class Certification (“Plaintiffs’ Proffer”).

[309]*309The following summary of the facts in this case relies, in part, on the Prior R & R. As indicated by the citations contained in the Prior R & R, not all of these facts may be undisputed. However, to the extent that the facts are disputed, the following summary is based on Plaintiffs’ version of events.

Defendants are United States subsidiaries of sanofi-aventis SA, a French pharmaceutical firm (Sec. Am. Complt., ¶¶ 5-6; Answer, ¶¶ 5-6). According to Defendants, the corporation named by Plaintiffs as Sanofí-Aventis U.S., Inc. is actually named sanofi-aventis U.S. Inc. and is not a proper party to this action (Answer, p. 2); the entity named by Plaintiffs as Sanofi-Aventis U.S., LLP, is actually a limited liability company, sanofi-aventis U.S. LLC (id., at 1); and some of the acts which Plaintiffs attribute to Defendants were actually committed by a related entity, Aven-tis Pharmaceutical, Inc. (“API”) (see id., ¶¶ 5, 14-16). For purposes of this memorandum and order, this Court will attribute acts and omissions on the part of one or more of these related entities to Defendants so as to avoid unnecessary complexity.

Sometime prior to March 2000, Defendants developed a prescription antibiotic, telithromycin, which was marketed under the brand name Ketek (Sec. Am. Complt., ¶ 10; Answer, ¶ 10). Early in 2000, Defendants submitted a New Drug Application (“NDA”) to the Office of New Drugs at the United States Food and Drug Administration (“FDA”), seeking approval to sell Ke-tek in the United States (Sec. Am. Complt., ¶ 12; Answer, ¶ 12). That NDA sought to have Ketek approved for the treatment of four specific conditions or “indications”: acute bacterial sinusitis (“ABS”), acute exacerbation of chronic bronchitis (“AECB”), community-acquired pneumonia (“CAP”), and tonsillopharyngi-tis (id.).

In June 2001, the FDA determined that it would not approve Ketek for treatment of tonsillopharyngitis and would only approve Ketek for the treatment of the other three indications if Defendants provided more evidence of Ketek’s safety and efficacy (Sergeants I, 2011 WL 824607, at *1 (citing Plaintiffs’ Proffer at 28)). To provide this evidence, Defendants commissioned a large clinical study known as “Study 3014” (Sec. Am. Complt., ¶ 14; Answer, ¶ 14). Defendants hired Pharmaceutical Product Development, Inc. (“PPD”), a contract research organization, to monitor the study and contracted with another entity, The Copernicus Group, Inc. (“Copernicus”), to monitor patient safety (Sergeants I, 2011 WL 824607, at *2).

Early in the course of its evaluation, PPD raised concerns regarding the integrity of data collected by the office of Dr. Marie Anne Kirkman Campbell, a physician who treated the largest number of patients in the study (Sergeants I, 2011 WL 824607, at *2 (citing Plaintiffs’ Proffer at 31)). Thereafter, the FDA’s Office of Criminal Investigation (“the OCI”) determined that there had been misconduct and protocol violations at several other sites with high patient enrollment (id. (citing Plaintiffs’ Proffer at 38-39)). However, after the FDA again declined to approve Ketek and requested more information regarding Study 3014, Defendants issued a report that, Plaintiffs claim, not only omitted any mention of the study’s problems but falsely represented that the study had been conducted in accordance with good clinical practice (id. (citing Sec. Am. Complt., ¶26)). According to Plaintiffs, Defendants also claimed Ketek’s safety and efficacy profile matched that of other antibiotics, even though they (i) knew “that Study 3014 actually showed that Ketek [310]*310was almost three times more likely to result in a possibly medication-related, serious adverse event; (ii) knew that Ketek was neither more efficacious nor as safe as widely available alternatives; and (iii) knew that claims that Ketek did better against antibiotic resistant pathogens were not scientifically supported” (id. (citing Plaintiffs’ Memorandum In Support Of Class Certification at 3, nn. 10-14)).

In April 2004, after receiving Defendants’ report, the FDA approved Ketek for three indications: ABS, AECB and CAP (Defendants’ Statement of Undisputed Material Facts in Support of their Motion for Summary Judgment (“Defendants’ 56.1”), ¶ 1; Plaintiffs’ Response to Defendants’ Local Rule 56.1 Statement of Undisputed Facts (“Plaintiffs’ 56.1”), ¶ 1). Immediately thereafter, Defendants launched a marketing campaign, seeking to have Ketek prescribed for “off-label” uses in addition to the three indications for which it was approved (Sergeants I, 2011 WL 824607, at *3).

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20 F. Supp. 3d 305, 2014 WL 1894303, 2014 U.S. Dist. LEXIS 65714, Counsel Stack Legal Research, https://law.counselstack.com/opinion/sergeants-benevolent-assn-health-welfare-fund-v-sanofi-aventis-us-llp-nyed-2014.