United States ex rel. Booker v. Pfizer, Inc.

188 F. Supp. 3d 122, 2016 U.S. Dist. LEXIS 68019, 2016 WL 3017381
CourtDistrict Court, D. Massachusetts
DecidedMay 23, 2016
DocketCIVIL ACTION NO. 10-11166-DPW
StatusPublished
Cited by18 cases

This text of 188 F. Supp. 3d 122 (United States ex rel. Booker v. Pfizer, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts 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. Booker v. Pfizer, Inc., 188 F. Supp. 3d 122, 2016 U.S. Dist. LEXIS 68019, 2016 WL 3017381 (D. Mass. 2016).

Opinion

MEMORANDUM AND ORDER

DOUGLAS P. WOODLOCK, UNITED STATES DISTRICT JUDGE

I. BACKGROUND

Relators Alex Booker and Edmund He-bron brought this qui tam action against Pfizer, Inc., on behalf of the federal government, 25 states, and the District of Columbia, alleging violations of the federal False Claims Act (“FCA”) and state analogues, chiefly.related to the promotion, of the prescription drug Geodon. The relators filed this action on July 13, 2010, and thereafter amended their complaint a number of times. The Fifth Amended Complaint is now the operative pleading, The United States has declined to intervene in this action.

Relators’ allegations are discussed in detail in my March 26, 2014 Memorandum and Order, U.S. ex rel. Booker v. Pfizer, Inc., 9 F.Supp.3d 34 (D.Mass.2014). In this Memorandum, I assume familiarity with those allegations and with the issues raised in this litigation.

Briefly stated, Booker and Hebron were sales representatives in Pfizer’s Neuroscience Division and promoted a variety of pharmaceutical drugs, including Geodon (zipraisidone). They allege that Pfizer improperly promoted Geodon in a variety of ways. Improper Geodon promotion had been the subject of previous false claims litigation against Pfizer, which had settled and resulted in a 2009 Corporate Integrity Agreement between Pfizer and the federal government. Relators asserted that Pfizer continued to' promote Geodon unlawfully even after that Agreement. This action concerns only Pfizer’s conduct after August 31, 2009, when the settlement was reached.

Among other things, relators allege that Pfizer promoted Geodon for uses not approved by the Food and Drug Administration (“off-label” uses), misrepresented the clinical effects of Geodon to physicians, and paid kickbacks to prescribing physicians through a sham speaker series in order to induce additional Geodon prescriptions. These allegations are said to implicate the False Claims Act because claims for reimbursement arising from them were submitted to federal health care programs. Additionally, relator Booker alleges that he was unlawfully fired in retaliation for his whistleblowing activities.

In the March .26, 2014 Memorandum and Order, I dismissed many aspects of the action. Specifically, I dismissed allegations [128]*128of “reverse” false claims involving Pfizer’s failure to comply with its Corporate Integrity Agreement; claims based on Pfizer’s allegedly fraudulent conduct in promoting its drugs, including the misrepresentation of clinical information; claims based on Pfizer’s alleged misbranding of drugs; off-label promotion claims brought under state law; all claims relating to a second drug, Pristiq; and certain off-label promotion claims relating to Geodon. In the March 26, 2014 Memorandum and Order, I also concluded that the Relators had adequately pled their claims concerning the off-label promotion of the drug Geodon for children and adolescents, as a bipolar maintenance monotherapy drug, and at excessive dosages. In addition, I permitted relators’ claims alleging false claims caused by kickbacks to proceed under both the federal False Claims Act and state equivalents. Finally, I denied Pfizer’s motion to dismiss relators’ retaliation claims.

The parties have conducted discovery and have moved for summary judgment: Pfizer seeks summary judgment on the entirety of the case and relators seek it only on Pfizer’s knowing off-label promotion of Geodon. Relators have failed to comply with the requirements of Local Rule 56.1, which requires a “concise statement”—of the material facts as to' which there is no genuine issue to be tried—to be filed along with its motion for summary judgment and a statement of the issues where a genuine issue does exist to be filed along with its opposition to summary judgment. First, they assert that their statement of facts is incorporated into their briefing in support of summary judgment; second, they provide nothing resembling a response to Pfizer’s statement of uncontested facts as contemplated by Local Rule 56.1. Such disregard of the Local Rules could provide grounds sufficient for denial of relators’ motion'for summary judgment and is certainly grounds to deem admitted the statements set forth in Pfizer’s statement of uncontested facts. See Zimmerman v. Puccio, 613 F.3d 60, 63 (1st Cir.2010) (discussing importance of L.R. 56.1 and applying its sanctions).

For purposes of this Memorandum, where relators’ briefing provides adequate references to the evidentiary record, I have treated that briefing as responsive to the requirements of Local Rule 56.1 in order to assure myself that the shortcomings in Rule 56 practice by relators’ counsel do not obscure the merits of the case; nevertheless, I also proceed by accepting the relevant Pfizer statements of fact as uncontested. See Swallow v. Fetzer Vineyards, 46 Fed.Appx. 636, 638-39 (1st Cir.2002) (district courts have discretion over sanctions under Rule 56.1 but should still “parse the record” where’factual analysis required). Given this posture, I will discuss the evidence topically in this memorandum.

II. STANDARD OF REVIEW

On a motion for summary judgment, the moving party bears the burden of showing that “that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). An issue is genuine if it “may reasonably be resolved in favor of either party.” Vineberg v. Bissonnette, 548 F.3d 50, 56 (1st Cir.2008). A fact is material if it could sway the outcome of the litigation. Id. In determining whether genuine disputes of material fact exist, all reasonable inferences must be drawn in the non-movant’s favor. Id.

Once the moving party has carried its burden, the burden shifts to the non-moving party, which must provide specific and supported evidence of disputed material facts. LeBlanc v. Great Am. Ins. Co., 6 F.3d 836, 841 (1st Cir.1993). The non-mov-[129]*129mg party “may not rest upon mere allegation or denials” and must “establish a trial-worthy issue.” Id.

Cross-motions for summary judgment “do not alter the basic Rule 56 standard.” Adria Int’l Grp., Inc. v. Ferre Dev., Inc., 241 F.3d 103, 107 (1st Cir.2001). Rather, the court must assess each motion for summary judgment independently and “determine whether either of the parties deserves judgment as a matter of law on facts that are not disputed.” Id.

III. OFF-LABEL PROMOTION OF GEODON

Off-label promotion can give rise to False Claims Act liability because if government health programs do not cover particular off-label uses, seeking reimbursement for those off-label uses would be a false claim; causing such claims to be submitted is within the proscriptions of the FCA as well. Booker, 9 F.Supp.3d at 51-52. Medicaid, the program at issue here,1 covers both on-label uses and off-label uses recognized in specific drug compendia identified by statute. Id.

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Cite This Page — Counsel Stack

Bluebook (online)
188 F. Supp. 3d 122, 2016 U.S. Dist. LEXIS 68019, 2016 WL 3017381, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-ex-rel-booker-v-pfizer-inc-mad-2016.