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

• Decision Date: 23 May 2016
• Docket Number: CIVIL ACTION NO. 10-11166-DPW
• Citation: 188 F.Supp.3d 122
• Parties: United States of America, States of California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Virginia and Wisconsin and the District of Columbia ex rel. Alex Booker and Edmund Hebron, Plaintiffs, v. Pfizer, Inc., Defendant.
• Court: U.S. District Court — District of Massachusetts

188 F.Supp.3d 122

United States of America, States of California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Virginia and Wisconsin and the District of Columbia ex rel. Alex Booker and Edmund Hebron, Plaintiffs,

v.Pfizer, Inc., Defendant.

CIVIL ACTION NO. 10-11166-DPW

United States District Court, D. Massachusetts.

Signed May 23, 2016

Sonya A. Rao, United States Attorney's Office MA, Robert P. Patten, Attorney General's Office, Boston, MA, Kevin J. Darken, Cohen, Foster & Romine P.A., Tampa, FL, Thomas N. Burnham, Burnham International Law Office, PC, Ann Arbor, MI, for Plaintiffs.

Brien T. O'Connor, Kirsten V. Mayer, Emily J. Derr, John P. Bueker, Maria M. Carboni, Nicholas Bradley, Ropes & Gray, Boston, MA, for Defendant.

MEMORANDUM AND ORDER

DOUGLAS P. WOODLOCK, UNITED STATES DISTRICT JUDGE

I. BACKGROUND

Relators Alex Booker and Edmund Hebron 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 of "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-moving 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. Accordingly, relators purport to show that Pfizer promoted Geodon

for three non-reimbursable indications—use in children and adolescents, use as a bipolar monotherapy maintenance drug, and use at excessive dosages not approved by the FDA—leading to false claims against Medicaid.

The "sine qua non" of a False Claims Act violation is, as the name of the statute would suggest, an "actual false claim." U.S. ex rel. Karvelas v. Melrose – Wakefield Hosp. , 360 F.3d 220, 225 (1st Cir.2004). Without proof of a false claim, there is no liability under the False Claims Act. There is some flexibility in the specificity with which a false claim must be pled, particularly where a defendant does not itself submit claims directly to the government. U.S. ex rel. Rost v. Pfizer, Inc. , 507 F.3d 720, 732–33 (1st Cir.2007). However, a necessary condition for establishing liability is proving the existence of a false claim.

In this case, relators cannot meet this basic threshold requirement with respect to their off-label promotion claims. First, relators appear to rely primarily on aggregate data to show that false claims must have been submitted to the government as a result of off-label promotion. Such mathematical deductions, even if statistically sound, do not suffice to prevent summary judgment. See U.S. ex rel. Quinn v. Omnicare Inc. , 382 F.3d 432, 440 (3d Cir.2004) ("Without proof of an actual claim, there is no issue of material fact to be decided by a jury. [Relator]'s theory that the claims ‘must have been’ submitted cannot survive a motion for summary judgment."); United States v. Kitsap Physicians Serv. , 314 F.3d 995, 1003 (9th Cir.2002) (damages may be extrapolated from aggregate information, but "submission of a single false claim" necessary); U.S. ex rel. Crews v. NCS Healthcare of Illinois , Inc., 460 F.3d 853, 856 (7th Cir.2006) (adopting reasoning of Third and Ninth Circuits).

Notably, the First Circuit has deemed it a "close call" whether an FCA complaint could survive a motion to dismiss where it did not identify specific claims but had "identified, as to each of the medical providers (the who), the illegal kickbacks (the what),...