United States District Court, D. Massachusetts
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,
PFIZER, INC., Defendant.
MEMORANDUM AND ORDER
DOUGLAS P. WOODLOCK UNITED STATES DISTRICT JUDGE.
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.
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.
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.
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 whistle
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.
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
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.
STANDARD OF REVIEW
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.
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
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.
OFF-LABEL PROMOTION OF GEODON
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,  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
“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.
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
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), the rough time
periods and locations (the where and when), and the filing of
the false claims themselves.” U.S. ex rel.
Duxbury v. Ortho Biotech Products, L.P., 579 F.3d
13, 30 (1st Cir. 2009). Here - on summary judgment rather
than a motion to dismiss - relators have not offered even
this level of specificity as to any particular false claim.
point to case law allowing circumstantial evidence that false
claims were submitted, see United States v. Acadiana
Cardiology, LLC, 2014 WL 1323388, *3 (W.D. La., March
31, 2014) and U.S. ex rel. El-Amin v. George
Washington University, 522 F.Supp.2d 135, 143 (D.D.C.
2007). But those cases are fully consistent with the
requirement that an actual false claim be established. They
dealt with whether a particular Medicare claim form must be
submitted or whether a “mountain of billing
records” could instead be used to demonstrate specific
false claims. El-Amin, 522 F.Supp.2d at 142. Here,
relators have pointed to no such specific false claim, on a
claim form, in billing documents, or otherwise. Given this
record, no reasonable jury could find that a false claim
exists and gives rise to False Claims Act liability.
relators cite to affidavits from Booker himself and from
another Pfizer sales representative, Dave Furmanek, which
aver that they know false claims for off-label uses to have
been submitted. Booker, for example, declares that “I
know that Dr. [Jordan] Balter wrote at least one Geodon
prescription for a dosage exceeding the package insert
maximum which was paid for by the Missouri Medicaid program
in the period between September 1, 2009 and January 5,
2010.” Nearly identical statements, with the doctor and
off-label use changed, are repeated through the declaration.
Furmanek, for his part, states that “I know that Dr.
[Slawomir] Puszkarski wrote at least one Geodon prescription
for a child or adolescent patient which was paid for by the
Illinois Medicaid program after he became a Geodon speaker at
the end of March 2010.”
evidence, however, is plainly inadmissible. Under Federal
Rule of Civil Procedure 56(c)(4), “[a]n affidavit or
declaration used to support or oppose a motion must be made
on personal knowledge, set out facts that would be admissible
in evidence, and show that the affiant or declarant is
competent to testify on the matters stated.” The First
Circuit has been clear that declarants must do more than
simply claim a fact to be true. The purpose of summary
judgment “is not to replace conclusory allegations of
the complaint or answer with conclusory allegations of an
affidavit.” Santiago v. Canon U.S.A., Inc.,
138 F.3d 1, 6 (1st Cir. 1998). Thus, the First Circuit has
deemed inadmissible descriptions of an affiant’s
meetings with certain company “representatives”
where the representatives were not named, the time of the
meetings was unstated, and the specific contents of the
conversation were undefined. Perez v. Volvo Car
Corp., 247 F.3d 303, 316 (1st Cir. 2001). Here, even
less information is provided; indeed, Booker and Furmanek do
not claim to have developed their information from direct
participation in conversations with doctors. They provide no
foundation for their claims or information at all about the
source of their statements. The affidavits will, as Pfizer
moves [Dkt. No. 179], be struck from the record insofar as
they purport to show the existence of a false claim.
Id. at 315 (affidavit lacking any detail should be
struck selectively where inadmissible). Bare assertions that
false claims were submitted are no substitute for admissible
evidence of false claims, which remain entirely lacking. This
alone is enough to require summary judgment on
relators’ off-label promotion claims.
even if relators could point to any such claims, they face a
more fundamental challenge. It has not been demonstrated that
any of the states in which Pfizer allegedly promoted Geodon
for off-label uses and in which Geodon was so prescribed
(precisely what states those are is, again, unstated) bar
reimbursement for off-label uses. Many states cover certain
off-label, non-compendia uses. Cf. U.S. ex rel.
Polansky v. Pfizer, Inc., No. 04-CV-0704 (ERK), 2009
WL 1456582, at *9 (E.D.N.Y. May 22, 2009) (“the
Medicaid scheme does not contain a flat prohibition against
reimbursement for off-label prescriptions. Instead, it leaves
the issue to the discretion of the states”). For
example, Pfizer states, and relators do not contest, that the
Illinois Medicaid program covered Geodon for children over
eight and allows it to be covered with prior authorization
for children under eight, while Florida’s Medicaid
program covered Geodon for children aged six and over. In
such states, a doctor who prescribes Geodon for a pediatric
patient is not seeking the improper reimbursement of a
non-covered drug but rather reimbursement for a drug that the
state has chosen to cover. This is not a fraud on the federal
government; it is the ordinary and anticipated operation of a
health program, and there is no room for False Claims Act
liability. See U.S. ex rel. Banigan v. Organon
USA Inc., 883 F.Supp.2d 277, 294 (D. Mass. 2012)
(“if a state Medicaid program chooses to reimburse a
claim for a drug prescribed for off-label use, then that
claim is not ‘false or fraudulent, ’ and
liability cannot therefore attach for reimbursement”);
U.S. ex rel. Worsfold v. Pfizer Inc., No.
CIV.A. 09-11522-NMG, 2013 WL 6195790, at *3-4 (D. Mass. Nov.
22, 2013) (“Whether a claim for payment is
‘false’ for purposes of liability under the FCA,
in the off-label promotion context, turns on whether the
claim is reimburseable under the relevant federal program,
i.e. Medicaid or Medicare.”).
basic analysis might be viewed as complicated by a closer
examination of the relevant statutory language, but in the
end the outcome is the same. Relators argue that the federal
Medicaid statute does not grant states the discretion to
cover additional off-label, non-compendium uses. This
interpretive question is of some relevance because a claim
for reimbursement might be false even where states purport to
cover a drug if the Medicaid statute does not permit them to
do so. See, e.g., U.S. ex rel. Brown v. Celgene
Corp., No. CV 10-3165-GHK SSX, 2014 WL 3605896, at *4
(C.D. Cal. July 10, 2014) (“courts are ...