United States District Court, E.D. Pennsylvania
UNITED STATES OF AMERICA ex rel. YOASH GOHIL, Plaintiff
AVENTIS, INC., et al., Defendants
Yoash Gohil brings this False Claims Act lawsuit on behalf of
the United States against his former employer Sanofi-Aventis
U.S., Inc. (Aventis) and its subsidiaries. Mr. Gohil alleges
that Aventis engaged in a fraudulent pharmaceutical marketing
scheme, which caused numerous healthcare providers to submit
false claims to federally-funded health insurance programs.
Aventis has moved for a partial judgment on the pleadings,
asserting a statute of limitations bar and a First Amendment
defense. I will deny this motion.
Gohil was employed by Aventis and its predecessor companies
from February 1982 until his resignation in June 2002. At all
relevant times, Mr. Gohil was a Senior Oncology Sales
Specialist whose duties included the marketing, promotion,
and sale of pharmaceuticals manufactured by Aventis. This
case concerns the marketing of Taxotere, a chemotherapy agent
manufactured by Aventis which Mr. Gohil was assigned to
promote and sell in the Philadelphia region.
the Food and Drug Administration (FDA) approved Taxotere for
the treatment of patients with Non-Small Cell Lung Cancer and
Breast cancer, but only after the failure of prior platinum
based chemotherapy. This is also known as second line
treatment. In November 2002, the FDA approved Taxotere for
first line treatment of Non-Small Cell Lung Cancer. There
were no other approved medical indications. Between 1996 and
2004, Taxotere was the most expensive taxane on the market. A
substantial portion of individuals who are treated with
Taxotere are participants in a federal insurance program
including Medicare, Medicaid, CHAMPUS/Tricare, and the
Federal Employee Health Benefit Plan (FEHBP).
2000, Aventis was formed through the merger of RPR and
Hoechst Marion Roussel. Rhone-Poulenc Rorer Pharmaceuticals,
Inc. (RPR) had manufactured and marketed Taxotere. The
plaintiff was an employee of Hoechst and then became an
employee of Aventis. After the merger, he was assigned to
plaintiff alleges that, from 1996 until 2004, Aventis engaged
in a marketing plan which promoted Taxotere for off-label
uses. Gohil alleges that Aventis trained and directed its
employees to misrepresent the safety and effectiveness of the
off-label use of Taxotere to expand the market for Taxotere
into unapproved settings. He claims Aventis also paid
healthcare providers illegal kickbacks-i.e., sham
unrestricted grants, speaking fees, travel, entertainment,
sports and concert tickets, preceptorship fees, and free
samples and free reimbursement assistance-to incentivize
providers to prescribe Taxotere for off-label uses. By the
means of this fraudulent marketing scheme, Aventis
dramatically increased revenue on sales of Taxotere from $424
million in 2000 to $1.4 billion in 2004.
Insurance Programs will pay for an off-label use of a
prescription drug if the drug is used for a medically
accepted indication or the drug is medically necessary.
Aventis marketed Taxotere for off-label use in the first line
treatment of Breast Cancer and Non-Small Cell Lung Cancer,
for the second line treatment of Ovarian Cancer, and for the
treatment of other unspecified medical indications. According
to Gohil, the prescription of Taxotere in these settings
would not be eligible for reimbursement. Additionally,
prescriptions of Taxotere which were “produced through
the payment directly or indirectly of a kickback” were
ineligible for reimbursement. As a result, Aventis'
fraudulent marketing scheme allegedly caused a substantial
number of healthcare providers to submit claims for
reimbursement to Governmental medical reimbursement systems
for the use of Taxotere, which would not have otherwise been
paid had the Government reimbursement programs known of
Aventis' fraudulent marketing scheme.
RELEVANT PROCEDURAL HISTORY
Gohil filed his original False Claims Act (FCA) qui
tam complaint under seal on May 17, 2002. He filed his
First Amended Complaint on July 19, 2002 under seal. In June
2002, Mr. Gohil resigned from Aventis, and he initiated a
wrongful termination action against Aventis in New Jersey
Superior Court pursuant to New Jersey's Conscientious
Employee Protection Act and New Jersey's Law Against
Discrimination. In the state court lawsuit, Mr. Gohil alleged
that Aventis retaliated against him because he objected to
sales activities which violated federal and state laws,
including FDA regulations.
parties engaged in discovery in the New Jersey action.
Aventis produced tens of thousands of pages of training
materials, manuals, and journal abstracts about Taxotere. Mr.
Gohil took depositions of several current and former Aventis
employees. After the close of discovery but before any
judgment was entered, the parties settled the New Jersey
action on October 19, 2005. The settlement agreement included
a broad release of liability in favor of Aventis.
August 15, 2006, the Government declined to intervene in this
qui tam case. The case was unsealed and a summons
issued to Aventis on September 11, 2006. With leave of court,
Mr. Gohil filed the Second Amended Complaint under seal on
February 9, 2007; the Government again declined to intervene.
The Second Amended Complaint was unsealed on February 29,
First Amended Complaint outlined facts regarding FCA
violations for sales of both Taxotere and Anzemet (another
oncological drug product marketed by Gohil while working for
Aventis). The Second Amended Complaint deleted the majority
of facts and claims related to the sale of Anzemet, leaving
claims and facts regarding the sale of Taxotere as the
primary focus. The Second Amended Complaint also added
more detail about the Taxotere claims laid-out in the First
Amended Complaint. The Second Amended Complaint defined the
applicable timeframe as 1996 to 2004.
contentious jurisdictional discovery period (which included
an interlocutory appeal), the defendants moved to dismiss the
Second Amended Complaint based on several theories: the
general release the plaintiff executed in connection with the
settlement of the New Jersey lawsuit, the original source
requirements of the FCA, and the plaintiff's failure to
allege Aventis' supposed fraudulent conduct with
particularity as required under Rule 9(b). I denied that
motion in part and granted it in part. I dismissed Counts III
and IV of the plaintiff's Second Amended Complaint
without prejudice because those Counts were factually
defendants filed a motion for reconsideration of my decision
regarding the public disclosure bar's effect on claims
related to years 1996-1999 and 2002-2004. I denied that
granted the plaintiff leave to file a Third Amended
Complaint. The defendants again moved to dismiss Counts III
and IV of that complaint, arguing again that these claims
were factually deficient and did not meet the heightened
pleading standard of Rule 9(b), required of qui tam
pleading. See U.S. ex rel. LaCorte v. SmithKline Beecham
Clinical Labs., Inc., 149 F.3d 227, 234 (3d Cir. 1998).
I denied this motion and placed the parties on a discovery
defendants now move once more for the dismissal of Counts III
and IV under Rule 12(c)(i.e., a motion for judgment on the
pleadings), based on two legal defenses not previously
STANDARD OF REVIEW UNDER RULE 12(C)
the pleadings are closed--but early enough not to delay
trial--a party may move for judgment on the pleadings.”
Fed.R.Civ.P. 12 (c). When a defendant moves to dismiss a
claim because it fails to offer a basis upon which relief can
be granted under Rule 12(c), the same standard used in
deciding motions under Rule 12(b)(6) is applied to motions
brought under Rule 12(c). See, e.g., Turbe v.
Gov't of V.I., 938 F.2d 427, 428 (3d Cir. 1991);
United States v. Cephalon, --- F.Supp.3d ---, No.
08-287, 2016 WL 398014, at *2 (E.D. Pa. Feb. 2, 2016).
District courts may grant a motion for judgment on the
pleadings under Rule 12(c) “only if, viewing all the
facts in the light most favorable to the nonmoving party, no
material issue of fact remains and the moving party is
entitled to judgment as a matter of law.” Knepper
v. Rite Aid Corp., 675 F.3d 249, 257 (3d Cir.
2012)(citing Rosenau v. Unifund Corp., 539 F.3d 218,
221 (3d Cir. 2008)). See also Sikirica v. Nationwide Ins.
Co., 416 F.3d 214, 220 (3d Cir. 2005); Society Hill
Civic Ass'n v. Harris, 632 F.2d 1045, 1054 (3d Cir.
1980). “[I]f the pleadings do not resolve all of the
factual issues in the case, a trial on the merits would be
more appropriate than an attempt at resolution of the case on
a Rule 12(c) motion.” 5A C. Wright & A. Miller,
Federal Practice and Procedure § 1367, at 515 (1990).
defendants offer two grounds for dismissal: (1) they argue
that the plaintiff's claims dating between 1996 and 2000
are barred by the statute of limitations; and (2) the parts
of plaintiff's Counts III and IV of the Third Amended
Complaint based on “truthful, non-misleading
speech” are barred by First Amendment free speech
The False Claims Act Statute of Limitations
the False Claims Act (FCA), persons who submit fraudulent
applications for payment to the United States are liable to
the Government in a civil action for civil penalties and
treble damages. 31 U.S.C. § 3729(a)(1) (West 2015). The
qui tam provisions of the act empower private
individuals, like Mr. Gohil, to file lawsuits on behalf of
the United States seeking damages sustained by the Government
for the payment of false claims. 31 U.S.C. § 3730(b).
Relators, the citizen plaintiff in a FCA action, must file
their complaints under seal and serve the Government with a
copy of the complaint and disclosure of all material
evidence. 31 U.S.C. § 3730(b)(2). The court cannot lift
the seal until the Government investigates the claims and
either decides to take over the action or notifies the court
that it declines to intervene in the case. 31 U.S.C. §