United States District Court, N.D. Illinois, Eastern Division
UNITED STATES EX REL. JANICE KEEN, Plaintiff and Relator,
TEVA PHARMACEUTICALS USA INC., TEVA PHARMACEUTICAL INDUSTRIES LTD., CEPHALON, INC., AND TEVA SALES AND MARKETING, INC., Defendants.
MEMORANDUM OPINION AND ORDER
JORGE L. ALONSO United States District Judge
Janice Keen, brings this case on behalf of the United States
under the False Claims Act, 31 U.S.C. §§ 3729
et seq., against her employer, defendant Teva
Pharmaceuticals USA, Inc., and other associated business
entities (collectively, “defendants” or
“Teva”). Defendants move to dismiss. For the
following reasons, the motion is granted.
2005, relator began working for defendant Cephalon, Inc.
(“Cephalon”) as a pharmaceutical sales
representative. Teva subsequently acquired Cephalon as a
wholly-owned subsidiary in 2011.
sales representative for Cephalon and then Teva, relator
participated in promoting, marketing, and selling Amrix, a
prescription medicine used to treat muscle spasms. Relator
alleges in her complaint that after Teva acquired Cephalon,
it began to train its sales force to market Amrix in a
deliberately misleading way by emphasizing visual aids and a
simple “core message”-“Amrix is the only
once-daily extended release cyclobenzaprine”-without
devoting sufficient attention to details critical to ensuring
safe and effective use of Amrix.
particular, relator alleges that Teva marketed Amrix
“off-label, ” or for use in a manner for which it
had not received regulatory approval. Relator contends that
Teva's marketing tactics were misleading in four ways.
she alleges that Teva misleadingly promoted Amrix as not
merely an “adjunct” to rest and physical therapy
but as a treatment that was sufficient by itself to stop
muscle spasms. Teva's promotional materials contained
pictures of people engaged in strenuous activities, as if
Amrix alone had enabled them to participate in those
activities, and Teva instructed its salespeople to emphasize
these visual aids in promoting Amrix. Additionally, it
instructed salespeople to give iPad presentations, which
allowed them to breeze through safety information that was
difficult to see on the small iPad screens.
relator alleges that Teva promoted Amrix beyond its approved
use to treat “acute” cases on a short-term basis,
i.e., for periods of two to three weeks, by
distributing co-pay coupons that patients most often used to
obtain thirty doses of Amrix, or a month's supply.
Additionally, Teva promoted Amrix to physicians who worked in
pain clinics and predominantly treated patients with chronic
pain, without warning these physicians that Amrix was
approved for short-term use in acute, not chronic, cases.
relator alleges that Teva misleadingly overstated the
efficacy of Amrix by promoting it as a treatment that will
allow patients to get back to their everyday activities, when
in fact Amrix had not been shown to significantly expand the
range of activities patients could engage in.
relator alleges that Teva omitted from its promotion of Amrix
the “fourth arm” of the Amrix study, which dealt
with daytime drowsiness. Teva trained its sales force to use
as a selling point the fact that fewer patients treated with
Amrix reported extreme drowsiness than patients treated with
generic, immediate-release cyclobenzaprine. However, the
difference is only a few percentage points; 17-19% of Amrix
patients reported extreme drowsiness, whereas 24% of generic
cyclobenzaprine patients did. Relator alleges that Teva's
sales presentations should have used the actual figures of
the fourth arm of the Amrix study, rather than misleadingly
citing facts without providing the proper context for
amended complaint consists of four counts. In Count I,
relator claims that Teva violated the False Claims Act, 31
U.S.C. § 3729(a)(1)(A) and (B), by knowingly causing
physicians to prescribe Amrix in situations for which it was
not approved for use, with the effect that pharmacies
submitted false claims to United States government health
care programs, such as Medicare and Medicaid, seeking payment
for filling Amrix prescriptions.
Count II, relator alleges that Teva's off-label marketing
violated the terms of a Corporate Integrity Agreement
(“CIA”) that Cephalon entered into with the
Office of Inspector General (“OIG”) of the
Department of Health and Human Services. The CIA required
Teva to report and correct any “probable violation[s]
of criminal, civil, or administrative laws applicable to any
federal health care program and/or applicable to any FDA
requirements relating to the promotion of Cephalon products,
” and it set out stipulated penalties for any breach.
(Am. Compl. at ¶ 24, ECF No. 22.) Relator claims that
Teva is liable under 31 U.S.C. § 3729(a)(1)(G) for
failing to pay the stipulated penalties it owes under the
Counts III and IV, relator makes similar claims under the
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