Jeffrey Lewis v. AbbVie, Inc., f/k/a Allergan

Date: 09-05-2025

Case Number: 20-CV-956

Judge: Damon R. Leichty

Court: United States District Court for the Norther District of Indiana (St. Joseph County)

Plaintiff's Attorney:

Defendant's Attorney:

Description: South Bend, Indiana employment law lawyer represented the Plaintiff claiming he was retaliated against for whistle blowing.

This case stems from Jeffrey Lewis’s experience as a sales
representative for AbbVie, a global pharmaceutical manufac-
turer, in 2019 and 2020. As a salesman, Lewis marketed
AbbVie’s drugs to medical providers to increase prescrip-
tions, and thus, revenue for AbbVie. We focus on one type of
advertising practice—“off-label” marketing.
A medical provider can prescribe a drug for either (1) its
Food and Drug Administration (FDA) approved use on the
label or (2) its unapproved “off-label” use. The Food, Drug,
and Cosmetic Act (FDCA) and accompanying regulations
generally prohibit pharmaceutical companies like AbbVie
from promoting off-label uses to the public or medical pro-
viders. 21 C.F.R. §202.1(e)(6)–(7). Providers are free to pre-
scribe drugs for off-label use, but drug companies cannot be
the ones to suggest the idea.2
Another rule of thumb important to this case: Medicare
and Medicaid do not reimburse off-label prescriptions unless
one of three medical compendia have sanctioned the use.
During his employment with AbbVie, Lewis was “regularly
made to re-certify [his] awareness and understanding” that
off-label marketing was unlawful and told that non-
compliance with these regulations “constitute[d] a personal
and corporate risk” of “state and federal anti-fraud statutes.”
Vraylar is one of AbbVie’s drugs. It is an antipsychotic
medication the FDA has approved for treating schizophrenia,
bipolar mania, and bipolar I depression. Bipolar depression is
medically distinct from major depression disorder (MDD) be-
cause MDD patients do not experience mania and mixed emo-
tion episodes, a necessary feature of a bipolar diagnosis.3 As
such, the FDA has approved different medicines and thera-
pies for bipolar depression and MDD. Specifically, there are
only three approved antipsychotic drugs for treating MDD;
Vraylar is not one of them.
Any use of Vraylar to treat MDD is off-label. The only way
a provider could deploy Vraylar on-label in MDD treatment
is when they believe the patient actually presents with bipolar
depression, in addition or alternate to MDD.
But according to Lewis, after the FDA approved Vraylar
for bipolar depression treatment, AbbVie began aggressively
peddling the drug to providers for off-label uses. From 2019
to 2020, AbbVie pushed Vraylar as an effective medicine for
(1) substance abuse and (2) MDD.
Regarding substance abuse treatment, AbbVie identified
practitioners who were known to prescribe Vraylar for addic-
tion treatment and paid them to speak at AbbVie’s lecture se-
ries. At these events, the speakers encouraged the audience,
comprised of other providers, to follow their lead of using
Vraylar to combat substance abuse. After several of these
talks, some audience members told Lewis they took that ad-
vice. AbbVie also had Lewis convey the results of a “study”
purporting to show that Vraylar was an effective addiction
treatment drug on provider visits. The “study” consisted of
one clinician’s experience.
AbbVie’s MDD off-label campaign was more extensive.
Beginning in 2019, the company trained its sales representa-
tives to pitch Vraylar as an early treatment option for patients
with MDD, premised on the notion that bipolar depression
and MDD were hard to distinguish. The message to providers
was to eschew standardized protocol for diagnosing MDD
and immediately turn to Vraylar.
The campaign came amid an ambitious sales target for em-
ployees like Lewis. Every representative was to recruit 200
new Vraylar prescribers, each writing 7 to 10 prescriptions per
week, by year’s end. To do so, AbbVie pushed representatives
to position Vraylar as a Selective Serotonin Reuptake Inhibi-
tor (SSRI) replacement, which it was not. SSRIs constitute an
important part of many MDD treatment plans. But because
Vraylar was not an SSRI, characterizing it as one was off-label.
Nonetheless, if questioned by providers, Lewis was to assure
them not to worry about labels. Internal documents reflected
the same guidance. Vraylar was a “Great Antidepressant,”
and providers should avoid labeling.
The company advanced a full-court press strategy. In ad-
dition to honing the SSRI-substitute message, AbbVie propa-
gated a study—also to be used in pitches—to falsely claim
Vraylar must be used earlier in MDD treatment plans. More-
over, as with the substance abuse playbook, the firm utilized
its paid speaking program to reward and incentivize provid-
ers who prescribed Vraylar for MDD. These opportunities
compensated speakers $1,500 to $2,500 per hour. And,
AbbVie directed its Vraylar message to “mid-level” provid-
ers, like nurse practitioners or internist doctors, rather than
psychiatrists, because they were easier to persuade than those
with greater bipolar and MDD expertise.
The campaign seemed to pay off. Anecdotally, specific
providers told Lewis they began to prescribe Vraylar for
MDD treatment. Stepping back, Vraylar sales increased 88%
6 No. 24-3121
in the first three fiscal quarters after AbbVie began the off-
label project, and revenue from Vraylar sales increased 70%
in the second quarter of 2020 alone. Critically for the claims
Lewis brought, Medicare and Medicaid account for roughly
40% of annual prescription drug spending in the United
States.
Despite AbbVie’s ongoing success, Lewis faced blowback
for refusing to push Vraylar’s off-label use. When he did not
comply with company messaging, he was told to hammer
practitioners harder about Vraylar as a MDD drug or else risk
replacement by a “bolder” representative. He dug in, and
complained to his direct supervisor and the Human Re-
sources Department about the off-label initiative. By the sum-
mer of 2020, he was emailing HR that he worried about being
“noncompliant” when pitching Vraylar off-label and related
issues of “corp policy.” He alleges to have raised concerns
over the program’s “illegality,” but never framed his internal
grievances as related to defrauding the government through
the off-label campaign. Instead, he complained of regulatory
risks. As a result of his whistleblowing, Lewis claims to have
lost a promotion and received excessive work.
In November 2020, Lewis brought a False Claims Act
(FCA) qui tam action against AbbVie. Relevant to this appeal,
Lewis argued that AbbVie violated the FCA by (1) causing the
government to pay fraudulent insurance claims, 31 U.S.C.
§3729, and (2) retaliating against him for whistleblowing. 31
U.S.C. §3730(h). The government investigated for four years
before deciding not to intervene. Shortly after, AbbVie filed a
motion to dismiss.

Outcome: Dismissed.

Affirmed

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Defendant's Experts:

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