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

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.

Dismissed.



Affirmed