Lawsuit: AbbVie Used Kickbacks and Nurse Ambassadors to Boost Humira Sales

The State of California has filed suit against drug maker AbbVie, alleging that the company provided kickbacks to healthcare providers throughout the state to encourage them to prescribe its brand-name adalimumab, Humira, and used a network of registered nurses to mislead patients about the risks associated with the drug.

According to the heavily redacted lawsuit, AbbVie engaged in a “classic” kickback scheme by offering prescribers cash, meals, drinks, trips, and patient referrals. It also provided physicians with valuable goods and services, such as insurance and prior authorization processing, as well as practice management hardware and software.

The lawsuit centers on AbbVie’s use of a network of registered nurses, called Ambassadors, who visited patients in their homes. These nurses trained patients on administering their subcutaneous injections and provided patient care, paperwork help, and other services, all of which alleviated burdens on prescribers’ practices in exchange for selecting Humira from a range of available treatments.

However, says the suit, these nurses were explicitly trained by AbbVie to downplay the risks of taking Humira, which carries black box warnings for serious adverse events (AEs), such as malignancy. The Ambassadors were also trained to avoid answering any questions about AEs by offering to help patients get their Humira for under $5 per dose.

Also included in the lawsuit are allegations that AbbVie used its employees to suggest that patients take higher doses of Humira than are FDA approved in order to sell more of the drug.

AbbVie’s alleged scheme was brought to light by Lazaro Suarez, a registered nurse in Florida, who worked for AbbVie via a subcontractor, QuintilesIMS (now IQVIA), as a nurse educator and patient ambassador between 2013 and 2014. According to the suit, Suarez became aware of the nationwide reach of AbbVie’s nurse network because his success as an Ambassador led him to a role as a trainer of other staff.

While Suarez initially took the job as an Ambassador to help care for patients with challenging diagnoses, says the suit, he later “…felt that the focus of the Ambassador program was getting and keeping patients on Humira to maintain and increase AbbVie’s profits.”

The State of California has demanded a jury trial, and is seeking injunctive relief, assessments of 3 times the amount of each claim for compensation for insurance contracts on Humira, and civil penalties of $10,000 for each fraudulent claim presented to an insurance company.

This is not the first occasion on which AbbVie has been accused of using unfair means to increase its profits on its top-selling product. In August, the Initiative for Medicines, Access, and Knowledge, a public interest group, released a report that called AbbVie “the worst patent offender” in the pharmaceutical landscape for forging a patent estate around Humira while raising the drug’s price by 144% since 2012. Furthermore, given AbbVie’s settlements with biosimilar developers that will not allow a biosimilar adalimumab to reach US patients prior to 2023, US lawmakers have called on the Federal Trade Commission to investigate whether AbbVie’s settlements are lawful.