Wilmington, DE On May 17, an investor sued AbbVie, alleging that the manufacturer of Humira defrauded investors by permitting the company to engage in an illegal “kickback scheme” that caused the value of the stock to plummet. The shareholder derivative lawsuit arises from a number of whistleblower lawsuits, including one filed in California in 2018. These brought to light AbbVie’s scheme to induce doctors to prescribe Humira by showering them with cash, meals, drinks, gifts, trips, patient referrals and the services of nurse “ambassadors.” Ranney v. Gonzalez is just the latest fallout from AbbVie’s controversial “white coat marketing” efforts.
While some see the work of the nurse ambassadors or nurse educators as a valuable service to patients, others see an abuse of the relationship of trust between medical professionals and patients. Still others see pharmaceutical companies working to create their own internal, closed health care systems. Ranney, however, focuses on whether the practice was bad business, especially since the “white coat” marketing scheme had already caused AbbVie to pay million-dollar settlements.
Humira was a big money-maker - with links to serious illnesses
Humira is an immunosuppressant medication often used to treat conditions like rheumatoid arthritis, juvenile idiopathic arthritis, Crohn's disease, plaque psoriasis, ulcerative colitis and psoriatic arthritis. However, it can also lower the body’s ability to fight infections or make an existing infection worse. It has been linked to serious conditions including cancer, heart failure, blood cell problems, liver problems and a lupus-like syndrome.
Separate and apart from the therapeutic plusses and minuses, however, AbbVie had important reasons to push Humira. Humira generated $20.7 billion in revenues for AbbVie in 2021. Hefty price increases for the drug during the previous year boosted apparently boosted Humira revenues after several years of relatively flat sales and growing competition from biosimilar drugs. Even before the recent price increases, however, a single uninsured injectable dose might reportedly cost as much as $2,500. In 2021, the latest round of price increases attracted Congressional hearings.
White coat marketing
In earlier lawsuits against several drug makers, whistleblowers raised questions about whether the use of nursing staffs — which AbbVie called “nurse ambassadors” — was medically appropriate.
The lawsuits contend the companies hired third-party contractors to deploy nurses — who interacted with patients by phone or through home visits — to ensure that prescriptions were refilled. The drug makers also allegedly provided kickbacks to physicians in the form of free insurance processing assistance, medical practice management software, and marketing assistance to persuade them to prescribe their drugs.
A common practice
It was not just AbbVie, of course. Eli Lilly used nurse educators for its insulin drugs to treat diabetes. The same is true of Gilead Sciences and its HIV and hepatitis C drugs. Bayer used nurse educators to market its cancer and multiple sclerosis drugs. Amgen used these medical professionals for cancer-related treatments, and AstraZeneca for blood thinners. Many, including patients and the nurses, argue that the nurses teach patients how to use complicated medications, work to resolve drug-related problems, and help with insurance paperwork. Was it a common practice? Certainly.
Is “white-coat marketing” an ethical practice?
That’s a harder question. It may depend on whether patients, themselves, benefit, whether the marketers gave medical advice, and whether the professional assistance provided by the nurses enabled and encouraged patients to keep taking Humira rather than exploring other options that might be less expensive and work as well or better. Was the treating physician’s medical judgment clouded by financial incentives?
But was it bad business?
In 2018 the California Department of Insurance, along with a nurse who had worked in AbbVie’s nurse ambassador program, brought a lawsuit that alleged that AbbVie violated the California Insurance Frauds Prevention Act.
The $24 million settlement that followed:
prohibited AbbVie from describing ambassadors to prescribing clinicians as extensions of their offices and providing them with any contact information for ambassadors who interact with patients;
required that ambassadors disclose to patients that they are paid by AbbVie and do not work under the direction of the patient's prescribing clinician;
required AbbVie to provide patients with the FDA–approved Humira medication guide;
required AbbVie to train nurse ambassadors to state that they do not provide medical or treatment advice and that patients should direct all medical questions and treatment-related questions to their prescribing clinicians; and
required that nurse ambassadors not be evaluated or compensated based on patient adherence to the company’s drug.
Evidence concerning the settlement amount (which is larger than the revenues generated by Humira for AbbVie in 2021) will certainly be an element of the plaintiffs’ case in Ranney. The lawsuit was only filed quite recently, so the positions of both sides have yet to fully develop. Nonetheless, it is worth watching how whistleblower lawsuits and the shareholder’s derivative lawsuit arguably work toward the same social goal of protecting the doctor/patient relationship.
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