AbbVie has had success growing Humira sales to the top position in biopharma globally, but a new lawsuit in California alleges the company used a massive fraud scheme to protect revenues at the expense of patient safety.
California’s insurance commissioner Doug Jones on Tuesday unveiled the suit (PDF) against AbbVie, alleging the company paid kickbacks to doctors and used a network of nurse "ambassadors" to cut out communications between patients and their doctors.
On a call with reporters Tuesday, Jones said AbbVie paid out cash, meals, drinks and more to secure scripts for the world’s bestselling drug. But the scheme went further than that, he added.
AbbVie hired a network of "ambassadors" to go into patients' homes and provide care and assistance, the state claims. California says AbbVie provided nurses to physicians at no cost in exchange for Humira prescriptions.
Jones said the scheme was "particularly egregious" because when patients brought concerns over side effects and more to their ambassadors, the nurses didn’t take those complaints to physicians. As AbbVie employees, the nurses served as a communication "cut out" to protect AbbVie’s interest of maintaining and growing Humira prescriptions, according to the commissioner.
An AbbVie nurse whistleblower in Florida brought the alleged conduct to the California department’s office. Private insurers paid out $1.2 billion in Humira claims from 2013 to August 2018, according to the commissioner, and now the state wants to recoup losses and more.
A representative for the company said AbbVie believes "the allegations are without merit."
"AbbVie operates in compliance with the many state and federal laws that govern interactions with healthcare providers and patients," she said. The company’s nurses do not "replace or interfere with interactions between patients and their healthcare providers," she added.
The company has faced scrutiny over Humira’s patents and prices in recent years, even as the company's stock price and sales have soared. In a patent lawsuit defense, biosimilar maker Boehringer Ingelheim alleges the company pursued overlapping and non-inventive patents to develop a "patent thicket" and protect the blockbuster. A report from Initiative for Medicine, Access & Knowledge on Tuesday found that 89% of Humira’s patents were filed after the FDA had already approved the drug.
Humira brought in more than $18 billion last year, representing about two-thirds of AbbVie’s total sales.
As it has worked to defend the product, AbbVie has settled patent lawsuits in recent months with other biosim makers that allow their competitors to enter the U.S. market in 2023. Meanwhile, Europe will start to see biosim competition next month.
AbbVie’s shares were down about 2.5% Tuesday afternoon after the announcement.
Other drugmakers Eli Lilly and Novo Nordisk have each faced allegations of using nursing services as kickbacks in recent years. Novo, for its part, reached a deal on its allegations last May. A judge tossed the case against Eli Lilly last month on grounds that the allegations weren’t specific enough, but he gave the plaintiffs a chance to restate their claims.
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