Nine years after the whistle first blew, AbbVie and Abbott Laboratories have finally settled a marketing investigation claiming they beefed up prescriptions for the heart drug TriCor by handing out kickbacks and touting it for unapproved use.
The companies will share the $25 million settlement, which stems from alleged events from 2006 to 2008, when Abbott’s pharmaceuticals business—spun off as AbbVie in 2013—was still in-house.
It’s a tiny fraction of the $1.6 billion Abbott shelled out to wrap up its Depakote marketing case back in 2012, but the company previously paid $184 million to settle lawsuits claiming that it continually reformulated TriCor to fend off generics.
According to the TriCor whistleblower lawsuit, Abbott sales representatives persuaded doctors to increase prescriptions by handing out goodies to doctors, including gift baskets and gift cards, and shelling out consulting and speaking fees.
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Abbott also allegedly promoted TriCor for unapproved uses, the Department of Justice said in a statement. A fenofibrate designed to improve the balance of lipids in the blood, TriCor was only approved to treat patients with high triglycerides and high levels of LDL cholesterol, but Abbott representatives allegedly claimed it could do more, including treat or prevent cardiovascular complications.
Neither Abbott nor AbbVie admitted wrongdoing as part of the settlement, and neither company was required to strike a corporate integrity agreement—a promise to improve compliance practices and behave—though they’re a common feature in Justice Department marketing settlements.
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The federal investigation was launched after a former Abbott sales representative, Amy Bergman, filed a whistleblower lawsuit in 2009 under the False Claims Act. It was unsealed in 2012, when the Justice Department declined to join the case. At the time, Bergman’s attorney said she intended to press on with the lawsuit anyway and the government later decided to join in.
“Kickback schemes are a form of illegal pay-to-play business practices that have no place in our healthcare system; they interfere with physician-patient relationships and drive up the cost of health care,” said William McSwain, U.S. Attorney for the Eastern District of Pennsylvania. “Off-label promotion and marketing practices similarly prioritize drug companies’ profits over patient care.”
Bergman’s share of the $25 million settlement amounts to $6.5 million. “Ms. Bergman’s efforts, and those of her attorneys, were critical to our favorable resolution of this case,” McSwain said.
Meanwhile, AbbVie is facing a different set of kickback allegations, in this case from the California Insurance Commissioner. That lawsuit, filed last month, accuses AbbVie of using nurse "ambassadors" to care for Humira patients as a way to pump up sales for its megablockbuster drug.