Abbott Laboratories and AbbVie Inc. have agreed to pay more than $25 million to settle a long-standing whistleblower lawsuit claiming the drug companies illegally promoted the triglyceride drug TriCor for off-label purposes and provided doctors and other prescribers with unlawful kickbacks to boost sales.
Amy Bergman, a former Abbott sales representative, filed the lawsuit under the whistleblower provisions of the False Claims Act in 2009. The U.S. Department of Justice declined to intervene in the case, but it moved ahead without the government’s direct involvement, surviving attempts by Abbott and AbbVie to have the case thrown out.
According to the whistleblower complaint, Abbott and AbbVie promoted TriCor for unapproved uses related to cardiac health risks when it was only approved by the U.S. Food and Drug Administration (FDA) to treat conditions related to high glyceride levels.
Although TriCor was not approved for treating various heart conditions, promotion of the drug for those purposes left taxpayers on the hook for the costs. Doctors prescribing TriCor for off-label uses to beneficiaries of government health care programs billed Medicare, Medicaid and Tricare for the treatments. The whistleblower complaint claimed this activity took place from 2006 through 2008.
The whistleblower complaint also claimed that Abbot and AbbVie fueled TriCor sales by providing meals, gift baskets, gift cards, and other unlawful kickbacks to physicians who pushed the drug on patients. The companies also paid generous sums to doctors for consulting and speaking engagements, which were really just another prop to increase TriCor prescriptions, the whistleblower complaint asserted.
“Federal law protects patients from medical providers who write prescriptions so they can enrich themselves, and from drug companies who do not play by the rules in their marketing and promotional efforts,” said U.S. Attorney William McSwain in an announcement.
“Kickback schemes are a form of illegal pay-to-play business practices that have no place in our health care system; they interfere with physician-patient relationships and drive up the cost of health care,” he said, adding that “off-label promotion and marketing practices similarly prioritize drug companies’ profits over patient care.”
Whistleblowers whose non-intervened False Claims Act cases lead to a recovery for the U.S. government are entitled to an award of up to 30 percent the total judgment or settlement. Ms. Bergman will receive a whistleblower award of $6.5 million – more than 26 percent of the settlement.