Abbott Laboratories and AbbVie Inc. to Pay $25 Million to Resolve False Claims Act Allegations of Ki

https://www.justice.gov/usao-edpa/pr/abbott-laboratories-and-abbvie-inc-pay-25-million-resolve-false-claims-act-allegations

Department of Justice
U.S. Attorney’s Office
Eastern District of Pennsylvania

FOR IMMEDIATE RELEASE
Friday, October 26, 2018

Abbott Laboratories and AbbVie Inc. to Pay $25 Million to Resolve False Claims Act Allegations of Kickbacks and Off-Label Marketing of the Drug TriCor®

PHILADELPHIA – United States Attorney William M. McSwain announced today that pharmaceutical companies Abbott Laboratories and AbbVie Inc. (“Abbott”) will pay $25 million to resolve allegations that it employed kickbacks and unlawful methods of marketing and promotion to induce physicians to prescribe the drug TriCor®.

The settlement resolves allegations that, between 2006 and 2008, Abbott knowingly paid kickbacks to physicians in order to induce TriCor® prescriptions. Abbott, through its sales representatives, allegedly provided physicians with improper gift baskets, gift cards, and other items to induce prescriptions of TriCor®. Abbott also engaged health care providers for consulting services and speaking engagements, where one purpose of the remuneration for the programs was to induce or reward physicians for TriCor® prescriptions.

In addition to the kickback allegations, the settlement also resolves allegations that Abbott engaged in unlawful methods of off-label marketing and promotion relating to the sale of TriCor® for unapproved indications. The FDA-approved indications for TriCor® during this time period were for use, in conjunction with diet, to treat patients with hypertriglyceridemia, mixed dyslipidemia, or hypertriglyceridemia. However, Abbott marketed the drug off-label for: (1) use in treating, preventing, or reducing cardiovascular events and other cardiac health risk; (2) use in combination with statin drugs, and (3) use as a first-line treatment of diabetic patients, including treatment to prevent or reduce cardiac health risks in diabetic patients. These uses were not FDA-approved and were not covered by federal healthcare programs.
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As a result of today’s $25 million settlement, the federal government will receive $23.2 million, and state Medicaid programs will receive $1.8 million.