Abbott Labs and Abbvie Inc. pay $25 million to settle with Government on allegations of kickbacks and off label marketing of TriCor

Pharmaceutical companies Abbott Laboratories and AbbVie Inc. (“Abbott”) will pay $25 million to settle federal allegations that it paid kickbacks and unlawfully marketed and promoted the drug TriCor® 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. The only FDA-approval  for TriCor® during this time period were for use, in conjunction with diet, to treat patients with hypertriglyceridemia, mixed dyslipidemia, or hypertriglyceridemia.

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. As a result of the $25 million settlement, the federal government will receive $23.2 million, and state Medicaid programs will receive $1.8 million.

This settlement resolves allegations in a lawsuit filed in the Eastern District of Pennsylvania by Amy Bergman, a former Abbott sales representative, under the qui tam, or whistleblower, provisions of the False Claims Act.  The qui tam provisions permit private parties to sue for false claims on behalf of the government and to receive a share of any recovery.  Ms. Bergman will receive $6.5 million as her share of the recovery in the case. Attorneys Marc Raspanti, Pam Brecht, Mike Morse and Bob Nicholson of Pennsylvania represented Ms. Bergman.

The lawsuit is captioned United States ex rel. Amy Bergman, et al. v. Abbott Laboratories, Civil Action No. 2:09-cv-04264999 (E.D. Pa.).  The claims resolved by the settlement are allegations only; there has been no determination of liability.