On October 26, 2018, it was announced that Abbott Laboratories and AbbVie Inc. (collectively “Abbott”) settled allegations that the company employed kickbacks and other unlawful methods of marketing and promotion to induce physicians to prescribe the drug TriCor®. A former Abbot sales representative, Amy Bergman, brought the lawsuit under qui tam provisions of the False Claims Act.
The case resolves allegations that from a period from 2006 and 2008, Abbott knowingly paid kickbacks to physicians to get them to prescribe TriCor, including improper gift baskets, gift cards, and other items. Abbott also allegedly 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 prescribing TriCor prescriptions.
In addition to the alleged kickbacks resolved by this settlement, allegations of unlawful methods of off-label marketing and promotion for TriCor for unapproved indications were also resolved. During the period in question, the FDA had approved TriCor for patients with hypertriglyceridemia or mixed dyslipidemia. However, Abbott marketed the drug 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,” uses not FDA-approved and not covered by federal healthcare programs.
United States Attorney General William McSwain announced the settlement, saying, “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. Off-label promotion and marketing practices similarly prioritize drug companies’ profits over patient care. We are proud to partner with HHS-OIG to protect the integrity of our health care programs.”
The settlement figure is $25 million, of which the federal government will receive $23.2 million and state Medicaid programs will receive $1.8 million. Ms. Bergman, the qui tam relator, will receive $6.5 million as her share of recovery in the case.
Prior Allegations and Settlements
Abbott is no stranger to False Claims Act or off-label marketing allegations and settlements. In 2012, Abbott Laboratories, Inc. agreed to pay $1.6 billion to resolve civil and criminal allegations that it promoted Depakote for uses not approved by the United States. In that case, it was more than just a settlement resolving allegations, Abbott actually pled guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding. At that point, Abbott entered into a Corporate Integrity Agreement (CIA) for five years.
Then, in December 2013, Abbott Laboratories agreed to pay $5.475 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce doctors to prescribe several different vascular prescriptions, including paying physicians for teaching assignments, speaking engagements, and conferences.