Abbott cholesterol drug subject of false-marketing suit
By Peter Frost, Tribune reporter
4:41 am, August 22, 2012
A former Abbott Laboratories saleswoman has filed a federal lawsuit against the company, accusing it of illegally promoting its cholesterol drug TriCor for uses not approved by regulators, including the prevention of cardiac health risks in patients with diabetes.
The suit was filed in September 2009 in U.S. District Court in the Eastern District of Pennsylvania by Amy Bergman. It was filed under the False Claims Act on behalf of the federal government, 22 states andWashington, D.C.
It was previously confidential under laws designed to protect would-be whistle-blowers who come forward with information about alleged health care fraud, but it was unsealed last week after federal and state governments declined to intervene.
Bergman, who says she was an Abbott saleswoman from 1999 through 2008, alleges in the suit that she was "trained, directed, incentivized, and encouraged" by Abbott to promote TriCor for so-called off-label and medically unnecessary uses. She also claims the company directed her to give illegal kickbacks to doctors to encourage them to prescribe the drug.
In doing so, she alleges, the company defrauded federal health programs, including Medicaid, for an eight-year period between 2000 and 2008.
Drugmakers are barred from actively promoting drugs for uses not approved by the Food and Drug Administration, though doctors have the discretion to prescribe drugs for so-called off-label uses.
TriCor is a prescription pill that was approved by the FDA in 1998 for use in reducing amounts of fatty substances in the blood like cholesterol and triglycerides and increasing high-density lipoprotein, or HDL.
It accounted for $987 million in U.S. sales in 2011, though it is scheduled to face generic competition this year, Abbott said in a securities filing.