Abbott bolstered the drug's sales by marketing TriCor in a “deceptive manner — including through kickbacks, misleading and off-label marketing,” the news release says.
According to the lawsuit, the company marketed TriCor as a treatment for heart health risks in diabetic patients even though the drug had not been approved for that use by the U.S. Food and Drug Administration.
The company “made regular representations concerning the efficacy of TriCor which were contrary to the FDA-required labeling, were false and misleading and which did not present the FDA-required fair balance of information regarding uses and risks,” the lawsuit alleges.
The FDA has approved TriCor for treatment of high cholesterol.
The suit was filed in 2009 in U.S. District Court in Philadelphia, under the federal False Claims Act, but it was not unsealed until last week, after the U.S. Department of Justice decided not to take over the case. A decision by the federal government not to intervene in such cases typically includes an evaluation of the likelihood of winning.
One of Ms. Bergman's lawyers, Robert Nicholson, of Fort Lauderdale, Fla., said the Justice Department's decision would not affect the outcome of the case, according to a story published today by the Chicago Tribune.
An Abbott spokesman said in an emailed statement that the allegations are without merit.
TriCor, which is scheduled to face competition from generic versions this year, is among the products to be sold by AbbVie, the pharmaceutical company Abbott plans to spin off later this year.