PHILADELPHIA–A Pennsylvania federal judge has refused to throw out a whistleblower’s claims that Abbott Laboratories submitted false claims to Medicare and other government health care programs and engaged in an illegal scheme of paying kickbacks to doctors in an effort to boost sales of its cholesterol drug TriCor.
Illinois-based drug giant Abbott Laboratories took legal action year seeking to have the lawsuit dismissed on the basis that its allegations were not specific enough.
U.S. District Judge C. Darnell Jones disagreed with those assertions, saying that the complaint, filed by former Abbott sales representative Amy Bergman under the U.S. False Claims Act, “provides myriad details of Abbott’s marketing statements that contradict its FDA-approved label.”
“Based on numerous allegations made in relator’s amended complaint about the off-label marketing of TriCor being based on false or misleading studies and the risks associated with those off-label uses, the amended complaint fulfills the pleading requirements,” the judge’s memorandum stated.
In her September 2009 lawsuit, Ms. Bergman alleged that Abbott ordered and trained its sales force to promote TriCor for unapproved and medically unnecessary purposes – a strategy big pharmaceutical companies sometimes use when the benefits are likely to outweigh any risks, such as potential civil fines and lawsuits.
According to Law360, the judge dismissed a few of the older allegations and a few state claims, but upheld most of the lawsuit’s allegations.
The U.S. Food and Drug Administration (FDA) approved TriCor to reduce cholesterol and lipid levels in some patients. Ms. Bergman alleges that Abbott pushed the drug as a treatment for cardiac health is diabetic patients and as a drug to be used in combination with statins, purposes which were not FDA approved. This activity lasted from 2002 to at least 2008, she alleges.
The lawsuit states that Abbott made marketing claims about TriCor’s efficacy and safety that weren’t backed by clinical studies. Knowing this, Abbott allegedly instructed Ms. Bergman and other sales representatives to downplay the risks while falsely underscoring efficacy by using clinical studies of other drugs.
Ms. Bergman also alleges that Abbott provided its sales force with funds to entice doctors to prescribe TriCor for unapproved purposes and as a reward for those who did – violations of U.S. Anti-Kickback laws.
The population targeted by Abbott’s TriCor sales campaign included the elderly, poor, disabled, and any others likely needing assistance from taxpayer-funded health care programs.