Little more than four months after Abbott Laboratories plead guilty to charges that it aggressively promoted and sold its anti-epileptic drug Depakote for unapproved, off-label purposes, another lawsuit against the company has been unsealed, revealing that the drug giant may have pushed its cholesterol drug TriCor illegally in the same manner.
The whistleblower lawsuit, filed in September 2009 under the False Claims Act by former Abbott saleswoman Amy Bergman became public after federal and state governments declined to intervene.
According to the Chicago Tribune, “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.” The Tribune article further state that Bergman “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.”
The charges are remarkably similar to allegations that Abbott promoted Depakote for unapproved uses over several years starting in 1998 when it established and trained a specialized sales force to market the drug in nursing homes for the treatment of agitation and aggression in elderly dementia patients. This illegal practice continued for several years, even after Abbott was forced to discontinue a clinical trial of Depakote for dementia patients in 1999 when several patients began experiencing a number of adverse reactions.
Additionally, from 2001 through 2006, Abbott marketed Depakote as an effective treatment for schizophrenia, although its own earlier clinical studies found that Depakote wasn’t effective in treating the condition. Depakote failed the schizophrenia trials, but Abbott waited two years to inform its sales force of those results and another two years to publish them. Meanwhile, the company continued to promote the drug as an effective schizophrenia treatment.
Abbott agreed to settle the civil and criminal charges with the U.S. government for a near record $1.5 billion.