It was announced yesterday that Abbott Laboratories has pleaded guilty in a Depakote marketing case. According to the U.S. Department of Justice, Abbott promoted the drug for nonapproved uses. Depakote (divalproex sodium) is an anti-seizure medication approved to treat epilepsy, migraines. and bipolar mania.
In addition to pleading guilty, Abbott Laboratories agreed to pay $1.5 billion over the allegations, which includes a $700 million criminal fine and forfeiture, as well as civil settlements of $800 million with the federal government and states, said the Associated Press (AP). According to Deputy Attorney General James Cole, this settlement with Abbott reflects the government’s resolve “to hold accountable those who commit fraud,” wrote the AP.
At a Justice Department news conference, U.S. Attorney Timothy Heaphy said that the drug maker’s top levels systematically advertised Depakote for purposes other than what federal regulators had approved, said the AP, noting that the activities were not conducted by “some rogue sales representatives,” but, rather, were part of a long-term strategy conducted from 1998 to 2006. Heaphy is the U.S. attorney for the western district of Virginia.
In another case, Virginia Attorney General Ken Cuccinelli announced a $100 million settlement with Abbott over consumer claims in 45 states and the District of Columbia, said the AP. The claims were brought about under the Virginia Consumer Protection Act and involved Abbott’s promotion of Depakote for unapproved uses.
Abbott admitted to marketing Depakote for unapproved uses, such as the treatment of schizophrenia, agitated dementia, and autism, and to training a specialized sales force to market Depakote for the treatment of dementia, said the AP. Depakote, noted the AP, was not subject to federal mandates meant to ensure nursing home residents are not unnecessarily medicated.
Clinical trials were unable to show that Depakote was more effective than antipsychotic drugs in the treatment of schizophrenia, said the AP, citing the court papers.
Abbott has been at the center of a number of legal actions taken against it for allegedly violating consumer protection laws over how Depakote was sold and marketed. In addition to allegations of off-market labeling and a U.S. Justice Department investigation, litigation and investigation by a committee comprised of various attorneys general from different states, and eight lawsuits filed against Abbott, former and current Abbott directors and senior executives are facing shareholder derivative lawsuits claiming a breach of fiduciary duty.
Abbott was accused of promoting Depakote to treat unapproved conditions that also included sexual compulsions, in addition to schizophrenia, agitated dementia, and autism. According to prior whistleblower suits, Abbott has been marketing Depakote for off-label use since the 1990s.
Depakote litigation took place between 2007 and 2010, when former and current Abbott employees filed lawsuits. In February 2011, the U.S. Justice Department announced that it was joining the whistleblower lawsuits.