Abbott Laboratories, the maker of Ensure, PaediaSure, Similac and Vicodin, pled guilty to misbranding and illegally marketing its drug Depakote. Abbott will pay a $1.6 billion fine and undergo five years of probation under an agreement reached with the U.S. Department of Justice in which Abbott admitted that from 1998 to 2006 it kept a separate, specially-trained sales force to market Depakote to nursing homes for the control of aggression and agitation in elderly patients with dementia, even though no credible scientific research existed showing Depakote was effective for that use. Abbott also admitted that from 2001 through 2006 it marketed Depakote for the treatment schizophrenia, in the absence of any proof that the drug was effective for that condition, either. Abbott funded two separate studies on the use of Depakote for schizophrenia, but neither study met its set goals. Abbott took two years to tell its sales force about the failed studies, and in the meantime kept marketing Depakote for schizophrenia. The case against Abbott arose in 2007 when a former Abbott saleswoman filed a lawsuit accusing the company of encouraging its sales force to illegally promote use of Depakote in nursing homes and publicly-operated mental health centers, where most patients are covered by federal health programs like Medicaid. Whistleblowers also filed suits against Abbott in Virginia, Illinois and the District of Columbia accusing the company of paying illegal kickbacks to doctors and pharmacists to discuss off-label uses of Depakote to increase sales.
Main source: Courthouse News Service, May 7, 2012