Abbott Laboratories are subject to pay for their off-labeling marketing of the drug, Depakote. They have pleaded guilty to the unlawful promotion they have submitted various health facilities to, specifically elderly homes.
Abbott misbranded Depakote to gain more profits from mostly senior aged patients. They claimed that it could control agitation and aggressions in dementia patients, and that it also could treat schizophrenia. Not only was neither use approved by FDA, but Abbott ran their own studies on whether Depakote could control agitation and aggression in dementia patients along with schizophrenia. Both studies failed in these treatments. The FDA had only approved drug for epileptic seizures, bipolar mania and prevention of migraines. Abbott even had to discontinue sales of Depakote for use of dementia back in 1999, because of the negative side effects that accompanied it.
They had marketed their drug to be combined with another atypical anti-psychotic to treat schizophrenia, even though test results showed that the mixture of Depakote did not have any effect. The use of the single atypical anti-psychotic drug was enough treatment without Depakote. They had even developed programs and materials to train consultant pharmacists about the off label use to encourage the unapproved usage.
“Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies,” said the acting associate attorney general involved with the case. “As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price.” (Frieden Watkins, 2012)
Abbott is subject to pay $1.6 billion, which is the second largest fraud settlement involving a drug company.
KP Law is dedicated to serving those who are persecuted by drug companies. This kind of abuse could even be labeled as elderly abuse, in which KP Law will also not stand for. If you or a loved one has been taken advantage of by a drug company, then call KP Law for a free consultation.