Abbott Laboratories agrees to pay $1.6 billion dollar fine for illegal marketing of Depakote
The pharmaceutical maker announced this week that it would pay this combined criminal and civil fines by agreement with the federal government, after admitting that it violated federal law in marketing the anti-seizure medication. As seems to be the case in most pharmaceutical manufacturers' punishments, the fines probably don't even approach the profits the company earned by its illegal conduct.
Although Depakote was approved for sale by the FDA, the FDA did not approve its use for schizophrenia or dementia. Abbott illegally set up a "specialized sales force" that attempted to persuade nursing homes and others to purchase the drug to control patients' and residents' agitation. This effort to "sedate" elderly patients, without securing FDA screening of the use for this purpose, was considered particularly egregious, given the patients' inability to protect themselves or to give their informed consent.
Abbott also wrongly marketed the drug for schizophrenia, even though its own clinical trials had not proven the drug to be more effective than existing antipsychotic medications. Doctors may experiment with "off-label" or unapproved, untested uses of FDA-approved drugs, however, the manufacturer cannot market a drug for such an un-tested use. In Michigan, drug manufacturers enjoy immunity for FDA-approved drugs--even though the approval was not secured for the marketed use of the drug. Michigan is the only state that affords pharmaceutical manufacturers this form of immunity.