Depakote maker Abbott Laboratories has agreed to pay a total of $1.6 billion to settle claims that it allegedly marketed its anticonvulsant drug for off-label uses. The agreement marks the end of a four-year investigation into the marketing practice of Abbott, spurred by whistleblower claims that the drug firm marketed Depakote to doctors to treat autism, dementia and schizophrenia, even though it is only approved as a treatment for epilepsy, bipolar disorder and migraine headaches. While doctors are permitted to prescribe medications for off-label uses when they see fit, drug companies are prohibited from promoting their drugs for unapproved uses. Abbott is said to have engaged in this unlawful practice on an extreme level.
POTENTIAL DANGERS OF DEPAKOTE
Depakote is an anticonvulsant drug manufactured by Abbott Laboratories that has been on the market in the U.S. since 1983. Since that time, Depakote has been used successfully in the treatment of seizures associated with epilepsy and the manic phase of bipolar disorder, as well as in the prevention of migraine headaches. Unfortunately, Depakote’s success in these areas has been marred by its illegal promotion by Abbott and the potential for the anticonvulsant to cause birth defects in babies exposed to the drug in pregnancy. The active ingredient in Depakote is valproic acid, which functions by inhibiting the firing of certain impulses in the brain that cause seizures.
ILLEGAL USE OF DEPAKOTE IN NURSING HOMES
The most egregious of Abbott’s marketing actions involved elderly patients, said associated attorney general Tony West. The drug company admitted to training salespersons to market Depakote to nursing homes as a method of subduing elderly patients suffering from dementia. Abbott’s sales force apparently continued to engage in this behavior even after the company’s own clinical trials showed that such patients often suffer from anorexia, dehydration and drowsiness. The drug firm also reportedly provided doctors with illegal kickbacks.
DEPAKOTE LAWSUITS FOR BIRTH DEFECTS
While these nursing home patients and their families will not be taking part in the Depakote settlement, the monies will be distributed amongst the U.S. states that filed Medicare and Medicaid fraud claims. It is technically considered fraud for a company to cause doctors to prescribe and then bill the government for unnecessary, and perhaps dangerous, treatments. A number of additional Depakote lawsuits have been filed across the United States on behalf of parents who believe their children have been adversely affected by the anticonvulsant drug. Studies have shown that women who take Depakote while pregnant may have an increased risk of giving birth to babies with severe birth defects, including spina bifida, heart defects and neural tube defects.