Depakote Lawsuit Considered by Attorneys General Over Marketing

A group of attorneys general are considering whether to file a lawsuit over Depakote, bringing criminal charges against Abbott Laboratories over how it marketed the popular epilepsy drug. 

The committee of attorneys general are from eight states who believe the company may have violated their consumer protection laws by marketing the medication for off-label uses, according to a report disclosed this week by Abbott Laboratories. The company has already set aside $1.5 billion to settle similar claims brought by the U.S. Justice Department (DOJ).

Off-label marketing occurs when a drug manufacturer promotes a drug for uses not approved by the FDA, which is illegal. While doctors may prescribe approved medications for any reason they deem appropriate, companies are barred from marketing or encouraging such use.

According to allegations raised by the DOJ, Abbott promoted Depakote for use as a nursing home “chemical restraint”, suggesting that it could reduce aggression and agitation among the elderly. The attorneys general who are now considering a claim for payments made by their states come from Florida, Illinois, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina and Texas.

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, it has been widely used off-label for other purposes.

Abbott Laboratories also faces a number of Depakote lawsuits filed on behalf of minor children who were born with birth defects and malformations after their mothers were given the medication during pregnancy.

Side effects of Depakote pregnancy use has been linked to a risk of severe health problems for unborn children, especially when the drug is taken during the first 28 days of the pregnancy, when neural tube closure and other critical formations are taking place.

In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.

One of the more commonly reported problems involves children diagnosed with spina bifidia after Depakote use during pregnancy.  However, other birth defects associated with Depakote include, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems.