Abbott Faces Lawsuit for Depakote Off-Label Marketing

Baltimore, MDWhen it comes to marketing drugs like Depakote, drug companies are expected to adhere to the law and not market the drug for unapproved uses. Patients expect that they can look at Depakote's label and see a full list of Depakote side effects, which reportedly includes a risk of Depakote birth defects. Lawsuits filed against Abbott, however, allege the company not only marketed Depakote for unapproved use, but also failed to adequately warn patients about the risks associated with the medication.

According to The Wall Street Journal (02/07/11), the US Justice Department announced it will take over at least some lawsuits filed against Abbott, which alleged the company promoted off-label use of Depakote. The lawsuits were initially filed by whistleblowers—current or former Abbott sales representatives—between 2007 and 2009.

According to the lawsuits, Abbott marketed Depakote for the treatment of conditions that the FDA had not approved. Depakote is FDA-approved for seizure disorders, bipolar disorder and migraine prevention. Although Abbott allegedly marketed the drug for treatment of dementia, Alzheimer's disease and schizophrenia, it is not approved to treat those conditions.

Off-label use of a medication is not illegal. It is, however, illegal for a company to market a drug for off-label uses.

Investigators are also examining whether Abbott violated Medicare or Medicaid reimbursement laws in marketing Depakote for off-label use.

Meanwhile, more lawsuits have been filed against Abbott alleging Depakote caused birth defects. The lawsuits allege that Abbott marketed Depakote while downplaying the risks of birth defects, even though valproic acid (the main ingredient in Depakote) is reportedly known to cause birth defects if taken during the early stages of pregnancy.

Plaintiffs accuse Abbott of making and marketing a defective product. According to The Record (02/01/11), more than two dozen parents from across the US filed a lawsuit together in St. Clair County.

Depakote has allegedly been linked to birth defects, including spina bifida, heart defects and genital defects. Other birth defects reportedly linked to the use of Depakote include cleft palate, undescended testes and hand malformations.

The US Food and Drug Administration (FDA) has classified Depakote as pregnancy category D because of the risk of serious birth defects in children exposed to the medication prior to birth.