DOJ Intervenes in Depakote Whistleblower Lawsuit Over Illegal Marketing

Federal prosecutors are stepping in to take over three whistleblower lawsuits against Abbott Laboratories that claim the drug maker illegally promoted Depakote, an epilepsy medication. 

The U.S. Department of Justice (DOJ) has decided to intervene in lawsuits brought by former Abbott employees who claim that the company gave doctors seminars in off-label use of Depakote and then lied about what the seminars were about. The whistleblowers claim Abbott told doctors they could use Depakote to treat dementia and Alzheimer’s disease.

Depakote (valproic acid) is an anti-seizure drug approved by FDA in 1983 for the treatment of epilepsy. It belongs to a class of drugs based on valproate; which includes Depacon, Stavzor, and the first drug in the class, Depakene, which was first approved in 1978. It is also often used to treat bipolar disorder and depression.

The drug is not approved for the treatment of dementia or Alzheimer’s disease. While doctors are allowed to prescribe approved medications for non-approved uses, it is illegal for drug companies to promote such “off-label” uses that have not been approved by the FDA.

The Depakote lawsuit was originally filed by Susan Mulcahy, Doreen Merriam and Sondra Knowles, all from Massachusetts. Mulcahy and Merriam were specialty account executives with Abbott Laboratories at the time the lawsuit was filed and Knowles is a former employee. The details of the complaint were sealed until the DOJ announced it would intervene.

Under the qui tam provision of the False Claims Act, whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

According to the plaintiffs, Abbott threw what it called “Selling Skills Workshops” that taught sales reps how to promote Depakote for off-label uses and conducted stealth seminars for doctors on using the drug in nursing homes to treat dementia and Alzheimer’s disease patients. In addition, the lawsuit claims that Abbott offered sales representatives bonuses for off-label promotions, offered doctors kickbacks for prescribing Depakote, gave nursing homes false information about Depakote side effects and uses, and had favorable articles ghostwritten in medical journals.

Abbott Laboratories also faces a number of birth defect lawsuits over Depakote that have been filed by women who claim that use of the medication during pregnancy caused their children to suffer spina bifida, cleft palate, heart defects and other birth malformation. The complaints allege that Abbott failed to adequately warn about the risks associated with using Depakote during pregnancy.

In 2006, the FDA added a “black box” warning about the potential risk of a 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.

In May 2010, researchers found that Depakote side effects for unborn babies could be caused by using the drug as early as the first trimester, which means that by the time many women discover they are pregnant, it could be too late to get off the drug and avoid birth defects for their unborn child.