Abbott Laboratories has been sued by a number of people regarding the side effects of Depakote, many of whom claim the drug caused birth defects. It has been reported that Abbott Labs is also talking to federal prosecutors to settle Depakote cases brought by the government, which involve accusations of illegal marketing practices for Depakote. Depakote is brand name of divalproex sodium. It is used for treating various types of seizures, as well as manic and bipolar disorders, epilepsy and migraines. The number of lawsuits against Depakote is increasing sharply day by day.

One lawsuit against the maker of Depakote has attracted significant attention, as government has intervened in it. In that lawsuit, three former employees alleged that Abbott Labs tried to promote Depakote for “off-label” treatment of Alzheimers and as a chemical restrainer for elderly patients. The company promoted it to calm down patients of old age who get aggressive or agitated, and the government believes it risked lives by doing so.  Depakote causes severe side-effects and its off label use can result in harmful effects.

Depakote was approved by the FDA in many phases. It was approved to treat epilepsy in 1983. In 1995, it was approved by the FDA for treating migraine headaches. Finally, it got approval for treating manic or bipolar disorders. But it is extensively prescribed for other non-approved, or “off-label” conditions. It is used to treat different types of seizure disorders.  It is widely used to treat dementia or Alzheimer’s disease, for which it is not approved. Under FDA regulations, it is illegal for a drug manufacturer to promote non-approved uses of a drug.

In addition to lawsuits involving personal injuries resulting from the side effects of the drug, Depakote was also the subject of a whistleblower lawsuit filed by Susan Mulcahy, Doreen Merriam and Sondra Knowles. All the plaintiffs are from Massachusetts. Mulcahy and Merriam worked with Abbott as specialty account executives and Knowles was also an employee at Abbott Labs. Details of case were revealed after intervention by the US Department of Justice. On May 20, 2011 the Department of Justice informed a federal judge that it was intervening in the matter and is talking to the pharmaceutical company regarding settlement of this case. It asked the court to postpone case deadlines to allow the parties to continue settlement talks.

The whistleblower who reports a false claim or act that defrauds the government are able to get a portion of money recovered by government from the lawbreaker under the qui tam provision of the False Claim Act. The whistleblower should be the first person to bring the case before government. He or she cannot divulge any details about the case before the intervention of Department of Justice.

Abbott has been facing numerous lawsuits over side effects of Depakote. Most cases are related to spina bifida. Spina bifida is believed to be caused in newborns when mother are prescribed Depakote during pregnancy. The effects can be more pronounced and even fatal if taken during first trimester of pregnancy, especially in first 28 days. Depakote has been reported to be linked with spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems in newborns.

FDA asked the manufacturer to add a black box warning regarding these risks in 2006. It is advised that pregnant women, women planning to have a baby and women in their childbearing age avoid use of Depakote and consult a doctor before using it.

The intervention by the U.S. Department of Justice has been a set back for Abbott Labs, and the company will undoubtedly face hard times in other lawsuits involving Depakote as well.

###LT