Anti-Epilepsy Drug Risk Of Birth Defect. Spina bifida is a condition where the bones around the spine do not form correctly. The anti-epilepsy drug Depakote increases the risk of this birth defect. A lawsuit is filed on behalf of a boy born with this condition. Plaintiffs allege that Abbott, the manufacturer of Depakote, neglected to warn of the risks. The boy’s mother began taking the drug in 2015 to treat her severe bipolar disorder and filed the lawsuit that same year.
Rate of Birth Defects
Plaintiffs in litigation presented expert witness testimony from Dr. Godfrey Oakley Jr., former director of the Centers for Disease Control and Prevention’s Division of Birth Defects and Development Disability. He testified before the Illinois jury that among mothers taking valproic acid, the active ingredient in Depakote, the rate of birth defects is 10 to 15 percent. The rate of spina bifida among this group is between 1 and 2 percent, which is between 40 and 80 times higher than babies who were not exposed to Depakote before birth. “There is no question on this drug that it causes spina bifida,” said Dr. Oakley, reports Law360.
In 1982, Dr. Oakley participated in a study showing that Depakote was linked to over a 20-fold increased risk of spina bifida. He noted that doctors should have been alerted to this risk. Spina bifida develops during the first 24 to 28 days after conception. “It happens before a woman knows she’s pregnant,” Oakley told jurors.
The trial is expected to last three weeks. The plaintiff is seeking damages for costs connected to the spina bifida, which may cost $30 million. This is the sixth Depakote spina bifida lawsuit to go to trial. A group of 25 plaintiffs was awarded $38 million, according to Law360.
National law firm Parker Waichman LLP has extensive experience representing clients in litigation alleging birth defects as well as other injuries. The attorneys are available to answer any legal questions for those seeking information for a potential lawsuit.
A recent European study confirmed that Depakote was linked to an increased risk of birth defects. The French National Agency for the Safety of Medicines (ANSM) and the national health insurance administration found that the medication is “highly teratogenic,” or harmful to a developing fetus.
Depakote Birth Defects History
The U.S. Food and Drug Administration (FDA) began notifying healthcare professionals about the risk of birth defects linked to Depakote in 2009. Plaintiffs in the litigation allege that women who took the drug and healthcare professionals were not aware of the risks to pregnant women.
Depakote was the second-most prescribed drug to treat epilepsy in 2006, according to Consumer Affairs. The FDA also approved the drug to treat bipolar disorder and migraines.
Now, the warning label for Depakote says that the drug can lead to serious birth defects in pregnant women. The FDA warns that children born to mothers who took Depakote are 12.5 times more likely to develop birth defects. Regulators warned in 2013 that Depakote and related drugs are contraindicated for pregnant women who suffer from migraines. The FDA cited a study revealing that the drug was linked to lower IQ scores in children whose mothers took Depakote while pregnant.
Depakote Off-Label Marketing
Abbott has also dealt with government allegations of off-label marketing (a drug used in a manner not approved by the FDA) with Depakote. A press release in May 2012 issued by the Department of Justice, said Abbott pleaded guilty and agreed to pay $1.5 billion to settle allegations that it promoted Depakote for elderly patients with dementia, even though the FDA had not approved it for this purpose. “Today’s settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud,” said James M. Cole, Deputy Attorney General. “We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”
Abbott admitted they had a specialized sales force focused on promoting Depakote in nursing homes to control agitation and aggression in elderly patients with dementia. A criminal investigation was launched and Abbot reached a $1.5 billion settlement with the FDA in 2012, for misbranding its product. Eight plaintiffs alleged that Abbot Laboratories and its competitor Abbie Vie were both aware of the risks valproate posed to unborn fetuses even before they actually began selling and marketing Depakote. The government also said Abbott marketed Depakote in combination with other medications to treat schizophrenia despite clinical proof showing otherwise.