A popular antiepileptic drug, Depakote (divalproex sodium) is also prescribed for the treatment of migraine headaches and bipolar disorders’ manic phases. It is sometimes prescribed in conjunction with selective serotonin reuptake inhibitors (SSRIs).
First introduced in the U.S. in 1983 by global pharmaceutical company, Abbott Laboratories, Depakote has been used by millions of patients. Since 2013, Abbott’s spinoff, AbbVie, has been manufacturing the drug.
Depakote has been linked to serious complications such as birth defects, which have resulted in numerous lawsuits.
Depakote is associated with a wide-range of medical complications from loss of appetite to more serious and debilitating side effects such as birth defects and suicidal thoughts and behavior.
In 2013, the U.S. Food and Drug Administration (FDA) issued a public safety communication regarding Depakote and other valproate drugs. The FDA warned that because valproate drugs were associated with lower IQs in children, pregnant women should not take these medications for the prevention of migraines. The FDA also advised that pregnant women being treated for epilepsy or manic episodes/bipolar disorder should only take valproate drugs if the benefits of the drug outweigh the risks of birth defects.
In a study published in the New England Journal of Medicine, researchers studied women who had taken valproic acid drugs during their first trimester of pregnancy and compared them to women who had not taken the drugs. Findings showed women who had taken a valproic acid drug early in pregnancy may have more than 12 times increased rate of giving birth to a child with spina bifida compared to women who had not taken the drug. The study also showed increased risk for cleft palate, craniosynostosis (abnormal skull development), atrial septal defect (heart defect), polydactyly (extra finger or toe), and hypospadias (penis abnormality).
In 2008, the FDA issued a safety alert warning that patients who take antiepileptic drugs may have an increased risk for suicidal thoughts and behavior. The FDA subsequently required drug manufacturers to update their prescription labels to include a warning about this risk.
The Department of Justice (DOJ) launched an investigation into Abbott Laboratories’ alleged misbranding of Depakote. The DOJ claimed that the company had illegally promoted Depakote for uses the FDA hadn’t approved. In May 2012, Abbott Laboratories pleaded guilty to a criminal misdemeanor for misbranding Depakote. The company agreed to settle the government’s criminal and civil claims for $1.5 billion.
Under product liability law, manufacturers and sellers have a duty to ensure that their prescription drugs meet certain patient standards. Prescription drugs must be defect-free and safe for patient use. Drug manufacturer and sellers can be held responsible for any injury that results if a prescription drug carries a product defect that is unreasonably dangerous.
There have been numerous Depakote lawsuits filed involving allegations of birth defects in the state and federal courts. Plaintiffs alleged that the drug’s manufacturer provided defective warnings about the risk of birth defects. Plaintiffs claim that if they had known about this risk, they wouldn’t have taken the drug during pregnancy. New Depakote lawsuits continue to be filed in the courts.
In addition, some families who lost a loved one to suicide have filed wrongful death lawsuits, claiming that Depakote contributed to their loved one’s death. Under wrongful death laws, close relatives can sue the person or company responsible for a loved one’s death. If the court rules in favor of the surviving family, surviving family members could be awarded damages for any medical or funeral costs, loss of the deceased financial support, as well as loss of companionship or emotional support.
If you or a loved one suffered injuries or death associated with the use of Depakote, you could receive compensation for damages. Most birth defects aren’t curable, so a damages award may include costs for future medical care. For more information, contact one of our experienced Gacovino Lake attorneys at 1-800-246-HURT (4878).