Depakote (divalproex sodium) is a popular antiepileptic drug. The medication is also prescribed for the prevention of migraines and for the treatment of bipolar disorder's manic phases. Although Depakote isn't a selective serotonin reuptake inhibitor (SSRI), doctors sometimes prescribe the drug in conjunction with SSRIs.
Global pharmaceutical company Abbott Laboratories introduced Depakote to the U.S. marketplace in 1983. Since 2013, Abbott's spinoff AbbVie has manufactured the drug. Over the years, millions of patients have taken the medication. Unfortunately, Depakote has been linked to serious medical complications such as birth defects. As a result, numerous lawsuits have been filed in the courts.
Depakote is associated with a wide-range of medical complications. Some are relatively minor such as loss of appetite. Others are quite serious and debilitating such as birth defects and suicidal thoughts and behavior.
In 2013, the 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 shouldn't take these medications for the prevention of migraines. In addition, the FDA advises that pregnant women who are being treated for epilepsy or manic episodes associated with bipolar disorder should only take valproate drugs in instances in which the benefits of the drugs outweigh the risks of birth defects.
There is also some medical evidence linking Depakote and other valproic acid drugs to other types 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 hadn't taken the drugs. According to the researchers' findings, women who had taken a valproic acid drug in early pregnancy may have more than a 12 times increased rate of giving birth to a child with spina bifida compared to women who hadn't taken the drug. The study also found increased risks for cleft palate, craniosynostosis or abnormal skull development, atrial septal defect (heart defect), polydactyly (extra finger or toe), and hypospadias (penis abnormality).
Suicidal Thoughts and Behavior
In 2008, the FDA issued a safety alert regarding antiepileptic drugs such as Depakote. The FDA warned 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.
Abbott Laboratories' Guilty Plea
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 subsequently pleaded guilty to a criminal misdemeanor for misbranding Depakote. The company also 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 patients. If a prescription drug carries a product defect that is unreasonably dangerous, the drug's manufacturer and sellers can be held responsible for any injuries that result.
A number of plaintiffs have filed Depakote lawsuits involving allegations of birth defects in the state and federal courts. In the lawsuits, plaintiffs have 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 entity responsible for a loved one's death. If the suit is successful, surviving family members could be awarded damages for any medical or funeral costs, the loss of the deceased's financial support, and the loss of companionship or emotional support.
Get Legal Peace of Mind With Your Depakote Claim
A major benefit of filing a Depakote lawsuit is that plaintiffs could receive compensation for their injuries. Typical injury damages include lost wages, medical expenses, and pain and suffering. Because most birth defects aren't curable, a damages award may include projected costs for future medical care. If you or your child have been exposed to a dangerous substance, it's a good idea to contact an experienced product liability attorney.
Contact a qualified product liability attorney to make sure your rights are protected.