Depakote Side Effects Lawsuit

What Is Depakote?

Depakote is a drug that was widely used for a time, and it was manufactured and distributed by Abbott Laboratories. It was made and marketed to help those who suffered from manic depressive disorder, and Depakote was specifically used to help with the manic episodes that are part of this unfortunate condition. The drug was successful for several years, but it wasn't long before Depakote attorneys began to field calls and meet with new clients.

Specifically, Depakote was linked with a host of extremely serious side effects, and they can be organized into two categories. The first includes the less serious side effects that children of mothers who took Depakote while pregnant experienced. The second category describes the most serious side effect, and Depakote attorneys heard many heart-breaking stories of the damage that this drug did to the mothers' fetuses. Regardless of category, however, if you have suffered as a result of using this medication, contact a Depakote lawyer at Ennis & Ennis, P.A. today to schedule a free, confidential legal consultation.

Category 1 - Less Serious Depakote Side Effects

Although these side effects are considered "less serious," they are still significant injuries to suffer through no fault of your own. Your child will be forced to deal with these problems throughout his or her life:

• Cleft Palate
• Hand Deformations
• Heart Malformations
• Undescended Testicles
• Pulmonary Stenosis

Category 2 - Most Serious Depakote Side Effects

The second category of side effects includes conditions that are either life-threatening, life-shortening, or both:

• Growth Retardation
• Neural Tube Formations
• Spina Bifida
• Serious Skeletal Defects
• Fetal Death

Depakote Study

A study has shown that the effects of Depakote can be devastating for newborns exposed to the drug before birth. The study, released in the August 8, 2006 issue of Neurology, found that major congenital malformations and fetal death were more common for women who took Depakote while pregnant compared with women who took other antiepileptic drugs.

The study also found that the effects of Depakote were dependant on the dose taken. The study compared women who took Depakote while pregnant with women who took Lamictal, Tegretol, and Dilantin.

Of the women who took Depakote while pregnant, 20.3% had babies who experienced serious adverse outcomes. This is compared with 10.7% of those taking Dilantin, 8.2% on Tegretol, and 1.0% on Lamictal. The serious adverse events in babies who were exposed to Depakote included coarctation of the aorta, atrial septal defects, hydronephrosis (distention and dilation of the renal pelvis), cleft palate, dysplastic ribs, pulmonary stenosis, hand malformations, undescended testes, hypospadias (a birth defect in males that involves the urethral opening occurring in the wrong place), and hypoplastic right heart.

Women who took a high dose of Depakote had a higher likelihood of giving birth to a baby with defects. Those who were at or above the average first trimester dose had adverse outcomes at a rate of 24.2% whereas those who had doses below the average had adverse outcomes at a rate of 9.1%

According to a warning at rxlist.com, antiepileptic drugs should only be given to women of childbearing potential if they are absolutely essential in the management of seizures. The same warning says that the risks of neural tube defects may be higher in mothers who received Depakote during the first trimester of pregnancy. Hepatic failure which resulted in the deaths of newborns and infants were also reported after the mothers took Depakote while pregnant. Depakote has also been linked to birth defects such as poor growth, developmental delays, short and broad noses, small teeth and small head.

Additionally, the risk of having a child born with spina bifida is approximately one to two percent when the fetus was exposed to Depakote, whereas in the general population, spina bifida occurs in fewer than one in one thousand births. Unfortunately, spina bifida develops during the fourth week of pregnancy at which point many women do not even realize that they are pregnant. Spina bifida is a birth defect in which the spinal column fails to completely close which results in a lesion on the newborn's back and a loss of feeling from the lesion down.

Animal studies have shown that exposure to Depakote before birth increases the likelihood of malformations, intrauterine growth retardation and death of the newborn. Malformations included skeletal system defects and neural tube closure defects.

Depakote is known generically as divalproex sodium and is prescribed to treat seizures. It is a compound of sodium valproate and valproic acid and is therefore sometimes referred to as valproate. It works by affecting chemicals in the body that may cause seizures. Depakote was also approved by the U.S. Food and Drug Administration (FDA) in 1995 for the short-term treatment of bipolar disorder.

Depakote is FDA pregnancy category D because it can harm an unborn baby. Women who are pregnant or planning on becoming pregnant should speak with their doctors to discuss their options because Depakote has been linked to birth defects. Depakote can also pass into breast milk and harm a nursing baby.

On February 7, 2011 the U.S. Justice Department decided to take the lead in lawsuits accusing Abbott Laboratories (ABT) of illegally promoting anti-seizure drug Depakote for uses not approved by regulators, including dementia.

The Justice Department filed notices last week in federal court in western Virginia saying it would intervene in at least three lawsuits against Abbott that were previously confidential under laws designed to protect would-be whistleblowers who come forward with information about alleged health-care fraud. The lawsuits were made public as a result of the department's intervention.

The lawsuits were filed between 2007 and 2009 by people who said they were current or former sales representatives for Abbott at the time their suits were filed.

Depakote was once one of Abbott's top-selling drugs, with $1.6 billion in sales for 2007, before patent expirations cleared the way for sales-eroding generic competition.

The lawsuits generally allege Abbott promoted Depakote to treat conditions such as dementia in the elderly, Alzheimer's disease and schizophrenia, which aren't consistent with the prescribing label approved by the Food and Drug Administration. The FDA-approved uses for Depakote include treating seizure disorders, bipolar disorder and prevention of migraines.

The lawsuits allege Abbott's promotion of such off-label uses caused false claims for prescription reimbursement to be submitted to federal health programs including Medicaid.

Drug makers are generally barred from actively promoting off-label drug uses, though doctors have the discretion to prescribe drugs for off-label uses.

Several drug makers, including Pfizer Inc. and Eli Lilly & Co., have reached hefty settlements to resolve off-label marketing investigations in recent years. Whistleblower cases have factored into these settlements. Those who file whistleblower suits are eligible to receive a cut of the money, under federal law.

Abbott previously disclosed federal prosecutors were investigating its marketing of Depakote. Last year, a judge in western Virginia ordered Abbott to hand over to prosecutors some of Chief Executive Miles White's emails as part of the probe. Abbott had been fighting subpoenas for the emails.

"The unsealing of these complaints is a routine step in the process," said Abbott spokesman Scott Stoffel. "Because the investigation is ongoing, we do not intend to comment on the details."

If you have taken Depakote and experienced serious Depakote side effects call our Depakote lawyer today to find out about an Depakote lawsuit. With offices in Washington D.C. and throughout Florida we are ready to help Depakote side effects victims nationwide. Let our Depakote Attorneys evaluate your case for free today. Fill out our online case evaluation form on this page or call us toll free at: 1.800.856.6405 for your free, confidential case evaluation.

Under no circumstances should you discontinue taking any medication, including Depakote, without first consulting with your doctor.

Depakote Spina Bifida Lawsuit News Archive

Terms of Use & Privacy Policy