Depakote Birth Defect Verdict - Consumer Justice Foundation

Depakote Birth Defect Verdict

Written by Faith Anderson on June 2, 2015

Punitive Damages Added to Depakote Birth Defect Verdict Brings Total Award to $38 Million

A Missouri jury has ordered Depakote maker Abbott Laboratories and its AbbVie subsidiary to pay an additional $23 million in punitive damages to the family of a girl born with birth defects after being exposed to the anticonvulsant drug in pregnancy. The punitive damages, which are designed to punish the drug maker for its reckless actions surrounding the marketing of the medication without adequate warnings about the risk of Depakote birth defects, will be added to the $15 million in compensatory damages awarded last week, for a combined verdict of approximately $38 million. If you took the anticonvulsant drug Depakote while pregnant, and your child was born with a serious birth defect, consult a reputable Depakote lawyer to explore your possible compensation options.

Potential Pregnancy Risks of Depakote

Depakote is a best-selling anticonvulsant drug approved by the FDA in 1978, and prescribed to treat certain forms of epilepsy. Before its patent expired in 2007, Depakote was a blockbuster medication that generated roughly $1.5 billion in annual sales for AbbVie’s predecessor. However, side effects of Depakote in pregnancy have been linked to severe birth defects in babies, and in 2006, the FDA added a new “black box” warning to the Depakote label, notifying consumers and the medical community about the potential risk of birth defects from Depakote use in pregnancy, after a study found that 20% of pregnant mothers who gave birth while taking Depakote had a child with a congenital malformation or birth defect.

A growing body of research has identified a substantial risk of birth defects associated with a baby’s exposure to Depakote during pregnancy, and in May 2013, the FDA announced new restrictions on Depakote pregnancy use, contraindicating the drug for pregnant women, but only as a treatment for chronic migraines, not for the treatment of epilepsy. At the same time, the FDA changed all valproate-based drugs, including Depakote, from a pregnancy Category “D” to Category “X,” as it pertains to the treatment of migraine headaches. The FDA reserves a Category “X” classification for medications about which there is positive evidence of human fetal risk that clearly outweighs any possible benefits of the drug treatment.

Lawsuits Filed Over Birth Defects from Depakote

In response to these disturbing studies and FDA warnings, hundreds of Depakote birth defect lawsuits have been brought against Abbott Laboratories, on behalf of women who became pregnant while taking the anticonvulsant drug. Unfortunately, many of these women gave birth to babies with devastating malformations, including spina bifida, cleft lip, cleft palate, malformed limbs, skull abnormalities, holes in the heart, neural tube birth defects, and urinary tract problems. In fact, numerous studies have indicated that the Depakote pregnancy risk is highest when the drug is taken during the first trimester of pregnancy – a time when many women aren’t yet aware that they are pregnant.

This latest Depakote birth defect lawsuit was filed on behalf of 12-year-old Maddison Schmidt, who was born with numerous birth defects and health complications after being exposed to Depakote in utero, including a severe and life-long neural tube birth defect called spina bifida. The initial compensatory damages in the case were awarded last week, and the punitive damages came after extended jury deliberations during a second phase of the trial, where the Schmidt family argued that Abbott and AbbVie should be punished for failing to provide the public with adequate warnings regarding the potential for Depakote to interfere with fetal development and cause serious birth defects.

While the outcome of this Depakote birth defect case will not have any binding impact on future claims, it may influence eventual negotiations to reach Depakote settlement agreements with families, in order for Abbott and AbbVie to avoid additional court cases. It is estimated that, in the 35-plus years Depakote has been on the market in the United States, the anticonvulsant drug has been prescribed to more than 2.4 million Americans, and according to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), out of the 35,000 women prescribed Depakote or similar medications, about 375 become pregnant every year.

Contact an Experienced Depakote Lawyer for Help

Birth defects and congenital malformations allegedly resulting from a baby’s exposure to Depakote in pregnancy can result in serious complications, including life-long injuries requiring costly medical treatment. Spina bifida is a particularly devastating birth defect, characterized by the incomplete closure of the backbone and membranes surrounding the spinal cord. There is no known cure for spina bifida, and children born with the birth defect often require surgery to repair the malformation, sometimes followed by lifelong treatment and assistance to allow the child to achieve the highest possible level of function and independence.

If you believe your child has been adversely affected by birth defects from Depakote, such as spina bifida, growth retardation, heart malformations, limb defects or skeletal abnormalities, allegedly caused by exposure to the anticonvulsant in pregnancy, contact an experienced Depakote attorney today for legal help. You may have grounds to file a Depakote birth defect lawsuit against Abbott Laboratories and its AbbVie subsidiary, in order to seek fair and timely reimbursement for your child’s injuries, pain and suffering, and current and future medical bills. With a qualified Depakote attorney on your side, you can protect your legal rights and pursue the compensation your child deserves.

Sources:
http://www.neurology.org/content/67/3/407.abstract
http://www.fda.gov/downloads/drugs/drugsafety/ucm350748.pdf

Posted Under: Birth Defects, Dangerous Drugs, Depakote, Drugs During Pregnancy, Legal, Neural Tube Defects, News, Spina Bifida
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