Over ten years ago, the Food and Drug Administration (FDA) determined that pregnant women who take Depakote (valproate) have a much higher chance of giving birth to a baby who suffers low IQ or a birth defect. In response, the FDA required Abbott Laboratories, the manufacturer of Depakote, to include stricter warnings on the drug’s label. However, a recent slew of lawsuits filed on behalf of children with Spina Bifida, autism and other birth defects claim that Abbott Lab’s revised warnings failed to convey the serious risk of birth defects that taking Depakote during pregnancy presents.

If you gave birth to a child who has a lower-than-expected IQ or suffers from a birth defect such as Spina Bifida, your child’s condition may have been entirely preventable. While this is certainly challenging news to hear, current laws allow families to bring a product liability claim against the manufacturer of Depakote. To learn more about how families can pursue compensation for the lifelong challenges their child faces because of Depakote, click here to view our recent post on the topic.

What Is Depakote?

Depakote is the brand-name version of the drug valproate, which is manufactured by Abbott Laboratories. Valproate, which is a derivative of the valerian flower, was first developed in 1882; however, it wasn’t until the 1960s that the drug’s anticonvulsant properties were discovered. Since then, it has been widely prescribed to treat patients suffering from seizure disorders, including epilepsy. More recently, doctors began prescribing Valproate to treat bipolar disorder and to prevent migraine headaches. The drug works by blocking certain neurotransmitters and increasing levels of gamma-aminobutyric acid (GABA) in the brain.

Valproate products include:

• Valproate sodium (Depacon),

• Divalproex sodium (Depakote, Depakote CP, and Depakote ER), and

• Valproic acid (Depakene and Stavzor).

There are also several generic versions of each of these drugs, which are identifiable by the drug’s chemical name Valproate sodium, divalproex sodium, or valproic acid.

What Are the Risks of Taking Depakote While Pregnant?

As early as 2011, the Food and Drug Administration reported that Depakote use during pregnancy was linked to lower IQ scores as well as serious birth defects. The FDA also noted that other forms of valproate present the same risks. Some of the birth defects that have been linked to Depakote use include:

• Spina Bifida,

• Autism Spectrum Disorder,

• Heart and neural tube defects, and

• Intellectual disability.

In 2011, the FDA determined that “the risk of use in pregnant women clearly outweighs any possible benefit of the drug” for the treatment of migraine headaches. The FDA took a more conservative approach for patients taking Depakote for seizure disorders or bipolar disorder, noting that “valproate products should only be prescribed if other medications are not effective in treating the condition or are otherwise unacceptable.”

The risk of Depakote use for pregnant women is significant. For example, the FDA notes that children born to mothers who were taking Depakote during pregnancy were 30 to 80 times more likely to develop neural tube defects than children born to mothers who did not take the drug. Additionally, in 2013, the FDA found that “The difference in average IQ between the children who had been exposed to valproate and the children who had been exposed to other antiepileptic drugs varied between 8 and 11 points depending on the drug to which valproate was compared.”

More recently, the FDA has linked the use of valproate and Depakote during pregnancy to various birth defects, including neural tube defects, such as spina bifida and acephaly. The FDA has also linked valproate use by pregnant women with cleft lip and cleft palate in newborn babies, as well as cardiovascular malformations.

Is Abbott Labs Liable for Birth Defects Caused by Depakote?

Whether Abbott Labs bears responsibility for birth defects resulting from Depakote depends on who you ask. Hundreds of families have filed lawsuits against Abbott Laboratories under a product liability theory, seeking to hold the company financially liable for their children’s conditions.

Product liability cases are a type of personal injury claim in which someone who was injured by a product seeks to hold the product’s manufacturer financially liable for their injuries. Product liability claims generally fall into one of two categories: those involving defective products and those involving dangerous products that do not contain adequate warnings.

Unlike most other types of personal injury cases, parents bringing a defective drug lawsuit against the drug’s manufacturer do not typically need to prove that the manufacturer was negligent. Simply put, if a medication is defective or the product’s packaging fails to adequately warn patients about the dangers the product presents, the manufacturer can be held liable for any resulting injuries.

Most Depakote lawsuits that have been filed against Abbott Labs are based on “defective design” and “failure to warn” theories. These lawsuits have resulted in some families receiving significant compensation. For example, in May 2012, a jury in St. Louis ordered Abbott to pay $15 million in compensatory damages and $23 million in punitive damages to the family of a girl who was born with Spina Bifida after her mother took Depakote during pregnancy. However, just a few months before that, a jury accepted Abbott Lab’s defense in a similar case, finding that while Depakote caused the child’s Spina Bifida, his mother was on notice about the drug’s risks. Thus, these cases largely depend on case-specific circumstances.

Families who have a child that was born with a birth defect and whose mother took Depakote during pregnancy may have a claim for compensation against Abbott Laboratories. However, given the complexity of these cases, those interested in learning more should reach out to an experienced Depakote lawyer for assistance.