June 27, 2022 – Deciding to take any medication during pregnancy is a tough decision. Of course, expecting mothers trust their doctors only to prescribe medication that is safe to take during pregnancy. However, doctors rely on the warnings provided by drug companies when making these critical decisions. But what happens if a drug manufacturer fails to disclose all the risks associated with the medication? Doctors won’t be aware of the risks and may prescribe the medication to patients who could suffer tremendously. In these situations, the manufacturer of the drug may be liable for any resulting injuries through a product liability lawsuit.
If you took Depakote or another form of valproate sodium during pregnancy and your child has a lower-than-expected IQ or suffers from a birth defect, you may have a legal claim against Abbott Laboratories. If successful, you could recover meaningful compensation that will enable you to overcome many of the challenges you face. Not only that, but defective drug lawsuits also send a message to prescription drug manufacturers that they cannot continue to market medications they know to be harmful without warning consumers. At the law firm of Console & Associates, P.C., we recognize the difficulties your family has gone through and want to help you make a difference. Our team of personal injury lawyers is actively investigating product liability claims against the manufacturers of Depakote. As a part of our investigation, we are scheduling free consultations for parents of children born with birth defects after their mother took Depakote during pregnancy. We can help you understand your rights and explain your legal options.
Depakote is a prescription medication manufactured by Abbott Laboratories that is used to treat epilepsy, bipolar disorder and to prevent migraines. The medication was developed in 1882; however, it wasn’t until the 1960s that the drug’s anticonvulsant properties were discovered. It wasn’t until more recently that Depakote was used to treat bipolar disorder and migraines.
Depakote is a type of valproate. Other valproate products include:
In the early 2000s, reports began to surface that pregnant women who took Depakote were giving birth to babies with severe birth defects. There were also reports that otherwise healthy children whose mothers took Depakote during pregnancy suffered lower-than-expected IQs. These reports prompted the FDA to look into whether Depakote is safe for use during pregnancy.
The FDA concluded that Depakote dramatically increases the risk of various birth defects if taken during pregnancy. This prompted the FDA to change its stance on the drug, and, in 2011, the FDA began advising that “the risk of use in pregnant women clearly outweighs any possible benefit of the drug” for the treatment of migraine headaches. The FDA provided similar, although more conservative, advice for mothers taking Depakote for seizure and bipolar disorders, explaining Depakote “should only be prescribed if other medications are not effective in treating the condition or are otherwise unacceptable.”
In addition to changing its official position on the safety of Depakote for pregnant mothers, the FDA also required Abbott Laboratories to update the serious risks the drug presents if taken during pregnancy. For example, the FDA reports that children born to mothers who were taking Depakote during pregnancy were 30 to 80 times more likely to develop neural tube defects (such as Spina Bifida) 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.”
Abbott Laboratories complied with the FDA’s demand; however, many have since claimed that the warnings included on Depakote’s packaging failed to adequately apprise pregnant mothers of the risks. This has led to a slew of product liability claims being filed against Abbott Laboratories.
Product liability cases are a type of personal injury claim where a person who was injured by a product seeks to hold the product’s manufacturer financially responsible for their injuries. There are three types of product liability claims:
While some of the cases against Abbott Laboratories alleged a design defect in Depakote, most are failure to warn claims. In a failure to warn claim, a manufacturer can be held liable for any harm stemming from the use of its product if the injured party can prove that the manufacturer did not provide adequate warning to consumers about the health risks the product presents.
For example, in 2017, the Minnesota Supreme Court upheld a $38 million verdict awarded to a woman who was born with Spina Bifida and other birth defects after her mother took Depakote while she was pregnant. The court pointed to the fact that “there was evidence Abbott [Laboratories] was aware there were studies indicating Depakote was much more dangerous in terms of birth defects than its label suggested.” For example, the label Abbott Labs included on Depakote indicated that the CDC estimated the chance of giving birth to a baby with spina bifida was one to two percent. However, at the time, Abbott Labs was aware of studies suggesting that “the risk of spina bifida amounts to a twenty fold increased risk compared to the background rate in the general population.”
There have been several other Depakote cases in addition to this one with mixed results. These cases tend to hinge on whether the jury believes Abbott Labs’ argument that a mother who took Depakote during pregnancy knew of the risks involved.
Depakote exposure during pregnancy greatly increases the chances of being born with a serious and life-altering birth defect. If you or your child was exposed to Depakote during pregnancy, the law firm of Console & Associates, P.C. can help you determine if you have a case against Abbott Laboratories. At Console & Associates, P.C., we are actively investigating Depakote lawsuits on behalf of those who believe they were affected by the dangerous drug. If you are interested in learning more about pursuing a Depakote product liability claim against Abbott Laboratories, reach out to an experienced Depakote lawyer at Console & Associates, P.C. at 866-778-5500 or contact us online. We will attentively listen to your story, answer your questions, and offer you guidance about how you may be able to pursue a claim against the parties responsible for your child’s completely preventable condition.