Lyrica, Depakote, Other Anti-Seizure Drugs Risk of Birth Defects. The personal injury attorneys at Parker Waichman LLP are investigating potential lawsuits on behalf of clients who experienced birth defects related to the use of anti-epileptic, or anti-seizure medications such as Depakote or Lyrica. The firm continues to offer free legal consultations to individuals with questions about filing a Depakote or Lyrica birth defects lawsuit.
In May 2016, the journal Neurology published a study evaluating the risk of birth defects in women taking pregabalin (the generic name for Lyrica) compared to a control group. Women in the control group did not take any antiepileptic drugs or any medications associated with an increased risk of birth defects. The study involved data from 164 pregnant women taking Lyrica and 656 pregnant controls. Authors analyzed data collected between 2004 and 2013.
Researchers found that, after excluding for chromosomal aberration syndromes, use of Lyrica during pregnancy was associated with a higher rate of major birth defects. “A significantly higher major birth defect rate in the pregabalin group was observed after exclusion of chromosomal aberration syndromes, and when cases with exposure during first trimester of pregnancy were analyzed separately,” authors wrote.
Overall, the findings suggested an increased risk of major birth defects
Overall, the findings suggested an increased risk of major birth defects associated with use of Lyrica during the first trimester of pregnancy. The authors noted, “However, several limitations such as the small sample size, differences across groups in maternal conditions, and concomitant medication exposure exclude definitive conclusions, so these results call for confirmation through independent studies.”
According to Epilepsy.com, the website for the Epilepsy Foundation, the main birth defect associated with seizure drugs is congenital malformation. Congenital malformation occurs in two to three percent of the general population; the risk increases to between four and six percent in women with epilepsy. Birth defects may be more likely to occur when women take more than one anti-seizure drug. The risk appears to be higher with valproic acid or valproate, the generic name for Depakote.
The most common birth defects are cleft lip and cleft palate, and heart, urinary or genital system defects. Exposure to Depakote during pregnancy is associated with lower IQ and an increased risk of autism, research from the NEAD (Neurodevelopmental Effects of Antiepileptic Drugs) study shows.
Depakote Birth Defects Lawsuit Filed, Alleges Anti-Epileptic Drug caused Spina Bifida
Parker Waichman notes that lawsuits have been filed over birth defects allegedly caused by anti-seizure medications. For example, court records show that Abbott Laboratories is facing a Depakote birth defects claim alleging that the drug caused spina bifida. According to the complaint, the plaintiff took Depakote during pregnancy and gave birth to a daughter with spina bifida, a condition affecting the neural tube, a structure in the developing fetus that eventually becomes the brain and spinal cord. Physicians performed a very complicated operation to repair the neural tube while the child was still in the womb.
The surgery was successful. However, the lawsuit states, the hospital that performed the procedure notes the child’s muscles will likely never reach full strength. The child can walk on her own but also sometimes uses a wheelchair.
The suit alleges that Depakote caused the child to develop spina bifida
The suit alleges that Depakote caused the child to develop spina bifida, and that Abbott failed to properly warn about these risks. However, the drug maker has argued that the plaintiff should have known about the risks of taking Depakote while pregnant in 2004. Additionally, Abbott tried to have the case dismissed based on statute of limitations. This motion was rejected by U.S. District Judge Nancy Rosenstengel, who said that the lawsuit is not barred for this plaintiff. “…it is undisputed that the Illinois statute of limitation does not bar the current claim,” the judge stated.
Under Illinois law, minors can sue for injuries at any time. They can also pursue litigation two years after they turn 18. Therefore, courts have ruled that the Depakote spina bifida case can move forward.
Other lawsuits have been filed alleging birth defects associated with the use of Depakote. One case was filed in January 2016 on behalf of eight plaintiffs from different states. The complaint alleged various birth defects and malformations, including spina bifida, cleft palate, cleft lip, limb and digit deformities, facial dysmorphism, mental developmental delays, genitourinary malformations and heart defects. Abbott allegedly knew of these adverse events, but failed to warn patients or the medical community.
Since 2009, the U.S. Food and Drug Administration (FDA) has warned about the risk of birth defects associated with the use of Depakote during pregnancy. Lawsuits allege that patients were unaware of the risks and that they would have chosen a different treatment option if they were informed.
The current label on Depakote warns that the drug can cause serious birth defects
The current label on Depakote warns that the drug can cause serious birth defects if taken during pregnancy. Regulators state that birth defects are “much higher” than average or 12.5 times worse in children whose mothers took Depakote while pregnant. In 2013, the FDA said Depakote and related medications should not be prescribed to pregnant women for migraines. The agency cited a study linking Depakote exposure to lower IQ scores.
In addition to individual lawsuits, Abbott has also faced litigation from the federal government. The company was accused of marketing Depakote off-label, or in ways not approved by the FDA. According to a May 2012 press release issued by the Department of Justice, the company pleaded guilty and agreed to pay $1.5 billion to settle allegations that it marketed Depakote for elderly patients with dementia, even though the FDA had not approved it for this indication. “Today’s settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud,” said James M. Cole, Deputy Attorney General, according to the release. “We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”
Abbott admitted to promoting Depakote off-label to elderly patients. Specifically, the release states, the company acknowledged that it had a specialized sales force focused on marketing Depakote in nursing homes to control agitation and aggression in elderly patients with dementia. The company was also accused of marketing Depakote off-label in combination with other drugs to treat patients with schizophrenia.