Hundreds of people are suing AbbVie over birth defects they say were caused when pregnant women took Depakote. The federal courts have put the cases on hold to allow parties to try to settle them. So far, trials have ended in mixed results. Depakote lawsuits allege the drugmaker’s warnings about the risk of birth defects were defective. Women suing over Depakote say had they known of the birth defect risk, they would not have taken the drug while pregnant.
*UPDATE: In June 2018, a federal judge in Illinois put all Depakote lawsuits on hold to allow for complex settlement negotiations.
As of early 2018, AbbVie faced 619 pending Depakote lawsuits, according to the company’s corporate filings. More than 90 percent of the claims were pending in the U.S. District Court for the Southern District of Illinois.
In June of 2018, all cases were put on hold to allow the parties to focus on settlement negotiations.
Families began filing the first Depakote birth defect lawsuits in state court in 2010. This was nearly 30 years after the drug went on the market.
Depakote litigation says the drug caused serious birth defects in children whose mothers took Depakote while pregnant.
Depakote is used to treat seizure disorders and prevent migraine headaches. Doctors also prescribe it to lessen the manic phase of bipolar disorder.
Several Depakote lawsuits were moved to federal court on Jan. 18, 2012. By Sep. 20, 2016, the U.S. District Court for the Southern District of Illinois had 129 Depakote cases pending on its docket. The cases involved about 698 plaintiffs.
Multiple Depakote lawsuits have gone to trial. Results have been mixed. The first verdict against Depakote’s maker was for $38 million. Jurors awarded the money to a girl who was born with spina bifida.
Depakote lawsuits seek compensation for injuries suffered by children whose mothers took Depakote when they were pregnant.
Birth defects included spina bifida. Spina bifida is a condition that occurs when the baby’s spinal cord fails to develop properly.
Another injury suffered by these children is microcephaly. This is when the baby’s head is abnormally small.
Depakote lawsuits also allege unborn children were disfigured and suffered other disorders.
Families accuse Abbott and its successor AbbVie of downplaying the dangers of Depakote. Lawsuits claim the drug is defectively designed and inadequately tested.
Abbott Laboratories brought Depakote to the market. In 2011, the company spun off its pharmaceutical division into another corporation called AbbVie.
Depakote lawsuits name both Abbott and Abbvie as defendants.
Abbott has not announced a global Depakote settlement to resolve birth defect lawsuits. But U.S. Chief District Judge Michael J. Reagan issued an administrative order on June 7, 2018.
“There have been some tentative settlements reached.”
The order terminated all pending motions and transferred more than 100 cases to Judge David R. Herndon for “purposes of settlement administration.”
Judge Nancy J. Rosenstengel focused attorneys on efforts to settle.
In January 2018, plaintiffs in more than 250 cases joined the defendants to ask the court to put their cases on hold to allow complex settlement negotiations. Reagan granted the motion.
Abbott paid $1.5 billion to the federal government and 24 states for promoting Depakote for off-label use. This was the second largest settlement paid by a drug company at the time.
The U.S. Justice Department accused the company of maintaining a specialized sales force to market the drug for uses not approved by the U.S. Food and Drug Administration. The unapproved uses included schizophrenia, depression and anxiety. This happened between 1998 and 2006.
While it’s legal for doctors to prescribe drugs for unapproved uses, it’s illegal for manufacturers to promote such uses. That’s because the FDA regulates manufacturers, not doctors.
Several Depakote cases have gone to trial. Some Depakote litigation has resulted in verdicts in favor of the drugmaker. Others have ended in multi-million-dollar awards for plaintiffs.
There are no known Depakote class action lawsuits. Instead, hundreds of individual cases are being heard in U.S. District Court in the Southern District of Illinois.
Often when large numbers of cases involve the same issues and defendants, the courts will organize them as a multidistrict litigation (MDL). In this arrangement, a single judge will make decisions over all pretrial matters.
The judge will also conduct the early trials. Known as bellwethers, these first trials are designed to give parties an idea of how the remaining cases will resolve.
This is hoped to guide attorneys in potential settlement negotiations. The court has not given Depakote litigation an official MDL designation. But the court is handling lawsuits in a similar manner.
Please seek the advice of a medical professional before making health care decisions.
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