Depakote Lawsuits

As of early 2018, AbbVie faced 635 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.

Families began filing the first Depakote birth defect lawsuits in state court in 2010. This was nearly 30 years after the drug — which is used to treat seizures and bipolar disorder — went on the market.

Several lawsuits were moved to federal court on Jan. 18, 2012. By Sept. 20, 2016, the U.S. District Court for the Southern District of Illinois had 129 cases pending on its docket.

Litigation says the drug caused serious birth defects in children whose mothers took it while pregnant. Women suing Abbott and its successor AbbVie say had the companies adequately warned them of the risk, they would not have taken the drug while pregnant.

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. As of November 2022, there have been no new developments in this litigation, and the Illinois MDL has been closed.

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.

Lawsuits seek compensation for injuries suffered by children whose mothers took the drug when they were pregnant. These injuries include birth defects of the spine, heart and head, and other developmental disorders.

Lawsuits allege that defendants should have known about the risk as far back as 1980 — when researchers released one of the first reports connecting Depakote to birth defects.

By 1983, medical literature had documented a 20-fold increase in spina bifida among infants whose mothers had used the drug during pregnancy, according to a complaint and jury demand. Yet, Abbott failed to inform doctors and patients of the risk. Plaintiffs claim the drug increases the risk of fetal malformation compared to other anti-seizure medications.

Some birth defects mentioned in lawsuits include:

• Spina bifida
• Physical malformations such as cleft palate or clubbed foot
• Cognitive impairment
• Cardiac defects
• Skeletal abnormalities

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. U.S. Chief District Judge Michael J. Reagan granted the motion.

Reagan issued an administrative order on June 7, 2018, that terminated all pending motions, and he transferred more than 100 cases to U.S. District Judge David R. Herndon for “purposes of settlement administration.”

Another judge involved in the Illinois cases, U.S. District Judge Nancy J. Rosenstengel, also focused attorneys on efforts to settle. In April 2018, she put remaining cases on hold to “enable the Court to conduct an aggressive, timely settlement campaign.”

Past Lawsuit over Spina Bifida, Disfigurements Ends in Settlement

In June 2016, Abbott settled a lawsuit before a jury in the U.S. District Court for the Eastern District of Missouri handed up a verdict. Terms of the settlement with Thomas and Beth Forbes on behalf of their son were not disclosed. The child was born with disfigurements and spina bifida after mother Beth Forbes got pregnant while taking Depakote for depression in April 2003, records show.

Multiple cases have gone to trial, and results have been mixed. Initially, the court tried cases one plaintiff at a time. However, Judge Rosenstengel in Illinois determined that approach and efforts for reaching a global settlement had failed.

The judge decided to combine similar cases and hold joint trials. “Given the number of litigants in this case, trying cases one plaintiff at a time is not a feasible option,” she said in a Sept. 20, 2016, memorandum and order.

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. Department of Justice accused the company of maintaining a specialized sales force between 1998 and 2006 to market the drug for uses not approved by the U.S. Food and Drug Administration. The unapproved uses included schizophrenia, depression and anxiety.

During a four-year investigation, federal officials found that Abbott violated FDA regulations and state and federal laws. The company illegally promoted the drug to control agitation and aggression in elderly dementia patients.

It created programs and materials about off-label use of Depakote to train pharmacists at long-term-care pharmacies that serviced nursing homes, and it paid millions of dollars in rebates based on increased use of the drug.