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.
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: Drugmaker Didn't Warn Women
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.
- Spina bifida
- Physical malformations such as cleft palate or clubbed foot
- Cognitive impairment
- Cardiac defects
- Skeletal abnormalities
Court Pauses Current Cases for Settlement Negotiations
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.
Juries Reach Mixed Verdicts
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.
The first case to go to trial was in March 2015. It lasted for about 15 court days before the jury reached a verdict in favor of Abbott. During the trial, Mary and Daniel Kaleta sought $30 million for their son Danny, who was born with spina bifida. Abbott didn’t deny Depakote caused the son’s injuries, but argued the mother understood the risks.
The first verdict against Abbott was for $38 million and came in May 2015. A St. Louis state-court jury ordered Abbott to pay $15 million in compensatory damages and $23 million in punitive damages to Maddison Schmidt, a girl whose adoptive family alleged her spina bifida was tied to her birth mother’s use of Depakote to treat epilepsy during pregnancy. The Missouri Supreme Court upheld that verdict in 2017.
An Ohio jury reached a verdict in favor of Abbott in a November 2015 trial. Pamela Rheinfrank’s daughter Maria was born in 2003 with microcephaly and other disorders. Rheinfrank had been taking the drug to treat her epilepsy. The jury decided that the Rheinfrank didn’t prove that Abbott failed to provide adequate warnings about the risks of taking the drug while pregnant.
An Ohio federal jury ruled for Abbott in February 2017. Kevin and Christin Hutchens alleged their son was born in 2003 with microcephaly as a result of the mother taking Depakote while pregnant. Christin Hutchens was taking the drug for epilepsy in 2002 when she conceived her son. Abbott argued the drug’s label explicitly warned of the birth defect risk. The jury found the couple didn’t prove Abbott failed to adequately warn of the drug’s risks. The jury also said they failed to prove the drug was defective or that the company committed fraud.
Federal jurors in Illinois awarded $15 million to Christina Raquel in June 2017. Raquel blamed her use of the drug for her son’s birth defects. The serious injuries required the boy to have 12 surgeries. He uses a wheelchair.
Abbott Pleads Guilty to Off-Label Promotion, Pays $1.5 Billion
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.
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