Nearly three decades after Abbott started selling Depakote, families began filing the first Depakote birth defect lawsuits in state court in 2010. Depakote is a drug used to treat seizure disorders, mitigate the manic phase of bipolar disorder and prevent migraine headaches. Lawsuits claim the drug is defectively designed and inadequately tested. They accuse Abbott of downplaying the dangers of Depakote, including the risk of birth defects such as spina bifida, when the baby’s spinal cord fails to develop properly; microcephaly, when the baby’s head is abnormally small; and disfigurements and other disorders.
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 cases, involving about 698 plaintiffs, pending on its docket directly related to Depakote litigation. Cases continue to be filed each month, according to the court.
Initially, the court selected representative cases for fast-track trials. Known as bellwether cases, these cases were intended to facilitate the resolution of the many outstanding cases by allowing parties to see the strengths and weaknesses of the evidence and the merit of the remaining claims. Trials were set for March 2015, October 2016 and November 2016.
The first case to go to trial was D.W.K., a Minor by Mary Kaleta and Daniel Kaleta, Individually and as Parents and Next Friends of D.W.K., v. Abbott Laboratories, Inc., No. 14-cv-847 (S.D. Ill. 2014). The March 2015 trial, which involved one plaintiff, 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.
In July 2016, the court determined the bellwether process and the efforts for reaching a global settlement had failed. U.S. District Judge Nancy J. Rosenstengel said: “Given the number of litigants in this case, trying cases one plaintiff at a time is not a feasible option.” She instead decided combine similar cases and hold joint trials. The judge has said on multiple occasions that she intends to try all cases on her docket by the end of 2017.
Birth Defect Verdicts and Settlements
Depakote was first approved by the FDA in 1983. In 1988, the agency declared it a category D pregnancy risk, meaning “there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.”
In 2003, the FDA required Abbott to add a black box warning to the packaging, the FDA’s strictest warning, explaining that pregnant women’s use of Depakote could harm their developing fetuses. Eight years later in 2011, the agency approved new warning language regarding developmental delay. In the interim, women who were taking Depakote for its approved uses became pregnant, and some had children with birth defects. Many have sued Abbott, with varying results.
Z.H. et al. v. Abbott Laboratories, Inc., et al.
In February 2017, an Ohio federal jury cleared Abbott of charges that it failed to warn patients that Depakote caused birth defects. The plaintiffs, Kevin and Christin Hutchens, allege their son was born in 2003 with microcephaly as a result of the mother taking Depakote while pregnant. Christin Hutchens was taking Depakote for epilepsy in 2002 when she conceived her son. Abbott argued the drug’s label explicitly warned of the birth defect risk of Depakote. The jury found the Hutchenses 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.
B.F. et al. vs. Abbott Laboratories
In June 2016, Abbott settled a lawsuit before a jury in the U.S. District Court for the Eastern District of Missouri handed down 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, court records show.
Pamela Rheinfrank et al. v. Abbott Laboratories, Inc., et al.
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 Depakote 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 Depakote while pregnant.
Schmidt v. Abbott
The first verdict against Abbott in a Depakote case came in May 2015. A St. Louis state-court jury ordered Abbott to pay $15 million in compensatory damages and $23 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.
Criminal and Civil Penalties for Misbranding
In 2012, Abbott was forced to pay a $1.5 billion settlement for promoting Depakote for off-brand use. The U.S. Department of Justice brought action against Abbott, alleging that between 1998 and 2006 the company maintained a specialized sales force to market Depakote for uses not approved by the FDA. Off-label use is not uncommon; physicians may prescribe a drug for a purpose for which it lacks FDA approval if there’s real-world evidence of its effectiveness and safety before a clinical trial has been completed. However, the FDA has rigorous standards for drug use and approval, and sees false or misleading off-label promotion as dangerous to public health.
During a four-year investigation, the Justice Department found that Abbott violated federal FDA regulations and state and federal laws in marketing the drug to promote off-label uses, including schizophrenia, depression and anxiety. The company created programs and materials to train pharmacists at long-term-care pharmacies that serviced nursing homes about off-label use of Depakote and paid millions of dollars in rebates based on increased Depakote use. In May 2012, Abbott agreed to pay $1.5 billion to the federal government and 24 state governments to settle charges of illegal marketing of Depakote. Abbott also pleaded guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients. The civil and criminal penalties represented the second-largest monetary settlement by a drug company at that time.