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Depakote Lawsuits

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.

depakote 250 mg tablet
Depakote Lawsuit Facts
  1. Injuries Birth defects, spina bifida, heart defects, craniofacial defects, neural tube defects, cognitive impairment
  2. Defendants Abbott Laboratories Inc., AbbVie Inc.
  3. Top Verdict $38 million
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*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.

Illustration of fetus
Depakote lawsuits claim that the drug caused serious birth defects in children whose mothers took the drug while pregnant.

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.

Why People File Depakote Lawsuits

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.

Accusations Against Depakote Manufacturers

Families accuse Abbott and its successor AbbVie of downplaying the dangers of Depakote. Lawsuits claim the drug is defectively designed and inadequately tested.

Abbott Logo
AbbVie logo

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.

Depakote Settlements

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.”

Judge Nancy J. Rosenstengel during a February 2018 status conference

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.

Off-Label Promotion of Depakote

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.

Depakote Guilty Plea
In 2012, Abbott pleaded guilty to a federal charge of misbranding Depakote. The company promoted Depakote for agitation and aggression in elderly dementia patients.

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.

Depakote Verdicts

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.

Notable Depakote Verdicts
  • May 2015
    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 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.
  • November 2015
    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.
  • February 2017
    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 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.
  • June 2017
    Federal jurors in Illinois awarded $15 million to Christina Raquel in June 2017. Raquel blamed her use of Depakote for her son’s birth defects. The serious injuries required the boy to have 12 surgeries. He uses a wheelchair.

Depakote Class Action Lawsuits

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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13 Cited Research Articles

  1. Lexis Legal News. (2017, September 14). Missouri Supreme Court: $38M Depakote Birth Defect Verdict Came From ‘Fair Trial.’ Retrieved https://www.lexislegalnews.com/articles/20404
  2. Bellon, T. (2018, January 22). Federal judge pauses more than 250 Depakote cases pending settlement talks. Retrieved https://www.reuters.com/article/products-depakote/federal-judge-pauses-more-than-250-depakote-cases-pending-settlement-talks-idUSL2N1PH1WG
  3. In Re Depakote. (2018, January 19). United States District court for the Southern District of Illinois. Case No. 3:13-cv-52. Joint Motion for Entry of Administrative Order. Document 1174. Retrieved http://www.pacer.gov
  4. U.S. Department of Justice. (2012, May 7). Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil investigations of Off-Label Promotions of Depakote. Retrieved https://www.justice.gov/opa/pr/abbott-labs-pay-15-billion-resolve-criminal-civil-investigations-label-promotion-depakote
  5. In Re Depakote. (2018, February 3). United States District court for the Southern District of Illinois. Case No. 3:13-cv-52. Transcript of Status Conference. Document 1180. Retrieved http://www.pacer.gov
  6. In Re Depakote. (2018, June 7). United States District court for the Southern District of Illinois. Case No. 3:13-cv-52. Administrative Order. Document 1199. Retrieved http://www.pacer.gov
  7. Lexis Legal News. (2017, February 3). Defense Verdict Returned By Ohio Federal Jury In Depakote Birth Defect Trial. Retrieved http://www.lexislegalnews.com/articles/14524/defense-verdict-returned-by-ohio-federal-jury-in-depakote-birth-defect-trial
  8. Lexis Legal News. (2015, November 3). Ohio Federal Jury Returns Defense Verdict In Depakote Birth Defect Trial. Retrieved http://www.lexislegalnews.com/articles/3657/ohio-federal-jury-returns-defense-verdict-in-depakote-birth-defect-trial
  9. Madison – St. Clair Record. (2015, April 9). Abbott Labs cleared in Depakote bellwether trial; Plaintiff sought $30 million over child's birth defects. Retrieved http://madisonrecord.com/stories/510557829-abbott-labs-cleared-in-depakote-bellwether-trial-plaintiff-sought-30-million-over-child-s-birth-defects
  10. Feeley, J. and Bross, T. (2015, May 28). Jury: Abbott Must Pay $23M in Punitive Damages Over Depakote. Insurance Journal. Retrieved http://www.insurancejournal.com/news/midwest/2015/05/28/369817.htm
  11. Casetext. (2016, September 20). Lead Consolidated Case. Retrieved https://casetext.com/case/alexander-v-abbott-labs-inc
  12. Reuters. (2017, June 9). AbbVie suffers $15 million loss in Depakote birth-defect trial. Retrieved http://whtc.com/news/articles/2017/jun/09/abbvie-suffers-15-million-loss-in-depakote-birth-defect-trial/
  13. AbbVie. (2018, March 31). Quarterly Report filed with United States Securities and Exchange Commission. Form 110-Q). Retrieved http://investors.abbvie.com/node/11691/html
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