February 6, 2017 — A federal jury in Ohio has cleared Abbott Laboratories and AbbVie on all claims of wrongdoing in a trial over the birth defect risk of Depakote.
Depakote (valproic acid) is an anti-seizure drug that is used to treat epilepsy and migraine headaches. It is also one of the most dangerous medications to take during pregnancy due to birth defects.
The trial involved a boy named “Z.H.” who was born in 2003 with microcephaly (abnormally small skull), developmental delays, hypospadias, and other birth defects after his mother used Depakote.
Lawyers for the family said she never would have used Depakote if the label had adequately warned about the risk of birth defects.
In 2002, the year Z.H. was conceived, the label on Depakote had not been updated since 1983 — but it did have a 10-paragraph warning about birth defects and a “Black Box” label about spina bifida.
The “Black Box” warned about a 1-2% risk of spina bifida, which lawyers said was misleading because that meant a 2,060% increased risk. Lawyers also said the 10-paragraph warning was inadequate because it falsely claimed there was not enough data on other birth defects.
Abbott is facing around 800 lawsuits involving Depakote birth defects. Last year, an appeals court upheld a $38 million jury award to a girl named Maddison Schmidt. In July 2016, another trial in Missouri ended in a confidential settlement to the family of a boy named “B.F.”
Many Depakote lawsuits involve developmental delays, including Z.H., but legal claims involving this injury have not been successful. Abbott actually tried to update the label with warnings about developmental delays in 2005, but the FDA rejected those warnings until 2009.
In recent years, the FDA has re-classified Depakote as a Pregnancy Category X medication and issued a number of warnings about birth defects, such as:
- Spina bifida
- Low IQ
- Developmental delays
- Cleft lip / cleft palate
- Brain and spinal cord defects
- Skull defects
- Heart defects
- And more
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