February 6, 2017 — Abbott Laboratories Inc. has won a trial in Ohio involving Depakote birth defects, less than 3 months after the drug-maker lost an appeal of a $38 million jury award.
Abbott and AbbVie were cleared on all claims of wrongdoing in a defense verdict entered on February 2, following a 12-day jury trial.
The lawsuit was filed by the parents of “Z.H.,” a boy who was born in 2003 with microcephaly (small skull and brain), developmental delays, hypospadias, and other birth defects after his mother used the anti-seizure drug Depakote while pregnant.
The family accused Abbott of inadequately warning women and doctors about the risk of birth defects from Depakote. In 2002 — the year Z.H. was conceived — Depakote had a “Black Box” warning label for spina bifida and a 10-paragraph warning about other birth defects.
Those warnings had not been updated since 1983 and lawyers said they were outdated and misleading. For example, although the label warned that 1-2% of babies exposed to Depakote would be born with spina bifida, this actually translated to a 2,060% increased risk.
The 10-paragraph warning claimed there was not enough data on the incidence of other birth defects, but lawyers said Abbott was aware of data from multiple studies and could have updated labels before 2002.
Developmental delays are a notable exception. Abbott unsuccessfully attempted to update the label with stronger warnings in 2005, but was rejected by the FDA until stronger evidence emerged in 2009. Lawsuits involving children who were born with developmental delays after being exposed to Depakote have not been successful.
Other trial outcomes have been mixed. In April 2015, Abbott won another trial after a jury in Missouri declined to award damages to Danny Kaleta.
However, in November 2016, an appeals court in Missouri upheld a $38 million jury award to a girl who was born with spina bifida after being exposed to Depakote. In June 2016, a boy with spina bifida named “B.F.” was paid an undisclosed settlement as the jury deliberated after a 10-day trial in Missouri.
The FDA now classifies Depakote as a Pregnancy Category X drug and has issued multiple warnings about birth defects since 2009. It is estimated to cause birth defects in at least 20% of babies who are exposed. The list of birth defects linked to Depakote includes:
- Spina bifida
- Neural tube defects (anencephaly, etc.)
- Cleft lip / cleft palate
- Brain and spinal cord defects
- Low IQ
- Head and skull defects
- Heart defects
- And more