AbbVie loses $15 million Depakote birth-defect case

Court cases for the anti-seizure medicine Depakote continue to rumble on for AbbVie, with the latest case finding AbbVie liable to pay $15 million in damages for the care of a boy born with birth defects. There are a further 700 cases pending across the US regarding the drug, with this case taking place in a federal court in Illinois.

The family brought the case against the pharmaceutical company after they claimed that the risk of damage to the unborn child, during pregnancy, was not properly highlighted. The mother had taken Depakote for the treatment of bipolar disorder whilst pregnant and her son was subsequently born with a split spine.

The boy is wheelchair-bound and has undergone 12 surgeries since birth to try help with problems associated with the birth defects he lives with. The damages were awarded to cover the cost of the boy’s medical treatment for the rest of his life.

It is the second winning case against AbbVie, with one other such case of a child born with numerous birth defects after her mother had taken Depakote during pregnancy. In 2015, a jury in St. Louis County Circuit Court awarded $38 million to the plaintiff – with $15 million provided in compensation and a further $23 million awarded in punitive damages.

Depakote was formerly a blockbuster drug but has courted controversy after dubious sales practices that led to numerous court cases. It is internally known as a "dirty drug" due to the label warnings making the drug a tough sell. It has had such warning labels in place since 1983, regarding birth defects and spina bifida.

It led Abbott, who later spun-out AbbVie as a separate entity, to aggressively market the drug, including in off-label uses. This led to a $1.1 billion settle with the US Justice Department over its marketing tactics for its use as a chemical restraint in elderly patients with dementia.

The medication is now known as a "Pregnancy Category X" drug that can only be used as a last resort treatment for women of childbearing age.

With this case being one of hundreds of such cases, it remains to be seen how costly the drug could become to AbbVie.