November 21, 2014 — The family of a boy who was severely injured by high-dose Botox in an “off-label” treatment for cerebral palsy have been awarded $6.5 million by a federal jury in Vermont, according to Law360.
The lawsuit was filed by Lori and Kevin Drake on behalf of their 7 year-old son, Joshua. In 2010, his pediatrician recommended Botox to treat mild muscle spasticity. When the first dose had no effect, the pediatrician doubled the dose.
Soon afterward, Joshua developed severe side effects, including facial swelling, slurred speech, respiratory difficulties, vomiting, and seizures. He now must be constantly monitored by a special aide because he continues to suffer from seizures.
The Burlington Free Press reports that the jury in Burlington, Vermont awarded $2.5 million in compensation and $4 million in punitive damages to the Drake family.
The jury found Allergan, the manufacturer of Botox, was negligent for promoting Botox “off-label” for uses that were never approved by the FDA, and at unsafe doses in children:
“The FDA made clear to Allergan in 2009 that it was free to warn physicians about the maximum safe dose for children, but to date Allergan has failed to make that information public. … Instead of warning, Allergan continues to sponsor ‘medical education’ activities and dosing schedules that encourage physicians to use unsafe doses higher than 8 u/kg.”