$6.5 Million Awarded in Off-Label Botox Lawsuit

November 21, 2014 — Law360 reports that a federal jury in Burlington, Vermont have ordered Allergan to pay $6.5 million to a boy who was injured by “off-label” injections of Botox.

The plaintiffs, Lori and Kevin Drake, filed the lawsuit on behalf of their 6 year-old son, Joshua, who has cerebral palsy. In 2010, his pediatrician prescribed injections of Botox for the treatment of mild muscle spasticity — an “off-label” indication that was never approved by the FDA.

After the first dose didn’t work, he was given a second dose that was twice as large as the first, according to the Burlington Free Press.

Soon after, he suffered an allergic reaction that caused facial swelling, slurred speech, respiratory difficulties, vomiting, and seizures. As a result of the treatment, he continues to suffer from seizures and must be monitored by a special aide at all times.

According to the complaint:

“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.”

The jury determined that Allergan was liable for the boy’s injuries because they promoted Botox to treat muscle spasticity at unsafe doses. They awarded the family $2.5 million in compensation and $4 million in punitive damages for gross negligence.

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