Botox-maker Allergan Inc. was ordered by a federal court jury to pay $212 million to a Virginia man who alleged that use of the drug left him severely disabled.
The verdict awarded Douglas Ray, 67, $12 million in compensatory damages and $200 million in punitive damages — the largest penalty ever in a Botox injury case.
Ray was injected with the drug in 2007 to treat hand tremors. He quickly fell ill with a fever and rash, said his lawyer, Ray Chester.
Ray suffered brain damage and now requires round-the-clock care, the lawyer said.
The suit, filed in U.S. District Court in Richmond, Va., alleged that Irvine-based Allergan failed to adequately warn Ray's doctor about the potential risks of Botox for off-label use.
Known primarily as a wrinkle-buster, doctors also have prescribed the drug for treating serious medical conditions such as cerebral palsy and chronic migraines.
"The use of Botox on both cosmetic and medical purposes is only approved for very narrow uses by the FDA," Chester said after the verdict was announced Thursday.
"But Allergan has promoted it to doctors all over the country for uses other than wrinkles."
Allergan spokeswoman Caroline Van Hove said the company complied with all federal guidelines and might appeal the decision.
"The verdict … is inconsistent with Allergen's past and current actions to properly warn physicians and patients about the potential risks of Botox," she said.
Even if the decision by the jury is upheld, Allergan might have to pay only a small fraction of the penalty.
Van Hove said that Virginia state law caps punitive damages at $350,000.
Ray's attorney said he plans to fight the constitutionality of that state law.
Ray's wife, Peggy, was elated by the verdict.
"I'm so grateful we had a jury that paid attention to the facts," she said, "I thank God almighty because Botox gave my husband brain damage. He sleeps almost 24 hours a day and he speaks very few words."
In September, Allergan agreed to pay the federal government $600 million to settle civil and criminal allegations that it illegally marketed and sold the drug through 2005 for unapproved uses, such as treating headaches.
Allergen shares Thursday rose 6 cents to $79.42.