MONTPELIER, Vt. (AP) — A New York couple who said Botox treatment of their son's cerebral palsy left him with life-threatening complications and sued its manufacturer won a $6.75 million verdict from a federal jury on Thursday.
The verdict, in U.S. District Court in Burlington, came three days after the announcement that Parsippany, New Jersey-based drugmaker Actavis would acquire Botox maker Allergan for $66 billion, one of the biggest acquisitions announced this year.
A lawyer for Mineville, New York, residents Lori and Kevin Drake said Joshua Drake, now 7, suffered calf spasms due to mild cerebral palsy until he got Botox injections to treat them at a Burlington hospital in 2012. The lawyer, Ray Chester, said Joshua has since developed epilepsy and must have an aide with him at all times in case he needs life-saving medications during a seizure.
Thursday's verdict came four years after Irvine, California-based Allergan agreed to pay $600 million, pleading guilty to a federal criminal charge and settling the government's civil complaint that it had improperly promoted Botox for off-label uses including juvenile cerebral palsy. The injections that damaged Joshua were given by a doctor in Burlington at the Fletcher Allen Health Care hospital, now known as the University of Vermont Medical Center, 19 months after the 2010 court action.
Chester said the doctor and the hospital were not defendants in the lawsuit.
Phone messages and an email sent to Allergan on Thursday afternoon drew no immediate response. At the time of its 2010 settlement with federal prosecutors in Atlanta, the company said Botox had been approved for treatment of juvenile cerebral palsy in 70 countries but not the United States.
Botox, which is purified from botulinum, one of the most toxic substances in the world, went on the market in 1989 and gained quick fame as a treatment for wrinkles in aging faces. Its uses since have expanded to include treatment of neck spasms, eye muscle disorders and excessive underarm sweating, among other maladies. Its manufacturer has pushed hard to expand its uses.
The list of government allegations that led to Allergan's guilty plea in 2010 said it set up a patient advocacy group to push regulators and insurers to approve more uses for Botox.
"Doctors were paid $1,000 each to attend the patient advocacy group's regional workshops, where Allergan reimbursement personnel coached them on how to successfully lobby health care payers to cover off-label uses of Botox," it said.
Allergan, in its 2010 statement, said it was "committed to conducting its business consistent with high ethical standards."
Lori Drake, from her home in New York's Adirondack Mountains, said by telephone Thursday that she has her doubts.
"This is a truly lethal drug, and we need to make sure people know how lethal it is," she said. "And this company is more worried about profits than about the safety of the consumers utilizing those products."