Allergan Inc.'s Botox Put Boy on Respirator, Lawyer Tells Jury

Allergan Inc. pushed Botox for use by children without regulatory approval, said a lawyer for a 6-year-old Oklahoma boy who wound up on a ventilator after he was injected with the drug. The mother of Jackson Wells claims the injection, given to treat spasticity in his legs, caused the boy to develop acute botulism, leaving him unable to breathe on his own. While he was able to get off the respirator, he was left with a seizure disorder, vision problems and a permanent diminished ability to speak, breathe and eat, Ray Chester, his lawyer, said in an opening statement at trial today in federal court in Oklahoma City. Allergan didn’t provide dosage levels because it was promoting the drug for use with children with spasticity despite a lack of approval from the U.S. Food and Drug Administration, Chester said. This led to an overdose and Jackson’s current condition, he said. Botox, Allergan’s best-selling product, generated more than $1.7 billion in sales last year, about equally divided between uses for medical purposes and wrinkle treatment, according to the company’s earnings statement this month. The company is projecting as much as $2 billion in 2013 sales. Medical Condition: “They were only worried about sales,” Chester said today. “They were not worried about kids being injected at levels where the monkeys died,” he told the jury, referring to company tests. “He was given over two times the maximum dose of Botox and developed botulism as a result of it,” Chester said. A lawyer for Irvine, California-based Allergan agreed that Wells got botulism from the Botox injection from his doctor, Edward Wright, while denying liability for the child’s medical condition or any failure to warn of risks. “The warnings were adequate, clear, complete and Dr. Wright was well-informed,” Vaughn Crawford, Allergan’s attorney told the jury today.

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