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.
“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.
“Dr. Wright will testify that the use of Botox to treat spasticity, though off-label, is recognized as the standard of care,” Crawford said.
The boy has a “degenerative and progressive brain disease” called leukodystrophy, Crawford said in his opening statement. “Jackson Wells’ condition today is the result of the natural progression of his leukodystrophy,” he said.
Botox, used as a wrinkle smoother, is a purified form of the poison botulinum and is given as an injection. It has also been approved for multiple other uses, including for chronic migraine headaches, for “muscle stiffness” in the fingers and arms and “upper limb” spasticity.
Allergan officials in September 2010 agreed to plead guilty to a charge of misbranding Botox by promoting it for unapproved uses and to pay a total of $600 million in fines and damages. The drugmaker agreed to pay $375 million in criminal fines and $225 million to resolve civil claims filed by the U.S. Justice Department over Botox’s marketing campaign.
U.S. District Judge Robin J. Cauthron today reversed a decision to allow the Wells family’s attorneys to cite Allergan’s guilty plea in the trial.
“The misbranding charge at issue involved allegations of off-label promotion to treat pediatric spasticity, the condition J.W. suffered from and for which he received Botox injections,” the judge wrote on Feb. 7, in deciding it was relevant for the trial. “Allergan illegally promoted Botox to Dr. Wright, J.W.’s injector during the time period covered by the plea.”
Allergan had asked Cauthron to reconsider the decision.
“There is no basis for the court to permit plaintiffs to call Allergan a criminal from the outset of this trial,” the company’s lawyers said in a Feb. 15 filing.
Cauthron agreed today and withdrew the order.
“I made a finding I should not have made,” Cauthron said before the jury was brought in for opening statements. “Allergan raised some points in argument that swayed me to the other side.”
Cauthron said she might reconsider her decision later in the trial.
The lawsuit is Wells v. Allergan Inc., CIV-12-973-C, U.S. District Court, Western District of Oklahoma (Oklahoma City).