An Orange County jury Tuesday declined to hold Botox maker Allergan Inc. liable in the death of a 7-year-old Texas girl being treated for cerebral palsy because it found the company's warning labels adequate.
The closely watched case is believed to be the first to go to trial over allegations that the botulinum toxin-based drug contributed to a death. At issue was the safety of the blockbuster cosmetic drug in the higher dosages that are used in pediatric cerebral palsy cases and the adequacy of the Irvine manufacturer's warning labels.
Kristen Spears, who was born with severe cerebral palsy, began receiving large doses of Botox at age 6 in an effort to reduce debilitating limb spasticity. The girl died Nov. 24, 2007, at the age of 7.
Best known as a face-lift-in-a-syringe, Botox can relax contorted muscles and sometimes help young patients walk without surgery. U.S. regulators have not specifically approved the use of Botox in children, but doctors may legally prescribe it as an "off-label" use. Dosages used in such patients are many times those recommended for facial wrinkle injections.
Dee Spears alleged that her daughter died as a result of an overdose of Botox, which led to respiratory failure and pneumonia, and that Allergan failed to adequately warn the girl's pediatrician of the drug's risks.
The jury, which deliberated for several hours over two days, did not agree. The panel found that Botox posed risks of "a substantial danger" that "ordinary consumers" would not have recognized, according to the verdict form.
But jurors concluded that Allergan did not breach its duty to warn of those potential risks and therefore could not be held responsible for any potential adverse effect.
In a statement, Allergan said the outcome supported the company's position that "Botox played no role in the passing of Kristen Spears.
"The evidence presented in this case and acknowledged by the jury showed that Kristen died as a direct result of the progression of her condition, and that any symptoms or issues affecting Kristen's health were present before Kristen first received treatment with Botox."
Ray Chester, the lawyer for Dee Spears, said jurors never got to the question of whether Botox played a role in Kristen's death because they found the company's warnings adequate.
Chester said the verdict was frustrating because it came months after the U.S. Food and Drug Administration concluded that the Botox label did not reflect its full risk and ordered Allergan to replace it with a "black box" warning of potentially serious reactions.
"We still believe the warning was inadequate, and we will not give up the fight," said Chester, who is representing plaintiffs in other Botox cases pending against Allergan.
Bryan Liang, executive director of the Institute of Health Law Studies at the California Western School of Law in San Diego, said that although the company may be pleased with the win, the verdict says nothing about whether Botox contributed to Kristen's death.
Allergan faces another civil trial set for next month in Oklahoma City.
"The ball game isn't over," Liang said. "It may be with respect to Dee Spears, but certainly not with respect to Allergan."