Quoted from http://www.latimes.com/news/local/la-me-botox3-2010mar03,0,25189.story
Botox maker is not liable in girl's death, O.C. jury says
The case involving the 7-year-old cerebral palsy patient from Texas was believed to be the first of its kind to go to trial. The girl's family alleged that the product was responsible for her death.
By Lisa GirionMarch 3, 2010
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.