Allergan, Inc. has been found not responsible for the death of a seven-year-old girl with cerebral palsy who was treated with the company’s sometimes controversial drug Botox. After deliberating for less than three days, an Orange County (CA) Superior Court jury voted 10-2 in favor of the company, concluding that Kristen Spears died as a result of pneumonia and respiratory failure and not as a result of the Botox used to treat the symptoms of her cerebral palsy.
Botox is often used to relieve the muscle spasms common in patients with cerebral palsy because it can be used selectively. Although the drug is not specifically approved for this use by the Food and Drug Administration, doctors are allowed to use it in so-called off-label treatments if they feel it is justified.
Dee Spears, Kristen’s mother, alleged in her $60 million lawsuit that Botox was responsible for the respiratory failure that was the ultimate cause of her daughter’s death in November of 2007.
According to an article in the Orange County Register, juror David Reyes of Orange said he concluded that Botox couldn’t be singled out as a substantial reason for Kristen’s demise. “So many other things could be faulted in her death,” he said.
According to plaintiff’s attorneys, Allergan concealed information about the risks of Botox, putting the public at risk. Specifically, the suit alleged that Allergan considers doses over 8 units per kilogram (2.2 pounds) of patient body weight to be overdoses, and that the company trained Kristen’s doctor to administer doses larger than 8 units per kilogram. According to the Register article, while some jurors believed that to be true, Allergan was not allowed to release that information because Botox is not approved for the treatment of cerebral palsy.
According to laindependent.com, Kristen received 7 treatments with Botox over a 16-month period. The lawsuit alleged that her health began to deteriorate during the period she was receiving the Botox, but Allergan’s attorneys noted that she had been suffering seizures her entire life.
In a statement, Allergan said: “The trial relates to a very sad and unfortunate situation, and our hearts go out to Dee Spears for the loss of her daughter, Kristen. However, the jury’s conclusion supports the evidence that Botox played no role in the passing of Kristen Spears.
According to a statement by Allergan, “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.”
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