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Orange County trial will focus on Botox's safety in children's cerebral palsy treatments

The family of Kristen Spears alleges an overdose of the drug manufactured by Irvine-based Allergan Inc. killed her at age 7. The firm has said the family cannot prove the allegations.

January 27, 2010|By Lisa Girion

In May 2007, European regulators asked Allergan and two competitors to add information to labels and warn doctors that the toxin could spread, causing botulism symptoms.

Two months later, on July 16, 2007, consulting firm BioSoteria Inc., in a confidential report to Allergan, identified 207 patients with medical problems, including several deaths, associated with the spread of toxin.

A third of the cases identified by BioSoteria occurred in people treated for wrinkles; the rest were treated for muscle spasms, muscle spasticity and eye problems. Proportionally more problems were reported among children.

Kristen's care proceeded as such reports flowed into Allergan, according to depositions and documents filed in court.

The Amarillo, Texas, pediatrician who treated Kristen said in a deposition that he learned to use Botox on children with cerebral palsy at Allergan-sponsored seminars in 2000 and 2001.

Dr. Rolf Habersang, who is a critical care pediatrician and medical professor at Texas Tech University, and his nurse practitioner wife, Pia, both testified that they believed that Allergan arranged and paid for them to fly to an Irving, Texas, seminar.

Allergan also sent Habersang to Little Rock, Ark., to train with a pediatric neurologist, the Habersangs said.

The doctor testified that he learned to dose children with 15 units of Botox per kilogram of body weight.

That is nearly twice the maximum dosage that Allergan considers safe for children, according to the deposition testimony of Allergan executive and neurologist Mitchell Brin.

But, Brin testified, the company never shared its maximum dosage information with physicians because of a federal ban on marketing for non-approved uses that it believed prohibited such communications.

Still, Allergan's sales agents discussed the use of Botox for juvenile cerebral palsy patients with the Habersangs repeatedly, visiting the practice about 50 times over several years, according to motions and depositions.

One sales agent told the Habersangs that other physicians were using Botox "in the range of 10 to 15" units per kilogram, Pia Habersang said in her deposition.

Allergan said in a court motion that Rolf Habersang was aware of the risks of Botox when he treated Kristen, although Habersang testified that he was unaware of the reports of seizures and breathing, swallowing and other difficulties among pediatric cerebral palsy patients. He said he would have shared such information with parents.

In June 2006, the suit alleges, Kristen's health was stable. Over the next 15 months, the 33-pound girl got seven Botox treatments in her legs, groin and chest.

Kristen's health deteriorated dramatically, the suit alleges.

Already subject to seizures, Kristen got them more frequently, and they got worse, according to one motion.

She was hospitalized 10 times for repeated bouts of breathing and swallowing difficulties and pneumonia, it says.

About six weeks after her last treatment, Kristen stopped breathing.

She died on Nov. 24, 2007, at the age of 7.

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