Allergan cleared in lawsuit over 7-year-old's death

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By WIRE SERVICES

SANTA ANA -- Allergan Inc. was cleared Tuesday of responsibility for the death of a 7-year-old who was prescribed Botox to treat her cerebral palsy.   

A jury rejected Dee Spears' claim that her 7-year-old daughter Kristen received too much of the drug best known for reducing wrinkles, but prescribed by many doctors for cerebral palsy patients because it relaxes muscles in a specific part of the body rather than the entire body, which may not be necessary.

"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,'' Allergan said in a statement. "However, the jury's conclusion supports the evidence 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.''   

Attorney Ray Chester, who represented Spears, and Vaughn Crawford, who represented the Irvine-based pharmaceutical company Allergan, could not be immediately reached for comment.   

Chester said in his opening statement that Botox is not approved by the U.S. Food and Drug Administration for cerebral palsy patients, while Crawford countered that many drugs are prescribed for symptoms in ways not FDA-approved.

At issue in the trial was whether the dosage was proper and whether Botox spread through Kristen's body, killing her with the toxin that makes up the medicine.

Crawford told jurors that Kristen Spears was born with multiple health issues because her birth mother used drugs while pregnant and the girl was born with the umbilical cord around her neck.   

At birth, Kristen suffered spasms in all of her limbs, was legally blind, could not talk or stand up and was unable to sit up without help, Crawford said.   

"She lived her whole life in a diaper,'' he said.   

The girl also suffered from acid reflux and had difficulty swallowing, so stomach acid would sometimes seep into her lungs, which would cause bacterial infections that would lead to pneumonia, Crawford said.   

Kristen's doctor, Rolf Habersang, an Amarillo, Texas-based pediatrician and medical professor at Texas Tech University, prescribed Baclofen, which she took for most of her life, Crawford said.   

Kristen needed higher doses of the anti-spasmodic over time, and as she was reaching the dosage limit, Habersang discussed alternatives such as implanting a pump to distribute Baclofen, but her adoptive mother Dee Spears didn't want that, Crawford said.   

Dee Spears also did not want her daughter to undergo surgery, which also carried risks, Crawford said.   

Kristen Spears received her first Botox injection in June 2006 and received six more injections over the next 16 months, Crawford said.   

The injections helped relax the girl's muscles enough that she no longer suffered  "scissoring of the legs,'' Crawford said.   

Chester said the girl's health continued to deteriorate after the first injection as she suffered seizures. Crawford countered the girl had suffered seizures since birth, including times when she would suffer up to 18 seizures a day.   

Crawford also said although patients in trial runs did suffer seizures from Botox, there was no evidence to suggest a causal relation between the two, and the instances of seizures were the same for those who took placebo pills as those given Botox.   

Botox can be deadly if it spreads, causing botulism, but that is an "extremely rare phenomenon'' and only happens with "extremely high doses,'' Crawford said. Those doses would have to be "significantly beyond'' what Habersang gave Kristen Spears, he argued.   

Kristen Spears died from respiratory failure and pneumonia. There was no evidence Botox caused those conditions, Crawford said.   

Chester said Botox weakened muscles controlling the girl's breathing and swallowing, which led to the respiratory failure and pneumonia.   

Kristen Spears died a year before the FDA ordered labels warning of Botox's potential to cause botulism symptoms, including life-threatening difficulty with swallowing and breathing.   

Her mother's lawsuit alleged Allergan officials knew similar problems had been reported two years before her daughter's death.

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