“Botox was a significant factor” in the death of 7-year-old Kristen Spears, a Texas toxicologist testified in a $20 million lawsuit brought by the girl’s family against Botox-maker Allergan.
Michael Nicar (pictured at right), technical director of the pathology department’s laboratory at Baylor University Medical Center in Dallas, was hired by attorneys for Kristen’s mother, Dee Spears, to analyze her daughter’s medical records. Kristen suffered from cerebral palsy and was receiving Botox injections to ease her leg spasms.
Irvine-based Allergan denies that Botox led to Kristen’s death.
“This trial relates to a very sad and unfortunate situation,” the company said in a public statement. “Our hearts go out to Kristen Spears’ family. However, Botox in no way caused or contributed to Kristen Spears’ death.
“The evidence will show Kristen Spears died due to the natural progression of her disease and that any symptoms or issues allegedly attributed to Botox were present before Kristen was first injected,” Allergan said.
The girl died Nov. 24, 2007, after receiving seven sets of Botox injections and being hospitalized seven times during a 16-month period.
Nicar, who has a Ph.D. in environmental science, said “I have no doubt that she would have lived beyond that date were it not for the Botox,” early in his two days of testimony.
“There were indications of spread of the toxin,” he said. “Breakthrough seizures indicate toxin was getting into the brain. Pneumonia shows it was getting into the lung area.”
Allergan attorney Vaughn Crawford challenged Nicar’s qualifications and conclusions during cross examination Friday.
Under questioning, Nicar acknowledged that he is not certified by the American Board of Toxicology. Nicar also agreed that a consensus of doctors recommends Botox as a treatment for cerebral palsy.
He stuck with his opinion that Botox was to blame for Kristen’s death even after Crawford questioned him about an array of other drugs she was taking. Some of them have potential side effects similar to Kristen’s symptoms.
Kristen (pictured above) was injected with therapeutic-strength Botox, which has more serious potential side effects than the weaker cosmetic-strength Botox Cosmetic.
Last year, the Food and Drug Administration required Allergan and the makers of rival forms of botulinum toxin to toughen the drugs’ warning labels.
The new Botox warning states that the effects of high doses can spread from the injection to other areas of the body, causing symptoms similar to those of botulism, including potentially fatal problems with swallowing and breathing.
The FDA has a different position on Botox Cosmetic, for which it has seen “no definitive serious adverse event reports of distant spread of toxin” after Botox is injected at recommended doses to smooth wrinkles between the eyebrows.
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