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SANTA ANA — The family of a 7 year old girl is suing Allergan Inc., the maker of Boxtox, claiming the child died from an overdose of the drug.

Kristen Spears started receiving Botox injections at the age of 6 to help calm spasms in her legs caused by cerebral palsy, according to her family.

Botox, best known for its cosmetic uses, has also been prescribed to relax muscles in cerebral palsy patients and can sometimes help young patients walk without surgery, according to experts.

Kristen died on November 24, 2007 of respiratory failure and pneumonia, according to her death certificate. Her mother, Dee, alleges that an overdose of Botox weakened muscles controlling her breathing and led to her death.

The trial began Tuesday in Santa Ana with opening statements. It is believed to be the first case alleging a fatal reaction to the drug to reach trial.

Spears’ attorney Ray Chester told jurors that his client’s adopted daughter received too much Botox and that it led to her death.

Attorney Vaughn Crawford, who represents Allergan Inc., said the evidence in what’s expected to be weeks-long trial will show Botox did quite the opposite. The drug alleviated many of Kristen’s symptoms, and the cause of her death was common for those who suffer from cerebral palsy, he said.

Federal authorities mandated “black box” labels that warn of potentially serious reactions to the drug last year. The case opens a window into the Irvine-based drug maker’s own records of reported ill effects, showing that the company knew of some serious problems linked to neurotoxins such as Botox as early as 2005.

Botox uses botulinum toxin, a powerful poison, to block neural communications, allowing muscles that produce worry lines or gnarled limbs to relax. A few injections smooth wrinkles, while larger doses are required to relax arms and legs.

At issue in the trial will be the dosage and whether Botox spread through the girl’s body, killing her with the toxin that makes up the medicine.

Jurors will hear testimony from experts who will go into technical scientific detail about how botulinum toxin works.

Botox is approved in the United States specifically to treat frown lines, crossed eyes and other conditions. It yields $1.3 billion in annual sales.

The drug, however, can be legally prescribed at doctors’ discretion for a variety of other purposes, including cerebral palsy. It is also specifically approved for cerebral palsy in many other countries. Its use for that condition alone contributed $47 million to Allergan’s bottom line in 2007.


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