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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
  • Kristen Spears got seven Botox treatments.
Kristen Spears got seven Botox treatments.

Kristen Spears started getting Botox injections at the age of 6 -- not to smooth furrows in her brow, but to calm spasms in her legs.

The girl was born with severe cerebral palsy, and Botox, best known as a face-lift-in-a-syringe, can relax contorted muscles and sometimes help young patients walk without surgery.

Instead, Kristen's mother alleges, an overdose of the drug killed her.

Opening arguments in a negligence lawsuit by Dee Spears against Botox manufacturer Allergan Inc. are set for today in Orange County.

At issue is the safety of the blockbuster drug, especially in the higher dosages that are used to treat children with cerebral palsy.

It is believed to be the first Botox case alleging a fatal reaction to reach trial, and is one of several pending suits related to the drug's cosmetic and non-cosmetic uses.

The trial comes less than a year after federal authorities mandated "black box" labels that warn of potentially serious reactions to Botox. And it opens a window on 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.

Allergan declined to comment on the trial. In a court motion, Allergan says that Kristen died of a bacterial infection and that her mother cannot prove Botox killed her.

When the suit was filed, a spokeswoman characterized the drug's safety record as "remarkable." Serious side effects, she said, were rarely reported in more than 15 million treatments over two decades.

In a confidential 2008 report to federal regulators, Allergan said it found that the risk of death among children with cerebral palsy was low and that fatalities often resulted from underlying poor health.

Approved in the United States specifically to treat frown lines, crossed eyes and other conditions, Botox yields $1.3 billion in annual sales. But the drug 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.

The drug 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.

Kristen died in November 2007 of respiratory failure and pneumonia, according to her death certificate. Experts hired by Dee Spears say Botox weakened muscles that controlled her breathing and swallowing, leading to respiratory failure and pneumonia.

Kristen's death came more than a year before the U.S. Food and Drug Administration ordered the labels warning of the drug's potential to cause botulism symptoms, including "potentially life-threatening swallowing and breathing difficulties and even death."

At the same time, the agency required Allergan to notify physicians that the toxin could spread beyond the injection site and to prepare a patient guide saying that it was not known whether Botox was safe for children or for other patients whose conditions it had not been approved to treat.

Spears alleges that Allergan knew problems had been reported at least two years before Kristen died. What's more, she alleges, Allergan encouraged Kristen's pediatrician to treat cerebral palsy patients with Botox and helped with his training.

"I don't want this to happen to anyone else's child," she said in a statement.

In preparation for the trial, Allergan was required to produce safety assessments of Botox and other confidential internal reports. Portions of some documents were obtained by The Times after Orange County Superior Court Judge Ronald L. Bauer unsealed them.

The documents include a 2005 letter sent by a European health official that alerted Allergan of reports that botulinum toxin had spread beyond the injection site among patients who sought cosmetic treatment. There was at least one similar drug manufactured by another company in the European market, and the letter did not specify which products the reports related to.

Trouble with swallowing and "aspiration have been reported to occur secondary to muscle weakness in the muscle in the neck region," the letter says. "Fatal cases of aspiration have been reported."

In a confidential response dated Sept. 16, 2005, Allergan said its internal database contained 436 "serious adverse event" reports related to Botox.

Of those, 201 were "serious, healthcare professional-confirmed cases with events possibly due to remote spread of the toxin," including 42 after facial wrinkle treatments.

Also in 2005, documents show, Allergan sent a confidential report to the FDA, saying that an analysis identified 38 patients -- 20 children, most of them with cerebral palsy, and 18 adults -- who had suffered seizures after Botox injections.

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