A $20 million Botox death case against Allergan focuses on whether the company hid evidence of the drug’s dangers.
The Irvine-based manufacturer of Botox has been forced to reveal confidential safety documents in the lawsuit filed by the mother of Kristen Spears (pictured), a cerebral palsy patient who died at age 7 after receiving Botox injections to ease her leg spasms.
The mother, Dee Spears, is seeking $20 million in damages from Allergan.
The company says the girl’s death from pneumonia and respiratory failure was not caused by Botox. Sadly, the company says, that’s frequently how children with cerebral palsy die.
Testimony focused on a confidential Allergan list of 207 patients who suffered medical problems after Botox injections, including seven who died. At issue was whether Botox caused any of those medical problems, especially symptoms distant from a Botox injection site, and whether Allergan made public what it knew.
The trial’s first witness was Beta Bowen, Allergan’s head of medical affairs, who is responsible for the department that distributes medical information to patients and physicians.
During two days of questioning by plaintiff’s lawyer Ray Chester, Bowen said that Allergan research in 2004 found that high doses of Botox caused symptoms of botulism in laboratory animals.
Botulism is a muscle-paralyzing disease caused by the Clostridium botulinum bacteria, which produce a toxin that in weakened form is used to make Botox. Symptoms of botulism include drooping eyelids, slurred speech, difficulty swallowing, pneumonia, respiratory failure and muscle weakness.
Bowen testified that the company used a list of 24 botulism symptoms to search a database of Botox-related medical incidents, seeking cases that might indicate that the drug was spreading in the body beyond where it’s injected.
The search turned up about 3,000 incidents involving both Botox and one or more of those symptoms. Chester focused on a list of incidents compiled for Allergan in July 2007 by a drug-safety consulting firm, which narrowed down the 3,000 incidents to 207 that might turn out to be evidence of Botox spreading in the body.
Seven of those 207 incidents were fatalities.
Chester questioned why the confidential July 2007 list of 207 Botox-related incidents, including seven deaths, turned into a list of 25 Botox-related incidents and no deaths two months later in a report Allergan submitted to the Food and Drug Administation.
Bowen testified that Allergan investigated the 207 incidents and ruled out ones where actual symptoms weren’t like botulism – a person with muscle weakness but also a range of flu symptoms, for example.
“No deaths were determined to be directly attributable to the spread of toxin,” she said.
Last year, the FDA reached a somewhat different conclusion. In August, it required Allergan and the makers of rival forms of botulinum toxin to strengthen 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 noted that it wasn’t targeting Botox Cosmetic. It stated, “No definitive serious adverse event reports of distant spread of toxin effect have been associated with dermatologic use of Botox/Botox Cosmetic at the recommended doses (for frown lines between the eyebrows or severe underarm sweating).”
The FDA action came after the advocacy group Public Citizen in early 2008 publicized physicians’ reports of 16 deaths of patients who had been injected with Botox or a similar drug.
Of the 16 deaths, 15 patients were being treated with powerful therapeutic-strength injections of botulinum toxin for disorders such as Kristen Spears’ juvenile cerebral palsy. Only one of the 16 patients had injections of cosmetic-strength Botox. She was a 47-year-old woman who died from complications associated with staphylococcus pneumonia seven weeks after getting a wrinkle-smoothing Botox injection.
Photos of Kristen Spears at age 6 (top photo) and age 2-3 (bottom photo) are courtesy of Dee Spears.
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