Allergan failed to warn of dangerous Botox side effects, lawsuit claims
Adverse reactions to the popular wrinkle-erasing drug have been rare, its Irvine-based manufacturer says.
More than a dozen Botox users and relatives filed a lawsuit today contending the blockbuster wrinkle-buster injured them or killed their relatives, and they blamed maker Allergan Inc. for failing to warn them of the dangers.
The suit, filed in Orange County Superior Court near Allergan's Irvine headquarters, links the toxin-based drug to three deaths, including one in March of a 69-year-old Texas nurse who received injections for neck and shoulder pain.
The second death was that of 7-year-old girl with cerebral palsy, also from Texas, who died in 2004, allegedly after receiving injections to control limb spasticity.
The third death occurred earlier this week in Arizona. In that case, the 71-year-old woman allegedly got Botox injections for wrinkles around her mouth at a mall clinic a year ago. After that, the suit says, she had trouble swallowing and breathing, was unable to speak and lost weight until she died.
The suit also contends that Botox injections for approved uses, such as smoothing frown lines, and unapproved uses, such as treating migraines, left 12 other plaintiffs with a range of disabilities, including blurred vision, numbness, allergic reactions, flu-like symptoms, muscle weakness and difficulty breathing.
Allergan spokeswoman Caroline VanHove said she could not discuss the suit in particular. But, she said, "it is important to recognize that Botox has a remarkable safety record. The product was first approved nearly 20 years ago and today benefits 21 different patient populations across more than 75 countries.
"It is important to recognize that Botox is often administered to patients who suffer from chronic, debilitating neurological conditions who are at increased risk for mortality from underlying diseases, concomitant medications and other risk factors."
She said its safety record has been validated by the distribution of more than 18 million vials of Botox over 19 years with more than 15 million treatments performed around the world. Serious adverse events have been reported rarely, she said.
Several of the plaintiffs in the lawsuit were hospitalized and suffer from chronic, life-altering conditions. The most common of the side effects cited in the suit is the loss of the ability to swallow, which causes a slow death from starvation or asphyxiation.
