More than a dozen Botox users and relatives filed a lawsuit Wednesday contending that 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 a 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, a 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. All three deaths involved uses of Botox that were not approved by federal regulators.
The suit also contends that Botox injections both 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."
Botox is often administered to patients who are suffering from chronic, debilitating neurological conditions and are already at increased risk from underlying diseases, she said.
VanHove said Botox's safety record had been validated by the distribution of more than 18 million vials of the drug over 19 years, with more than 15 million treatments performed around the world. Serious adverse events have rarely been reported, she said.
Several of the plaintiffs in the suit were hospitalized and suffer from chronic, life-altering conditions. The most-common side effect cited in the suit is a loss of the ability to swallow, which causes a slow death from starvation or asphyxiation.
