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.
“Botox is causing major injuries and death, and it’s well-documented but not widely known,” said Ray Chester, a Texas lawyer who leads a nationwide team of lawyers involved in the suit. “So thousands of people are getting these injections with no warnings to speak of. Then they fall ill with serious illnesses and, in some cases, they are not even aware that it’s the Botox that caused it.”
VanHove said that Allergan had been the target of other Botox suits, but she declined to detail them.
One suit resulted in a high-profile Los Angeles trial that cleared Botox in 2004. In that case, Irena Medavoy, the wife of a movie studio founder, claimed she got terrible headaches from the injections a Beverly Hills dermatologist gave her to keep her wrinkles at bay. Medavoy lost her claim against her dermatologist, and the case against Allergan was dismissed.
Botox is derived from botulinum toxin Type A, a form of one of the deadliest known poisons. In its raw form, the toxin kills by interrupting the communication between nerves and muscles, causing them to relax and leaving the victim paralyzed and susceptible to suffocation.
Allergan maintains that the toxin, as sold as Botox, is purified, highly diluted, safe and effective. Injected locally, it smooths wrinkles by relaxing muscles. The effect is temporary, wearing off in a few months if injections are not repeated, the company says.
Originally developed to treat people with crossed eyes, Botox became a worldwide cosmetic juggernaut after it won approval several years ago as a treatment for vertical frown lines between eyebrows. Sales surpassed $1.2 billion last year.
Botox also is used for a variety of maladies, including migraines -- uses that have not been approved by the Food and Drug Administration. Such off-label prescribing is a legal practice for physicians. But manufacturers are not allowed to promote off-label uses.
In February, the FDA warned that it was reviewing reports of at least one death and other serious reactions among patients to botulinum-based drugs, including Botox and competitor Myobloc.
FDA officials said at the time that they were unaware of any deaths among cosmetic users.
The most serious of the reported problems occurred in children with cerebral palsy who were treated for arm and leg spasms with doses many times those recommended for cosmetic treatments.
The FDA warning followed the consumer group Public Citizen’s announcement in January that it found reports linking 16 deaths to the use of Botox or Myobloc from 1997 to 2006.
The group also found that 180 patients had developed life-threatening conditions after being injected, leading to 87 hospitalizations.
In March, Allergan disclosed that the U.S. Department of Justice was looking at the company’s promotion of its best-selling drug. Allergan, which received a subpoena for information from the U.S. attorney in the Northern District of Georgia, said it understood the inquiry involved questions about the use of Botox for headaches.
The suit filed Wednesday contends that the injuries arose from both approved and non-approved cosmetic and therapeutic uses of Botox. The three deaths allegedly occurred as a result of off-label uses -- two as therapeutic treatments for muscle problems and the third for smile lines, a non-approved cosmetic use.
“Allergan emphasizes that Botox is a miracle drug and has often compared it to ‘penicillin,’ ” the suit says. “Meanwhile, Allergan obscures that Botox is a highly lethal toxin with serious and life-threatening side effects.”
Allergan continuously monitors the safety of Botox in clinical practice, spokeswoman VanHove said.
“This means, we evaluate any adverse event report that we receive following treatment with Botox or Botox Cosmetic, even though often times there is only limited information available and causality is not established,” she said. “Given its high profile, it is not surprising that Botox might eventually attract an attempt of this kind.”
“In fact, we are aware that the plaintiff lawyers in this case have been soliciting claims regarding Botox over the Internet for months,” VanHove said. “However, it still remains disappointing to see irresponsible allegations about a product that has done so much good for so many patients suffering from debilitating conditions.”