Botox was approved the Food and Drug Administration (FDA) in 1989 for the cosmetic treatment of facial lines. It is made from bacterium Clostridium, best known as the bacteria that causes botulism. Lethal in large doses, it paralyzes nerve endings in small doses, causing muscles to relax. When it is injected into the forehead area, lines and furrows disappear temporarily.
"This is a toxin. It has been studied as a biological weapon and is actually the most lethal substance on the planet"Ray Chester's client, 48-year-old Sharla Helton, a doctor, alleged that Botox injections caused her constant pain, blurred vision and difficulty breathing—all symptoms consistent with botulism. "Botox is lethal and the problem is you can't really tell where you are injecting it," says Chester. "If you hit a blood vessel or if the Botox spreads outside the muscle it can travel body wide and lead to botulism."
Unable to work, Helton had to sell her practice and quit her job as medical director at Oklahoma City hospital. "She was earning about $500,000 a year," says Chester. "It was a good-sized verdict, we could have asked for more, but we tried to be conservative about it."
Allergan, which earns about $1.3 billion a year from sales of its anti-wrinkle drug, calls the verdict "inconsistent with all credible and scientific medical evidence" and plans to appeal.
Untended consequences from Botox injections surfaced as far back as 2004. In February 2008, the FDA linked Botox to adverse reactions, including respiratory failure and death due to the toxin's ability spread through the body.
Immediately after the FDA reported the link between Botox and botulism, Dee Speers contacted Chester. Her seven-year-old daughter died after being injected with Botox to ease muscle spasms associated with cerebral palsy.
"She thought, 'Oh my God, that's what happened to my daughter,'" says Chester.
Chester sued Allergan on behalf of Speers and her daughter. He lost the case, but has continued to pursue other cases since.
"This is a toxin," says Chester. "It has been studied as a biological weapon and is actually the most lethal substance on the planet."
The FDA approval dose for Botox is 20 units, but Chester says Allergan encourages use over the approved limits by selling Botox in 50 unit vials, which can only be used once for hygienic reasons. "Over two thirds of their sales were off-label," says Chester. "And in the case of Dr. Helton, she was given 50 units in the upper part of her face."
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In September, Chester is heading for court in Orange County, California where a healthy 70-year-old nurse died after being injected with Botox to ease neck pain. "She had 100 units of Botox injected into her neck and it immediately affected her ability to swallow. She lost 40 pounds in five months and had to have a feeding tube put and ultimately went down hill and died."
Ray Chester is an attorney with McGinnis, Lochridge & Kilgore in Austin Texas. He areas of practice include business litigation, personal injury, product liability, pharmaceutical litigation and other contingent fee matters. He has tried over 30 jury cases and achieved numerous multimillion dollar verdicts and settlements.