In a huge settlement, $212 million dollars has been awarded to a victim of Botox, as Allergan the manufacturer, has conceded that the drug did in fact cause a California man brain damage and disability. However, this case took place in Virginia.
Douglas Ray Jr., 67, filed suit against Allergan Inc. after complaining that Allergan did not warn his doctor regarding the negative effects of the drug. The suit asked for $12 million in compensatory damages and left the punitive damages up to the jury.
Ray’s lawyer stated regarding the settlement:
“We asked that it be big. This is the biggest Botox award, for sure, and it’s got to be one of the biggest around here.”
Ray was given an injection of Botox in 2007 for treating a hand tremor and writer’s cramp. He complained that Botox caused severe medical complications and disability. Apart from this Ray had lost $643,800 in the medical expenses for his treatment.
Caroline Van Hove, a spokeswoman for the pharma giant responded:
“The verdict reached today is inconsistent with Allergan’s past and current actions to properly warn physicians and patients about the potential risks of Botox. Every known and knowable risk associated with Botox treatment based on the scientific properties of the drug was in fact warned about.”
Botox is Allergan’s top-selling drug, with $1.42 billion in sales last year, or 29% of the drugmaker’s revenue.
So what actually are the risks of using Botox in general?
The majority of drug-related problems seen in adults came after treatment for muscle spasms and cervical dystonia, a type of neck contraction for which the drugs are approved. Some of those patients had to be hospitalized and put on mechanical ventilation in order to breath. While the agency said it has received reports of botulism symptoms in patients taking the drug for anti-wrinkle uses, none of those cases have been confirmed.
Deputy Director of the FDA, Dr. Ellis Unger said in a 2009 Associated Press article:
“We don’t want to discourage (Botox) use, but people need to understand the risks involved.”
Allergan added:
“Botox has been marketed in the United States for nearly 20 years, its safety and efficacy profile are well understood, and reports of suspected distant spread have been rare.”
Although botulinum toxin is a lethal naturally occurring substance, it can be used as an effective and powerful medication. Researchers discovered in the 1950s that injecting overactive muscles with minute quantities of botulinum toxin type-A would result in decreased muscle activity by blocking the release of acetylcholine from the neuron by preventing the vesicle where the acetylcholine is stored from binding to the membrane where the neurotransmitter can be released. This would effectively weaken the muscle for a period of three to four months.
The company said it is evaluating the basis for an appeal, noting that Virginia state law caps punitive damages at $350,000. Last year, Allergan plead guilty and paid $600 million to resolve a federal probe involving marketing Botox for unapproved non-cosmetic uses.
Written by Sy Kraft