A Virginia jury has awarded $212 million to a man who alleged that side effects of Botox led to him to suffering brain damage.
According to Bloomberg News, the lawsuit was filed by 67 year-old Douglas Ray, who alleged that he was disabled by permanent brain damage after receiving Botox injections to treat writer’s cramp in his right hand. The complaint accused Allergan Inc., the manufacturer, of failing to warn about the risk of brain damage from Botox triggering an autoimmune reaction. (WCxKit)
In late April, a jury in the U.S. District Court for the Eastern District of Virginia in Richmond awarded Ray $12 million in compensatory damages and $200 million in punitive damages. However, Virginia tort reform laws will reportedly cap the punitive damages award at $350,000.
Botox, which includes limited quantities of the bacteria associated with the development of botulism poisoning, is approved for both cosmetic use to reduce the appearance of wrinkles in the skin and to treat medical conditions such as strabismus (crossed eyes), hyperhidrosis (excess sweating), cervical dystonia (involuntary contractions of the neck muscles) and blepharospasms (involuntary blinking of the eye). However, it also commonly used off-label at high doses to treat stiff and jerky movements associated with cerebral palsy in children.
A number of Botox problems have been reported among users, where the medication can spread from the area of the injection to other parts of the body. This can result in symptoms of botulism poisoning, such as paralysis, difficulty swallowing, respiratory distress and other issues. These Botox side effects have most commonly been seen among children with cerebral palsy, where the typical Botox dose is substantially larger.
In October 2010, Allergan pled guilty to charges of illegally marketing Botox and agreed to pay $600 million to settle the charges. (open-ended)
According to allegations raised in the lawsuit over Botox marketing, the company went as far as training doctors how to bill for unapproved uses and created a Botox Reimbursement Hotline to help doctors get reimbursed for using Botox in ways that have not been sanctioned by the FDA.
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