A California jury has ruled in favor of drug maker Allergan, Inc. in the first Botox lawsuit to go to trial, involving the death of a 7 year-old girl with cerebral palsy who received Botox injections to alleviate muscle problems associated with her disability.
The verdict was handed down Tuesday by an Orange County jury in a wrongful death Botox lawsuit brought by Dee Spears, the mother of Kristen Spears. The jury deliberated for under three days before returning a defense verdict. At trial, the drug maker argued that Spears’ November 2007 death was caused by complications of her cerebral palsy, not a result of a Botox overdose that weakened the muscles that controlled her ability to breath, as the mother alleged.
Botox 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.
Minute quantities of Botulinum Toxin A are contained in Botox, which is the bacteria associated with the muscle paralyzing condition Botulism. A number of adverse event reports have been associated with side effects of Botox, where the medication spreads from the area of the injection to other parts of the body. These Botox problems have most commonly been seen among children with cerebral palsy, where the typical Botox dose is substantially larger.
In February 2008, the FDA issued a warning about the risks associated with use of Botox to treat cerebral palsy, after receiving a number of adverse event reports involving sudden death, breathing problems and other potentially life-threatening injuries. A “black box” Botox warning was added to the medication in August 2009, warning about the risk of botulism-like side effects, such as swallowing and breathing difficulties, that can occur if the injection spreads to other areas of the body.
More than a dozen people have filed lawsuits over Botox against Allergan, alleging that the company illegally promoted the medication for non-approved uses and failed to adequately warn about the risk of these severe and potentially life-threatening Botox injuries.