Botox Lawsuit Over Cerebral Palsy Treatment Results in $6.7M Verdict
A federal jury has ordered Allergan Inc. to pay $6.75 million in a lawsuit brought by a New York family, which alleged that side effects of Botox injections given for treatment of cerebral palsy caused a severe allergic reactions in their son, resulting in permanent injuries.
The injections were given to Joshua Drake, now 7, in 2012, as a treatment for minor calf spasticity caused by cerebral palsy.
According to allegations raised at trial by his parents, Kevin and Lori Drake, the two Botox injections caused him to suffer facial swelling, speech problems, difficulty breathing, seizures and vomiting. As a result of the Botox complications, the family indicates that Joshua now has epilepsy, and the seizures are now a permanent problem. In addition, Joshua must now be constantly accompanied by a specially trained aide to deliver life-saving medications in case one of the seizures strikes.
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The jury award was handed down by a jury in the U.S. District Court for the District of Vermont, following three weeks of testimony and three days of deliberations. The verdict includes both punitive and compensatory damages.
Small quantities of the bacteria associated with the development of botulism poisoning are contained in Botox, which is approved by the FDA 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).
While Botox is not approved by the FDA as a cerebral palsy treatment, it has been prescribed by some doctors to treat spasticity associated with the disability. While doctors are able to prescribe approved medications for any use they see fit, drug makers are prohibited from promoting such “off-label” uses.
In 2010, Allergan agreed to pay $600 million after pleading guilty to charges brought by the Department of Justice that it promoted Botox illegally for the treatment of cerebral palsy spasticity.
The FDA added a new “black box” warning about the risk problems from Botox in 2009, indicating that the medication may spread from the area of the injection to other parts of the body. Most of these reactions were seen when the injections were given off-label, particularly for treatment of muscle spasticity in children with cerebral palsy.
Botox as a cerebral palsy treatment involves considerably higher doses of the medication, which has been associated with development of symptoms similar to botulism poisoning, such as paralysis, difficulty swallowing, respiratory distress and other issues.
Following the verdict in the Botox lawsuit brought by the Drake family, the drug maker has not indicated whether it intends to appeal. Allergan was bought earlier this week by Actavis for $86 billion.
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