Boy developed epilepsy following “off-label” use of drug to treat spasms
A couple from upstate New York were recently awarded $6.75 million after Botox injections left their son, who is now seven years old, suffering from life-threatening epileptic seizures, according to U.S. News & World Report. Although Botox is well known for removing wrinkles, in recent years it has also been promoted for “off-label” uses by its manufacturer, such as, in this case, treating leg spasms caused by cerebral palsy. According to the lawsuit, the manufacturer promoted Botox to the family’s doctor without explaining the side effect risks.
The couple say their doctor recommended two Botox injections, one in 2010 and a larger dose in 2012, as a way of treating their son’s leg spasms, which were a result of his mild cerebral palsy. After the second dose, the child began to develop an adverse reaction to the treatment, including facial swelling and breathing difficulties, according to the Burlington Free Press.
Most seriously, the child has since developed epileptic seizures which, the lawsuit claims, are a result of the Botox injections. He now requires somebody to be with him at all times in case another seizure requires life-saving medical attention. He must also take medication twice a day in order to control the seizures
Botox has not been approved by the U.S. Food and Drug Administration for treating spasms in children, meaning that such treatment is considered “off label.” However, the manufacturer of Botox had marketed the injections to the family’s doctor as a way of treating childhood spasms without detailing the potential side effects.
As a result, the parents say they were not properly informed about the health risks of the injections. It was only until they did their own research-following their son’s adverse reaction-that they found out about those risks. For example, an animal study performed by the manufacturer found that doses of Botox in excess of eight units per kilogram of a patient’s weight could be dangerous. By comparison, their son’s second injection was at 12 units per kilogram.
Although the above lawsuit was filed against Botox’s manufacturer rather than the doctor who recommended the treatment, the case nonetheless highlights how medical practitioners may be prone to making errors when treating patients. Particularly, as in this case, when a doctor recommends a certain treatment based on incomplete information then the consequences for patients and their families can be disastrous.
Anybody who has been the victim of alleged medical malpractice should contact a qualified attorney as soon as possible. Malpractice claims often require specialized experience and knowledge of the medical profession, including of how errors happen and what effect they can have on patients.