The Cochran Firm Legal Blog

When a 7-year-old girl with cerebral palsy died in November 2007, her mother blamed the BOTOX treatments she was injected with. BOTOX, usually used to lessen wrinkles in the face, has several off-label uses, including relaxing the muscles of children with cerebral palsy. However, the dead girl's mother claims an overdose of the medication killed her daughter.

This trial is believed to be the first one targeting BOTOX as the cause of a death to make it this far. It is one of several lawsuits that are pending related to BOTOX and its non-cosmetic uses.

It is alleged by the mother, lawyers, and experts that BOTOX weakened the young girl's muscles that controlled her breathing and swallowing. This lead to pneumonia and respiratory failure, which is noted as the cause of her death on the official death certificate. Allergan, the maker of BOTOX, claims the girl died of a bacterial infection, and that there is no proof BOTOX was the reason she died.

BOTOX was given to the girl to calm spasms she suffered in her legs. The lawsuit alleges that she was given seven injections in her chest, legs, and groin over a 15-month time span. The 33-pound child suffered seizures prior to the injections, but they got worse after the treatment started.

Physician and Drug Company at Odds

The trial focuses not only on the drug, but the doctor who administered the treatments. He testified he learned to give children 15 units of BOTOX per kilogram of body weight. Allergan says this is twice the amount they advise is safe for children. The say the company would never share the maximum dosage information with physicians since this would violate a federal ban on marketing non-approved uses for drugs, also known as off-label uses.

This information is disputed in motions and depositions, which show Allergan representatives visited the physician's practice around 50 times over several years to discuss the use of BOTOX on juvenile cerebral palsy patients. The physician claims one rep said other doctors were using ten to 15 units per kilogram of BOTOX on their patients.

Last year, federal authorities noted serious reactions to BOTOX with black box labeling. It has also come to light that as early as 2005, there were problems the drug maker knew of. In 2005, a European health official sent a letter to Allergan reporting botulinum toxin, the active part of BOTOX, was spreading beyond the injection site in patients using it for cosmetic reasons. The letter noted muscle weakness in the neck region, trouble with swallowing, and "fatal cases of aspiration."

The child's death came a year before the Food and Drug Administration ordered the labels on BOTOX to include warnings that the drug could cause "life-threatening swallowing and breathing difficulties and even death."

If you or a loved one has been injured due to side effects or reactions from taking a drug, please contact the experienced product liability attorneys at the Cochran Firm today. We serve clients nationwide.