According to several pediatricians, off-label use of the wrinkle-reducing drug, Botox is not uncommon. Pediatricians and other doctors report using the drug to treat muscle spasticity or migraines, however, the drug is not given in the small, cosmetic doses like those used to smooth wrinkles in those cases. Instead, the drug is given in much larger doses–as high as 15 times the amount used in cosmetic procedures.
Nevertheless, Dee Spears took Allergan, the maker of Botox, to court this Wednesday. Spears alleges that the company wrongfully promoted untested, off-label use of the drug, which ultimately caused the death of her 7-year-old daughter who was treated for cerebral palsy-related muscle spasms using Botox. Spears’ daughter, Kristen, began receiving the injections when she was six years old and died in 2007 after suffering more severe seizures, difficulty swallowing, and pneumonia. While Allergan sends its regrets to Dee, they don’t believe their drug caused her little girl’s death. However, Dee is determined to keep other children from a similar fate–a fate that she believes is tied to off-label use of Botox.
In an investigation conducted by ABC News, most doctors they contacted had positive experiences with using Botox to treat pediatric cerebral palsy. However, according to Spears’ court documents, independent research has identified 16 deaths, 87 hospitalizations, and 180 life-threatening conditions associated with off-label Botox use. In Kristen’s case, her pediatrician injected 15 units of Botox per kilogram of the child’s weight–a dosage that is considered high, but "reasonable" according to the severity of her condition. While many of the doctors felt that off-label use of Botox isn’t inherently dangerous, Dr. Richard Besser, senior health and medical editor for ABC News, did state that there is a rare side effect that can occur with Botox. Since Botox is injected, it does have the potential to move from the injection-site to other nearby areas such as other muscle groups. When that happens, the muscles can become paralyzed, causing the breathing or swallowing difficulties that Kristen experienced. Overall, Kristen was hospitalized 10 times for repeated troubles with breathing or swallowing. While the results of the case remain to be determined, Allergan is wary that the case will stop more patients from seeking Botox has a cosmetic remedy for their wrinkles.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.