Dee Spears, of Potter County Texas, took Botox manufacturer Allergan to court Wednesday, alleging that Botox injections were responsible for her seven-year-old daughter's 2007 death.
Kristen Spears, who was six when she began receiving injections of Botox (botulinum toxin), was not using Botox for its well-known cosmetic purposes, but to treat the muscle spasms she suffered as a result of cerebral palsy.
Unlike the small, cosmetic doses of Botox that are used to treat wrinkles, larger doses of the toxin -- up to 15 times larger -- are commonly used off-label to treat other ailments such as migraines and muscle spasticity.
The court case address Spears' claim that Allergan wrongfully promotes untested, off-label uses of the drug, misrepresents Botox's safety record, and continually fails to adequately warn health care providers of all the known risks of the product, according to court documents.
Spears believes Botox injections were behind her daughter Kristen's increased severity of seizures, difficulty swallowing, and ultimate death from pneumonia in November, 2007.
"I am here because I believe Botox was the cause of her death," Spears told ABC News correspondent Mike Von Fremd on Wednesday.
But though the company sends their sympathy to the Spear family, Allergan spokesperson Crystal Muilenburg told ABC News that the company believes "the evidence presented in this case will show that Botox did not play a role in this."
No matter the outcome, experts say this case may incite fear in the millions of patients who regularly use Botox cosmetically and the many others who use the large, therapeutic doses of the product.
Doctors who currently use therapeutic Botox in their practice also fear that patients will hastily discontinue use as a result of the case.
"I suspect that this is going to be all over the press," says Dr. Stephen Thompson, chief of Neurology at the Hackensack University Medical Center, in New Jersey, who has treated children with cerebral palsy with Botox for eight years.
According to Allergan, Botox is approved for more than 20 indications across 80 countries and currently is used to treat juvenile cerebral palsy in more than 60 countries.
While cosmetic use of Botox has become the vogue in more recent years, off-label (not approved by the FDA) use of the product for various types of muscle spasms has been common for nearly three decades, says Dr. Gaelyn Garrett, director of the Vanderbilt Voice Center at Vanderbilt University.
"Although Botox is not licensed for use in children with cerebral palsy, it is not at all unusual for pediatricians to use drugs that are off-label," says Dr. Richard Besser, senior health and medical editor for ABC News.
He points out that a recent study from UCLA found that 60 percent of doctor visits involve prescribing off-label drugs.
In addition, independent research by the American Academy of Neurology and the European Pediatric Neurology Society have supported the efficacy of using of Botox injections for spastic disorders, including cerebral palsy.