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.
Off-Label Uses Abound
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.
In practical experience, the doctors with Botox experience whom ABC News contacted had overwhelmingly positive experiences treating pediatric cerebral palsy with the drug, though all emphasized that in cases of a rare negative side effect or incorrect dose, it is essential that patients seek immediate medical attention.
Thompson says that after eight years of administering Botox therapeutically, he hasn't "had any patient with serious adverse reaction," and that the "incidence of side effects is very, very low."
"I don't believe her seizures were made worse by the Botox," said Thompson, who was not involved in treating Kristen, noting that patients with cerebral palsy are already at increased risk for pneumonia and Botox may not have contributed to contracting it.
"Properly dosed and diluted, botulinum toxins should not induce systemic side effects" such as breathing difficulties, adds Dr. Maurice Sholas, practice director of Rehabilitation at Children's Healthcare of Atlanta.
"I've been injecting patients with Botox for 12 years," says Garrett. "Patients are aware of potential side effects, [but] by and large, Botox has been proven to be very safe."
And Allergan fully endorses their safety record. Muilenburg notes that Botox is "one of the most widely researched medicines in the world" and Botox sponsors affirm that the toxin is "safe" and "effective".
But Spears' would beg to differ.
When Botox Goes Wrong?
According to court documents, independent research has identified 16 deaths, 87 hospitalizations, and 180 cases life-threatening conditions associated with Botox injections, not including the death and injury claims that will be brought to court in this case.
"I don't want this to happen to anyone else's child," Spears said in a statement to the court, according to the Los Angeles Times.
"All drugs have potential side effects and one side effect of Botox is that it can, on occasion, migrate from the injection site, to other muscle groups," notes Besser. "When this hits the respiratory muscles, it can make breathing difficult."
This rare side effect, along with paralysis of the muscles needed for swallowing are particularly relevant for Kristen's case, notes Sholas, and he says that if the patient was given too much of the medication or to potent a dose, these side effects could have occurred.
Kristen's pediatrician, Dr. Pia Habersang testified that she gave Kristen 15 units of Botox per kilogram of the child's weight, reports the L.A. Times and Sholas and Thompson both say that this dosage is on the high end but still considered a reasonable dose for this condition.
However, Kristen required hospitalization 10 times for repeated bouts of breathing and swallowing difficulties in the months of her Botox treatment, according to a motion in court, the L.A. Times reported.
"Whether or not Botox played a role remains to be seen," says Garrett, who was also not involved in treating Kristen. but the take home message here is "to make sure patients or their parents are aware of this rare side effect and that they seek treatment immediately if there is any respiratory difficulty," adds Besser.
"People have to understand [that] no medication is 100 percent safe," says Thompson.
But Thompson also feels that it is essential that people understand the benefits this medicine can offer when used properly. "[It] provides significant benefit and can improve quality of life for kids with cerebral palsy," he says.
"We still have patients booked for and continuing to receive Botox on a regular basis. I hope that our patients for whom this is appropriate continue to use it."