Indiana Couple Blames Botox for Death of Daughter

Indianapolis, INThe US Food and Drug Administration (FDA) has approved Botox injections for only a handful of indications, but off-label use continues on a wide scale. According to a proposed lawsuit in Indiana, off-label use of Botox for muscle spasms triggered the death of a 10-year-old girl with cerebral palsy.

Audrey Wells was born October 16, 1997. Later diagnosed with cerebral palsy, Audrey started experiencing rigidity and severe pain in her hip when she was eight years old. After acquiring a series of medical opinions, her parents decided that Botox might help.

Audrey received her first Botox injection in the fall of 2007 at Riley Hospital for Children in Indianapolis. The procedure went well, according to the Tribune, and Audrey seemed to improve significantly.

A few days after the initial injection, Audrey showed signs of having difficulty eating. Her parents suspected it had something to do with a recent change in her medication. However, when the same thing happened following her second Botox injection in February 2008, her parents became concerned and took their lethargic daughter to the doctor.

On their second visit, Audrey was having trouble breathing and her fingertips were turning blue. The doctor advised Jill Wells to take her daughter to the hospital immediately.

En route to Memorial Hospital, the girl began making "shallow breathing noises" and then stopped breathing altogether. By the time they arrived at the hospital emergency department, the little girl was already dead.

"It was in black and white even before they injected my daughter with this," said an angry Brandon Wells, pointing to the FDA guidelines. "It doesn't get any clearer than right here. That Botox killed my little girl."

Brandon and Jill Wells have filed a complaint against doctors and Allergan, the manufacturer of Botox. The suit mirrors a similar wrongful death case that went to trial in California and claimed that complications from cerebral palsy triggered the death of a seven-year-old girl. The jury found for the defense on March 2, the Associated Press (AP) reports.

The parents had blamed the death of their daughter on the Botox injections she was given to treat limb spasticity, an off-label use that has become widely accepted in the medical community. Allergan had previously stated that few problems have been reported from more than 15 million Botox treatments spanning 20 years.

Physician Irving Haber, a board member with United Cerebral Palsy and professor at the Indiana University School of Medicine, agrees that Botox treatment for muscle spasms is not only routine, but also highly beneficial. Dr. Haber told the South Bend Tribune on 3/14/10 that he has been giving Botox injections to patients suffering muscle conditions for more than 15 years and has seen only one serious adverse reaction in that time. The doctor says Botox can do wonders for patients with limited movement because of constricted muscles.

Botox was only given FDA approval for the treatment of wrinkles between the eyebrows, cervical dystonia (a condition marked by repetitive contraction of neck muscles), severe underarm sweating, crossed eyes and abnormal twitches of the eyelids. In 2009, however, when the FDA mandated a boxed warning for Botox, along with a medication guide and revised prescribing information, the new warnings applied to both approved and non-approved off-label uses.