Parents of Vermont Girl Blame Botox For Her Death
IN PHOTO: A sample of Botox is seen at the Long Island Plastic Surgical Group at the Americana Manhasset luxury shopping destination in Manhasset, New York September 30, 2010. Patients of the office will have the opportunity to schedule an Americana personal shopper on their behalf to shop for them during their appointment. Reuters/Shannon Stapleton

The parents of a young woman from Vermont, who suffered from cerebral palsy and died in 2014, has filed a lawsuit against the Botox maker, blaming the company for their daughter's death.

Twenty-one-year-old Mandy Fortuna was found dead on the morning of Sept 25, 2014. Her parents filed a lawsuit on April 9, complaining that the Botox maker Allergan has failed to state warnings on the risks associated with the use of the drug. The complaint also stated that the company was negligent and had violated the Vermont Consumer Fraud Act.

Fortuna began her Botox treatments in 2007. The complaint states that the treatment has caused a deterioration of her condition. In 2014, her condition worsened. According to lawsuit documents, Fortuna continually gagged and choked and was unable to clear out her secretions. She had difficulty in holding her head up and also began experiencing seizures.

Despite that, doctors insisted on more Botox treatments on her hands and additionally on her lower limbs. Additionally, the complaint also states that based on the animal studies and post-marketing studies conducted for Allergan, the drug shows to be unsafe when given at doses greater than 8 units per kilogramme of body weight. A testimony given in a 2014 case suggested that if Botox is given in very high doses, the drug could spread around the injection site, initiating detrimental immune responses.

In November 2014, a family from New York was awarded $6.75 million by a Vermont jury in their lawsuit against the same company. Seven-year old Joshua Drake was also a cerebral palsy patient, and according to the family lawyer, Drake developed epilepsy following administration of Botox injections for his condition.

Both Fortuna and Drake were treated by the same doctor. Allergan is questioning the verdict, saying that Botox can be safely used to manage leg spasms.

The U.S. Food and Drug Adminsitration does not approve Botox as treatment for pediatric spasticity, as stated in the lawsuit documents. The treatment is categorised as “off-label use.” Most of Botox sales are for off-label indications, and the company provides doctors insufficient disclosure of the risks associated with the drug.

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