Athough it is not uncommon for patients to have reactions to injection treatments, it is uncommon to hear about a small child receiving a Botox treatment. According to a complaint filed in U.S. District Court last year, Kevin and Lori Drake say their son with mild cerebral palsy was given Botox shots as a treatment. They further claim that a Burlington doctor recommended that they treat their son’s mild lower limb spasms with Botox in 2010 and again in 2012. When the first dose of Botox did not work, the doctor administered a second, larger dose later.
Court records showed that the boy suffered a severe allergic reaction, including facial swelling, slurred speech, respiratory difficulties, vomiting, seizures and other permanent side effects. The couple claims that their son had no history of seizures before the treatment but now suffers them, along with a chronic heightened immune system and the need for constant monitoring and medical treatments.
Botox, or botulinum toxin, is intended as an injectible treatment to paralyze muscles in a particular area, usually the face. The US Food and Drug Administration has not approved Botox to treat the condition of the Drake’s son (pediatric spasticity), so the treatment is referred to as “off-label”.
Despite the fact that the product bears many warnings, the Drakes argue that Allergan did not properly warn the public of all the potential dangers of using Botox. The court documents allege negligence, defects in design, and violations of the Vermont Consumer Fraud Act. The Drakes also claim that Allergan markets Botox as a treatment for a “wide variety of off-label uses,” including pediatric spasticity. Court documents state that one such organization was called WE MOVE and was used to promote off-label uses of Allergen products.
Surprisinly, the couple is not suing the doctor, Dr. Scott E. Benjamin. Instead, they are seeking unspecified damages in excess of $75,000 from the manufacturer of Botox. Allergan, has categorically denied all allegations.
Allergan acknowledges that Botox can travel into the blood stream outside the injected areal, and that in rare instances, a harmful immune response can occur. However, they argue that Botox is too big a molecule to enter into the brain.
Other doctors testifying for the Drakes claim that Botox can enter the brain, causing seizures. Allergan stands by its position that the warnings and instructions at the time of the child’s injury were “legally adequate” and that the injuries and/or the expenses incurred by the Drakes were caused by alteration, improper handling and other unforeseeable misuse of their product.
The case is ongoing and is expected to reach a resolution in late 2014.
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