Botox Lawsuit Alleges Brain Damage from Treatment

A Virginia woman has filed a Botox lawsuit against Allergan, Inc., claiming that injections meant to cure a head tremor caused her to suffer brain injuries, movement disorders and dementia.

The complaint was filed by Cynthia Vandenboom in Richmond City Court, alleging that Allergan failed to warn consumers that Botox side effects can cause serious autoimmune responses, brain injury and botulism. The lawsuit is the latest in a series of claims against Allergan over problems with Botox.

Vandenboom indicates that she was given Botox injections to treat a head tremor. As a side effect of Botox, Vandenboom alleges that she suffered a variety of serious and permanent injuries caused by the injections. She experienced rashes, fever, vomiting, severe pain and confusion shortly after being given the injections. Eventually, she developed autoimmune encephalitis movement disorder, lost some of her cognitive functions and now trouble walking. As a result of the Botox injury, the lawsuit claims that she requires care and help from others to conduct a number of daily activities.

Botox is approved for both cosmetic use to reduce the appearance of wrinkles in the skin and to treat medical conditions such as strabismus (crossed eyes), hyperhidrosis (excess sweating), cervical dystonia (involuntary contractions of the neck muscles) and blepharospasms (involuntary blinking of the eye). However, it also commonly used off-label, such as for treatment of stiff and jerky movements associated with cerebral palsy in children.

Extremely minute quantities of Botulinum Toxin A are contained in Botox, which is the bacteria associated with the muscle paralyzing condition Botulism.

Vandenboom says Allergan should have warned users of the chance that Botox toxin, which the lawsuit describes as being 100 times stronger than cyanide, would migrate outside of the injection area and could cause significant injury. The lawsuit accuses Allergan of product liability, negligence and breach of warranty, and seeks $10 million in compensation and $1 million in punitive damages.

There is currently a Botox trial underway in California, filed on behalf of 15 people who also allege that they suffered severe or fatal side effects from Botox treatments. Among the plaintiffs in the case are the families of two young children who died after Botox injections to treat cerebral palsy.

The FDA warned about potential risks associated with Botox in February 2008, after a number of reports were received involving deaths, breathing problems and other adverse reactions associated with use of Botox. At that time, the FDA indicated that the adverse reactions were most commonly seen among children with cerebral palsy, where the typical dose of Botox injection used is substantially larger than what is normally prescribed for cosmetic purposes.

In August 2009, the FDA announced a new “black box” warning about the risk of Botox problems, including potentially life-threatening botulism-like side effects. The warning now alerts users that the toxin used in Botox and other some other products could spread from the area of the injection to other areas of the body. This could cause botulism symptoms, including life-threatening swallowing and breathing difficulties or death.