The parents of a teen who died of botulism claim in Orange County Superior Court it was caused by Allergan of Irvine illegally pushing off-label uses of Botox.
Doctors can prescribe drugs for uses beyond what is specified on warning labels, but drug companies cannot by law.
Botox is routinely injected into the faces of older people who want to remove wrinkles, but 16-year-old Marcus Jarosch used the drug to treat spasticity in his legs. His parents, Judy and Kai Jarosch, state in their suit Marcus died in June 2011 after getting two Botox injections in the preceding months. He'd developed "respiratory difficulties, gastrointestinal difficulties, seizures, dysphagia, and cardiac arrest," according to the complaint.
"Prior to the date when Marcus Jarosch was injected with Botox, Allergan had never disclosed in the United States–in any warnings, advisories to doctors, or promotional or marketing materials–that Botox can cause botulism," reads the complaint, noting the U.S. Food and Drug Administration only approved Botox for cosmetic treatments of lines between the eyes and for certain therapeutic uses but not to treat spasticity.
Allergan is accused of creating and funding organizations such as the Neurotoxin Institute to promote Botox for off-label uses and of publishing, sponsoring and funding medical articles, dinners, talks and demonstrations encouraging physicians to inject Botox for non-FDA-approved uses.
The Jarosches, who are represented by Karen L. Karavatos of Robinson Calcagnie Robinson Shapiro Davis in Newport Beach, seek punitive damages for wrongful death, strict liability, failure to warn, deceit by concealment and negligent misrepresentation.