Parents Claim Botox Killed Their Son

SANTA ANA, Calif. (CN) - Botox migrated from its injection site and killed their teen-age son with botulism, parents claim in court.

Parents of the late Marcus Jarosch sued Allergan in Orange County Court.

They claim Allergan illegally pushed Botox for off-label uses and failed to warn of its potentially lethal effects.

Doctors may prescribe drugs for off-label uses, but drug companies cannot push them for that.

Judy and Kai Jarosch claim their son died at 16 on June 2011 after getting Botox injection to treat spasticity in his legs.

"Although its side effects were not widely known to injecting physicians or patients in the United States at the time decedent was injected, Botox can migrate outside the injected muscles and affect other muscles in the area," the complaint states. "More seriously, Botox can cause systemic effects sometimes known as botulism. The most common systemic effects of botulism or Botox poisoning are flu-like symptoms, muscle weakness, dysphagia (difficulty swallowing), respiratory difficulties and death.

"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."

Marcus Jarosch was injected with Botox on Feb. 16, 2011 and May 18, 2011. He died on June 10, 2011, after developing "respiratory difficulties, gastrointestinal difficulties, seizures, dysphagia, and cardiac arrest," his parents say in the complaint.

The U.S. Food and Drug Administration approved Botox for cosmetic treatments of lines between the eyes and for certain therapeutic uses, but not to treat spasticity, the parents claim. But Allergan pushed it to doctors for that and other off-label uses, according to the complaint.

"This plan included encouraging physicians to use Botox for a wide variety of indications while never identifying in any meaningful fashion which indications are approved by the FDA. Allergan created and funded organizations such as the Neurotoxin Institute to promote Botox for off-label uses," the complaint states.

The parents claim that Allergan published materials and funded medical articles touting the benefits of Botox for off-label uses, and sponsored dinners, talks and demonstrations to encourage physicians to inject Botox for these purposes.

Allergan called Botox "well-tolerated" and "safe," and as a "miracle drug" like penicillin, the parents say.

"Side effects are rarely mentioned and instead are consistently understated," the parents claim.

Allergan pleaded guilty in 2010 "to off-label promotion and agreed to pay $600 million in civil and criminal penalties to the United States Government," according to the complaint.

The Jarosches seek punitive damages for strict liability, failure to warn, deceit by concealment, negligent misrepresentation and wrongful death.

They are represented by Karen L. Karavatos with Robinson Calcagnie Robinson Shapiro Davis, of in Newport Beach.

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