The parents of a boy who died following an injection with Botox is suing drug maker Allergan, alleging that the drug maker illegally touted Botox for off-label uses and neglected to warn of its possibly deadly side effects.
The parents of the then-16-year-old Marcus Jarosch allege that Botox moved from the injection site, killing their son. Marcus received the Botox injection to treat spasticity in his legs, Courthouse News Service wrote. “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.”
While physicians are free to prescribe medications for unapproved—so-called “off-label”—uses, drug makers are banned from marketing drugs for reasons not approved by the U.S. Food and Drug Administration (FDA).
Allegan makes two versions of Botox, Botox Cosmetic for the treatment of wrinkles, and Botox, which is approved to treat blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). In April 2009, the FDA mandated a black box label—the agency’s strongest—for Botox and similar products that warned of the risk of adverse events when the effects of a botulinum toxin injection spreads beyond the injection site.
The label revision followed an FDA safety review prompted by reports of adverse reactions that resembled botulism infections in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity.
The treatment of spasticity is not an approved use; however, Allergan touted Botox to physicians for that and other off-label uses, the complaint states, said Courthouse News Service.” 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, Courthouse News Service wrote.
“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,” the complaint also states, according to Courthouse News Service.
Marcus received two Botox injections, one on February 16, 2011 and one on May 18, 2011. Marcus died on June 10, 2011 after developing “respiratory difficulties, gastrointestinal difficulties, seizures, dysphagia, and cardiac arrest,” his parents stated in the complaint. His parents claim that Allergan published materials and funded medical articles touting the benefits of off-label Botox and sponsored events pushing doctors to inject Botox off-label, Courthouse News Service said.
Allergan touts Botox as being “well-tolerated,” “safe,” and a “miracle drug” said Marcus’ parents, who claim that “side effects are rarely mentioned and instead are consistently understated.” In 2010, Allergan pleaded guilty “to off-label promotion and agreed to pay $600 million in civil and criminal penalties to the United States Government,” the complaint notes. The Jarosches seek punitive damages for strict liability, failure to warn, deceit by concealment, negligent misrepresentation, and wrongful death, said Courthouse News Service.
The $600 million Botox settlement with the Justice Department stemmed from allegations made by two whistle blowers that Allergan had illegally marketed the drug for off-label uses. The tactics Allergan used included paying doctors to attend meetings promoting unlawful marketing and to lobby healthcare payers to cover off-label use of the drug. The company also spent $8 million on a purportedly independent, online neurotoxin education organization to “stimulate increased use of Botox,” the Justice Department said.