Botox Troubles Mount for Allergan

It’s been a tough few months for the maker of <"">Botox. Just last month, Allergan agreed to a $600 million settlement with the US Justice Department for illegally marketing Botox, just as it was reported to have settled a wrongful death lawsuit filed by the family of one Botox recipient. That news came on the heels of a $15 million judgment assessed by an Oklahoma jury in another Botox injury lawsuit.

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 U.S. Food & Drug Administration (FDA) mandated a black box label for Botox and similar products that warned of the risk of adverse events when the effects of a botulinum toxin injection spreads beyond the site where it was injected.

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. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. However, doctors are permitted to use approved drugs in anyway they see fit, though drug makers are legally barred from promoting such use.

The $600 million Botox settlement with the Justice Department that was announced last month 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.

Also in September, various media outlets reported that Allergan had reached an out-of-court settlement with the family of 70-year-old Sondra Bryant. According to their lawsuit, Bryant had died in 2008 after receiving 100 units of Botox to treat shoulder pain. Two to three weeks later, she began to have problems swallowing, and eventually needed a feeding tube. At her death, she had dropped to 79 pounds, down 28 pounds from her weight when she got the Botox shots. Her family claimed Bryant was never informed of Botox’s possible risks.

The $15 million Botox verdict involved the case of Dr. Sharla Helton of Oklahoma City, who received injections for wrinkles. Following her fifth Botox treatment in 2006, Dr. Helton claims she developed botulism poisoning. She was eventually forced to sell her medical practice and stepped down as medical director of Lakeside Women’s Hospital in Oklahoma City because of pain and weakness resulting from Botox side effects, her lawsuit claims.

One juror told The Oklahoman that the jury found negligence because Allergan’s 2006 product labeling did not have adequate information about side effects. The juror said the jury came to that conclusion after comparing a 2006 label with the 2009 label.

Allergan says it plans to appeal the jury’s decision.

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