(CN) - Allergan, which makes Botox, tells doctors to administer the drug in a way that is "grossly unsafe and inappropriate" and could expose patients to HIV or hepatitis, a doctor says in a class action in Los Angeles Federal Court. Allergan advertises vials of Botox as safe for multiple use, and even recommends "Botox parties" in which a single vial is used for multiple patients, even though the drug's label warns against just that, the class claims. Allergan dismissed the complaint as having "no merit" on Thursday.
Lead plaintiff Ivan Goldsmith says Allergan has aggressively promoted Botox, while jacking up its wholesale price from $400 per vial in 2005 to more than $1,000 per vial today. Sales of the drug have exceeded $1 billion.
But Allergan spokeswoman Caroline Van Hove asserted that the product's prescribing label indicates that the vial is for single-use. She added that the lawsuit serves as a reminder to patients to "consult with a trained and qualified health care professional" who uses the product "in accordance with the prescribing information included in the product package."
"The complaint further recites alleged facts about Botox Cosmetic and its price and contains accusations concerning Allergan's promotional and educational practices that are demonstrably false," Van Hove said.
One single-use vial of Botox contains 50 to 100 units, which must be used or discarded within 4 hours, Goldsmith says. A typical treatment for wrinkles accounts for just 20 units, and a dosage to treat certain eye disorders takes about 2 units; the rest of the Botox should be discarded, Goldsmith says.
If responsible physicians use Botox as directed on its label, a $500 treatment would not offset the purchase of a single-use $1,000 vial, according to the complaint.
Botulinum toxin, the active ingredient in Botox, decreases muscle activity and blocks nerve impulses that trigger muscle contractions. Goldsmith says the FDA is investigating whether Allergan has promoted Botox for used other than the four that have been approved by the FDA.
Sharing a single-use vial among multiple patients violates guidelines from the Centers for Disease Control and medical boards, Goldsmith says. He claims that Allergan misrepresents the correct use of Botox to physicians and provides physicians with unrealistic profit estimates based on multiple use of Botox vials.
A Las Vegas-based scandal erupted in February 2008 when the state notified more than 40,000 patients of a chain of clinics "about a potential exposure to hepatitis from multiple uses of single-use vials of Propofol, another drug product approved for single-use administration and often promoted and used in multiple procedures," according to the complaint. "Following this controversy, in May 2008 Allergan began importing and/or repackaging Botox in smaller 50-unit vials. ... The smaller vials are still promoted for multi-use by Allergan."
Goldsmith says Allergan has spent $41 million marketing the drug to physicians and consumers in a single year - 2007.
Goldsmith says he "is aware of countless instances of off-label and misleading promotion, both publicly and privately, by Allergan sales representatives. References to 'Botox parties' using a single 100-unit vial across numerous 'party' attendees were included in continuing medical education ('CME') programs and other promotional forums hosted or promoted by Allergan."
Goldsmith seeks class damages for breach of warranty and unfair business practices and an order barring Allergan from pushing Botox for uses warned against on its label. He is represented by Rosemary Rivas with Finkelstein Thompson of San Francisco.
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