Last Updated Oct 5, 2009 11:03 AM EDT
Allergan denies the claims, according to Courthouse News.
A single-use vial of Botox contains 50 units or more of the drug, and must be thrown away within four hours of the first use. But each FDA-approved application for Botox requires only 1.25 to 20 units; the remainder is waste, Goldsmith alleges.
Further, each vial costs about $1,000, but each patient treatment costs only $500. It is therefore impossible for a doctor buying Botox to make a profit unless he uses each "single-use" vial on more than one patient, Goldsmith claims. When Goldsmith did so, the suit states:
"... his business model was in violation of the label."Allergan told CN:
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.Allergan funds CME companies that teach doctors how to inject patients with the drug at Botox parties, the suit claims:
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."By double-dipping into each Botox vial, party guests are at risk of infection from HIV or Hepatitis, the suit claims.
Allergan has received eight warning or untitled letters from the FDA regarding its Botox promotion since 1998, the suit states.
The suit complicates Allergan's legal situation on Botox. In addition to the Goldsmith suit, Allergan is engaged in these actions:
- defending itself against a Department of Justice subpeona into off-label use of Botox for migraine;
- applying to the FDA for approval to promote Botox for migraine;
- suing the FDA for the right to make truthful off-label claims for Botox.
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