Local firm must stop selling Botox knockoff

A Florida judge wants to protect unsuspecting consumers from 'tragic consequences.'

The Associated Press and IRWIN M. GOLDBERG
Tucson Citizen

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Tucson-based Toxin Research International, its owners and other associated companies must stop selling a Botox knockoff, recall all the product that has been sold and turn leftover product over to the Food and Drug Administration, U.S. attorney spokesman Carlos B. Castillo said yesterday.
"They are supposed to work with the FDA to identify all purchasers of the product" so it can be recalled, he said.

The verbal order came after a daylong preliminary injunction hearing in Florida, Castillo said.

TRI sold 3,000 vials of the raw botulism toxin, according to The Associated Press. The product's maker, List Laboratories in California, is blamed for the paralysis of four people injected with the toxin at an Oakland Park, Fla., clinic.

Toxin Research employed misleading and deceptive practices that are "likely to result in tragic consequences to the unsuspecting consumer," U.S. District Judge James Cohn said at the end of the hearing, according to AP. The company and its operators "have exposed the public to a great health risk."

The judge granted the government's request for an injunction to shut down Toxin Research and its botulism sales.

The company pitched the toxin for sale to 15,000 dermatologists, plastic surgeons and other doctors nationally, including 110 Arizona doctors, 27 of whom were in Tucson, government evidence showed at a hearing yesterday.

Thirteen of the Tucson doctors or their representatives told the Citizen they had nothing to do with TRI or its associated companies, save for perhaps receiving an unsolicited mailing about purchasing its product.

The other 14 doctors or their offices did not return calls.

According to court documents filed to obtain an emergency restraining order, two Arizona medical professionals did buy TRI's Botox knockoff, marketed as Botulinum Toxin Type A: Dr. Ann Murray of Lake Havasu City and Richard Allen, a physician's assistant in Anthem.

Neither was on the list.

Murray, according to the documents, used the product on herself and patients but destroyed the remaining product after reading about the Florida incidents.

At yesterday's hearing, Chad Livdahl, a microbiologist who owns the company, testified repeatedly that his sales were intended for research only and not for human use in place of the wrinkle treatment Botox.

Robert Gehrke, Livdahl's attorney, said his client "was not aware that some customers were using it on human beings."

Assistant U.S. Attorney Russell Koonin countered, "Those are not researchers that Dr. Livdahl is soliciting. Those are private, in-house physicians."

He told the judge that Toxin Research compared Livdahl's unlicensed product to Botox in an end run around federal regulations.

Investigators found evidence that two other Livdahl companies, Powderz and Z Spa, were planning promotional seminars this month and in March for its products, according to the AP.

The companies and their operators are targets of a criminal investigation, but no charges have been filed, the AP reported.

Livdahl has not applied for FDA approval for a generic Botox, but he testified that he was building a laboratory to produce a low-dose botulism product.

Neither Livdahl or the agency has publicly accounted for more than 2,300 vials. Livdahl estimated about 530 were damaged by lack of refrigeration, the FDA seized 134 at the Tucson office, and 51 were sold in South Florida, according to the AP.