Tucson doctors who sold fake Botox sentenced to federal prison

Dr. Chad Livdahl, the 34-year-old president of Toxin Research International Inc. and three affiliates, was sentenced to nine years in prison by U.S. District Judge James Cohn.

His wife, 34-year-old Dr. Zahra Karim, was sentenced to almost six years in prison but will likely serve less than two years because she will be transferred to her native Canada and is eligible for early release, her attorney said.

The couple pleaded guilty in November to fraud and conspiracy charges stemming from their shipments of botulinum toxin type A to more than 200 doctors around the country, making more than $1.7 million.

The botulinum toxin being pushed at physician workshops and conferences by Livdahl and Karim and their Tucson-based company, TRI, was not approved by the U.S. Food and Drug Administration for use on people and bore labels saying it was for research only, court documents show. But it was often falsely sold to patients as legitimate Botox.

Karim told Cohn she regretted her actions.

"This was all a big mistake, which I so sincerely wish I could undo, but I can't," she said.

Cohn called her "a very intelligent person" and appeared mystified at her involvement in the scheme.

"Why you got involved in this, I don't know. But I do know that laws have been broken," the judge said.

Livdahl has cooperated with the government's investigation into the doctors who were once his customers and could get time shaved off his sentence for continued cooperation. At his sentencing hearing, Livdahl also expressed remorse and sorrow for what he did.

"I do accept responsibility for my actions. I'm sorry for all the trouble I've caused," Livdahl said.

Livdahl and Karim have each already served a year of their sentences in pretrial detention. Karim, who has family in the Vancouver area, will be transferred to Canada in about nine months and probably released to her family under Canadian law, said her lawyer Jeffrey Harris.

They are also both responsible for paying restitution to the U.S. government of more than $345,000.

Also sentenced Thursday was University of Kentucky ophthalmologist Robert Baker, who pleaded guilty to charges that he helped distribute the unapproved drug. He had provided a testimonial letter that was used in mail brochures and Internet pitches. Baker got two years' probation, including 180 days of house arrest.

The knockoff drug was used on an estimated 1,000 patients, most of whom thought they were getting the brand-name Botox made by Allergan Inc., according to court documents.

The sentences came one day after one of TRI's customers - Fort Lauderdale-based Dr. Bach McComb - received three years behind bars for use of an unapproved drug. In late November 2004, McComb injected himself and three others with knockoff Botox that had not been properly diluted, causing botulism poisoning and nearly killing all four of them.

The serum that McComb used came directly from a TRI supplier, List Biological Laboratories, rather than from TRI itself. The botulism outbreak triggered by McComb's injections led federal investigators to TRI, which had supplied McComb previously with the unapproved product.

McComb's former girlfriend, Alma "A.J." Hall, testified via videotape at McComb's sentencing hearing that she still suffers numerous health and mental problems from the injection, which she thought was legitimate Botox. She said she was hospitalized for seven months, including four months when she was completely incapacitated yet could hear everything going on around her.

"I was trapped in my own body," Hall said. "What Dr. McComb did to me was deplorable, unbelievable and selfish."

Prosecutors said they had not uncovered any incidents similar to the Florida poisonings of McComb, Hall and Eric and Bonnie Kaplan stemming from the TRI product. But several patients have said that the knockoff drug did not work as advertised and that they were not told what they were getting.

Livdahl and Karim sold more than $1.7 million worth of their alternative Botox from about June 2003 until January 2005, according to court records. Others involved in the scheme are under investigation, prosecutors said.