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FDA Law Enforcers Crack Down on Botox Scammers

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Source of the Problem continued...

OCI agents arrested four individuals associated with TRI. Chad Livdahl, TRI's president, was convicted of fraud and misbranding a drug and sentenced to nine years in prison. His wife and co-owner, Zahra Karim, was sentenced to almost six years in prison. Other co-conspirators got lesser sentences.

OCI Special Agents examined TRI shipping records to track down more than 200 health care professionals who bought the unapproved drug from TRI. "The physicians were located throughout the country, from Manhattan to Las Vegas," says Philip Walsky, Assistant Special Agent in Charge in FDA's OCI Headquarters office. "They'd learn about the drug by going to a conference where TRI would give a spiel and demonstration to sell their product."

Many of the purchasers of the TRI product have been prosecuted. Some are serving time in federal prison and were ordered to pay restitution to their patients.

"Someone who abuses a position of trust for financial gain and subjects patients to unknown safety risks from unapproved medications will be held accountable," says Kim A. Rice, FDA Special Agent in Charge of OCI's Metro Washington Field Office. "FDA will aggressively pursue those who willfully circumvent laws that are in place to protect the consuming public."

OCI continues to investigate these cases, says Walsky.

How Patients Were Scammed

According to OCI agents, most of the health care professionals misrepresented the fake product to patients, leading them to believe they were receiving the real Botox Cosmetic. Some of the tactics they used were

  • advertising in brochures, magazines, and on Web sites that they specialized in treating facial wrinkles with Botox Cosmetic
  • displaying a certificate indicating they received training by the Botox Cosmetic manufacturer, when they did not
  • informing patients they would be receiving Botox Cosmetic
  • failing to tell patients they were getting a drug not approved for human use
  • asking patients to sign a consent form indicating they would be receiving injections of FDA-approved Botox Cosmetic

                                

  Sample Botox Cases Investigated by FDA's Office of Criminal Investigations

Defendant

Illegal Action

Result

Gayle Rothenberg, M.D., operator of Center for Image Enhancement, Houston

Injected more than 170 patients with unapproved drug, representing it as approved Botox Cosmetic

Indicted for mail fraud, misbranding a drug, making false statements to a federal agent; June 13, 2008, sentenced to 27 months in prison, restitution of $98,426, fine of $1,000

Mark E. Van Wormer, M.D., operator of GreatSkin clinic, Albuquerque, N.M.

Injected patients with unapproved drug, representing it as approved Botox Cosmetic

Indicted for fraud, misbranding a drug, tampering with documents; Dec. 14, 2007, sentenced to 1 year and 1 day in prison, restitution of $65,265, fine of $3,000

Albert Poet, M.D., operator of offices in Stafford Township and Montclair, N.J.

Injected patients with unapproved drug without telling patients

Indicted for mail fraud, misbranding a drug; Sept. 28, 2007, sentenced to 14 months in prison

Ivyl Wells, former M.D. and operator of Skinovative Laser Center, Boise, Idaho; surrendered medical license after charges were filed

Injected about 200 patients with unapproved drug, representing it as approved Botox Cosmetic

Indicted for mail fraud, misbranding a drug; Dec. 11, 2006, sentenced to 6 months in prison, 6 months home detention, restitution of $88,000, fine of $40,000, 300 hours community service

Jerome Lentini, M.D., operator of A Younger You clinics, Salem and Tigard, Ore., and his assistant, Cathryn Garcia, R.N.

Injected about 800 patients with unapproved drug, representing it as approved Botox Cosmetic

Indicted for misbranding a drug; Aug. 14, 2006, Garcia sentenced to 1 year in prison; Dec. 11, 2006, Lentini sentenced to 18 months in prison, restitution of $330,000

Chad Livdahl and Zarah Karim, owners of Toxin Research International, Tucson, Ariz.

Sold unapproved botulinum toxin, labeled "Not for Human Use," to more than 200 physicians throughout the U.S. to use on their patients

Indicted for mail and wire fraud, misbranding a drug; Jan. 26, 2006, Livdahl sentenced to 9 years in prison, restitution of $345,567, forfeiture of $882,565; Karim sentenced to 5.8 years in prison, restitution of $345,567