April 16, 2010
LOCAL PHYSICIAN SENTENCED FOR INJECTING PATIENTS WITH FAKE BOTOX
(HOUSTON) - Dr. Gayle Rothenberg, a local physician specializing in providing image enhancement services, has been sentenced to five and one-half months in federal prison and three years of supervised release for injecting patients with a fake Botox product not approved by the Food and Drug Administration (FDA) for human use, United States Attorney José Angel Moreno announced today.
United States District Judge Ewing Werlein Jr. sentenced Rothenberg today. In addition to the prison term, the court has ordered Rothenberg to pay $98,426 in restitution to her patients. As a condition of supervised release, Rothenberg is prohibited from seeking reinstatement of her medical license.
Rothenberg was convicted of misbranding of a drug while being held for sale and making false statements to an agent of the United States government after pleading guilty to both offenses on March 15, 2010. Rothenberg and Saul Gower, a local attorney and Rothenberg’s former husband, operated The Center for Image Enhancement located at 2000 Bering Drive in Houston.
Rothenberg was indicted in March 2007 for ordering and administering a drug called Botulinum Toxin Type A that was labeled with the warning “FOR RESEARCH PURPOSES ONLY, NOT FOR HUMAN USE.” During her re-arraignment hearing in March, Rothenberg admitted that despite the warning on the label and packaging, she injected more than 170 patients with the substance and represented to patients that they were receiving Botox Cosmetic®, a drug manufactured by Allergan Inc. and approved for human use by the FDA to treat facial wrinkles. Rothenberg also admitted that she advertised in brochures, magazines and websites that she specialized in treating facial wrinkles with Botox Cosmetic®, even though she intentionally stopped ordering Botox Cosmetic® because of a price increase in January 2004 and began ordering the unapproved drug from a company named Toxin Research International because it was half the price of Botox Cosmetic®. Rothenberg admitted that she did not tell her patients that they were receiving a drug that was not Botox®.
Gower pleaded guilty in 2008 to misbranding of a drug while being held for sale and making false statements to an agent of the United States government, then cooperated with the government and testified against his former wife at her trial. Gower is presently serving a four-year-term of probation for his convictions that he received art his sentencing on June 23, 2008. He was also ordered to pay $98,426 in restitution to patients and pay a fine of $1,000 as well as to perform 300 hours of community service within the first two years of probation. The Center for Image Enhancement has been closed since 2007.
This investigation leading to the charges and conviction of Rothenberg was conducted by the FDA Office of Criminal Investigations. Assistant United States Attorneys Samuel J. Louis and Stuart Burns prosecuted the case.
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