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June 16, 2008
LOCAL PHYSICIAN SENTENCED FOR INJECTING PATIENTS WITH FAKE BOTOX
(HOUSTON, Texas) - Dr. Gayle Rothenberg, a local physician specializing in providing image enhancement services, was sentenced to 27 months in federal prison for injecting patients with a product that was not approved by the Food and Drug Administration (FDA) for human use, United States Attorney Don DeGabrielle announced today. Rothenberg was previously convicted by a jury of conspiring to commit mail fraud, mail fraud, misbranding of a drug while being held for sale and making false statements to an agent of the United States government. Rothenberg was also ordered to pay $98,426 in restitution to her patients and a fine of $1,000.
Rothenberg and her husband, co-defendant Saul Gower, operated the Center For Image Enhancement located on Bering Drive in Houston, a medical clinic specializing in aesthetic medicine. 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.” Despite that warning on the label and packaging, Rothenberg injected more than 170 patients with the substance and represented to patients they were receiving Botox Cosmetic®, a drug manufactured by Allergan Inc. and approved for human use by the FDA to treat facial wrinkles. Although Rothenberg advertised in brochures, magazines and websites she specialized in treating facial wrinkles with Botox Cosmetic®, 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 (TRI) because it was half the price of Botox Cosmetic®.
During the two-week trial, jurors heard the testimony of many patients who indicated that in 2004 they sought the services of Rothenberg. Patients testified they were informed by Rothenberg and through advertisements distributed by her that they would receive the FDA-approved Botox Cosmetic®. Patients further testified they had not been informed that Rothenberg was administering a drug not approved for human use and would not have given consent for the use of a drug that was not FDA-approved. In Texas, physicians are prohibited from using drugs that are not FDA-approved. FDA agents had been conducting an investigation into TRI and discovered Rothenberg had ordered the counterfeit product. However, she lied to the agents, stating she had not used the TRI product on patients.
The investigation leading to the charges and conviction of Rothenberg was conducted by the FDA and was prosecuted by Assistant United States Attorneys Samuel J. Louis and Stuart Burns.
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