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March 25, 2007
LOCAL PHYSICIAN CHARGED WITH INJECTING PATIENTS WITH FAKE BOTOX
"The following article includes allegations as released by the government and should not be taken as truthful evidence or as any indication of guilt. As these allegations remain unanswered by the accused and unadjudicated by a court, they remain unproved and are just as likely false."
(HOUSTON) - A Federal Grand Jury has indicted Dr. Gayle Rothenberg, a local physician, and with participating in a scheme to substitute a cheaper, unapproved drug for the brand name drug Botox®, United States Attorney Don DeGabrielle announced today.
Dr. Rothenberg and her husband, Saul Gower, an attorney and office manager for Rothenberg’s medical clinic, Image for Image Enhancement, 2000 Bering Drive, Ste. 260, were charged in a fourteen count indictment with conspiracy, mail fraud, misbranding of a drug while held for sale and making false statements to an agent with the Food and Drug Administration. The indictment was returned on Wednesday, March 21, 2007.
Rothenberg and Gower were arrested earlier today upon surrendering to investigating agents at the offices of the United States Marshal at the federal courthouse. They are expected to make their initial appearance before a United States Magistrate Judge this afternoon.
Rothenberg and her husband are accused of conspiring together and perpetrating a scheme to profit from the use of a less expensive and unapproved form of Botulinum Toxin Type A, by selling it to her patients as, and that the price of, the more expensive FDA-approved Botox®. Botox® is a product marketed and sold by Allergan Inc. for use in treatments to reduce facial wrinkles.
In February 2004, Rothenberg and Gower are alleged to have returned from a conference and informed the staff at the medical clinic they had discovered a cheaper alternative to Botox®. Rothenberg and her staff began ordering the unapproved form of Botulinum Toxin Type A from a company located in Tucson, Arizona. Vials of the unapproved form of Botulinum Toxin Type A are clearly labeled “For Research Purposes Only, Not for Human Use”. The same warning is printed on invoices and product information sheets. High doses of Botulinum Toxin Type A, according to the indictment, can cause Botulism in humans.
From February 3, 2004 and continuing through September 8, 2004, Rothenberg is accused of injecting patients with the non-approved substance without informing them. Instead, the indictment alleges Rothenberg presented patients with a form called Inform Consent for Botox® Injection Therapy indicating that they would be receiving injections of FDA approved Botox® knowing she intended to use and did use the non-approved substance. Over one hundred seventy (170) patients received injections of the non-approved substance and Rothenberg and Gower were paid over $98,000 as a result of this scheme, according to the indictment.
Rothenberg and Gower are also accused of making false statements to Food and Drug Administration agents investigating the use of the non-approved substance. Gower allegedly knowingly lied when he told agents patients had not received injections of the non-approved substance. Rothenberg is accusing of lying when she told agents she did not have any invoices, documents or correspondence from the manufacturer of the non-approved substance when she was well aware that documents were still in her possession.
The conspiracy charge and ten counts of mail fraud each carry a maximum penalty of 20 years imprisonment and a $250,000 fine, upon conviction. The one count of misbranding a drug while held for sale carries a maximum penalty of 3 years in imprisonment and a $10,000 fine. A conviction for making a false statement to a federal agent carries a maximum penalty of 5 years imprisonment and a $250,000 fine.
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