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A prominent Houston doctor has been indicted for allegedly substituting a cheaper, unapproved drug for Botox.

KHOU

Dr. Gayle Rothenberg

Prosecutors say Dr. Gayle Rothenberg sold 170 patients what they thought were Botox injections.

A federal grand jury indicted Dr. Rothenberg for allegedly participating in the scheme with her husband, U.S. Attorney Don DeGabrielle said.

Dr. Rothenberg is a surgeon and anesthesiologist.

Dr. Rothenberg and her husband, Saul Gower, were charged in a 14-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.  

Gower is an attorney and office manager for Rothenberg’s medical clinic, Image for Image Enhancement at 2000 Bering Drive.

Rothenberg and Gower were arrested Thursday after surrendering to investigating agents at the offices of the United States Marshal at the federal courthouse. 

They posted $100,000 bond each after making their initial appearance before a United States Magistrate Judge Thursday 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 the more expensive FDA-approved Botox. 

"They were told that other doctors nationwide were using it without any side effects," said Joel Androphy, Rothenberg's attorney. "And there was no action at that time by the FDA to prevent its use or distribution."

But at least two patients are suing her, saying they now suffer neurological problems.

"They got something that was not FDA-approved Botox," said Bradley Leger, the plaintiff's attorney. "Something that is very, very toxic and it's causing them problems. It's causing them neurological problems."

Botox® is a product marketed and sold by Allergan Inc. for use in treatments to reduce facial wrinkles. 

According to federal investigators, 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 10 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 three years in imprisonment and a $10,000 fine. 

A conviction for making a false statement to a federal agent carries a maximum penalty of five years imprisonment and a $250,000 fine.

Dr. Rothenberg has appeared on 11News several times in the last few years as an expert on cosmetic procedures.

11 News checked her professional record with the Texas Medical Board. In a quarter of a century of practice, she has no prior complaints.

Dr. Rothenberg is still allowed to practice before facing trial in May.