Las Vegas Physician and Spouse Charged with Treating Patients with Non-fda Approved Version of Botox®
Las Vegas, Nev. – Stephen Lee Seldon, M.D. and his wife, Deborah Martinez Seldon, operators of "A New You Medical Aesthetics" in Las Vegas have been charged with drug adulteration and fraud for treating patients with a non-FDA approved drug and falsely representing to their patients they were receiving injections of the facial wrinkle treatment, Botox®, when the patients were actually being treated with a cheaper substitute drug that had not been approved by the FDA, announced Steven W. Myhre, Acting United States Attorney for the District of Nevada.
Stephen Lee Seldon, age 52, and Deborah Martinez Seldon, age 39, both of Las Vegas, were indicted by the Federal Grand Jury on Wednesday, June 27, 2007, and charged with 14 counts of Mail Fraud and one count of Adulterating a Drug While Held For Sale. They were arrested in Las Vegas this morning by federal investigators and appeared before United States Magistrate Judge Robert J. Johnston this afternoon for an arraignment and plea hearing. They pleaded not guilty to the charges and were released on a personal recognizance bond pending trial.
The Indictment states that Stephen Lee Seldon is a doctor licensed to practice medicine in Nevada, and Deborah Martinez Seldon is his wife and manager of his medical practice, "A New You Medical Aesthetics" (A New You), currently located at 3663 E. Sunset Road, Suite 303, Las Vegas.
Botox®, used for the treatment of forehead wrinkles, is the brand name of a drug derived from Botulinum Neurotoxin Type A, a highly potent toxin. When present in sufficient degree in humans, this toxin can cause botulism. The toxin is classified as both a drug and biological product under federal law, and no form may be distributed for use on humans unless it has been approved by the FDA. Allergan, Inc., of Irvine, California, is the only FDA approved manufacturer of Botox®; therefore, all doctors treating patients with Botulinum Neurotoxin Type A are required to use Allergan's Botox® products.
Another Botulinum Neurotoxin Type A product was marketed and sold to treatment providers by Toxin Research International, Inc.(TRI), of Tucson, Arizona. The product was sold in vials labeled, "For research purposes only, not for human use." TRI charged customers much less for its product than Allergan charged customers for Botox®. By using TRI's product instead of Botox®, physicians and others could increase their profits on each treatment.
The Indictment alleges that from about October 15, 2003, to September 16, 2005, Stephen Lee Seldon and Deborah Martinez Seldon offered and advertised Botox® injections at "A New You." They placed advertisements in local magazines offering Botox at low prices, and represented that Dr. Seldon was certified and specially trained by Allergan for Botox injections. The Seldons displayed and distributed Botox® promotional materials at "A New You," and displayed a certificate indicating that Dr. Seldon had been trained in the application of Botox®. In fact, patients were not receiving FDA-approved Botox® at "A New You," and Stephen Lee Seldon had no Allergan-approved training in the use of Botox®.
The Indictment also alleges that Stephen and Deborah Seldon had patients sign consent forms prior to receiving cosmetic procedures. The forms fraudulently represented that the defendant intended to use Botox® on the patients, when in fact, Stephen Lee Seldon knew he was going to inject his patients with the cheap alternative to Botox®.
The Indictment alleges that Stephen and Deborah Seldon ordered 38 500 I.U. vials of the unapproved Botulinum product between October 2003 and September 2004 for $36,925, approximately half of what Allergan would have charged for an equivalent amount of Botox®. The Seldons stopped purchasing Botox® from Allergan in October 2003, the same month they began purchasing the product from TRI.
In September 2004, Stephen Lee Seldon spoke at a seminar in Scottsdale, Arizona, sponsored by TRI, in which he promoted the use of TRI's alternative product and claimed that he used it on patients in his practice, notwithstanding the warning on each vial that TRI's product was for "Research purposes only, not for human use."
In late November, 2004, the national media publicized the hospitalization of four individuals who had contracted botulism after receiving injections of a non-FDA approved botulinum toxin at an unrelated medical clinic in Florida. Less than two months later, in January 2005, as part of the scheme and artifice, Deborah Martinez Seldon arranged for a secret purchase of, and received, 132 additional vials of TRI's product for $50,000 for use by Stephen Lee Seldon at "A New You."
The Indictment further alleges that Stephen Lee Seldon and Deborah Martinez Seldon took steps to conceal their fraudulent use of the cheaper alternative product by falsifying "A New You's" computerized medical records by deleting references to "Botox®" and changing these entries to the generic notation "Cosmetic Procedure." They also caused 28 vials of the cheaper alternative to be returned to the FDA in order to mislead investigators into thinking they were returning 28 vials of the original 38 vials purchased from TRI, when in fact, they had used all of the original TRI product on the patients at "A New You," and were returning vials that were part of Deborah Seldon's secret purchase of 132 vials from TRI in January 2005.
This case was initiated in November 2004 as a result of an investigation of TRI and its principal owners, Chad Livdahl and Zahra Karim. In 2005, Livdahl and Karim were convicted of Conspiracy and Mail Fraud in the United States District Court in the Southern District of Florida for unlawfully selling almost $2 million of Botulinum Toxin Type A to physicians. Livdahl and Karim are currently serving lengthy prison sentences. During that investigation, investigators seized documents indicating names of the physicians who had purchased the unapproved Botulinum product from TRI and who had attended training workshops sponsored by TRI's principals.
If convicted, the defendants face up to 20 years in prison and a $250,000 fine on each Mail Fraud counts, and up to one year in prison and a $100,000 fine on the Misbranding a Drug count.
The case is being investigated by the Food and Drug Administration Office of Criminal Investigations and the United States Postal Inspection Service, with assistance from United States Immigration and Customs Enforcement, and prosecuted by Assistant United States Attorney Crane M. Pomerantz.
The public is reminded that an indictment contains only charges and is not evidence of guilt. The defendants are presumed innocent and entitled to a fair trial at which the government has the burden of proving guilt beyond a reasonable doubt.