(LOS ANGELES) – A Federal Grand Jury has indicted Dr. David Cary Hansen, a dermatologist in West Hollywood, with participating in a scheme to substitute a cheaper, unapproved drug for the brand name Botox®.
Dr. Hansen is charged in a ten count indictment with mail fraud, causing the interstate transportation of a misbranded drug, receipt of a misbranded drug in interstate commerce and delivery thereof, and misbranding of a drug while held for sale. The indictment was returned on Wednesday, December 17, 2008.
Dr. Hansen was arrested earlier today and is expected to make his initial appearance before a United States Magistrate Judge this afternoon.
Dr. Hansen is accused of perpetrating a scheme to profit from the use of a less expensive and unapproved form of Botulinum Toxin Type A, by selling it to patients as 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 December 2003 and July 2004, Dr. Hansen is alleged to have purchased a total of at least twelve vials of the unapproved form of Botulinum Toxin Type A from a company located in Arizona. Vials of the unapproved form of Botulinum Toxin Type A were clearly labeled “For Research Purposes Only, Not for Human Use.” The same warning was printed on invoices and product information sheets. High doses of Botulinum Toxin Type A, according to the indictment, can cause Botulism in humans. Dr. Hansen is accused of injecting patients with the non-approved substance while falsely advising them that he was injecting them with Botox®.
“This indictment reflects the concern of the community about doctors who make profit, rather than patients’ health, their highest priority,” said Thomas P. O’Brien, United States Attorney for the Central District of California. “This was unscrupulous, potentially dangerous conduct motivated by profit. It was deceptive and risked the health and well-being of patients who placed their trust in the abilities and integrity of a licensed physician.”
“The FDA Office of Criminal Investigations considers this illegal conduct very serious and is fully committed to investigating and supporting the prosecution of those who represent and use a ‘not for human use’ drug as an FDA approved drug which endangers the public health. We commend the U.S. Attorney’s Office in the Central District of California for their diligence,” said Thomas Emerick, Special Agent in Charge, FDA Office of Criminal Investigations, Los Angeles Field Office.
The two counts of mail fraud each carry a maximum penalty of 20 years imprisonment and a $250,000 fine upon conviction. The six counts involving misbranding of drugs each carry a maximum penalty of 3 years in prison and a $250,000 fine. The indictment also charges two misdemeanor counts involving misbranding of drugs, which each carry a maximum penalty of one year in prison and a $100,000 fine.
This case is being investigated by Special Agents of the Food and Drug Administration, Office of Criminal Investigations and is being prosecuted by Assistant United States Attorneys Janet C. Hudson ((213) 894-6356) and Margaret Carter ((213) 894-7413).
An indictment is a formal accusation of criminal conduct, not evidence. Defendants are presumed innocent unless and until convicted through due process of law.
Release No. 08-157