22 March 2005 – LAWFUEL – The Law News Network – Marcos Daniel Jiménez, United States Attorney for the Southern District of Florida; and David W. Bourne, Special Agent in Charge, Food and Drug Administration, Office of Criminal Investigations, Miami Field Office, announced today the return by a grand jury sitting in Ft. Lauderdale of a 48-count Superseding Indictment adding as a defendant Robert Baker, M.D., a director of plastic surgery at the University of Kentucky in Lexington, Kentucky, in connection with the scheme to distribute fake Botox for use on humans, even though the product was never approved by the Food and Drug Administration (FDA) for such use. Also charged in the Superseding Indictment are the three (3) doctors and four (4) corporations charged in the initial Indictment. Those defendants are Chad Livdahl, N.D., Zarah Karim, N.D., Bach McComb, D.O., Toxin Research International, Inc. (“TRI”), Powderz, Inc., Z-Spa, Inc., and The Cosmetic Pharmacy, Inc.
All of the defendants are charged with conspiracy to defraud the United States, engage in mail and wire fraud, and misbrand a drug, in violation of Title 18, United States Code, Section 371. Additionally, all of the defendants are charged with two or more substantive counts of mail fraud, in violation of Title 18, United States Code, Sections 1341 and 1346, and Livdahl, Karim, McComb, TRI, and Powderz, Inc. are charged with wire fraud, in violation of Title 18, United States Code, Sections 1346 and 1343, and misbranding of a drug, in violation of Title 21, United States Code, Sections 331(c) and 333(a)(2). Livdahl also is charged with perjury, in violation of Title 18, United States Code, Section 1623(a). The Superseding Indictment seeks forfeiture of the ill-gotten gains, including $1,500,000.
According to the Superseding Indictment, the defendants purchased 3,081 vials, each containing five (5) nanograms of Botulinum Toxin Type A and other ingredients, in a formulation designed to imitate Allergan’s Botox®Cosmetic, the only product made with Botulinum Toxin Type A that is approved by the FDA for use in human beings. The defendants then engaged in a scheme to defraud by marketing and selling to health care providers for use in human patients the fake Botox as a cheap alternative to Allergan’s Botox® Cosmetic, without the administering health care providers advising their human patients that the fake Botox was not Allergan’s Botox® Cosmetic and was not approved by the FDA for use in human beings. The Superseding Indictment charges that Baker, along with Livdahl, Karim, and McComb, promoted the fake Botox at a workshop held in Scottsdale, Arizona, on July 19 and 20, 2003. The Superseding Indictment further charges that Baker provided Livdahl and TRI with a testimonial letter commending TRI’s fake Botox, and that this letter was then distributed by mail and displayed on TRI’s website to practicing health care providers in support of TRI’s marketing and sales efforts to practicing health care providers.
Additionally, McComb is charged with one (1) count of misbranding a drug in relation to his obtaining 10,000 nanograms of full-strength, raw Botulinum Toxin Type A from List Biological Laboratories, Inc., and administering this product to individuals as though it were Allergan’s Botox® Cosmetic, when, in fact, it was not. Based on prior court filings by the United States, this incident led to the development of severe botulism in four (4) individuals in the South Florida area, including McComb.
The conspiracy count carries a maximum statutory term of imprisonment of five (5) years and a maximum statutory fine of $250,000. The maximum statutory term of imprisonment and fine for each of the mail and wire fraud counts is twenty (20) years and $250,000, respectively. The maximum statutory term of imprisonment and fine for each misbranding violation is three (3) years and $250,000, respectively. As for the maximum statutory penalty on the perjury count, Livdahl faces a maximum term of imprisonment of five (5) years and a maximum fine of $250,000 fine.
Prior to filing criminal charges, the United States sought civil relief against Livdahl, Karim, Powderz, Inc., TRI, The Cosmetic Pharmacy, and Z-Spa, Inc. to stop these defendants from distributing the fake Botox. On January 11, 2005, in response to the United States’s motion for a preliminary injunction, United States District Judge James I. Cohn issued a civil injunction prohibiting these defendants from further distributing the fake Botox and requiring the defendants to initiate a recall of all previously distributed product and submit to inspections by the FDA, after a day-long hearing that included testimony from Livdahl and Karim. The criminal indictment includes one (1) count of perjury against Livdahl arising from his testimony at the preliminary injunction hearing on January 10, 2005.
Mr. Jiménez commended the investigative efforts of the Food and Drug Administration, Office of Criminal Investigations. The criminal case is being prosecuted by Assistant United States Attorneys Robin S. Rosenbaum and George Karavetsos. The civil case is being handled by Assistant United States Attorney Russell Koonin.
A copy of this press release may be found on the website of the United States Attorney’s Office for the Southern District of Florida at www.usdoj.gov/usao/fls. Related court documents and information may be found on the website of the District Court for the Southern District of Florida at www.flsd.uscourts.gov or on http://pacer.flsd.uscourts.gov.