2 February 2005 – LAWFUEL – The Law News Network – Marcos Daniel Jiménez, United States Attorney for the Southern District of Florida; and David Bourne, Special Agent in Charge, Food and Drug Administration, Office of Criminal Investigation, Miami Field Office, announced today that a 48-count Indictment has been unsealed charging three (3) doctors and four (4) corporations in connection with a 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. The Indictment charges defendants, 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., 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 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 Indictment seeks forfeiture of the ill-gotten gains, including $1,500,000.
According to the 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.
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 penalty of five (5) years’ imprisonment and a $250,000 fine. The maximum statutory penalty for each of the mail and wire fraud counts is twenty (20) years’ imprisonment and a $250,000 fine. The maximum statutory penalty for each misbranding violation is three (3) years’ imprisonment and a $250,000 fine. As for the maximum statutory penalty on the perjury count, Livdahl faces a maximum of five (5) years’ imprisonment and a $250,000 fine on that count.
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.
“This deadly toxin packaged in harmless looking vials, wrapped in the guise of medicine, and used on unsuspecting members of our community represents a grave threat,” said Mr. Jiménez. “Upon hearing of this threat, our prosecutors, along with the FDA, worked tirelessly to stop the vials from being sent out to anyone else and to hold those who seek to profit from them accountable.”
“FDA applauds this indictment by the U.S. Attorney’s office against these companies and individuals who were marketing potentially dangerous unapproved drugs as a less expensive alternative to Botox Cosmetic — the botulinum toxin type A product approved by FDA,” said Dr. Lester M. Crawford, Acting FDA Commissioner. “Once again we have learned how people can be harmed when they are given products that are not approved for use in human beings. FDA recommends that consumers go to licensed, reputable health providers and get assurances that they are getting the FDA approved product.”
Mr. Jiménez commended the investigative efforts of the Food and Drug Administration, Office of Criminal Investigation. 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.
