27 January – LAWFUEL – The Law News Network – R Alexander Acosta, 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 defendants Chad Livdahl, Zarah Karim, Bach McComb, Robert Baker, Powderz, Inc., Toxin Research International, Inc. (“TRI”), The Cosmetic Pharmacy, Inc., and Z-Spa, Inc., were all sentenced in Ft. Lauderdale federal court by United States District Court Judge James I. Cohn.
Defendant Livdahl, who pled guilty to one count of conspiracy to defraud the United States, to engage in mail and wire fraud, and to misbrand a drug, in violation of Title 18, United States Code, Section 371, and one count of mail fraud, in violation of Title 18, United States Code, Section 1343, was sentenced to 108 months’ imprisonment, followed by three years’ supervised release, joint and several restitution in the amount of $345,567.20, forfeiture to the United States of $882,565.00, and a $200 special assessment.
Defendant Karim, who pled guilty to the same charges as Livdahl, was sentenced to 70 months’ imprisonment, to be followed by three years’ supervised release, joint and several restitution of $345,567.20, and a $200 special assessment.
Defendant McComb, who pled guilty to one count of misbranding a drug in interstate commerce, in violation of the Food, Drug & Cosmetic Act, was sentenced to three years’ imprisonment, followed by one year of supervised release, and a $100 special assessment.
Defendant Baker, who pled guilty to one count of mail fraud, was sentenced to 180 days’ home detention, two years’ probation, $5,000 fine, and a $100 special assessment.
Lastly, each of the corporations, which had pled guilty to the conspiracy charge, was sentenced to joint and several restitution of $345,567.20. In addition, Powderz, Inc., the only one of the four corporations that is still active, was sentenced to three years’ probation.
U.S. Attorney Acosta stated, “The severe sentences imposed in this case are fair punishment for the callous crimes these defendants committed. Doctors and medical practitioners have a solemn duty to those for whom they care. These defendants breached that duty and endangered the lives of their patients by selling deadly toxin packaged in harmless-looking vials to unsuspecting patients
in our community. The pain and suffering they caused is immeasurable. They have now been held accountable for their actions.”
According to the Second Superseding Indictment, the conspiracy count charged that defendants Livdahl, Karim, Toxin Research International, Inc., Powderz, Inc., The Cosmetic Pharmacy, Inc., and Z-Spa, Inc., conspired to purchase 3,081 vials, each containing five 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 Second Superseding Indictment charged that health care providers then used the defendants’ Botulinum Toxin Type A on their human patients, despite labeling that stated, “For research purposes only; not for human use.”
McComb pled guilty to one count of misbranding TRI’s Botulinum Toxin Type A in interstate commerce, in that he arranged for the toxin to be shipped interstate, intending to use it on human beings in a manner inconsistent with the product’s labeling. Baker pled guilty to one count of mail fraud relating to the mailing of vials of TRI’s Botulinum Toxin Type A from TRI to a health care provider in Miami, Florida, in that he advised the health care provider that the product was safe for use in human beings, information upon which she relied in purchasing the Botulinum Toxin Type A and using it on human beings.
Mr. Acosta 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 forfeiture aspect of the case is being handled by Assistant United States Attorney Alison Lehr.
A copy of all 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 .
