The Department of Justice (DOJ) just announced that a plastic surgery group in Albany, New York, just pled guilty to <"http://www.yourlawyer.com/practice_areas/medical_malpractice">use of an unlicensed â€œbotoxâ€ substitute on unsuspecting patients. The Plastic Surgery Group, LLP (TPSG) pled guilty to one felony count of misbranding drugs in connection with the use, on unsuspecting patients, of a cheaper â€œBotoxâ€ substitute not approved by the U.S. Food and Drug Administration (FDA).
TPSG admitted that, with intent to mislead, it injected patients with Botulinum Toxin Type A manufactured by Toxin Research International, Inc. of Arizona (“TRI-toxinâ€) misbranded under the name of another drug, namely BOTOXÂ®/BOTOXÂ® Cosmetic. Five physicians, the practice administrator, and the Supervisory Nurse of TPSG pled guilty to strict-liability misdemeanor misbranding violations arising from the same conduct in 2004.
TPSG entered its guilty plea to felony charges and will be sentenced on December 14, 2009 in Albany. TPSG faces a fine of up to $500,000 and an order to pay restitution to about 150 patients who paid a total of approximately $100,000 for TRI-toxin injections while believing they were being treated with genuine BOTOXÂ®. The following pled guilty and face up to one year in prison and fines of up to $100,000 at sentencing:
Dr. William F. DeLuca, Jr., 58 of Latham, New York;
Dr. Steven Lynch, 65 of Slingerlands, New York;
Dr. Douglas M. Hargrave, 56 of Delmar, New York;
Dr. John D. Noonan, 62 of Slingerlands, New York;
Dr. Jeffrey L. Rockmore, 42, of Delmar, New York;
Practice Administrator Peter M. Slattery, 48 of West Sand Lake, New York; and
Supervisory Nurse Susan Knott (nee: Cole), 49, of Latham, New York.
Gary Tunkavige, Acting Special Agent-in-Charge of the FDAâ€™s Office of Criminal Investigations and Office of Chief Counsel, said, â€œThe FDA will continue to work tirelessly, on its own and in cooperation with the Department of Justice, to prevent and deter the illegal sale and use of unlicensed and unapproved drugs.â€
United States Attorney Andrew T. Baxter said, â€œThe Plastic Surgery Group of Albany misled about 150 patients who believed they were being treated with FDA-approved BOTOXÂ® when, in fact, they were being injected with a cheaper, unlicensed substitute. The dispositions announced today reflect a considered assessment of the nature and seriousness of that criminal conduct in the context of the positive contributions that the doctors and employees of this plastic surgery group have otherwise made to the Albany community over many years.â€
An attorney for TPSG said that the group admitted that, starting in approximately February 2004, TPSG stopped using the FDA-approved BOTOXÂ® and BOTOXÂ® Cosmetic on its patients seeking treatments with Botulinum Toxin Type A for facial wrinkles and insteadâ€”from in or about February 2004 though December 2004â€”TPSG injected approximately 150 patients with TRI-toxin, which had not been approved by the FDA for use on humans. TPSG never disclosed to any patient that they were being injected with a product other than BOTOXÂ® or BOTOXÂ® Cosmetic.
In fact, noted the DOJ in its release, TPSG repeatedly misled patients into believing they were being treated with an FDA-approved BOTOXÂ® substance, for example, through the use of the BOTOXÂ® name on various brochures, promotional materials, consent forms, and invoices provided to patients. Patients were charged the same, higher cost of BOTOXÂ® treatments, for the cheaper, unapproved TRI-toxin.