By James Limbach
ConsumerAffairs.com
August 12, 2009
The Plastic Surgery Group, LLP of Albany, New York, has pleaded guilty to one felony count of misbranding drugs in connection with the use, on unsuspecting patients, of a cheaper "BOTOX" substitute that was not approved by the Food and Drug Administration.
The group admitted that, with intent to mislead, it injected patients with Botulinum Toxin Type A manufactured by Toxin Research International, Inc. of Arizona ("TRI-toxin") misbranded under the name of another drug, namely BOTOX/BOTOX Cosmetic.
Five physicians, the practice administrator, and the Supervisory Nurse of TPSG also pled guilty to strict-liability misdemeanor misbranding violations arising from the same conduct in 2004.
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 BOTOX. Pleading guilty to misdemeanor charges were:
• Dr. William F. DeLuca, Jr., 58 of Latham, NY;
• Dr. Steven Lynch, 65 of Slingerlands, NY;
• Dr. Douglas M. Hargrave, 56 of Delmar, NY;
• Dr. John D. Noonan, 62 of Slingerlands, NY;
• Dr. Jeffrey L. Rockmore, 42, of Delmar, NY;
• Practice Administrator Peter M. Slattery, 48 of West Sand Lake, NY; and
• Supervisory Nurse Susan Knott (nee: Cole), 49, of Latham, NY.
The individuals face up to one year in prison and fines of up to $100,000 when they are sentenced in December.
"The Plastic Surgery Group of Albany misled about 150 patients who believed they were being treated with FDA-approved BOTOX when, in fact, they were being injected with a cheaper, unlicensed substitute," said United States Attorney Andrew T. Baxter. The dispositions, he said, "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."
In entering the guilty plea, an attorney for TPSG admitted that, starting in approximately February 2004, TPSG stopped using the FDA-approved BOTOX and BOTOX Cosmetic on its patients seeking treatments with Botulinum Toxin Type A for facial wrinkles. Instead, from in or about February 2004 though December 2004, TPSG injected approximately one hundred and fifty (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 BOTOX or BOTOX Cosmetic. In fact, TPSG repeatedly misled patients into believing they were being treated with an FDA-approved BOTOX substance, for example, through the use of the BOTOX name on various brochures, promotional materials, consent forms, and invoices provided to patients.
Despite the lower cost of the TRI-toxin to TPSG, patients were charged the same dollar amount they were previously charged for BOTOX treatments. About 150 patients paid a total of over $100,000 for these treatments during the period in 2004 when TPSG was administering TRI-toxin.
