Inspections, Compliance, Enforcement, and Criminal Investigations

February 9, 2010: Company Pleads Guilty to Misbranding of a Drug

OCI Small Clear Seal
 

Food and Drug Administration
Office of Criminal Investigations

U.S. Department of Justice Press Release

 

For Immediate Release
February 9, 2010

United States Attorney
Northern District of New York
Contact: Thomas A. Capezza
Assistant U.S. Attorney
(518) 431-0247

 

Grant C. Jaquith, Temporary Acting United States Attorney for the Northern District of New York, and Mark Dragonetti, Special Agent-in-Charge of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office, announced that THE PLASTIC SURGERY GROUP, LLP (TPSG) of Albany, New York, was sentenced and ordered to pay restitution in the amount of $106,686, and a fine of $200,000, in connection with TPSG's plea of guilty to one felony count of misbranding drugs, in violation of Title 21, United States Code, Sections 331(k), 352(i)(3), and 333(a)(2). TPSG was sentenced in Federal District Court in Albany, New York by District Judge Thomas J. McAvoy.

Additionally, Doctors WILLIAM F. DE LUCA, Jr., DOUGLAS M. HARGRAVE, JEFFREY L. ROCKMORE, STEVEN M. LYNCH, and JOHN D. NOONAN, were sentenced to probation with community service, and ordered to pay restitution in the amount of $106,686, and a fine of $5,000. TPSG's practice administrator, PETER M. SLATTERY, and supervisory nurse SUSAN F. KNOTT, were also sentenced and ordered to pay restitution in the amount of $106,686, and fines in the amount of $1,000 and $500, respectively. All individual defendants were sentenced in connection with their guilty pleas to one misdemeanor count of misbranding drugs, in violation of Title 21, United States Code, Sections 331(k), 352(i)(3), and 333(a)(1), in United States District Court in Albany, New York by Magistrate Judge David R. Homer.

According to plea agreements, starting in approximately February 2004 and continuing to December 2004, defendant TPSG ceased using the FDA-approved BOTOX® and BOTOX® Cosmetic and began exclusively using a non-FDA approved TRI-toxin on its patients seeking treatments with Botulinum Toxin Type A for facial wrinkles. Five (5) physicians, whose professional corporations were partners of TPSG (the "treating physicians"), with the assistance of TPSG nurses, injected approximately one hundred and fifty (150) patients with the unapproved product.

The charges follow an investigation by the Food and Drug Administration, Office of Criminal Investigations, New York Field Office. Further inquiries can be directed to Assistant U. S. Attorney Thomas A. Capezza, Albany, New York at (518) 431-0247.

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