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The Plastic Surgery Group LLP (TPSG) has pleaded guilty to one felony count of misbranding drugs. The group was convicted for using a cheaper Botox substitute.
The company will be saddled with a half a million fine and an order to pay restitution to 150 patients, who paid about $100,000 for the injections, believing they were genuine Botox.
TPSG confessed that it mislead patients by misbranding the cheaper Botox substitute. The substitute was manufactured by Toxin International Research Inc. and had yet to gain approval from the U.S. Food and Drug Administration.
Several personnel associated with the group also pled guilty to the misconduct, which was perpetrated in 2004. As published in The Business Review, these employees included:
Dr. William DeLuca Jr., 58, of Latham;
Dr. Steven Lynch, 65, of Slingerlands;
Dr. Douglas Hargrave, 56, of Delmar;
Dr. John Noonan, 62, of Slingerlands;
Dr. Jeffrey Rockmore, 42, of Delmar;
Practice administrator Peter Slattery, 48, of West Sand Lake;
Supervisory nurse Susan Knott.
The seven can face up to one-year imprisonment and up to $100,000 worth of fines. The sentencing for the seven is scheduled on December 15, while the practice is scheduled on December 14.
For a period of time between February 2004 and December 2004, in procedures involving only 151 patients, The Plastic Surgery Group used a form of Botulinum Toxin Type A, that the practice later came to learn was not approved by the FDA. The practice immediately stopped using this product upon learning of this matter, said the group in a statement.
TPSG concludes, It should not have happened. That is why the practice accepts responsibility.
Source: The Business Review
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