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Home >  News >  April, 2012

Liposuction Device Lawsuit Going Forward

Patient claims she wasn't notified of her role in product's safety testing.

Published: April 27, 2012

A federal judge has rejected a Pittsburgh plastic surgeon's request to dismiss a lawsuit involving a liposuction patient, a medical device in development and a clinical trial allegedly conducted without the patient's consent.

Dennis Hurwitz, MD, FACS, performed liposuction on the hips, thighs, arms and stomach of patient Rae Schiff in March 2010. According to court records, their pre-surgical consultations had not significantly addressed the possibility of using an investigational radiofrequency skin-tightening technology.

But Dr. Hurwitz used the device, called BodyTite by Israeli manufacturer Invasix, during the procedure, as part of a clinical trial for which the company was paying him. While it's presently marketed in Canada, Europe and Asia, BodyTite is still awaiting FDA approval in the United States.

In the months following her surgery, Ms. Schiff claimed to be in excruciating pain that was uncontrollable by medication as a result of the device's thermal injury to her cells, tissue, nerves and lymphatic system. In addition, she complained of irregular scars and scar tissue at the surgical site.

She sued Dr. Hurwitz for negligence, failure to obtain informed consent and battery, seeking a jury trial and financial damages. Not only was she unaware of and uncompensated for her participation in a clinical trial, the lawsuit alleges, she was not informed of the device's risks; the contraindications that might have disqualified her from the trial; the fact that the FDA hadn't approved the device and wasn't involved in the trial; and the payment Dr. Hurwitz was receiving from Invasix.

The lawsuit also cites the Hurwitz Center for Plastic Surgery, Invasix and the Essex Institutional Review Board (a for-profit company which oversaw the clinical trials) for negligence, infliction of emotional distress and unfair trade practices, among other charges.

Dr. Hurwitz, a representative of Invasix and Ms. Schiff's attorney did not immediately return calls seeking comment.

David Bernard

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