As reported by the Courthouse News Service, a woman has filed a medical malpractice lawsuit against a plastic surgeon that tried out a new liposuction device on her, which had yet to pass FDA approval, that left her in pain and scarred.
R.S., of Michigan, claims that Dr. D.H. used her body to test the device, called Invasix, for a sponsored trial that she was not aware of. While the Israeli-based company that manufactures the device –that was used on her hips, thighs, arms and stomach – paid D.H. for the try-out she was not paid.
The procedures were performed in 2010 at D.H.'s office in Pittsburgh.
Invasix BodyTite – described on the company's website as a radio frequency skin-tightening machine – has yet to be approved by the FDA for use on patients in the United States. Invasix has, however, been approved and is currently being used in Canada, Europe and some areas in Asia.
R.S. alleges that D.H. failed to tell her that she could be a paid participant in the trial. She further claims that he also never told her that she should have been excluded from the trials – as Invasix requested that their device was not to be used on over three areas of the body and D.H. had used it on four parts of R.S.'s body.
Post operatively R.S. experienced "uncontrollable" pain, irregular scarring and scar tissue. All of which were brought to D.H.'s attention.
On April 18 Judge Arthur Schwab did not dismiss R.S.'s case under the state's Unfair Trade Practices Act and Consumer Protection Law. In abbreviating the law Judge Schwab wrote, "Under the UTPCPL, a plaintiff must show that she justifiably relied on defendant's wrongful conduct or representations and that [s]he suffered harm as a result of that reliance."
Of his decision, Judge Schwab added, "Here, (R.S.) avers that confusion and deceptive conduct surrounded the affiliation, connection, and association Dr. (D.H.) had with the Invasix Devices and the 'BodyTite Procedure' as well as plaintiff's lack of knowledge of the clinical trial involving the Invasix device. Furthermore, along with numerous other averments concerning a UTPCPL violation, Dr. (D.H.) allegedly failed to warn (R.S.)of the potential dangers of the Invasix Device and, critically, allegedly misrepresented that the FDA approved, or was at least involved in the clinical trial, of the Invasix Device. Here, (R.S.) alleges that defendants failed to warn that the Invasix Device may cause thermal injury to cells, tissues, lymphatic systems and nerves of the body, which she alleges subsequently result in her injuries."
Named in the complaint as defendants are the Hurwitz Center for Plastic Surgery, Invasix, Essex Institutional Review Board and a yet-to-be determined Invasix agent.
Along with his Pittsburgh location, D.H. currently has offices in Beverly Hills and Brandywine according to his website. A fourth office is due to open in Soa Paulo, Brazil.
Contact a medical malpractice attorney if you have suffered at the hands of a medical practitioner. Oftentimes monetary awards, and change in policies, can be the welcome outcome.