(CN) – A Michigan woman can advance claims that a plastic surgeon used her as an unwitting and unpaid subject in a clinical trial for a liposuction device, a federal judge ruled.
Rae Schiff claims that Dennis Hurwitz used a device made by Israeli-based company, Invasix, to perform liposuction on her hips, thighs, arms and stomach at his Pittsburgh office in 2010. She claims that, unknown to her, Invasix paid Hurwitz to test the safety of the device in a sponsored trial.
Invasix BodyTite is a radio frequency skin-tightening device. The company says on its website that BodyTite is still awaiting Food and Drug Administration clearance but is already used in Canada, Europe and parts of Asia.
Schiff claims that Hurwitz never told her that the clinical study’s protocol excluded her as a BodyTite candidate because the Invasix device was not supposed to be used on more than three areas of the body. She also claims that Hurwitz never told her she could be paid as participant in the trial.
After the surgery Schiff allegedly complained of “uncontrollable” pain, irregular scars and scar tissue.
U.S. District Judge Arthur Schwab refused Wednesday to dismiss the case under the state’s Unfair Trade Practices Act and Consumer Protection Law.
“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,” Schwab wrote, abbreviating the law.
“Here, Schiff avers that confusion and deceptive conduct surrounded the affiliation, connection, and association Dr. Hurwitz 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,” Schwab wrote. “Furthermore, along with numerous other averments concerning a UTPCPL violation, Dr. Hurwitz allegedly failed to warn Schiff 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, Schiff 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,” the judge added.
Schiff’s complaint in Pittsburgh names the Hurwitz Center for Plastic Surgery, Invasix, Essex Institutional Review Board and an unknown Invasix agent as defendants.
Hurwitz’s website says he has been practicing plastic surgery since 1977. He has offices in Pittsburgh, Beverly Hills and Brandywine, with a fourth office opening in Soa Paulo, Brazil.
Neither the Hurwitz Center nor Invasix immediately responded to requests for comment.
Schiff’s attorney, Howard Louik with Goldberg, Persky and White, did not immediately respond to a request for an interview.