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Patient says surgeon used her as subject in clinical trial

A federal court has denied a motion to dismiss in an interesting case. The case is not in Texas, but it caught our attention because of our recent discussion of medical devices and Food and Drug Administration approval. The plaintiff claims the surgeon used an untested, unapproved medical device when he operated on her and the surgery had a permanent impact on her health. She was, in essence, an unwitting participant in a clinical trial.

The woman went to the plastic surgeon for liposuction on her hips, thighs, arms and stomach. The surgeon, who is now one of the defendants in the suit, used a radio frequency skin-tightening device manufactured by a company in Israel. The company says the device is approved for use in Europe, Canada and parts of Asia, but it has not yet been approved by the FDA.

The patient believes the company had paid the surgeon as an investigator for the device. The surgeon agreed to use the device on patients to test its efficacy and safety. The trials, however, were not approved by the FDA; the agency had not granted pre-market approval for the device.

In addition to using an untested device, the surgeon did not follow the manufacturer's guidelines for its use, according to the complaint. The manufacturer recommends using the device on no more than three parts of the body; in the plaintiff's case, he used it on four.

Since the surgery in 2010, the plaintiff has endured "uncontrollable" pain. She also complains of irregular scars and scar tissue. She says that neither the surgeon nor any member of his team warned her of the potential dangers of the procedure. The plaintiff also alleges violations of the state's consumer protection law. She is asking for compensatory and punitive damages.

The court's decision means only that the complaint can move forward. Whether the doctor, the manufacturer and the other defendants make further motions or decide to negotiate a settlement is yet to be seen.

Source: Courthouse News Service, "Plastic Surgeon Can't Dodge Lipo Patient's Suit," Matt Reynolds, April 23, 2012

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