On November 11, 1994, the 9th U.S. Circuit Court of Appeals, based in San Francisco, has upheld the FDA's right to seize a medical device illegally promoted as a cure for cancer, AIDS, and other diseases. The decision came after a three-year legal battle in which the device maker countersued FDA and others for more than $4 million in damages. U.S. marshals had destroyed the devices the preceding August.
Called the Bio-Ionic System, the device operated like a transcutaneous electrical nerve stimulation (TENS) unit, which FDA has approved only for treating pain. TENS devices transmit electrical impulses through electrodes placed on the skin. The Bio-Ionic System was one of several medical devices that were the focus of a 1992 congressional hearing, "Recent Trends in Dubious and Quack Medical Devices." At the hearing, the daughter of a deceased 54-year-old breast cancer patient testified about her mother's treatment with the Bio-Ionic System by Evans Rapsomanikis, the device's maker. She said he declared her mother free of cancer after the treatment, yet the mother died of cancer six weeks later.
Rapsomanikis owned the Paradise Pain Clinic and Kyttaron Energy Corp., both in Las Vegas, Nev. Kyttaron manufactured the devices, eleven of which were used at the clinic to treat patients.
The Paradise Pain Clinic came to FDA's attention in spring 1991, when the Nevada State Board of Medical Examiners contacted FDA's San Francisco district office about a complaint it had received from Jean Harris of Pleasant Hill, Ore. Harris, whose son is paralyzed from the neck down, told the board that she believed Rapsomanikis misrepresented himself as a medical doctor because he had indicated to another family member that he could cure quadriplegia. Harris took her son to Paradise Pain Clinic for therapy, but when the treatments failed, they returned to Oregon, refusing to pay Rapsomanikis' fee of $150 to $200 a treatment. The Nevada board investigated but found no evidence that Rapsomanikis referred to himself as a physician, and the case was dropped.
In summer 1991, Las Vegas TV station KVBC aired a two-part news report on Rapsomanikis's clinic. The report included interviews with two KVBC employees who posed as cancer patients. Both reported that Rapsomanikis told them he could cure their cancer. In an interview, Rapsomanikis told the reporter his treatment had an 80 percent success rate for cancer. In August 1991, an anonymous caller to the FDA's Las Vegas resident post told investigators the general location of where the devices were made. The FDA traced the exact site to a Las Vegas office building, where space had been leased under the name Paradise Pain Clinic.
In September, an investigator with FDA's San Francisco district office, posing as a breast cancer patient, and an investigator with the Las Vegas district attorney's office, posing as her brother, went to Paradise Pain Clinic. They met with Rapsomanikis, who told them he could cure her cancer after three weeks of treatment with the Bio-Ionic System. He also said he had treated numerous women with breast cancer and they all were fine. The investigators were given promotional videotapes and a packet of testimonials allegedly written by former patients who claimed Rapsomanikis' medical device had cured them of Guillain BarrŽ syndrome, chronic fatigue syndrome, Epstein-Barr virus, arthritis, and other diseases.
The next day, the investigator posing as the patient went to a Las Vegas chiropractor to whom Rapsomanikis had referred her. The chiropractor examined her and told her she had two lumps "the size of grapes" in her left breast. That same day, the investigator went to a medical doctor for a mammogram and breast ultrasound. Both tests revealed no lumps or cancerous growths in either breast. The investigator returned to Paradise Pain that same day, but Rapsomanikis apparently had become suspicious and refused to treat the one posing as the patient. He said that because she had no pain, she was ineligible for treatment at the pain clinic. In October, FDA obtained warrants to inspect the Paradise Pain and Kyttaron sites. Rapsomanikis was not present at either site.
At the clinic, FDA investigators interviewed the office manager and Rapsomanikis' assistant. At times, the employees refused to cooperate, denying the investigators access to patient records and trying to prevent them from taking photographs. According to the office manager, Rapsomanikis saw an average of 14 patients a day, with treatments generally lasting three hours a day for two to three weeks. The investigators detained 11 Bio-Ionic devices for 30 days by taping and tagging them with warnings about using the devices during the detention period.
Meanwhile, at Kyttaron, two other FDA investigators detained two completely assembled Bio-Ionic devices and various parts of partially assembled units, including 24 overstuffed chairs, 63 empty cabinets, and several batteries and battery chargers. At this time, the investigators also discovered that the company did not keep production records, as required by federal law.
Rapsomanikis, through his attorney, scheduled a meeting in November 1991 with FDA officials to discuss the devices' detention. The day before the meeting was scheduled, however, Rapsomanikis canceled it. That Nov. 13, he sued the FDA, individual FDA investigators, KVBC-TV reporters, and the Harrises, who had filed the initial complaint against him. His lawsuit kept the case open until last fall.
U.S. marshals seized a semitruckload of the detained items on Nov. 29, 1991, at Kyttaron. When the marshals arrived at Paradise Pain Clinic that same day to seize the devices there, they found the facility empty of all but two incomplete devices. An informant later told FDA that Rapsomanikis had moved the devices and promotional literature to another location the night before the seizure. Investigators never located the missing devices. The FDA believes that Rapsomanikis fled the country, possibly with some of his devices, and that he may have set up practice in London
This article was adapted from information in the October 1995 FDA Consumer magazine. The Bio-Physical Therapy Centre in London, England, which offered treatment with the "Bio-Ionic System," states that Rapsomanikis died in 2001.