A federal judge has held the Salt Lake manufacturer of an "AIDS Treating Machine" in criminal contempt of court for violating an earlier injunction against the sale of unapproved medical devices.
The verdict comes five months after Tim Themy-Kontranakis or Themy, owner of Ster-O-Lizer Manufacturing Co., was tried on the charge before U.S. District Judge J. Thomas Greene.In a 30-page ruling released Thursday, Greene said Themy wilfully disobeyed the court's original 1989 injunction and a 1994 order making it "absolutely clear" that the injunction applied to all untested and unapproved devices, including the AIDS Treating Machine.
Themy said he was bitterly disappointed by the judge's ruling, saying, "I thought that if a person invents something to help humanity, the government should encourage its citizens accordingly. Instead, the government goes out of its way to put such persons as myself out of circulation, chase them out of the country."
According to Themy, he and his son hold several patents on "electrochemical oxidation systems" that are used for the treatment of AIDS, cancer, hepatitis and skin disorders. He said he has sold "several thousand units" over the past 25 years "without a failure or complaints."
Federal prosecutors brought the case to court in 1986 after seizing a number of devices that were being marketed for use in sterilizing surgical instruments. Following hearings on the matter, the court "condemned" the so-called Ster-O-Lizers and issued its first injunction.
In 1994, the Food and Drug Administration asked the court to reopen the case after learning that Themy was manufacturing and actually using a new device - the AIDS Treating Machine - to treat patients.
The earlier injunction was then amended to cover the production or sale of the AIDS machine "or any other article or device intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, or intended to affect the structure or function of the body of man" without prior FDA approval.
At the contempt trial in January, an FDA investigator testified that he found Themy was still manufacturing and selling sterilizers and the AIDS Treating Machines after the July 6, 1994, court order. The FDA said one company letter dated July 25, 1994, promoted the machine as a "multi-billion dollar making opportunity."
Inspectors said machines were shipped to clients in Canada and Greece in 1994 and to Spain in 1995.
The FDA informed Themy on April 20, 1995, that he had not been granted an investigational exemption to produce the AIDS machine and warned if he continued to offer treatments he could be held in criminal contempt.
According to court documents, Themy replied "lives are more important than rules and regulations" and said he would proceed with the scheduled treatment of "three important peoples" the following day. Themy said he had been advised that the FDA "will not come here to attempt to stop me."
However, he apparently backed off after the FDA faxed a second warning on April 21: "The bottom line is that you cannot use the AIDS Treating Machine to treat human patients for any medical purposes."
In his ruling, Greene said, "Neither the 1989 order nor the 1994 order contains terms that are vague or difficult to understand." Yet, Themy and his company made sales presentations at medical offices, shipped the devices out of state and promoted the AIDS machine and sterilizer through the mail.
A Greek immigrant, Themy said, "Albert Einstein was chased out of Germany because of his extraordinary inventions. It seems that I am chased out of America because of my extraordinary inventions. Must I blame the government or special interest that controls the FDA?"
Barbara Shaw, executive director of the Utah AIDS Foundation, said her organization urges patients to be cautious about devices and treatments, including the AIDS Treating Machine, that have not been tested and approved by the FDA.
"We are always concerned that when dealing with a life-threatening illness, some people will try anything. That's why we strongly recommend working with the established medical community," Shaw said.