RIFE machine raises legal issues

A recent search of the FDA website for import alerts and warning letters regarding the RIFE machine disclosed the following.

This article is fairly dated, at this point, but it does give a flavor of enforcement activities.

Unproven Medical Claims Land Men in Prison

"It has been known to shatter cancer cells and AIDS cells in people."
--Salesperson for Life Energy Resources Ltd. (LER), Falconer, N.Y., referring to the firm's REM SuperPro Generator.

"Your kid gets chicken pox, use the REM [SuperPro Generator] immediately, and it will knock it out."
--Pascal (Pat) Ballistrea, LER distributor.

Two New York men are serving time in prison for making claims such as these touting the electrical-shock-producing REM device as a cure-all for many medical conditions. A third man is on probation for three years.

In a felony prosecution for device health fraud, the three men--LER's top distributors--were convicted and sentenced in 1993, 1994 and 1995, for selling unapproved medical devices and drugs.

Their illegal activities came to light in a three-year undercover probe by FDA, the U.S. Postal Inspection Service, and the U.S. Department of Justice.

In prison are Ballistrea, of Williamsville, N.Y., and Michael Ricotta, of Orchard Park, N.Y. Brian Strandberg, of Portland, Ore., who also served as LER's national marketing director, received probation.

FDA first learned about LER on April 7, 1989, when an employee of a Buffalo finance company contacted FDA's Buffalo district office to report suspicions about the company. The employee said a salesperson for LER had called to solicit financial backing for the company's REM SuperPro Generator. Claiming the SuperPro could treat AIDS and cancer, the LER salesperson had confided, "I'm saying this to you, but it goes no further. I really can't say this to you."

Later that month, FDA investigator Russ Davis inspected LER and learned from Christopher Bradish, LER director of operations, that the firm bought the REM SuperPro Generator and other electrical devices and numerous drugs from Zoetic Inc., of St. Francisville, Ill., and marketed them in a pyramid scheme to independent distributors, who sold them to retail customers, who could themselves become distributors.

Davis learned from another man present, Frank Costanzo, that LER had 263 retail customers acting as distributors in 38 states. Costanzo was president of the company that leased computers, software, and building space to LER. He later also became LER chief executive officer.

According to records Davis examined, LER sold the REM SuperPro for $1,380. Directions for the device called for patients to place their feet on metal pads, which were wired to allow an electrical current to run through the body. The company also sold similar but less expensive devices that produced less current than the REM SuperPro.

The drug products, including one called LifeMax Miracle Natural Balance Body Creme, sold for about $7 to $55, according to the records.

Davis told Bradish and Costanzo about the complaint FDA had received, adding that unproven medical claims misbrand a device, and selling misbranded devices is illegal. According to Davis, Bradish said LER instructs its distributors to use only official literature for marketing, but added that because distributors run their own businesses, he couldn't account for their actions. However, he said LER would terminate agreements with distributors making claims not in the official literature, and he would write to them all, reminding them of this and cautioning them not to make the kind of AIDS and cancer claims reported in the original complaint.

Davis collected some of the official marketing literature, which said the electrical devices could treat neuralgia, headache, jet lag, and other conditions. These uses also are unproven medical claims, so before departing, Davis informed the men that distribution of misbranded products may result in legal sanction, such as seizure, injunction or prosecution.

In 1989 and 1990, FDA continued to receive complaints about unproven claims for the REM SuperPro. So, FDA decided to take action.

"We realized that the only way we were going to get them was to do an undercover investigation," said Louis Kaufman, a compliance officer with FDA's Center for Devices and Radiological Health.

Posing as distributors, investigators Steven Libel, Joan Trankle, and Sherry Phillips, of FDA's Buffalo district office, and investigators Edward Edmiston and Victor Meo, of FDA's Seattle district office, infiltrated the LER organization. Libel, Trankle and Phillips centered their efforts on Ricotta and Ballistrea in New York. Edmiston and Meo investigated Strandberg in Portland, which is in FDA's Seattle district. Ricotta, Ballistrea and Strandberg were singled out because they were responsible for promoting LER's products.

The investigators bought LER's products and collected unofficial literature, known as the "underground packet." The packet included literature, audiotapes and videotapes of individuals claiming the products could cure cancer, AIDS, and other diseases.

In secretly recorded meetings and phone conversations, Ricotta, Ballistrea and Strandberg admitted sending underground materials to down-line distributors for use in promoting the REM SuperPro for such diseases as cancer and AIDS and the LifeMax Miracle Cream for such medical conditions as osteoporosis and premenstrual syndrome.

To support LER's claims that the REM SuperPro cured cancer and other diseases, the underground materials routinely referenced a book about the SuperPro Generator, precursor to the REM SuperPro. The book described work by the precursor's inventor, Royal Raymond Rife, who died in 1971. "REM" reportedly stood for "Rife's Electromagnetic."

Meanwhile, on April 19, 1990, FDA investigators Mark Prusak and William Lubas, who were not part of the undercover investigation, inspected LER's facility in Falconer, N.Y.

Costanzo, now the chief executive officer, refused to let Prusak see shipping and receiving records and distribution information and, when questioned by the investigators, Costanzo denied reports that LER made medical claims for its products. LER's Bradish said the devices were sold for relaxation and stress reduction.

By February 1991, FDA had gathered enough evidence to forward its findings to the Department of Justice.

On May 29, executing a search warrant at Ballistrea's house, FDA and the Postal Service found a large amount of product literature and videotapes. Although Ballistrea had sent undercover government investigators numerous materials on LER products in 1990 and 1991, he told the agents it had been more than a year since he had distributed such materials.

A grand jury investigation began in the summer of 1991. U.S. Attorney Dennis Vacco wrote, "Two of the more disturbing aspects of the investigation are the fact that some cancer patients have been using these devices without the knowledge of their physicians and as an alternative to chemotherapy."

On Feb. 25, 1993, Strandberg pleaded guilty in the U.S. District Court for the Western District of New York, in Buffalo, to two misdemeanor counts of distributing an unapproved device. In a plea agreement, he admitted knowing the REM SuperPro was not approved by FDA. He admitted sending materials containing medical claims for the device to customers and distributors.

Judge Leslie Foschio sentenced Strandberg on Dec. 21, 1993, to three years' probation with 200 hours community service and fined him $500 and a $50 special assessment.

On April 8, 1993, in the same court, the grand jury returned a 10-count indictment against Ballistrea and Ricotta.

The trial began Oct. 9. After four days, however, a mistrial was declared for Ballistrea, who was excused because of a back ailment. He was tried later.

During Ricotta's trial, according to the Nov. 18, 1993, Buffalo News, Ricotta denied selling the REM SuperPro for medical purposes, but he said he believed the product was effective treatment for bone and colon cancers, skin diseases, premenstrual syndrome, arthritis, bladder diseases, angina, insomnia, herniated disks, tumors, Lou Gehrig's disease, kidney ailments, emphysema, hearing problems, ear infections, and other illnesses.

On Nov. 19, Ricotta was convicted of two felony and four misdemeanor charges for conspiracy to defraud FDA, distributing an adulterated and misbranded medical device (the REM SuperPro), and distributing an unapproved new drug (LifeMax Miracle Cream).

On Feb. 2, 1994, Judge Richard Arcara sentenced Ricotta to three years, five months in prison and three years' supervised release and fined him $3,000 and a $200 special assessment.

"You are a menace and a threat to society," Judge Arcara told Ricotta, as reported next day in the Buffalo News. "Your sales strategy targeted the most vulnerable people, including those suffering from terminal disease. ... It is especially cruel because, in many instances, it proved false hope to people who had no hope."

After several hearings to determine whether Ballistrea was able to stand trial, his trial finally began Nov. 10, 1994. On Dec. 14, he was convicted of the same charges as Ricotta and of making false statements to FDA and the Postal Service.

On Sept. 22, 1995, Judge Arcara sentenced Ballistrea also to three years, five months in prison and three years' supervised release and fined him $275 special assessment.

Law Offices of Michael H. Cohen.