Alternative Heath Care Device Case -- Sale Of Unapproved Medical Device (Rife Machine) -- Attorney Commentary

On February 17, 2009, James Folsom was found guilty by a federal jury in United States District Court in San Diego of twenty-six felony counts relating to his sale of an unapproved medical device known as a Rife-type biofrequency device. For an article on the trial:
http://www3.signonsandiego.com/stories/2009/feb/18/bn18convict-medical-scam/?zIndex=55119

According to evidence presented at trial, from 1997 through 2008, James Folsom conspired with others to ship adulterated and misbranded Rife-type biofrequency devices in interstate commerce. The device, sold under names "NatureTronics," the “AstroPulse,” “BioSolutions,” “Energy Wellness,” and “Global Wellness,” consisted of a micro-current frequency generator with a digital readout, two stainless steel cylinders, two personal application plates with connectors and lead wires connecting the device to the cylinders and the plates. Users were provided with an operating manual that set forth hundreds of digital settings for the device, directed to specific conditions from AIDS, diabetes, stroke, and ulcers to worms. Users were advised to connect the cylinders or plates to the machine and touch them to the body for a recommended run time to treat each condition.

According to testimony at trial, the defendant purchased over 9,000 units, which he sold to distributors for approximately $1000-1200 and to retail customers for $1995, with sales of over $8 million. The devices were manufactured by the defendant and others in a San Diego location, which he failed to register with the Food and Drug Administration (FDA) as a device manufacturing establishment. There were other facts in this case that suggested fraud in that Folsom used the false name “Jim Anderson” when selling the device and used post office boxes, self-storage units, and bank accounts opened in the names of others to conduct his business, all in an alleged effort to avoid detection by the FDA. The defendant also marketed his device “for investigational purposes,” which the government alleged was to deceive consumers into the false belief that he possessed a valid investigational device exemption from the FDA.

The government’s theory at trial was that the devices were adulterated in that they were marketed without a valid investigational device exemption, without pre-market approval, and in violation of an electrical performance standard set by the FDA prohibiting lead wires that come into contact with patients from being able to come in contact with potentially hazardous voltages. The devices were also misbranded in that they were marketed without valid clearance from the FDA, did not bear the name and address of the manufacturer on the labeling, and were produced in an unregistered manufacturing establishment.

Related court documents and information may be found on the website of the District Court for the Southern District of California at http://www.casd.uscourts.gov/ or on http://pacer.psc.uscourts.gov/

Commentary: As attorneys who tried a case in November 2008 in Los Angeles involving a rife machine, other alternative health care issues and the alleged unlicensed practice of medicine, we have the following comments about the case.

First, if you are selling or using any type of "device" as part of alternative health care you need to be very careful about FDA regulation. Seek the advice of an attorney if you use, sell or market any device which could be under FDA regulation.

Second, if you are in alternative or complementary health care that you need to be careful about making any claims that a non-FDA approved device (or vitamins and supplements for that matter) can cure or treat any disease. One of the driving facts in Folsom's case was that marketing material found on several internet sites and promotional material said the device uses electrical frequencies to destroy diseased cells in the body. It also said the device was inspired by the work of San Diego inventor Royal Raymond Rife, who in the 1930s theorized that cells could be destroyed by directing precise radio frequencies at them. Rife believed cancers, viruses and other illnesses could be treated with the technology. Rife type machines have been used by alternative health care providers as an alternative method of promoting wellness for people with AIDS, cancer and other conditions . Seek the advice of an attorney if you are an alternative health care provider especially where you see persons with cancer and other diagnosed diseases.

Third, if you are engaged in alternative health care have all promotional material, including websites, reviewed by an attorney to ensure that there are no false claims and no claims to cure or treat any disease or condition.

Fourth, if you are investigated by the government assess the exposure you have at an early stage by a thorough analysis through counsel. Address the issues early and if the government contends that you are doing something illegal it is important to get an attorney involved immediately. In this case, we were informed that the government investigation went on for years and that early resolution of the case was rejected. Currently, Folsom is facing 15 years in prison.

Any questions or comments should be directed to: tgreen@greenassoc.com. Tracy Green is a principal at Green and Associates in Los Angeles. They focus their practice on the representation of individuals, businesses, licensed professionals, including health care professionals and providers.