Fake Medical Device Seller ConvictedFeb 23, 2009 | Parker Waichman LLP
A San Diego man was convicted by a federal jury for selling an unapproved medical device, the Union Tribune is reporting. James Folsom, 68, could land in prison for 140 years and is facing a-half million dollars in fines and 26 felony counts, said the Union-Tribune. Folsom remains in jail until his sentencing, scheduled for May 11.
It seems Folsom sold over 9,000 devices from 1997 through last year, distributing the bogus, unapproved devices to wholesalers and to retail customers, said the Union-Tribune. The devices were sold under names such as NatureTronics, AstroPulse, BioSolutions, Energy Wellness, and Global Wellness. The Union-Tribune reported that Folsom’s business brought in over $8 million in revenue. Assistant U.S. Attorney Melanie Pierson—a San Diego county prosecutor—told the paper that the Folsom case is the largest involving illegal medical devices she has seen in 20 years.
Officials for the U.S. Food and Drug Administration (FDA) testified that Folsom’s so-called device was never submitted to the agency for review. Apparently, the phony Folsom device is comprised of a small black box with dials, a digital screen, and wires that lead to a pair of stainless steel cylinders or metal plates, said the Union-Tribune, which explained that the device is plugged into an electrical socket, and a patient holds the cylinders or stands on the plates. According to marketing verbiage found on the Internet, the device uses electrical frequencies to attack and destroy diseased cells. The propaganda also states that Folsom’s device was inspired by inventor Royal Raymond Rife, also of San Diego, said the Union-Tribune. Rife apparently claimed, in the 1930s, that directing radio frequencies at cells could destroy diseased cells. Rife’s work was never proven and experts discredited the theory.
Meanwhile, Folsom is a former business associate of Kimberly Bailey. Bailey—who sold similar devices—is serving a life sentence since 2002 for plotting to kidnap, torture, and murder her business partner and lover. Folsom also conducted business under false names and marketed the device “for investigative purposes,” said the Union-Tribune. Using false names enabled Folsom to fly under the FDA’s radar, while saying the device was “for investigative purposes” falsely allowed buyers to believe the device was under FDA approval consideration.