California Man Convicted of Selling Unapproved Medical Devices

A San Diego man has been found guilty of illegally selling medical devices he claimed could treat a wide range of conditions and diseases using electrical currents.

A federal prosecutor said it was the largest case involving the sale of such unapproved medical devices in decades.

James Folsom, 68, could be sent to prison for more than 140 years and fined $500,000 after being found guilty by a federal court jury on 26 felony counts. He remains jailed awaiting sentencing, set for May 11, 2009.

From 1997 to 2008, Folsom sold more than 9,000 of his devices through wholesalers and retail clients, prosecutors said. The devices, with names like NatureTronics, AstroPulse, BioSolutions, Energy Wellness, and Global Wellness, were said to use electrical currents to destroy diseased cells in the body.

Folsom reportedly earned more than $8 million selling the devices, which were never submitted to the U.S. Food and Drug Administration, the federal agency charged with regulating all medical devices. In order to gain approvals, a medical device must be reasonably safe and effective, FDA officials testified during Folsom’s trial.

Prosecutors said Folsom conducted his illegal business under false names to avoid detection by the FDA. He also gave some users the impression that the device was being reviewed by the FDA for approval, which was not true, officials said.

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