U.S. Department of Justice Press Release

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U.S. Department of Justice Press Release

KANSAS CITY, KAN. – A California man has pleaded guilty to creating a fraudulent marketing scheme to sell medical equipment and drug treatments for a nonexistent epidemic of Lyme disease, U.S. Attorney Barry Grissom said today.

Robert W. Bradford, 79, Chula Vista, Calif., pleaded guilty to one count of conspiracy to commit mail fraud and to introduce misbranded drugs into interstate commerce. In his plea, Bradford admitted that he and codefendants made more than $400,000 selling a microscope they claimed could be used to diagnose Lyme Disease and a drug treatment plan they claimed could cure it. Bradford was the founder of a company doing business as American Biologics, which distributed marketing materials calling Lyme disease the “Plague of the 21st Century” and claiming that more than 50 percent of chronically ill people may be suffering from Lyme Disease.

The defendants violated the Food, Drug and Cosmetic Act because they were not registered with the Food and Drug Administration to produce drugs or medical devices. Some of the drugs produced by American Biologics were shipped from California to co-defendant John Toth in Kansas. The drugs caused one individual in Kansas to experience renal failure and another individual in Kansas to lapse into a coma and die.

“With the death of one victim and the severe physical harm suffered by another, this investigation highlights the dangers of distributing drugs and medical devices in circumvention of FDA’s lawful and legitimate functions of regulating those products,” said Patrick J. Holland, Special Agent in Charge, FDA Office of Criminal Investigations, Kansas City Field Office.

Bradford is set for sentencing Dec. 14, 2010. Prosecutors are recommending a year of home confinement, five years probation, restitution of $40,372 and a forfeiture money judgment of $400,000.

Co-defendants awaiting trial are Brigitte G. Byrd, John R. Toth and Carole R. Bradford.

Grissom commended the Food and Drug Administration – Office of Criminal Investigation, Assistant U.S. Attorney Scott Rask and John Claud, trial attorney with the Department of Justice’s Office of Consumer Litigation for their work on the case.

Source: FDA , Office of Criminal Investigations Release News

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