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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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April 25, 2013: Chiropractor and School Charged with Unlawfully Shipping Unapproved Devices

 

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Food and Drug Administration 
Office of Criminal Investigations

 


 

 

             U.S. Department of Justice Press Release

 

 

For Immediate Release
April 25, 2013

www.usdoj.gov/usao/wiw

United States Attorney

Western District of Wisconsin

Contact: Peter M. Jarosz

(608) 264-5158

 

Madison, Wis. - John W. Vaudreuil, United States Attorney for the Western District of Wisconsin, announced the filing of an information in U.S. District Court in Madison today, charging Dr. David Ray Toftness, 65, and the Toftness Post-Graduate School of Chiropractic, Inc., both of Amery, Wis., with shipping unapproved medical devices in interstate commerce.  Dr. Toftness faces a maximum penalty of one-year in prison and a $100,000 fine; the school faces a maximum penalty of a $500,000 fine and five years probation.

 

On January 18, 1982, Judge Robert W. Warren entered a judgement in a Western District of Wisconsin federal case brought by the United States against the Toftness-Post Graduate School and its president, Irwing N. Toftness, the uncle of the defendant Dr. David Ray Toftness.  The judgement prohibited manufacturing, promoting, selling, leasing, distributing, shipping, delivering or using in any way the Toftness Radiation Detector, or any device substantially the same as, or employing the same basic principles as, the Toftness Radiation Detector.  Without FDA approval, the device was being used in chiropractic work purportedly assisting in the diagnosis and treatment of injuries.  Irwing N. Toftness, a chiropractor, invented the device and it was utilized by the school in teaching other chiropractors.  The defendant David Toftness inherited the Toftness Post-Graduate School from his uncle, and became its president when Irwing N. Toftness died in 1990.

 

The information alleges that between February 2005 and September 2006, Dr. Toftness and the school shipped in interstate commerce unapproved Toftness Radiation Detectors, Toftness Devices, and Toftness Instruments.  The school violated the District Court’s 1982 Order in doing so, while Dr. David Toftness, who was not a party to the 1982 proceedings, was charged individually in a separate count with essentially the same activity.

 

In a related case, on September 9, 2010, United States Magistrate Judge Stephen L. Crocker imposed a $500 fine on Glen Thomas Lindahl, of Churubusco, Ind.  Mr. Lindahl manufactured the devices for the defendant and shipped them from Indiana to the defendant’s offices in Wisconsin.

 

Acting SAIC Patrick Holland, FDA/OCI Chicago Field Office stated:  "The FDA, Office of Criminal Investigations, is committed to ensure that those who introduce adulterated medical devices into interstate commerce, and those who willfully and knowingly disobey and resist a United States District Court Order in doing so, are prosecuted to the fullest extent of the law."

 

The charges against Dr. David Ray Toftness and the Toftness Post-Graduate School of Chiropractic are the result of an investigation conducted by the Food and Drug Administration, Office of Criminal Investigations, Chicago Field Office.  The prosecution of this case has been assigned to Assistant U.S. Attorney Peter M. Jarosz.

 

You are advised that a charge is merely an accusation and that a defendant is presumed innocent until and unless proven guilty.

 

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