Ex-Utah CEO pleads guilty to distributing unauthorized medical device

A former Utah CEO pleaded guilty to distributing a medical device intended to treat migraines that was not authorized by the United States Food and Drug Administration.

Mark Wright, 67, pleaded guilty on Oct. 11 to federal misdemeanor charges of introducing misbranded and adulterated devices into interstate commerce, according to a statement from the U.S. Attorney’s Office.

“The United States will continue to prosecute those who flout the Food, Drug, and Cosmetic Act by marketing unapproved, adulterated, and misbranded drugs and devices to the public,” said Trina A. Higgins, U.S. Attorney for the District of Utah. “These individuals pose a danger to the community and put the public’s health and safety at risk.”

Wright served as CEO of Utah-based medical device company Dolor Technologies Inc. from July 2013 to July 2017, according to court documents.

Dolor sold a device called the SpenoCath that the company said treated migraines by administering nerve blocks to a collection of nerves called sphenopalatine ganglion, which is located in the mid-face of the skull.

Wright admitted in his guilty plea Dolor never got approval or clearance from the FDA to distribute SphenoCath, “rendering the SphenoCath devices adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act,” the attorney’s office said.

The FDA urged Dolor in April 2014 to investigate the safety and effectiveness of SphenoCath, but Wright admitted the company never conducted a study, the statement said.

“Instead, Wright and Dolor continued to market the SphenoCath with the intention that it be used to treat migraine headaches by administering (sphenopalatine ganglion) nerve blocks. Among other things, Wright provided health care providers with marketing materials and unsolicited directions for unapproved use of the SphenoCath,” the attorney’s office said.

Wright is set to be sentenced Nov. 8.

“Patients must be able to trust that they are being treated with medical devices that have been shown to be safe and effective,” said principal deputy assistant attorney general Brian M. Boynton. “The Department of Justice will continue to take action against companies and individuals that put public health at risk by not complying with the law.” KSL News