WASHINGTON D.C., Oct. 20, 2023 (Gephardt Daily) — The CEO of a Utah-based medical supply company has pleaded guilty to charges of selling adulterated medical devices.
From July 2013 to July 2017, Mark Wright, 67, served as the chief executive officer of Dolor Technologies Inc., a Utah-based medical device company, according to a press release from the U.S. Department of Justice Office of Public Affairs.
“Dolor sold a device known as the SphenoCath, which was intended to treat migraine headaches by administering nerve blocks to the sphenopalatine ganglion (SPG), a collection of nerves located in the midface of the skull.
“As part of his guilty plea, Wright admitted that Dolor did not seek approval or clearance from the Food and Drug Administration (FDA) to distribute the SphenoCath for this intended use, rendering the SphenoCath devices adulterated and misbranded under the Federal Food, Drug and Cosmetic Act.” The FDA posted the same Oct. 13 press release on its website.
“Wright also admitted that, while FDA had recommended in April 2014 that Dolor proceed with investigational studies regarding the SphenoCath’s safety and effectiveness,” the DOJ said, “Dolor never conducted any such study.
“Instead, Wright and Dolor continued to market the SphenoCath with the intention that it be used to treat migraine headaches by administering SPG nerve blocks. Among other things, Wright provided healthcare providers with marketing materials and unsolicited directions for unapproved use of the SphenoCath.”
Sentencing is set for Nov. 8 in federal court in Salt Lake City.
“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, head of the Justice Department’s Civil Division. “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.”
“U.S. consumers rely on the FDA to ensure that their medical devices are safe and effective for their intended uses,” said Special Agent in Charge George M. Scavdis of the FDA’s Office of Criminal Investigations Metro Washington Field Office. “We will continue to investigate and bring to justice those who threaten the health of consumers by evading FDA requirements.”
