Mark Wright, 67, pleaded guilty in federal court to misdemeanor charges of causing the introduction of misbranded and adulterated devices into interstate commerce.
According to documents filed with the court, from July 2013 to July 2017, Wright served as the chief executive officer of Dolor Technologies Inc., a Utah-based medical device company. 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. Wright also admitted that, while FDA had recommended in April 2014 that Dolor proceed with investigational studies regarding the SphenoCath’s safety and effectiveness, 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.
U.S. Magistrate Judge Cecilia M. Romero presided at the plea hearing and set sentencing for 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, 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.”
“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 U.S. Attorney Trina A. Higgins for the District of Utah. “These individuals pose a danger to the community and put the public’s health and safety at risk.”
“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.”
The FDA’s Office of Criminal Investigations investigated the case.
Trial Attorneys David Hixson and Emily C. Powers of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorney Jacob Strain for the District of Utah prosecuted the case.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the District of Utah, visit its website at www.justice.gov/usao-ut.
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