CEO Pleads Guilty to Charges Involving Misbranded Medical Devices

CEO Pleads Guilty to Charges Involving Misbranded Medical Devices

Mark Wright, aged 67, entered a guilty plea on October 11 in federal court, admitting to misdemeanor charges related to the introduction of misbranded and adulterated medical devices into interstate commerce.

Unauthorized Marketing of the SphenoCath

According to court documents, from July 2013 to July 2017, Wright served as the Chief Executive Officer of Dolor Technologies Inc., a medical device company based in Utah.

Dolor Technologies marketed a device known as the SphenoCath, intended for treating migraine headaches by administering nerve blocks to the sphenopalatine ganglion (SPG), a collection of nerves in the midface of the skull.

FDA Violations and Lack of Clinical Studies

In his guilty plea, Wright confessed that Dolor Technologies did not seek approval or clearance from the Food and Drug Administration (FDA) to distribute the SphenoCath for its intended use.

This rendered the SphenoCath devices adulterated and misbranded under the Federal Food, Drug and Cosmetic Act.

Additionally, it was revealed that, despite the FDA’s recommendation in April 2014 for Dolor to conduct investigational studies on the SphenoCath’s safety and effectiveness, no such studies were conducted.

Instead, Wright and Dolor continued to market the SphenoCath with the intent of using it to treat migraine headaches through SPG nerve blocks.

Wright provided healthcare providers with marketing materials and unsolicited directions for the unapproved use of the SphenoCath.

Sentencing Date Set

U.S. Magistrate Judge Cecilia M. Romero oversaw the plea hearing and scheduled the sentencing for November 8.

Justice Department and FDA’s Vigilance

Principal Deputy Assistant Attorney General Brian M. Boynton, heading the Justice Department’s Civil Division, emphasized the importance of public trust in the safety and effectiveness of medical devices.

He stated that the Department of Justice would continue to take action against those who disregard the law, putting public health at risk.

Prosecution and Commitment to Public Safety

U.S. Attorney Trina A. Higgins for the District of Utah reiterated the commitment to prosecuting individuals who market unapproved, adulterated, and misbranded drugs and devices, emphasizing the threat they pose to public health and safety.

FDA’s Role in Ensuring Safety

Special Agent in Charge George M. Scavdis of the FDA’s Office of Criminal Investigations Metro Washington Field Office highlighted the role of the FDA in ensuring the safety and effectiveness of medical devices for their intended uses.

He stressed that the FDA would continue to investigate and bring to justice those who evade FDA requirements.

Investigative Entities and Legal Prosecution

The FDA’s Office of Criminal Investigations conducted the investigation in this case.

Trial Attorneys David Hixson and Emily C. Powers of the Justice Department’s Consumer Protection Branch, along with Assistant U.S. Attorney Jacob Strain for the District of Utah, prosecuted the case.

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