According to the Department of Justice (DOJ), on October 11, Mark Wright, the former CEO of a Utah-based medical device company, pleaded guilty in federal court to misdemeanor charges related to the introduction of misbranded and unapproved medical devices into interstate commerce.
Court records reveal that from 2013 to 2017, Wright served as the CEO of Dolor Technologies Inc. This company marketed the SphenoCath, a device designed to address migraine headaches by administering nerve blocks. However, according to the government, Dolor Technologies did not seek approval or clearance from the Food and Drug Administration (FDA) to distribute the SphenoCath for this intended use. The government alleged this failure to obtain FDA approval rendered the SphenoCath devices misbranded and adulterated under the FDA.
Moreover, the government also alleged that Dolor Technologies did not comply with the FDA’s recommendation to conduct investigational studies to assess the safety and effectiveness of the SphenoCath for its intended use. Despite this recommendation, Dolor Technologies continued to market the product for this unapproved use, providing healthcare providers with marketing materials and directions for its off-label application.
To avoid falling into legal pitfalls related to the approval of products and devices, healthcare providers should stay informed about the latest regulatory guidelines and changes. The attorneys at Chilivis Grubman represent clients of all types and sizes concerning criminal healthcare fraud and government investigations. If you need assistance with such a matter, please contact us today.