New Braunfels Wholesaler Brian Bailey, Charged With Selling Unapproved Medical Devices

Source- https://www.oag.state.tx.us/oagNews/release.php?id=3595

SAN ANTONIO – Texas Attorney General Greg Abbott charged a New Braunfels-based medical devices wholesaler with acquiring, stocking and selling products that were not approved for sale in the United States. A court-ordered temporary restraining order granted last Thursday halts the business activities of defendants Elite Med, LLC, S&B Marketing and Brian Bailey.

The State’s legal action cites defendants Elite Med, S&B Marketing Inc. and Brian Bailey with providing unapproved medical devices to Texas clinics and physicians. Last November, two of those clinics, Dr. Bliss W. Clark and Clark Orthopedics & Rehabilitation, agreed to pay civil penalties to the State and refrain from using unapproved medical devices in the future.

Clark Orthopedics and other physicians and clinics improperly acquired arthritis injections from Elite Med, which is not licensed to distribute those devices in Texas. Elite Med distributed Orthovisc, Synvisc, Hyalgan and Eufflexa, which it purchased in bulk from a Canadian company, M.T.E. Diagnostics. The injections are used to relieve arthritis-related pain in patients’ knees.

Although the injections, when properly labeled, are generally approved for use in the U.S., Elite Med failed to seek a license from the Texas Department of State Health Services (DSHS) to distribute the devices, which is a violation of state law.

According to inspectors with DSHS – which referred the case to the Attorney General’s Office – defendant Bailey operated Elite Med out of a small home on Hunter Road near New Braunfels. After inspecting Bailey’s records for the past six months, DSHS officers used lot numbers on invoices and conversations with the manufacturer to determine that the devices were actually intended for shipment to Turkey and other countries. However, the unapproved devices were shipped back into the U.S. by M.T.E. Diagnostics of Canada.

DSHS also found that labels on the devices were written in languages other than English, another violation of state law. Because the items were originally intended for export to another country, DSHS determined they were misbranded devices and not legally authorized for use in the U.S.

Bailey could provide no documentation to DSHS that Elite Med’s products were approved for importation or had been cleared for entry by the U.S. Customs Service.

According to the State’s enforcement action, the defendants violated the Texas Deceptive Trade Practices Act and the Health and Safety Code. The State is seeking civil penalties and attorneys’ fees.


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