Abbott: Medical devices not approved for sale in U.S.

By Jessica M. Karmasek | Jan 13, 2011


SAN ANTONIO (Legal Newsline) - Texas Attorney General Greg Abbott has charged a medical devices wholesaler with acquiring, stocking and selling products that were not approved for sale in the United States.

According to a statement from Abbott's office last week, 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 charges the defendants 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 any unapproved devices in the future.

Clark Orthopedics, and other physicians and clinics, allegedly acquired arthritis injections from Elite Med, which is not licensed to distribute those devices in Texas.

Elite Med allegedly 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 to distribute the devices, which is a violation of state law, Abbott says.

According to inspectors with the state health services department -- 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, 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, Abbott says. However, the unapproved devices were shipped back into the U.S. by M.T.E. Diagnostics of Canada, Abbott says.

The health services department also found that labels on the devices were written in languages other than English, another violation of state law, Abbott says.

Because the items were originally intended for export to another country, the department determined they were misbranded devices and not legally authorized for use in the U.S, Abbott says.

According to Abbott's office, Bailey could provide no documentation to health services department that Elite Med's products were approved for importation or had been cleared for entry by the U.S. Customs Service.

The defendants, according to the state's action, violated the Texas Deceptive Trade Practices Act and the Health and Safety Code.

The state is seeking civil penalties and attorneys fees, Abbott's office said.

From Legal Newsline: Reach Jessica Karmasek by e-mail at jessica@legalnewsline.com.

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