Texas Business reports: The Texas Attorney General’s office charged the physician-owner of a Harlingen-based orthopedic clinic with providing unapproved medical devices to patients. Under a court order obtained by the attorney general’s office, Dr. Bliss W. Clark and Clark Orthopedics & Rehabilitation must pay civil penalties to the State and are prohibited from using unapproved medical devices in the future. The defendants provide comprehensive care to Rio Grande Valley patients with degenerative disorders of the hip and knee. According to state investigators, the defendants improperly acquired arthritis injections from a New Braunfels wholesale distributor that was not licensed to distribute such devices in Texas. The injections, Orthovisc, Synvisc and Hyalgan, are used to relieve arthritis-related pain in patients’ knees. Although the injections are generally approved for use in the United States, the defendants’ wholesale supplier is not licensed to distribute the injections in the State of Texas. As a result, Clark Orthopedics purchased the injections from an unlicensed supplier in violation of Texas law. In addition, inspectors with the Texas Department of State Health Services’ (DSHS), which referred the case to the attorney general’s office, discovered that the defendants’ Hyalgan and Orthovisc products bore foreign-language labels and were intended for distribution in Turkey. Because the items were legally intended for export only, DSHS determined they were misbranded devices and unlawful for use in the United States. The distributor provided invoices to the State indicating that Clark Orthopedics purchased numerous Hyalgan kits, Synvisc and Orthovisc syringes from January 2008 until March 2009. According to the agreed final judgment, the defendants violated the Texas Deceptive Trade Practices Act and the Health and Safety Code. The defendants must pay $86,000 in civil penalties, attorneys’ fees and investigative costs. |
