The Supreme Court of Wyoming ruled Wednesday that a device surgically placed in an injured worker’s spine should not be covered by employer because the device was not approved by the U.S. Food and Drug Administration and thus was not proven to be safe or effective.
Linda Harborth injured her spine while working as a driller in a mine for the Powder River Coal Co. and subsequently underwent surgery to have an artificial disc placed in her spine, according to documents in Linda H. Harborth v. State of Wyoming, Department of Workforce Services, Workers’ Compensation Division. Records filed in the courthouse in Cheyenne, Wyoming, did not specify the dates of her injury and surgery.
The Department of Workforce Services, Workers' Compensation Division, denied benefits for the surgery because the artificial disc and the surgical procedure had not been approved by the FDA and that Ms. Harborth “had not produced sufficient objective medical support for their use,” records stated.
The state’s Medical Commission upheld the division's decision, determining that the procedure was both an "off-label" use of medical services and "alternative medicine" for which benefits were not authorized. That commission found that "nothing in the record presented demonstrates why the non-FDA approved device was necessary,” according to court records.
The district court affirmed the Medical Commission's decision and the state Supreme Court following suit, the five-judge panel unanimously finding that “substantial evidence supported the Medical Commission's determination that Ms. Harborth failed to provide sufficient documentation of the procedure's safety and effectiveness, thus rendering it ‘alternative medicine’ for which benefits were properly denied.”