Ed Kensik02.17.06
Midvale, UT-Utah Medical is deciding whether it will file a lawsuit against the FDA or ask the Department of Health and Human Services (HHS) to reconsider its claim of $7.3 million in damages after the medical device maker claimed fraudulent reports by inspectors.
The debate comes after the HHS notified Utah Medical on Feb. 15 that its claim of damages was denied. Utah Medical said it will now either ask for reconsideration or file a federal suit seeking the money.
In October 2005, a federal district judge dismissed the FDAs 2004 suit to shut down Utah Medical. The FDA elected to not appeal the decision, but Utah Medical wanted some compensation for the five year long ordeal against the company.
Utah Medical cited "fraudulent reports by inspectors, reviewers and other FDA employees, which led to an ordeal in which the company prevailed, but was significantly damaged."