The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Endotec Incorporated of Orlando, Florida, and Michael J. Pappas, Ph.D., President; Frederick F. Buechel, M.D., Medical Director; and Jared Pappas, Director of Regulatory Affairs, to stop the illegal distribution of unapproved, total joint replacement devices.

The government's complaint, filed by the U.S. Department of Justice in the U.S. District Court for the Middle District of Florida, charges Endotec with violating the Federal Food, Drug, and Cosmetic Act by distributing total joint replacement devices without an approved premarket application or without an approved clinical study. The complaint states that the company has carried out the illegal distribution of unapproved total joint replacement devices since March 15, 2002, despite the FDA's warnings that these actions were illegal.

The FDA advises consumers who have one of the Endotec replacement joints to continue with standard medical care and report any adverse events or problems to their physicians. If patients are unsure if they have an Endotec device, they should check with their physician.

These actions violate federal law because data establishing the safety and effectiveness of the devices has not been reviewed by FDA.

FDA requests that physicians report such any adverse events to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm, by phone, 1-800-FDA-1088, or by returning the postage-paid FDA form 3500 which may be downloaded from www.fda.gov/MedWatch/getforms.htm by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or fax, 1-800-FDA-0178.

The FDA has initiated this action to promote and protect the public health by enforcing the Federal Food, Drug, and Cosmetic Act. FDA regulates a broad spectrum of products, including food, human and animal drugs, vaccines, blood products, medical devices, electronic products that emit radiation, and cosmetics.

More Industry Headlines