FDA Gets Knocked Out in Endotec, I... ( Historic First Loss on...)

FDA Gets Knocked Out in Endotec, Inc. Ruling

Date:8/18/2008

Historic First Loss on Custom Medical Devices

SOUTH ORANGE, N.J., Aug. 18 /PRNewswire/ -- The following is being issued by Endotec, Inc. -- Vincent J. Capricci, 56, is a former public school superintendent for the Rockwood, PA school district, and an avid hunter, golfer and fisherman. After minor surgery a few years ago, he experienced a life threatening infection which destroyed his ankle joint. He was out of work for nine weeks and wheelchair bound. "I was walking bone-on-bone," Capricci said. "I had no cartilage and my ankle was the size of a grapefruit."

After several surgical consultations, Capricci faced two options; fusing the ankle which would severely limit his activity; or, surgically implanting a fixed-bearing ankle device which would last only about three years. Neither option seemed to fit Capricci's active lifestyle.

Soon however, Capricci discovered a third option; a custom mobile bearing ankle replacement system offered by Endotec, Inc. of South Orange, New Jersey, and used by Dr. Frederick Buechel of South Mountain Orthopedic Associates, South Orange, New Jersey. Capricci had 17 previous surgeries for ankle issues and the ankle replacement would be number 18.

But, if the Food and Drug Administration (FDA) had its way, Capricci would have never received the surgery that allows him to hunt, fish and bike. In 2006, the FDA sued Endotec claiming the company had distributed unapproved joint replacement devices. For 25 years the FDA has pursued a policy which has prevented custom mobile bearings ankle joints from reaching the US market. Mobile bearing ankle devices are used exclusively outside the US, which means that US citizens must travel abroad for this treatment.

When the trial kicked off in April 2008, the FDA came out brimming with confidence but quickly was knocked flat in a Florida federal courtroom. To the dismay of the FDA, Senior Judge G. Kendall Sharp ruled the ankle devices were custom-mad
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FDA Gets Knocked Out in Endotec, I...( Historic First Loss on...)