FDA Gets Knocked Out in Endotec, Inc. Ruling
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-made medical devices exempt from FDA regulation.
Eight years after his ankle replacement surgery, Vincent has no restrictions. He exercises regularly three-days a week, rides a stationary bike, lifts weights, hikes over mountain roads, traverses trout streams, and rides his 15-speed bike five to 10 miles several days each week.
"I have my life back," said Vincent. "I was a college athlete and high-school basketball coach, and I was extremely active. Following this surgery, I no longer have sharp or stabbing pains. I am continuing to improve and can get around better than I have in years."
"This is a huge victory because it allows me to do what I've been doing for 30 years which is replacing ankles in patients who need it," said Dr. Buechel. "The FDA is out of touch with reality. When they take common sense and distort it and try to limit it, they overstep their bounds and become bureaucrats -- ignoring the science underlying their regulatory authority."
Judge Sharp criticized the FDA in his decision, saying that the agency's "stringent regulations and strict interpretation of procedural requirements are resulting in technological innovation being stymied, rather than advanced." He noted that the FDA never alleged that Endotec's devices harmed any patients or were dangerous. Judge Sharp twice took the FDA to task for "stymieing progress and technological advancement." Moreover, he rebuked the FDA's expert witness on custom devices, associate director of regulatory guidance, Casper Uldriks, for defining a custom device in a way that was "so narrow as to make the definition useless."
"For the first time in history, the FDA has brought a suit on custom medical devices and lost," said Michael Pappas, Ph.D, CEO, Endotec, Inc. "This sends a powerful message to the industry not to fear the FDA, or to be intimidated by their tactics. Power not only breeds corruption, it also breeds arrogance, and arrogance breeds stupidity."
According to the July 21, 2008 e-newsletter, Health Imaging News, the FDA has lost enormous expertise in medical device regulation. " ... almost all of the leadership at the office of regulatory is leaving, including Associate Commissioner of Regulatory Affairs Margaret Glavin, who is retiring, and Assistant Commissioner for Compliance Policy David Horowitz, who was recently promoted to assistant commissioner for policy for the FDA. Deputy Director Deborah Ralston has left the agency as well."
The Endotec case revolved around the specifics of the FDA's approval procedures for medical devices. Most "class III" devices, which support human life or present a risk of injury, require FDA approval before they can be sold. The only exception is for "custom devices," which are not generally available and are intended for a specific patient, or made to the specifications of a specific surgeon for use in his or her practice.
About Endotec
Endotec Inc., founded in 1988, is a medical device company that specializes in the manufacture and distribution of biocompatible orthopedic implant products. The company's products include hip replacement and knee replacement, as well as the shoulder and ankle extremities.