Endotec to Challenge FDA Injunction
November 1, 2006
Last month, orthopedics manufacturer Endotec Inc. (Orlando, FL) announced plans to countersue FDA in response to the agency's allegations that the company illegally distributed medical devices without premarket approval (PMA) or a clinical study. The longstanding dispute between FDA and Endotec revolves around the company's Buechel-Pappas total ankle replacement system, which the company maintains is a custom device exempt from PMA requirements.
However, the agency says that the ankle replacement implant does not meet the criteria of a custom device. And now the agency is seeking a permanent injunction against Endotec, which it says has distributed the ankle replacement system since March 2002 in spite of FDA warnings that its actions are illegal.
Endotec president Michael Pappas, PhD, said that FDA's complaint “provides insufficient information and is so vague that it is difficult to formulate a precise response.” Nevertheless, he said, “Endotec is pleased that FDA took this action because it may result in a reasonable interpretation of the clauses providing these exemptions. Although these clauses have been in place for 30 years, FDA has yet to publish—as is customary—guidelines on their meaning. Perhaps now the court will help establish such guidelines. Endotec feels that it clearly is within the requirements of the law on the custom devices it manufactures.”
According to FDA, custom devices meet the following criteria.
• They necessarily deviate from devices generally available—such as devices with premarket approval—in order to comply with the order of an individual physician.
• They are not generally available to or generally used by other physicians.
• They are not generally available in finished form for purchase or for dispensing upon prescription.
• They are not offered for commercial distribution through labeling or advertising.
• They are intended for use by an individual patient named in the order of a physician and are to be made in a specific form for that patient, or are intended to meet the special needs of the physician in the course of professional practice.
Disputes between FDA and medtech manufacturers as to what constitutes a custom medical device are not new, according to Stephen D. Terman, an attorney with Olson, Frank and Weeda PC (Washington, DC) who specializes in regulatory compliance and medical device law. “The issue has been a source of controversy since the device regulations were established in 1976,” he says. “What FDA says constitutes a custom device is often much narrower than what industry may think.”
“There may be different interpretations of FDA's criteria relating to custom device PMA exemptions, but that's where the agency provides guidance,” says Wally Pellerite, director of strategic compliance for Quintiles Consulting, a division of Quintiles Transnational Corp. (Research Triangle Park, NC). “And in this case, every indication is that FDA made it clear that the Buechel-Pappas implant is not a custom device.” A former compliance official with FDA, Pellerite notes that the device is listed on Endotec's Web site and is sold in certain overseas markets as an “off-the-shelf product . . . hardly the criteria of a custom device.”
Pappas says that he has tried to have a reasonable dialogue with FDA. “The agency offered us a settlement, but to accept it would have meant that no one in the United States would be able to benefit from our device because mobile-bearing ankle implants are generally not available in this country,” he says.
Over the past 15 years, Endotec has filed three requests for 510(k) clearance of its ankle implant based on the design review of what the company considers a predicate device, Pappas says. The first two applications were rejected on grounds that Pappas calls unreasonable and unscientific.
Pappas says that an FDA reviewer of the pending 510(k) application told him that it cannot succeed because it involves a mobile-bearing device. “These actions appear to be based on an unwritten FDA policy that mobile-bearing devices can only be approved by PMA,” he says. “The reason for such a position is unclear since mobile-bearing condylar joints are clearly superior, particularly in the case of the ankle, to the fixed-bearing types for which FDA has granted 510(k) clearance.”
“FDA's criteria for a custom device are so narrow that I don't know how any device would meet the requirements,” says Endotec attorney Vello Veski of Palm Beach, FL. “More important is the fact the Buechel-Pappas ankle implant is ordered by a physician for a particular patient—and FDA does not have the authority to interfere with the practice of medicine.”
Quintiles' Pellerite disagrees. “Having a prescription or an order does not constitute a custom device,” he says. “These devices are apparently being made by the same process and using the same materials. If a company manufactures 10-inch and 12-inch catheters, are they custom devices? Of course not.”
In its countersuit, Endotec is seeking dismissal of the injunction order and compensation for damages to the company's reputation that have resulted from FDA's actions.
Attorney Veski says that Endotec has not yet responded to FDA's complaint because there was an error in the way in which it was initially served. The company will respond within the 60-day period as required by law, he says.
Endotec has reportedly built 30 to 40 Buechel-Pappas ankle replacement implants over the past five years. The only FDA-approved ankle replacement implant is the Agility system, manufactured by DePuy Orthopaedics Inc. (Warsaw, IN), a Johnson & Johnson company.
© 2006 Canon Communications LLC
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