WASHINGTON (CN) – ReGen Biologics claims that after the FDA approved its collagen meniscus implant for knees, the federal agency capriciously changed its mind, bankrupting the company.
ReGen says the FDA classified its meniscus implant as a Class II device in 2008, finding that it was “substantially equivalent to a legally marketed predicate device, a surgical mesh.” As a Class II device, the device could be used without FDA approval.
But in March this year, after Dr. Jeffrey Shuren took over as director of the FDA’s Center for Devices and Radiological Health, the agency rescinded its classification and reclassified the device as Class III, according to the complaint. As a Class III device, ReGen needs FDA approval to distribute the device in the United States.
“As a direct result of this FDA action, ReGen was forced into bankruptcy,” the company says. It also had to lay off workers.
ReGen says its implant is “a resorbable collagen-based surgical mesh composed primarily of bovine type I collagen.” It is used to reinforce weakened menisci, the soft tissue that acts as a shock absorber in the knee joint and protects cartilage.
ReGen claims the device has been used successfully in Europe for 10 years, “with very good results.”
(According to the American Academy of Orthopaedic Surgeons, about 581,000 knee replacement surgeries are performed each year at an estimated average cost of $40,000 per surgery. The complaint does not state how many, if any, of these $24.5 billion in surgeries could be made unnecessary or postponed through use of implants.)
ReGen says the FDA reviewed its classification of the device in 2009, and that the FDA’s preliminary report contained “numerous inaccuracies, misrepresentations, and omissions of material information.”
It claims the agency failed to seek ReGen’s input, and violated the Administrative Procedure Act by calling “a second and unprecedented” Orthopedic Advisory Panel Meeting.
The questions posed by the panel “were leading, suggesting negative implications regarding ReGen’s data, while failing to describe the positive clinical results described in ReGen’s 510(k) clinical data,” ReGen claims.
It claims the “FDA removed a safe and effective device from use without the statutory process required under the FD&C [Food Drug & Cosmetic] Act.”
ReGen seeks an injunction forcing the FDA to reverse its reclassification.
It is represented by Mark Heller and Matthew Hoffman with Goodwin Procter.