ReGen Biologics said Wednesday it filed a lawsuit against the FDA, calling the agency's rescission of approval for its device "arbitrary and capricious." The lawsuit was filed in the U.S. District Court for the District of Columbia.
The FDA approved ReGen's Menaflex knee repair device in 2008, despite protests by FDA scientists that it provided little, if any, benefit to patients.
When officials appointed by President Obama reviewed the decision last year, they concluded that the device should not have been cleared, saying the agency's review was influenced by outside pressure, including lobbying by lawmakers from the company's home state of New Jersey.
Menaflex is no longer available in the U.S. but remains on the market in Europe, where it has been used for a decade. The company's chief executive, Gerald Bisbee, said the FDA's action "has forced a small U.S. company, committed to improving patients' lives, into bankruptcy." The lawsuit argues that the FDA overstepped its authority by removing Menaflex from the market after it had already been cleared.
An FDA spokeswoman said the agency does not comment on pending legal matters.
Hackensack, N.J.-based Regen asked the FDA in 2005 to approve its device under the so-called 510k system, which allows speedy approval for devices that are similar to products already on the market.
ReGen argued that the Menaflex was comparable to shoulder joint implants sold by Johnson & Johnson, Stryker Corp. and other companies. FDA scientists rejected that argument again and again over several years, saying the device should go through a more rigorous approval pathway that requires patient testing.
The head of FDA's device division at the time overruled those scientists in late 2008 and cleared the device. The agency said last year the decision was incorrect and that Menaflex is "technologically dissimilar from devices already on the market."
