ReGen Biologics Sues FDA Over 510(k) Rescission

June 5, 2011

By Carmelina G. Allis

The “Menaflex” is a collagen meniscus implant intended to reinforce damaged meniscal soft tissue.  ReGen Biologics, Inc. obtained 510(k) clearance for the Menaflex in 2008 as a Class II device.  On March 30, 2011, FDA rescinded this clearance.  Last week, ReGen filed suit based upon the theory that FDA lacks authority under the Food, Drug, and Cosmetic Act (“FDCA”) to rescind a 510(k) clearance.  ReGen seeks a declaratory judgment that the Menaflex may be legally marketed in the U.S. as a Class II device.  The lawsuit was brought in the U.S. District Court for the District of Columbia and follows a petition ReGen filed last month with the U.S. Court of Appeals for the District of Columbia Circuit – see our previous post here – seeking review of the March 30, 2011 order.  ReGen has presumably filed two lawsuits to eliminate any argument by the government that the suit was filed in the wrong court.  Over the years, FDA has challenged suits filed in district courts or alternatively in a court of appeals by claiming that the plaintiff sued in the wrong court.  Filing in both courts, as ReGen did, should eliminate that potential argument in one of the courts.

The review of ReGen’s Menaflex 510(k) resulted from allegations that the agency’s review of the submission had departed from “FDA processes, procedures and practices.” Those allegations apparently stemmed, in part, from documents sent to U.S. Congressmen by FDA reviewers that raised questions about the integrity of the 510(k) review process for the Menaflex device.

In October 2010, FDA rescinded the 510(k) substantial equivalence determination alleging that the device does not have the same intended use as predicate surgical meshes.  ReGen’s complaint alleges that the agency’s determination is inconsistent with the findings of two Advisory Panels, and contrary to the conclusions of Dr. Daniel Schultz, the CDRH Director who granted 510(k) clearance.  The product is now subject to the more burdensome Class III, premarket application (“PMA”) approval requirements.

According to the complaint, counsel for the company asked FDA counsel “to identify the statutory or regulatory basis” for the rescission order, to which agency counsel declined to answer “stating that disclosure of the statutory basis for the order would be the equivalent of providing ‘legal advice,’ and that it is FDA’s policy not do so.”

The complaint alleges that FDA’s actions forced the company into bankruptcy, and have “create[d] substantial uncertainty in the device industry because the FDA could decide to revisit other products that were legally classified through the 510(k) premarket notification process without observing lawful processes.”

FDA has not yet responded to the complaint.  FDA has always asserted that the FDCA grants the agency authority to rescind 510(k)s, but that interpretation is not explicitly provided in the FDCA.  In contrast, there is a provision expressly granting FDA authority to withdraw a PMA approval (section 515).  FDA also has authority to ban devices that are unsafe (section 516) or to reclassify a device from Class II to Class III if information emerges that warrants reclassification (section 513).  FDA did not invoke those explicit procedures in this case.  The agency issued a proposed rule setting forth a procedure for rescission in 2001, but it was never finalized. 

It may be true that at least one court has ruled that FDA has implicit statutory authority generally claimed by administrative agencies to undo a decision based upon outright fraud or clear administrative error.  But the ReGen case seems to involve rescission of a 510(k) because a new set of agency officials arrived at a different judgment than their predecessors.

Categories: Medical Devices