Last Friday the D.C. Circuit reversed a lower court ruling in favor of the FDA in a lawsuit over the agency’s reversal of its own earlier approval of a surgical mesh used in knee replacement surgery.
The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of extreme political pressure. So it revoked the approval.
The manufacturer, ReGen Biologics, went into bankruptcy after the revocation. Ivy Sports Medicine, the company that acquired the rights in the bankruptcy proceedings, sued the FDA, alleging that the revocation was illegal. The district court gave the FDA summary judgment.
But Friday the appellate court reversed the FDA victory, ruling that the agency had failed to follow the revocation procedure specified by statute. That procedure calls for, among other things, a notice-and-comment period.
So the matter now goes back to the FDA with instructions to follow the statutory guidelines.
The case is Ivy Sports Medicine v. Burwell, Case No. 13-5139.
