PREVOR v. FDA: Round II in Court

August 1, 2013

By Allyson B. Mullen –

You may recall that French device maker PREVOR previously sued, and won, in litigation against FDA regarding FDA’s classification of Diphoterine® Skin Wash (“DSW”), a product used in industrial settings as a “first response” method to minimize chemical burns.  Hyman, Phelps & McNamara, P.C. represented, and still represents, PREVOR.  The Honorable Rosemary Collyer issued a lengthy Opinion granting PREVOR’s Motion for Summary Judgment and remanding the matter to FDA for further action consistent with her Opinion.  The original Complaint and the Judge’s September 2012 Opinion were discussed here and here

Despite the clear ruling from the Court, it took nearly eight months for FDA to issue a new classification decision for DSW.  In its May 25 letter to PREVOR, however, FDA reached the same conclusion to regulate DSW as a drug, disregarding the Court, the law, and earlier FDA precedent.

Yesterday, PREVOR filed a Complaint in the U.S. District Court for the District of Columbia challenging, for a second time, FDA’s determination that DSW is a drug-device combination product with a “drug” primary mode of action.  The Complaint alleges that FDA failed to follow the Court’s September 2012 ruling when, on remand, it arrived at the same conclusion it had reached in its earlier decisions.  PREVOR continues to assert that the administrative record demonstrates that DSW meets the statutory definition of a “device” because its primary intended purposes are not achieved through chemical action, but through physical or mechanical actions.  PREVOR alleges that FDA’s jurisdictional determination was therefore unlawful, and challenges FDA’s application of an entirely new test for whether a product is a device.

With this new litigation, PREVOR again seeks to vacate FDA’s finding, and asks the Court to declare that DSW is a “device,” or, in the alternative, that DSW is a drug-device combination product with a “device” primary mode of action.

Categories: Medical Devices