Court Vacates FDA’s Classification Decision (Again)

September 9, 2014

By Jennifer M. Thomas & Anne K. Walsh

French device maker PREVOR won another victory against FDA in litigation involving FDA’s interpretation of the statutory definition for “device.”  The first suit, as readers may recall (see our previous post here), resulted in a finding from District Court Judge Rosemary Collyer that FDA had acted arbitrarily and capriciously in classifying PREVOR’s Diphoterine® Skin Wash (“DSW”) as a combination product to be regulated as a drug.  The Court flatly rejected FDA’s interpretation of the “device” definition, and remanded the matter to FDA to make a new determination in compliance with her opinion.  In its subsequent decision, however, FDA boldly rejected the Court, the law, and FDA precedent, when it introduced a wholly new standard for interpreting the “device” definition (“meaningfully contributes”). So Prevor sued FDA again (see our previous post here).

In the September 9, 2014 opinion, Judge Collyer rightfully rejected FDA’s second attempt to evade the plain statutory language with a novel standard.  She adopted PREVOR’s plain meaning of “achieves,” and rejected FDA’s contention that “meaningfully contributes” is synonymous with “achieves.”  The Court also provided an evaluation of the context and legislative history of the “device” definition to support its decision.  Importantly, Judge Collyer found that “[t]he statute does not demand that FDA quantify the exact contribution of a product’s ultimate goal [in order to classify it as a drug].  However, it does require more than simply finding that the product would not work as claimed without chemical action.”  Slip Op. at 19 n. 7.

In its 23-page opinion, the Court rejected FDA’s decision and its reasoning as being “based on an erroneous and unreasonable interpretation of the law,” and remanded the case to FDA “to determine a standard that complies with the statutory requirements and to classify DSW accordingly.”  We do not know whether FDA will accept the Court’s ruling, but if so, we believe the right result is that FDA should regulate DSW as a device.

Hyman, Phelps & McNamara, P.C. (attorneys Jeffrey N. Gibbs, John R. Fleder, Anne K. Walsh, and Jennifer M. Thomas) represent PREVOR.  Amici curiae in the case include Alcoa, United Steel Workers of America, and the Washington Legal Foundation.