Prevor v. U.S. Food & Drug Admin.

• Decision Date: 09 September 2014
• Docket Number: Civil Action No. 13–1177 RMC
• Citation: 67 F.Supp.3d 125
• Court: U.S. District Court — District of Columbia
• Parties: Prevor, Plaintiff, v. United States Food and Drug Administration, Defendant.

67 F.Supp.3d 125

Prevor, Plaintiff

v.United States Food and Drug Administration, Defendant.

Civil Action No. 13–1177 RMC

United States District Court, District of Columbia.

Signed September 9, 2014

Eric P. Gotting, Keller & Heckman, LLP, Jeffrey N. Gibbs, Jennifer McVey Thomas, John Robert Fleder, Anne K. Walsh, Hyman, Phelps & McNamara, P.C., Washington, DC, for Plaintiff.

John William Medford Claud, Andrew E. Clark, U.S. Department of Justice, Washington, DC, for Defendant.

OPINION

ROSEMARY M. COLLYER, United States District Judge

After five years, Prevor and the Food and Drug Administration (FDA) continue to dispute whether Prevor's DiphoterineTM Skin Wash (DSW) should be regulated as a “drug” or a “medical device.” By giving unduly expansive meanings to certain language in the Federal Food, Drug, and Cosmetic Act, FDA declared DSW to be a drug. On remand from this Court, FDA hardly changed its reading of the statute and relied on an arbitrary standard that contravenes the plain meaning of the law. Accordingly, the Court will deny FDA's motion for summary judgment. The Court will grant summary judgment in part to Prevor, finding that FDA acted arbitrarily and capriciously in violation of the Administrative Procedure Act. However, the Court will deny Prevor's request to declare DSW a device and will remand to the Agency for further proceedings consistent with this Opinion.

I. FACTS¹

A. DSW

DSW was developed to prevent and minimize chemical burn injuries that occur in the industrial workplace due to accidental exposure to chemicals. The product “consists of a liquid substance contained in a canister propelled by pressurized gas.” Administrative Record (A.R.) [Dkt. 27] at 001. “DSW is used by spraying the pressurized contents of the canister on to the skin to physically and mechanically remove splashes of acids and bases off the skin by washing them away.” Id. “DSW is intended to: (1) remove splashes of acidic or basic substances off the skin by physically and mechanically washing the chemicals away from the skin, and (2) neutralize and dilute acids and bases.” Id. at 002. “The first use is a physical/ mechanical mode of action (comprises approximately 90% of DSW's overall effect), while the second one is a chemical mode of action (comprises approximately 10% of DSW's overall effect).” Id. DSW's “purpose is to help prevent and minimize accidental chemical burn injuries.” Id.

B. Statutory Framework

The nature of the dispute here necessitates a brief explanation of various FDA regulations and the definitions of “drugs,” “medical devices,” and “combination products” under the Federal Food, Drug, and Cosmetic Act (Food and Drug Act), 21 U.S.C. § 301 et seq. The Food and Drug Act defines a “drug,” in part, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and ... articles (other than food) intended to affect the structure or any function of the body of man or other animals.” 21 U.S.C. § 321(g)(1)(B) & (C). A device is defined, in part, as:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is ... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or ... intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Id. § 321(h) (emphasis added). This cases hinges on the distinction that a product is not solely a device if it achieves “its primary intended purposes through chemical action within or on the body.” Id. A product may, however, be both a drug and a device—this is referred to as a “combination product.” Id. § 353(g). A combination product is defined by regulation as “[a] product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity.” 21 C.F.R. § 3.2(e)(1).

To determine whether a combination product is to be regulated as a drug or a device, FDA must analyze the constituent parts of the product to determine whether the parts have a drug or device mode of action and which is the primary mode of action. See 21 U.S.C. § 353(g)(1) ; 21 C.F.R. § 3.2(k). “A constituent part has a device mode of action if it meets the [Food and Drug Act's] definition of device ... and it does not achieve is primary intended purposes through chemical action within or on the body of man or other animals....” 21 C.F.R. § 3.2(k)(2). “A constituent part has a drug mode of action if it meets the [Food and Drug Act's] definition of drug ... and it does not have a ... device mode of action.” Id. § 3.2(k)(3). A primary mode of action is defined as:

[T]he single mode of action of a combination product that provides the most important therapeutic action of the combination product. The most important therapeutic action is the mode of action expected to make the greatest contribution to the overall intended therapeutic effects of the combination product.

21 C.F.R. § 3.2(m). A “ ‘therapeutic’ action or effect includes any effect or action of the combination product intended to diagnose, cure, mitigate, treat, or prevent disease, or affect the structure or any function of the body.” Id. § 3.2(k). FDA considers the DSW canister and liquid solution, as a whole, to be a combination product, where the liquid is classified as a drug and represents the primary mode of action. Prevor contends that DSW is a single-entity product (a device) that does not achieve its primary intended purposes through chemical action.²

C. First FDA Decision

Prevor, a French company, submitted a Request for Designation (RFD) on August 13, 2009, asking the FDA Office of Combination Products to “confirm that DSW is a device to be regulated by the Center for Devices and Radiological Health.” A.R. at 001. On October 16, 2009, the Office of Combination Products notified Prevor that it had designated DSW as a combination product. Id. at 675. The Office first concluded that the pressurized canister that delivers the solution of DSW constitutes a device. It further concluded:

The liquid [component of DSW] appears to have two primary intended purposes: to wash the chemical off the skin and neutralize the chemical that is on the skin. Since this liquid achieves its primary intended purposes, at least in part, through chemical action, it does not meet the definition of a device. The liquid does, however, meet the definition of a drug at section 201(g) of the [Food and Drug] Act (21 U.S.C. 321(g) ). Accordingly, we have concluded that the liquid is a drug.

Id. at 676 (emphasis added). Because it found that DSW was comprised of both drug and device constituent parts, the Office of Combination Products determined that DSW was a combination product; it further found that the drug constituent part provided the greater contribution to the overall therapeutic effect and thus should be regulated as a drug by the Center for Drug Evaluation and Research (CDER). Id.

On March 24, 2010, Prevor timely sought review of that decision with FDA's Office of Special Medical Programs. On April 25, 2011, that Office affirmed the designation of DSW as a combination product that should be regulated as a drug, explaining:

In determining whether an article is a “device,” FDA must consider whether or not the article achieves its primary intended purposes through chemical action within or on the body of man. 21 U.S.C. § 321(h).... [I]f an article depends, even in part, on chemical action within or on the body to achieve any of its primary intended purposes, it does not meet the definition of a device.

Id. at 786 (emphases added).

D. P REVOR I

Prevor filed suit on June 28, 2011. After full briefing, this Court concluded that “FDA's reliance on extraordinarily expansive language (‘at least in part’ or ‘even in part’) demonstrates the agency's own recognition that without such an interpretation of ‘primary intended purpose,’ DSW could be designated a ‘device.’ ” P REVOR I, 895 F.Supp.2d at 97. While FDA maintained that its terms left room for a product with a de minimus chemical effect to be classified as a device, the Court was not so confident. “Inasmuch as the statute seeks to identify primary intended purposes that are achieved through chemical action, it would be significantly expanded if a primary purpose could automatically be achieved ‘at least in part’ or ‘even in part’ by chemical action.” Id. “The addition of such language when applying the statute substantively modifies the standard to be applied by expanding the reach of the exclusionary language.” Id. at 99. The record also showed that FDA had treated analogous products as devices, not drugs. Id. at 99–100. The Court suggested that “[t]here may be solid scientific reasons for FDA's new approach but these remain unexplained, at least without defining ‘primary’ in a manner consistent with the law.” Id. at 101. The matter was remanded for that purpose.

E. FDA Remand Decision

On remand, FDA again determined that “DSW is a drug-device combination product consisting of a drug solution and an aerosol spray device canister.” A.R. at 839. It explained that the solution met the drug definition because it “achieve[s] its primary intended purposes through chemical action.” Id. at 840 (citing 21 U.S.C. § 353(g) ; 21 C.F.R. Part 3). FDA further found that “the ‘primary mode of action’ of the combination product is attributable to the drug solution” because the solution “is expected to make the greatest contribution to overall intended therapeutic effect of DSW.” Id. The...