Philip Morris USA Inc. v. U.S. Food & Drug Admin., Civil No. 1:15-cv-01590 (APM)

Citation156 F.Supp.3d 36
Decision Date13 January 2016
Docket NumberCivil No. 1:15-cv-01590 (APM)
CourtUnited States District Courts. United States District Court (Columbia)
Parties Philip Morris USA Inc., et al., Plaintiffs, v. United States Food and Drug Administration, et al., Defendants.

Anthony J. Franze, Robert N. Weiner, Arnold & Porter LLP, Miguel A. Estrada, Amir Cameron Tayrani, Gibson, Dunn & Crutcher, LLP, Mark Steven Brown, Ashley Charles Parrish, King & Spalding, LLP, Noel John Francisco, Ryan Jeffrey Watson, Jones Day, Mark H. Lynch, Benjamin Conrad Block, Covington & Burling LLP, Washington, DC, for Plaintiff.

James T. Nelson, U.S. Department of Justice, Washington, DC, for Defendant.


Amit P. Mehta

, United States District Judge

Plaintiffs are a group of tobacco companies1 who seek my recusal in this case primarily because my former law partner provided legal services to an anti-tobacco organization—the Campaign for Tobacco-Free Kids (“CTFK”)—while I was in private practice. CTFK submitted comments to Defendant Food and Drug Administration (“FDA”) supporting the regulatory action that Plaintiffs now challenge. My former law partner advised CTFK in connection with those comments.

Plaintiffs advance 28 U.S.C. § 455(b)(2)

as their primary ground for disqualification. Under that statute, I must recuse if my former law partner's service as a lawyer to CTFK concerned “the matter in controversy” now before me. Plaintiffs argue that my former law partner's representation of CTFK concerned “the matter in controversy” because CTFK's comments endorsed the same FDA action that Plaintiffs now challenge. I disagree. My former law partner's advice to CTFK is too attenuated from the present litigation to constitute the same “matter in controversy.” CTFK simply advocated for the administrative action now in dispute. The organization is unlikely to become a party or witness in this matter; my former partner's legal advice to CTFK is unlikely to become an issue in this litigation; and CTFK will not directly receive a financial benefit or incur a liability resulting from the outcome of this case. Furthermore, a decision to recuse would encourage inappropriate judge-shopping by future litigants. Therefore, I conclude that Section 455(b)(2)

does not compel my recusal.

Plaintiffs also contend that I must recuse under 28 U.S.C. § 455(a)

because several factors create an “appearance of partiality.” Again, I disagree. Even when combined, the facts of (1) my former law firm's representation of CTFK and other anti-tobacco organizations, (2) my wife's present partnership in my former law firm, and (3) another former law partner's appearance in this matter as “Of Counsel for FDA, would not lead a reasonable observer, informed of the underlying details of these facts, to question my impartiality in this case. Section 455(a), therefore, does not require my recusal.

As further explained below, Plaintiffs' Motion for Recusal is denied.

A. The Case Before Me

This case concerns a challenge to a FDA “guidance,” issued on September 8, 2015, entitled “Guidance for Industry: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 2) (the “Guidance”). Compl., ECF No. 1, Ex. B, ECF No. 1-4. The Guidance “describes FDA's current thinking on whether and when a change to a tobacco product's label, product quantity in the package, additives, or specifications renders that later product a ‘new tobacco product’ subject to premarket review ....” Id. at 2. Plaintiffs have asserted that the Guidance is “unlawful and unconstitutional” for a host of reasons, including that the Guidance “contravenes ... the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act), violates the substantive and procedural requirements of the Administrative Procedure Act, and infringes Plaintiffs' First Amendment rights.” See Pls.' Mot. for Recusal, ECF No. 25, at 2 [hereinafter Recusal Mot.].

FDA issued a draft version of the Guidance in September 2011 (the “Draft Guidance”).2 As pertinent here, the Draft Guidance proposed that a label change to a tobacco product would create, with some exceptions, a “new tobacco product” under Section 910(a)(1)(B) of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, because a product label “is considered a ‘part’ of that product.” Admin. Rec., ECF No. 33 [hereinafter AR], Ex. D, ECF No. 33-5, at 085-87. On September 9, 2011, FDA published a notice that it would accept comments from the public regarding the Draft Guidance. Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Availability, 76 Fed. Reg. 55,927, 55,927

-28 (Sept. 9, 2011); AR, Ex. H, ECF No. 33-9, at 478-79.

CTFK, whose stated mission includes working to “reduce tobacco use and its deadly toll in the United States and around the world,”3 responded to FDA's request for input. On November 8, 2011, CTFK, jointly with other groups,4 submitted comments on the Draft Guidance. AR, Ex. F, ECF No. 33-7, at 179-203. The joint submission endorsed FDA's position that the label and packaging of a tobacco product is “part of that product.” Id. at 186 (We believe ... that the agency correctly notes that the label and packaging of a tobacco product is ‘part’ of that product.”). The groups also agreed with many of FDA's proposed answers to questions about when a labeling or packaging change would make a tobacco product a “new tobacco product” that would be subject to certain premarket requirements. Id . at 186-89.

In April 2013, CTFK again weighed in on the Draft Guidance through a second joint submission.5 AR, Ex. G, ECF No. 33-8, at 214-95; Recusal Mot. at 3. The second joint submission responded to comments regarding the Draft Guidance that tobacco companies had submitted to the FDA. Recusal Mot. at 3. Two of the Plaintiff companies (Philip Morris USA and U.S. Smokeless Tobacco Company) asserted—as they do in this litigation—that premarket submission of labeling and packaging changes would be contrary to the Tobacco Control Act and would violate the First Amendment. Id . at 2-3. Specifically, they argued that a label is not a “part” of a tobacco product and thus a labeling change would not create a “new tobacco product” under the Tobacco Control Act. Id.

(citing AR, Ex. G., at 266-67). CTFK and other groups responded to these criticisms by defending FDA's conclusion that a name change could constitute a “new tobacco product” and by asserting that the tobacco companies were wrong to argue that the Tobacco Control Act created a prior restraint on the renaming of substantially equivalent tobacco products. Id. (citing AR, Ex. G., at 266-67).

The FDA issued the final Guidance, which is the subject of this litigation, on September 30, 2015.6

B. Zuckerman Spaeder's Representation of CTFK

Before taking the bench7 in January 2015, I was a partner at the law firm of Zuckerman Spaeder LLP, where I practiced law for more than ten years. My wife also has been a partner at Zuckerman Spaeder since 2008 and has practiced there since 2000. Zuckerman Spaeder is known primarily as a litigation boutique that specializes in white-collar criminal defense and complex civil litigation. The firm has fewer than 100 lawyers.

Several of the firm's partners have expertise in food and drug law. One of them represents anti-tobacco groups, including CTFK. Zuckerman Spaeder's website reports that the firm “represented a leading public health group in negotiations over legislation to give the FDA jurisdiction over tobacco products, culminating in enactment of the [Tobacco Control Act], and advises this group regarding FDA implementation of the new law.”8 According to Plaintiffs, the aforementioned “leading public health group” is CTFK. Notice of Informational Request, ECF No. 14, at 2.

On October 21, 2015, Plaintiffs filed a Notice of Informational Request (the “Notice”). Id. at 1-5. The Notice asked that I “ascertain whether any Zuckerman Spaeder lawyer was involved in advising, counseling or representing CTFK or any other anti-tobacco organization in connection with the Guidance while [I] was a partner at the firm.” Id. at 3.

I responded to Plaintiffs' request on October 30, 2015, and disclosed the following:

While [I] was a partner of the firm, Zuckerman Spaeder provided legal counsel to CTFK relating to the comments that it submitted to the FDA in June 2013 about the draft Guidance. That legal advice pertained to, among other things, the “Label Changes” Question & Answer section of the draft Guidance. Zuckerman Spaeder did not provide any legal counsel to CTFK relating to the comments that it submitted to the FDA in November 2011 about the draft Guidance.

Response to Informational Request, ECF No. 24, at 1. Neither I nor my wife advised CTFK concerning the Draft Guidance. Id. at 1-2. Nor has either of us ever worked on behalf of CTFK on any other matter. And, although I generally knew that CTFK was a Zuckerman Spaeder client, I was not aware at the time the advice was given that the firm was advising CTFK in connection with the Draft Guidance. Id.

To the foregoing landscape, I add the following, which came to light after I filed my Response to the Informational Request and after Plaintiffs moved for my recusal. On November 19, 2015, Defendants filed a response to Plaintiffs' Motion for Recusal, in which they took no position on the Motion. Defs.' Resp. to Pls.' Mot. for Recusal, ECF No. 27, at 1. That filing identified, for the first time in these proceedings, William B. Schultz as “Of Counsel for Defendants, id .—though to date, he has not entered a formal appearance as counsel of record for Defendants.9 Mr. Schultz is presently General Counsel of the U.S. Department of Health and Human Services (“HHS”). He is also my former law partner at Zuckerman Spaeder. Mr. Schultz left the firm to become...

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