Philip Morris USA Inc. v. United States Food and Drug Administration

Procedural entryThis page is a short order in Philip Morris USA Inc. v. United States Food and Drug Administration. Read the opinion of the Court — 156 F. Supp. 3d 36
District Court, District of Columbia·Decided January 13, 2016·No. Civil Action No. 2015-1590·Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

)

Philip Morris USA Inc., et al., )

)

Plaintiffs, )

)

v. ) Civil No. 1:15-cv-01590 (APM)

)

United States Food and Drug ) Administration, et al., )

)

Defendants. )

_________________________________________ )

MEMORANDUM OPINION AND ORDER I. INTRODUCTION 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

1 The Plaintiffs are: Philip Morris USA Inc.; U.S. Smokeless Tobacco Company LLC; R.J. Reynolds Tobacco Company; American Snuff Company, LLC; Santa Fe Natural Tobacco Company, Inc.; and ITG Brands LLC.

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.

II. BACKGROUND 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

2 See Draft Guidance for Industry and FDA Staff: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Sept. 2011). Admin. Rec., ECF No. 33 [hereinafter AR], Ex. D, ECF No. 33-5, at 083-95. 3 According to its website, CTFK is:

a leading force in the fight to reduce tobacco use and its deadly toll in the United States and around the world. Our vision: A future free of death and disease caused by tobacco. We work to save lives by advocating for public policies that prevent kids from smoking, help smokers quit and protect everyone from secondhand smoke.

Who We Are, Campaign for Tobacco Free Kids, http://www.tobaccofreekids.org/who_we_are/ (last visited January 12, 2016).

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).

4 The other groups that joined in the November 2011 comments included: American Cancer Society Cancer Action Network; American College of Preventive Medicine; American Heart Association; American Lung Association; American Psychological Association; American Thoracic Society; Legacy; National Latino Tobacco Control Network; Partnership for Prevention; and Society for Research on Nicotine and Tobacco. 5 The groups that joined the April 2013 comments included: American Heart Association; American Lung Association; American Cancer Society Cancer Action Network; and Legacy.

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