Rozema v. U.S. Dep't of Health & Human Servs.
| Decision Date | 02 March 2016 |
| Docket Number | 5:14-CV-0495 (GTS/DEP) |
| Parties | Kyle Thomas Rozema, Plaintiff, v. U.S. Department of Health and Human Services; and U.S. Food and Drug Administration, Defendants, Philip Morris USA, Inc.; Lorillard Tobacco Co.; R.J. Reynolds Tobacco Co.; and Santa Fe Natural Tobacco Co., Inc., Intervenors-defendants. |
| Court | U.S. District Court — Northern District of New York |
KYLE THOMAS ROZEMA, Plaintiff, Pro Se, 340 East North Water Street, Apt. 3308, Chicago, IL 60611.
WILLIAM F. LARKIN, ESQ., Assistant United States Attorney, HON. RICHARD S. HARTUNIAN, United States Attorney for the, Northern District of New York, Counsel for Defendants, 100 South Clinton Street, Syracuse, NY 13261.
RICHARD T. SULLIVAN, ESQ., HARRIS BEACH LLP, Counsel for Intervenor-Defendant, Philip Morris USA, Inc., 726 Exchange Street, Suite 1000, Buffalo, NY 14210.
DOUGLAS S. CURRAN, ESQ., COVINGTON & BURLING LLP, Counsel for Intervenor-Defendant, Lorillard Tobacco Company, 620 Eighth Avenue, New York, NY 10018.
MEREDITH MOSS, ESQ., KING & SPALDING LLP, Counsel for Intervenor-Defendants, R.J. Reynolds Tobacco Company and Santa Fe Natural Tobacco Company, Inc., 1700 Pennsylvania Ave, NW, Washington, DC 20006.
filed by Kyle Thomas Rozema (“Plaintiff”) against the United States Department of Health and Human Services (“HHS”) and the United States Food and Drug Administration (“FDA”), are the following motions: (1) a motion for summary judgment filed by Defendants HHS and FDA (Dkt. No. 40); (2) a motion for summary judgment filed jointly by three of four Intervenor-Defendants, Philip Morris USA Inc. (“Philip Morris”), R.J. Reynolds Tobacco Company (“Reynolds”), and Santa Fe Natural Tobacco Company, Inc. (“Santa Fe”) (Dkt. No. 41); (3) a motion for summary judgment filed by the fourth Intevenor-Defendant, Lorillard Tobacco Company (“Lorillard”) (Dkt. No. 42); and (4) Plaintiff's cross-motion for summary judgment (Dkt. No. 45). For the reasons set forth below, Defendants' motions are granted, and Plaintiff's cross-motion is denied.
This action arises from Plaintiff's challenge to the administrative denial of his FOIA request dated September 19, 2013, directed to the FDA, for information regarding the quantities of menthol contained in cigarettes “by brand and by quantity in each brand and subbrand from 2000 to 2010.” (Dkt. No. 1, ¶ 6 [Plf.'s Compl.].) Generally, Plaintiff's Complaint alleges that HHS and FDA (collectively, “the Agency Defendants”) improperly withheld the requested records and that Plaintiff has exhausted his administrative remedies. (Id. , ¶¶ 7-15.) On that basis, Plaintiff seeks an Order directing the Agency Defendants to disclose the requested records and an award of costs and attorney's fees regarding his request. (Id. )
After Plaintiff filed his Complaint in this action, Philip Morris, Reynolds, Santa Fe, and Lorillard moved (collectively, “Intervenors”)1 moved to intervene for the purpose of defending against the disclosure of the information Plaintiff seeks, which includes menthol quantities contained in products manufactured by those entities. (Dkt. Nos. 14, 23, 27.) Those motions were granted without opposition by Plaintiff or the Agency Defendants. (Dkt. Nos. 22, 28, 34.)2
Congress enacted the Family Smoking Prevention and Tobacco Control Act (“the Act”), 21 U.S.C. § 387 et seq. ,
to grant FDA the authority to regulate, among other things, “all cigarettes [and] cigarette tobacco[.]” 21 U.S.C. § 387a(b) ; U.S. Smokeless Tobacco Mfg. Co. LLC v. City of New York , 708 F.3d 428, 430 (2d Cir.2013).3 As part of the Act, Congress also directed FDA to establish a twelve-member Tobacco Products Scientific Advisory Committee (“TPSAC”), the duties of which include providing advice, information, and recommendations to FDA on safety issues related to menthol cigarettes. 21 U.S.C. §§ 387g(e), 387q(c). While the Act grants a broad scope of authority to FDA, Plaintiff's FOIA request implicates that portion of the Act's statutory and regulatory framework governing the submission of health-related information to FDA by tobacco product manufacturers (“TPMs”).
More specifically, section 904 of the Act, 21 U.S.C. § 387d
, requires TPMs to submit to FDA certain information concerning, among other things, the cigarettes that they manufacture. As is relevant here, first, TPMs are required to submit “a listing of all ingredients, including tobacco, substances, compounds, and additives that are ... added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.” 21 U.S.C. § 387d(a)(1) (“Ingredient Listings”). Second, TPMs must submit, at FDA's request, documents and information related to research activities and scientific findings pertaining to, among other things, the health effects of tobacco products and their constituents. 21 U.S.C. § 387d(b)(1)–(3) (“Research Documents”). Third, and perhaps most importantly here, TPMs must submit listings of all constituents identified by FDA as harmful or potentially harmful (“HPHCs”) in each tobacco product, “by brand and by quantity in each brand and subbrand.” 21 U.S.C. § 387d(a)(3)
. FDA published a list of 93 HPHCs (“HPHC List”) in 2012, and menthol was not listed. 77 Fed. Reg. 20034, 20036–37 (Apr. 3, 2012).4 FDA is required to “place on public display” the HPHC quantities reported by TPMs in a format that is “not misleading to a lay person” and “in a manner determined by” FDA. 21 § U.S.C. 387d(d)(1).5 With limited exceptions not applicable here, any information that TPMs report to FDA pursuant to 21 U.S.C. § 387d, which also constitutes trade secret and/or commercial or financial information under FOIA Exemption 4, 5 U.S.C. § 552(b)(4), “shall be considered confidential and shall not be disclosed[.]” 21 U.S.C. 387f(c) ; see also 21 C.F.R. § 20.61(c) ().
As a preliminary matter, in his memorandum of law in opposition to the motions for summary judgment filed by Defendants and in support of his cross-motion for summary judgment, Plaintiff acknowledges that FDA “conducted an adequate search” in response to his FOIA request, but argues that it improperly withheld the responsive records that it located. (Dkt. No. 45 at 1 [Plf.'s Memo. of Law].) Plaintiff filed neither a response to Defendants' Statements of Material Facts nor a Statement of Material Facts in support of his cross-motion, as required by Local Rule 7.1(a)(3) of the Local Rules of Practice; indeed, in his memorandum of law, he asserts that no factual dispute exists and expressly incorporates by reference both the “background” and “legal standard” portions of the memorandum of law filed by the Agency Defendants. (Id. at 1-2.)
Pursuant to Local Rule 7.1(a)(3), a party moving for summary judgment is required to submit a statement of material facts. N.D.N.Y. L.R. 7.1(a)(3). Moreover, a party opposing a motion for summary judgment is required to submit a statement of material facts, even where the opposing party intends to admit facts asserted by the moving party. N.D.N.Y. L.R. 7.1(a)(3) (). Upon an opposing party's failure to submit a statement of material facts, “[t]he Court shall deem admitted any properly supported facts set forth in” a moving party's statement of material facts. Id.
[emphasis in original]. Plaintiff was reminded of his obligation to file a Rule 7.1 Response when the Agency Defendants and Philip Morris, Reynolds, and Santa Fe filed their respective motions for summary judgment.
In this case, Plaintiff does not (and apparently did not intend to) dispute any of the factual assertions advanced in support of Defendants' motions for summary judgment, but rather disagrees with FDA's application of the statutory framework–particularly FOIA Exemptions 3 and 4–in denying his FOIA request. (See, e.g., Dkt. No. 45 at 2 [] ). Indeed, Plaintiff does not dispute the factual assertions advanced by Intervenors in support of the proposition that menthol quantities in cigarettes constitute trade secrets and/or confidential commercial information (and thus, ostensibly, would fall within the ambit of FOIA Exemptions 3 and/or 4). As more fully discussed below, the crux of Plaintiff's argument appears to be that “FOIA Exemptions 3 and 4 are not binding authority in this case” because they are entirely inapplicable to the Act. (Id.
) To the extent that discussion of the factual background is necessary to illuminate the issue of whether Plaintiff's FOIA request was properly denied under applicable legal standards, that factual background is therefore drawn from the uncontradicted, record-supported facts set forth in the Rule 7.1 Statements filed by Defendants.
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