Am. Acad. of Pediatrics v. Food & Drug Admin.

• Decision Date: 12 July 2019
• Docket Number: Case No.: PWG-18-883
• Citation: 399 F.Supp.3d 479
• Parties: AMERICAN ACADEMY OF PEDIATRICS, et al., Plaintiffs, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants.
• Court: U.S. District Court — District of Maryland

399 F.Supp.3d 479

AMERICAN ACADEMY OF PEDIATRICS, et al., Plaintiffs,

v.FOOD AND DRUG ADMINISTRATION, et al., Defendants.

Case No.: PWG-18-883

United States District Court, D. Maryland, Southern Division.

Filed July 12, 2019

Beth Christine Neitzel, Kevin Matthew Lamb, Kelly Dunbar, Wilmer Cutler Pickering Hale & Dorr LLP, Dennis Henigan, Pro Hac Vice, Mark E. Greenwold, Pro Hac Vice, Swati Rawani, Pro Hac Vice, Campaign for Tobacco-Free Kids, Javier M. Guzman, Pro Hac Vice, Jeffrey B. Dubner, Pro Hac Vice, Democracy Forward Foundation, Washington, DC, Eve Lynne Hill, Brown Goldstein & Levy, LLP, Baltimore, MD, Lynn Eisenberg, Wilmer Cutler Pickering Hale and Dorr LLP, Washington, DC, DC, for Plaintiffs.

Eric B. Beckenhauer, Michelle Bennett, U.S. Department of Justice, Washington, DC, for Defendants Food and Drug Administration, Scott Gottlieb, U.S. Department of Health and Human Services, Alex M. Azar, II.

Kathleen Hoke Dachille, University of Maryland Carey School of Law, Baltimore, MD, for Defendant American Association for Respiratory Care.

MEMORANDUM OPINION AND ORDER

Paul W. Grimm, United States District Judge

In a Memorandum Opinion and Order issued on May 15, 2019, I concluded that Defendants the Food and Drug Administration ("FDA"), then-Commissioner of Food and Drugs Scott Gottlieb, the U.S. Department of Health and Human Services, and Secretary of Health and Human Services Alex M. Azar II violated the Administrative Procedure Act ("APA"), 5 U.S.C. § 701 et seq. by issuing the Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule: Guidance for Industry (Revised) ("August 2017 Guidance") without following the APA's notice and comment requirements. ECF Nos. 73, 74. Accordingly, I granted Plaintiffs'¹ motion for summary judgment and vacated the FDA's August 2017 Guidance.

Because the application deadlines set in the Deeming Rule² and the May 2017 Guidance³ (which otherwise would have applied following the vacatur) had passed, I ordered the parties to submit additional briefing regarding a remedy, while noting that "[a]ny Guidance providing for a compliance period will, of course, have to adhere to the notice and comment requirements of the APA." May 15, 2019 Mem. Op. 53.⁴ The parties have completed their briefing and responded to amicus curiae briefs that the State of Maryland and various organizations⁵ filed on behalf of the e-cigarette industry ("Industry"). Pls.' Remedy Br., ECF No. 78; Maryland Br., ECF No. 97; Defs.' Remedy Br., ECF No. 120; Indus. Br., ECF No. 121-1; Pls.' Reply, ECF No. 123; Pls.' Resp. to Indus. Br., ECF No. 124; Defs.' Resp. to Indus. Br., ECF No. 125. A hearing is not necessary. See Loc. R. 105.6. Balancing the need to address the existing public health crisis among today's youth, which both parties acknowledge, and the need to avoid creating an additional public health crisis if e-cigarette availability dropped so precipitously as to push users to combusted tobacco products, and considering both the FDA's laudable efforts to guide the premarket approval process and the Industry's lack of effort to obtain approval without an imminent deadline, I will impose a ten-month deadline for submissions and a one-year deadline for approval, as the FDA suggested.

Plaintiffs' Requests

Plaintiffs propose that the Court first order the FDA to

take whatever actions are necessary and in accord with the APA, to allow new tobacco products on the market as of the August 8, 2016 effective date of the Deeming Rule to remain on the market without being subject to FDA enforcement actions, only under the following conditions:

1. Applications for marketing orders must be filed within 120 days of issuance of this Court's order and products for which applications have not been filed within this period shall be subject to FDA enforcement actions;

2. Products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application.

Pls.' Remedy Br. 8, ECF No. 78. In their view, the four-month deadline for manufacturers is both reasonable and feasible because the manufacturers have been on notice that the deadline was looming and could be accelerated, and the FDA has encouraged them to move forward with their submissions before the deadline. Id. at 10–11. Second, Plaintiffs propose that the Court require the FDA to file quarterly reports with the Court "on the measures it is taking to carry out its premarket review responsibilities under the TCA [Tobacco Control Act], including reporting the number and nature of the enforcement actions it has undertaken against companies for marketing their products without a marketing order." Id. at 9. And third, Plaintiffs ask the Court to retain jurisdiction over this case. Id. The State of Maryland filed an amicus curiae brief in support of Plaintiffs' position, noting the health risks e-cigarettes pose to Maryland's youth and the consequential medical expenses the State will incur "[a]s these young Marylanders age and sicken" and seek treatment through Medicaid. Maryland Br. 1–2, ECF No. 97.

Plaintiffs argue that this relief is within the Court's "broad remedial authority," insisting that "the ‘Court may tailor its remedy to the unlawful agency behavior’ " and " ‘adjust its relief to the exigencies of the case in accordance with the equitable principles governing judicial action.’ " Pls.' Remedy Br. 7 (quoting Thompson v. U.S. Dep't of Hous. & Urban Dev. , 348 F. Supp. 2d 398, 464–65 (D. Md. 2005) ). Plaintiffs also acknowledge that "the court must act within the bounds of the statute and without intruding into the administrative province." See id. (quoting Thompson , 348 F. Supp. 2d at 465 ). Still, in Plaintiffs' view, "[t]here is ample authority for a Court to structure its remedy to account for the realities of immediate vacatur or reinstate the status quo." Pls.' Reply 2, ECF No. 123 (citing Andrulis Res. Corp. v. U.S. Small Bus. Admin. , No. 9-2569, 1990 WL 169318, at *2 (D.D.C. Oct. 19, 1990) ). They insist that the Court "may craft declaratory and injunctive relief designed to preclude a federal agency from acting in contravention of its statutory and regulatory authority." Id. at 6 (quoting Coal. For Gov't Procurement v. Fed. Prison Indus. , 365 F.3d 435, 460 (6th Cir. 2004) ).

Legal Precedent

The Sixth Circuit has noted the courts' authority to order injunctive relief to address agency action or inaction:

It is well-established that federal courts possess broad discretion to fashion equitable remedies. See United States v. R.W. Meyer, Inc., 932 F.2d 568, 572–73 (6th Cir. 1991) (observing the "principle of equity that the chancellor has broad discretion to frame a decree"). It also is established that we may craft declaratory and injunctive relief designed to preclude a federal agency from acting in contravention of its statutory and regulatory authority. See Howard v. Pierce, 738 F.2d 722, 730 (6th Cir. 1984) (holding that the court may award declaratory and injunctive relief in order to ensure that the Department of Housing and Urban Development adopted regulations consistent with its enabling statute). Furthermore, the court may require an agency to modify its current or future practices in order to account for past violations of its statutes or regulations. See Charter Township of Huron, Michigan v. Richards, 997 F.2d 1168, 1175 [ (1993) ] (acknowledging the court's authority to issue an injunction requiring the agency to conduct an environmental assessment notwithstanding the implementation of the completed action); Northwest Envtl. Def. Ctr. v. Gordon, 849 F.2d 1241, 1245 (9th Cir. 1988) (determining that claims asserted against federal agencies alleging that the agencies unlawfully authorized the overfishing of coho salmon during the 1986 season were not moot because the court could award injunctive relief in the form of "higher escapement provisions and lower quotas in 1989").

Coal. for Gov't Procurement v. Fed. Prison Indus., Inc. , 365 F.3d 435, 460 (6th Cir. 2004). And, in 1990, the District of the District of Columbia noted that "various appellate court decisions [have] affirm[ed] a district court's power to extend statutory deadlines to remedy improper agency delay." Andrulis Research Corp. v. U.S. Small Bus. Admin. , No. 90-2569(CRR), 1990 WL 169318, at *2 (D.D.C. Oct. 19, 1990) (citing Connecticut v. Schweiker, 684 F.2d 979, 997–99 (D.C. Cir. 1982) ; Burr v. Ambach, 863 F.2d 1071, 1077–78 (2d Cir. 1988), vacated, 492 U.S. 902, 109 S. Ct. 3209, 106 L.Ed.2d 560 (1989), aff'd on remand sub nom., Burr v. Sobol, 888 F.2d 258 (2d Cir. 1989) ; Smith v. Miller, 665 F.2d 172, 180 (7th Cir. 1981) ; Carey v. Klutznick, 637 F.2d 834, 837 (2d Cir. 1980) (per curiam)).

More recently the D.C. Circuit has held that "[w]hen a district court reverses agency action and determines that the agency acted unlawfully, ordinarily the appropriate course is simply to identify a legal error and then remand to the agency, because the role of the district court in such situations is to act as an appellate tribunal." N. Air Cargo v. U.S. Postal Serv. , 674 F.3d 852, 861 (D.C. Cir. 2012) (citing PPG Indus., Inc. v. United States, 52 F.3d 363, 365 (D.C. Cir. 1995) ); see N.C. Fisheries Ass'n v. Gutierrez , 550 F.3d 16, 20 (D.C. Cir. 2008) ("To be sure, the district court, sitting as a court in review of agency action under the Act and APA, should have done what a court of appeals normally does when it identifies an agency error: remand to the agency for further proceedings. As we have said, ‘[u]nder settled principles of administrative law, when a court reviewing agency action determines that an agency made an error of law, the court's inquiry is at an end: the case must be remanded to the agency for further action consistent with the corrected legal standards.’ " (quoting PPG Indus. , 52 F.3d at...