Minmax Corporation d/b/a Amera, Ruling Dismissing Request to Appeal, Docket No. A-19-128 (2019)

RULING DISMISSING REQUEST TO APPEAL

On September 4, 2019, Minmax Corporation d/b/a Amera (Respondent) filed with the Departmental Appeals Board (Board) a notice seeking to appeal the July 17, 2019 Initial Decision and Default Judgment issued by an Administrative Law Judge (ALJ), Minmax Corporation d/b/a Amera, DAB TB4091 (2019) (Initial Decision).¹

This case stems from a complaint filed by the Center for Tobacco Products (CTP) alleging that, on August 10, 2018, Respondent committed two violations of 21 C.F.R. § 1140.14, a regulation governing the sale and distribution of tobacco products.  The complaint further asserted that CTP had, in a prior case, obtained a judgment against Respondent for five other violations of section 1140.14.  Based on the alleged and previously adjudicated violations, the complaint asked the ALJ to impose on Respondent a civil money penalty of $11,182.

In the Initial Decision, the ALJ found that, after filing its answer to CTP’s complaint, Respondent failed to comply with “orders and procedures governing this proceeding and failed to defend its actions, which interfered with the speedy, orderly, or fair conduct of this proceeding.”  ALJ Decision at 2 (citing 21 C.F.R. § 17.35(a)).  Specifically, the ALJ found that Respondent failed to respond to CTP’s request for production of documents,

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failed to produce documents in response to the ALJ’s order to compel discovery, and repeatedly failed to defend its actions. Id. at 3.  Based on these findings, the ALJ sanctioned Respondent by striking its answer to the complaint. Id. at 4.  The ALJ then entered a default judgment in CTP’s favor, sustaining the proposed penalty. Id. at 5.

The Initial Decision – together with a cover letter informing Respondent of its right to appeal the decision under 21 C.F.R. § 17.47, and a copy of the Board’s Guidelines on “Appellate Review of Administrative Law Judges in Food and Drug Administration Tobacco Products Cases” – was served on Respondent electronically, via DAB E-File, on July 17, 2019.  Respondent had consented to service by that method by filing its answer to CTP’s complaint via DAB E-File and by not asking the ALJ to waive the Civil Remedies Division’s requirement to use DAB E-File to file and accept service of case- related documents.  See Acknowledgment and Pre-Hearing Order (December 19, 2018) ¶ 2; Civ. Rem. Div., “Guidance Establishing Procedures,” at 1.  

The regulation at 21 C.F.R. § 17.47(b) provides:

A notice of appeal may be filed at any time within 30 days after the [ALJ] issues an initial decision or decision granting summary decision. . . .  The Commissioner [of FDA] or the entity designated by the Commissioner to hear appeals [in this case, the Board] may, within his or her discretion, extend the initial 30-day period for an additional period of time if the . . . respondent files a request for an extension within the initial 30-day period and shows good cause.

Thus, in order to appeal an initial decision by an ALJ, a party must file a notice of appeal with the Board within 30 days after that decision is issued. The Board may extend the 30-day appeal period only if a party:  (1) files – within the 30-day appeal period – a written extension request; and (2) shows good cause for the requested extension.  The Board’s Appellate Review Guidelines, which were served on the Respondent on July 17, 2019, recite these and other regulatory requirements for obtaining Board review of an ALJ’s initial decision.

In this case, because the ALJ issued the Initial Decision on July 17, 2019, Respondent needed to file a notice of appeal by August 16, 2019, in order to obtain Board review of that decision.  Respondent did not file a notice of appeal until September 4, 2019, and did not request an enlargement of time before the August 16, 2019 deadline.

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In its notice of appeal, Respondent argues that the Board should accept the late-filed notice of appeal.  Respondent’s counsel, Bart E. Levy, asserts that the Respondent’s previous counsel, William Weiss, suffered multiple “massive myocardial infarctions and strokes at the beginning of 2019 and two weeks after the entry of the July 17, 2019 Initial Decision and Default Judgment.” NA at 5. Mr. Levy further states that all correspondence in regards to this matter was going to Mr. Weiss, who did not advise the law firm representing Respondent, Levy Law, LLC, “about the orders and procedures governing this proceeding and the Initial Decision and Default Judgment.” Id. Respondent argues that the late filing was the result of these “non-negligent circumstances,” and that the appeal was “filed within a short period of time once . . . [Respondent] was aware of the delay.” Id. at 12-13.  In support of these arguments, Respondent cites Pennsylvania state court decisions which, we note, have no precedential effect on Board decisions. See id. at 11-13.

We reject Respondent’s arguments.  The regulations require that a party seeking to extend the time allotted to file a notice of appeal must request an extension within 30 days after the initial decision has issued.  21 C.F.R. § 17.47(b)(2).  Respondent had ample time to inform the Board of Mr. Weiss’s medical condition and request an enlargement of time before the August 16, 2019 deadline, however neither Mr. Weiss, Mr. Levy, nor anyone from Levy Law, LLC made such a request by the regulatory deadline. Respondent asserts that Mr. Weiss first had health-related events at the beginning of 2019.  Thus, Levy Law, LLC should have been aware of Mr. Weiss’s medical condition and had in place procedures and safeguards to meet all of its deadlines in the event of an additional medical crisis.  Moreover, while Respondent attempts to inject elements of Pennsylvania state law into this federal administrative appeal, Respondent has identified nothing in the governing regulations or statutes that permit the Board to accept its late-filed appeal.

The Board is sympathetic to Mr. Weiss’s health condition and to the way his recent heart events disrupted his representation of Respondent in this appeal.  However, such sentiment cannot affect our consideration of whether Respondent’s notice of appeal was timely filed.  Respondent filed an untimely notice of appeal and did not timely ask the Board to extend the appeal deadline.  Accordingly, Respondent did not comply with the regulations governing the filing of appeals, and I dismiss the appeal.

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