United States v. Girod
| Decision Date | 24 June 2016 |
| Docket Number | Criminal Action No. 5: 15-87-DCR |
| Parties | UNITED STATES OF AMERICA, Plaintiff, v. SAMUEL A. GIROD, Defendant. |
| Court | U.S. District Court — Eastern District of Kentucky |
This matter is pending for consideration of Defendant Samuel Girod's motion to dismiss the Indictment under Rule 12(b)(1) of the Federal Rules of Criminal Procedure. [Record No. 45] The motion also includes certain in limine requests. The defendant argues that: (i) the United States and its agencies have violated his due process rights; (ii) the Food and Drug Administration ("FDA") and the prosecution lack standing to investigate and/or prosecute him; (iii) the Indictment is invalid; (iv) certain terms should be excluded from use at trial; and (v) the statutes governing Girod's conduct are unconstitutional.
Because this criminal action was referred to a United States Magistrate Judge for pre-trial matters pursuant to 28 U.S.C. § 636(b)(1)(B), Magistrate Judge Robert E. Wier issued a Recommended Disposition on June 8, 2016. [Record Nos. 4; 61] The magistrate judge recommends that Girod's motion be denied. Girod filed objections to the RecommendedDisposition.1 [Record No. 65] After reviewing all relevant materials, the Court agrees with Magistrate Judge Wier and will deny the motion to dismiss and the in limine requests.
In a criminal proceeding, a party may raise by pretrial motion any defense, objection, or request that the Court can determine without a trial on the merits. Fed. R. Crim. P. 12(b)(1). Such a motion may allege error in the underlying grand jury proceeding. Fed. R. Crim. P. 12(b)(3)(A)(v). For example, the defendant "may challenge the grand jury on the ground that it was not lawfully drawn, summoned, or selected, and may challenge an individual juror on the ground that the juror is not legally qualified." Fed. R. Crim. P. 6(b)(1); see also 28 U.S.C. § 1867. Because Girod proceeds pro se, the Court liberally construes his arguments. See Haines v. Kerner, 404 U.S. 520, 520 (1972).
A more detailed summary of the relevant facts is set forth in the Court's Memorandum Opinion and Order filed June 22, 2016. [Record No. 66, pp. 1-3] In essence, Girod is charged with twelve counts ranging from obstruction of justice to introducing into interstate commerce misbranded products in violation of 21 U.S.C. §§ 33l(a) and 333(a)(2). [Record No. 1, ¶¶ 17-44] The charges center around his manufacturing and distribution of certain salves at an establishment not registered with the FDA under 21 U.S.C. § 360(b)(l), (c)(l).
In his motion to dismiss the Indictment, Girod asserts that his due process rights were violated by the FDA's failure to follow the procedures in 5 U.S.C. § 554 and 21 U.S.C. § 335.[Record No. 45, pp. 1, 8] Second, the defendant alleges that the FDA lacks "standing" to investigate his activities and that the United States lacks standing to prosecute him because the products he manufactured and distributed at his establishment were not "drugs." [Id., p. 2] Along with this allegation, Girod seeks to exclude the use of certain "prejudicial" terms at trial. [Id.] He also seeks to exclude the testimony of certain witnesses. [Id., p. 3] Third, the defendant challenges the validity of the Indictment and the fairness of the grand jury proceeding. [Id., p. 8] Finally, Girod makes several arguments addressing the sufficiency of the evidence. [See Record Nos. 45-1; 45-2.] The Court agrees with the magistrate judge that none of these contentions have merit.
Girod argues that his due process rights were violated because the FDA did not comply with the requirements of 5 U.S.C. § 554 and the Secretary did not comply with 21 U.S.C. § 335. [Record No. 45, pp. 1, 8] As noted by the magistrate judge, 5 U.S.C. § 554 applies to adjudications "required by statute to be determined on the record after opportunity for an agency hearing." 5 U.S.C. § 554(a). An "adjudication" refers to "agency process for the formulation of an order," and a court is not an "agency." 5 U.S.C. § 551(1)(B), (7). Because a criminal prosecution in this Court is not an "adjudication" under Title 5 of the United States Code, § 554 does not apply to the proceeding at hand. In his objections, Girod claims that his actions should not be governed under the FDA's authority or regulations because the FDA did not follow its own procedures. [Record No. 65, p. 2] Regardless of whether Girod's argument would have merit at an agency hearing, it does not apply in a criminal prosecution in this Court because this Court's procedures are not governed by § 554.
Likewise, Girod's contention that the Indictment should be dismissed due to the Secretary's failure to comply with 21 U.S.C. § 335 lacks merit. As explained in the June 22, 2016 Memorandum Opinion and Order and in the Recommended Disposition, the § 335 mechanism is not a prerequisite to prosecution. United States v. Dotterweich, 64 S. Ct. 134, 135 (1943). [Record Nos. 61, p. 3; 66, p. 6] As explained by the Supreme Court in addressing a similar subsection of the Pure Food and Drugs Act, 21 U.S.C. § 1, et seq., that subsection was not meant to "hamper district attorneys, curtail the powers of grand juries, or make them, with evidence in hand, halt their investigation and await the action of the Department." United States v. Morgan, 222 U.S. 274, 282 (1911); see also United States v. Aossey, No. 14-CR-116-LRR, 2015 WL 4064312 (N.D. Iowa Jul. 2, 2015). In other words, while § 335 governs the FDA's behavior, it does not govern the prosecutor's or the grand jury's procedures.
Girod's objections merely reiterate the same argument. [Record No. 45, pp. 1, 65, p. 2] However, the defendant fails to identify any legal error in the magistrate judge's conclusion that § 335 is inapplicable to the situation at hand. For example, Girod attempts to distinguish Dotterweich, 64 S. Ct. at 135, by pointing out that the defendant in that case was a drug company. [Record No. 65, p. 2] However, in the present case, the exact issue for the jury to determine is whether Girod's establishment involved the manufacturing and distribution of "drugs." Therefore, Girod's alleged distinction between his case and Dotterweich may not be accurate. In any event, the status of the company in Dotterweich is irrelevant to the determination of whether the agency's failure to comply with § 335 bars a prosecution conducted by the United States.
The defendant highlights that, in United States v. Andreadis, the court focused on the importance of holding a § 335 hearing before a prosecution. 234 F. Supp. 341, 348 (E.D.N.Y.1964). [Record No. 65, p. 2] First, that case is not binding because it is a district court case from another circuit. See United States v. Flores, 477 F.3d 431, 438 (6th Cir. 2007). Second, the court in that case placed importance on the § 335 hearing because the defendant "gave [his] statement under the implied understanding or promise that it would be considered before a decision to prosecute was made." 234 F. Supp. at 348. Such a promise was relevant to the court's conclusion that the defendant was deprived of his right against self-incrimination while testifying at the hearing. See id. at 347. Thus, Andreadis' reasoning regarding the importance of the § 335 hearing is not relevant to the circumstances of the present action.
The defendant's "standing" argument is centered around the Federal Rules of Civil Procedure, rather than the criminal rules. [Record No. 45, p. 4] The magistrate judge concluded that the United States' standing to enforce federal criminal laws is unquestioned. [No. 61, p. 4] In his objections, Girod claims that there can be no standing because there are no victims of his conduct. [Record No. 65, p. 2] However, the defendant incorrectly assumes that the victims must be identified. Further, "diffuse injuries to the general public" and potential injuries are sufficient to create standing for criminal prosecution. See Rice v. Farley, No. 14-31-ART, 2014 WL 2441260, at *2-3 (E.D. Ky. May 30, 2014); Christian Schmidt Brewing Co v. G. Heileman Brewing Co., 753 F.2d 1354, 1358 (6th Cir. 1985) ().
The magistrate judge also determined that this Court properly has jurisdiction under 18 U.S.C. § 3231. [Record No. 61, p. 4] In his objections, Girod states that the Court's jurisdiction "is not in question." [Record No. 45, p. 3] Instead, he claims that the trial should not include evidence flowing from the FDA's investigation into his activities because the FDAviolated its own procedures under 21 U.S.C. § 335. [Id.] As aptly noted by the magistrate judge, the FDA has jurisdiction to conduct investigations of violations of the FDCA under 21 U.S.C. §§ 393, 360(b)(1), and 374. [Record No. 61, p. 4] Under those provisions, it properly gathered evidence from Girod's establishment. Girod's alleged violations of federal criminal laws is a separate issue from the FDA's alleged failure to comply with certain hearing procedures. Because § 335 is not a prerequisite to the United States' prosecution of Girod in this Court, Girod's standing argument fails.
Girod contends that the Indictment should be dismissed because the lab results show that he did not manufacture or distribute "drugs." [Record No. 45, p. 7] As explained in the June 22, 2016 Memorandum Opinion and Order, the term "drug" in 21 U.S.C. § 321(g)(1) has a special significance that differs from the generic use of the term in the laboratory analyses he references. [Record No. 66, p. 7; referring to Record Nos. 45-1; 45-2] For instance, that provision focuses on the "intended use" of the product. See 21 U.S.C. § 321(g)(1)(B)-(C). Further, the laboratory reports detected at least two alkaloids (sanguinarine and chelerythrine) that are present in bloodroot, which is often a...
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