United States District Court, E.D. Wisconsin
DECISION AFFIRMING JUDGMENT
C.N. CLEVERT, JR. U.S. DISTRICT JUDGE
Conrad LeBeau pled guilty to one misdemeanor count of introducing into interstate commerce a new drug that had not been approved by the Food and Drug Administration (FDA). See 21 U.S.C. §§ 331(d), 333(a)(1), 355(a). LeBeau’s conviction relates to his distribution of “Perfect Colon Formula #1, ” which he promoted as reducing food allergies. (See Information at 5.) LeBeau’s plea, before U.S. Magistrate Judge William E. Callahan, was conditioned on being allowed to appeal various matters he had raised in motions before the magistrate judge. Following entry of judgment, LeBeau appealed, and the case was assigned to this court. LeBeau represents himself on appeal.
APPELLATE PROCEDURAL BACKGROUND
A person convicted before a U.S. magistrate judge has an appeal as of right to the district court. 18 U.S.C. §§ 3402, 3742(h). In reviewing such an appeal, the district court shall apply the Federal Rules of Appellate Procedure. Fed. R. Crim. P. 58(a), (g)(2)(D); see § 3742(h); United States v. Shelton, No. 05-mc-00310, 2007 WL 328812, *4 (N.D. Ill. Jan. 31, 2007). Rule 58 provides that the defendant is not entitled to a trial de novo by the district judge. Instead, the scope of the appeal is the same as in an appeal to the court of appeals. Fed. R. Crim. P. 58(g)(2)(D).
Upon receipt of the case, this court determined that LeBeau’s appeal should be treated like an appeal to the U.S. Court of Appeals for the Seventh Circuit. This court directed the parties to designate the record and to brief the appeal as they would an appeal to the Seventh Circuit. The order referenced Fed. R. App. P. 28 and 32 and Circuit Rules 28(c) and 32 (7th Cir.) and included copies of the rules for LeBeau’s benefit. (Doc. 91.)
This court intended the parties to frame and discuss the issues on appeal rather than incorporate by reference all or any of the documents in the record. Magistrate Judge William Callahan had issued three separate decisions regarding several motions, and one of the briefs before Judge Callahan contained over seventy pages and several others contained over twenty-five pages. This court wanted the parties to narrow the issues on appeal and to succinctly present their arguments.
Neither party complied with their directions, LeBeau filed a brief that was difficult to understand. He spent pages discussing the legislative history and text of the Pure Food Act of 1906, even adding language to and rewording the text of the 1906 Act “to clarify and limit the breadth of the definition to the intended lableling targets of the law.” (Doc. 98 at 10-11.) Yet he did not sufficiently discuss the text of the statutes under which he was convicted. LeBeau discussed the pharmaceutical industry’s influence on Congress and the Center for Drug Evaluation and Research (Doc. 98 at 2-3), allegedly untruthful answers by the FDA to FOIA requests (id. at 5), and the contents of fourteen articles found at the National Library of Medicine (id. at 7-9). He conflated several constitutional issues. (See Id. at 6 (“This practice pre-empts the First Amendment and the ultimate effect is ‘restraint of trade’ that is not a power granted to Congress under Article I, Sec 8 of the U.S. Constitution. Restraint of trade by abridging freedom of the press violates not only the first amendment rights of the defendant, but also ‘freedom of choice in medicine’ reserved by the defendant under the 9th amendment. It further violates rights reserved to the states under the 10th.”).) And LeBeau confusingly questioned and argued whether the label on his Perfect Colon Formula changed the product’s material composition and whether a flyer he wrote about Perfect Colon Formula actually was a drug. (Id. at 17-20.) Instead of focusing on the issues he preserved in his plea agreement, narrowing the issues for this court on appeal, and arguing legal errors he believed Magistrate Judge Callahan made, LeBeau expanded the issues on appeal. Moreover, in his conclusion, LeBeau asked this court to allow him to withdraw his guilty plea. (Doc. 98 at 30.)
The United States filed a six-page brief stating its position that except for one issue, its prior briefs in the case had sufficiently addressed all issues, that those prior briefs (Docs. 37, 45, 68, and 76) were incorporated by reference, and that this court should “summarily adopt the reasoning set forth in Magistrate Judge Callahan’s decisions of September 21, 2011, December 7, 2011, and May 29, 2012.” (Doc. 99 at 2.) According to the government, “LeBeau’s arguments have been fully-litigated and Magistrate Judge Callahan’s reasoning is both compelling and comprehensive. There is no good reason to spill more ink before this case reaches the court of appeals.” (Id.) However, the government did address a case referenced by LeBeau that was decided after Magistrate Judge Callahan ruled. (Id. at 3-5.)
As a result, this court found it difficult to discern the issues LeBeau is appealing, what his arguments were, and what the government’s position was. To focus the arguments, the court conducted a hearing at which LeBeau said he wished to pursue three matters on appeal: (1) the “doctrine of overbreadth, ” (2) the “doctrine of legal impossibility, ” and (3) restraint of trade and “constitutional violation.” The court then directed LeBeau to file a new brief refining his arguments on appeal and the government to respond in detail to those arguments.
The case has now been rebriefed. Although LeBeau still seeks to incorporate prior filings in the case (see, e.g., Doc. 113 at 3-4 (stating his issues on appeal and that they were discussed in documents 28, 43, 58, 75, and 98), 4 (directing the court to a certain discussion in document 28), 14 (“For my arguments on the Doctrine of Overbreadth, see Doc 28 and 43 for the applicable sections. For a comparison of the Caronia case to mine, see Doc 98[, ] pages 22 to 30.”)),  this court can now better grasp his arguments.
The following discussion is based primarily on the revised briefs, although the original appellate briefs (but not necessarily the documents incorporated by reference) have received some consideration. Also, the court reviewed several of the briefs before Magistrate Judge Callahan. To the extent that the court has missed some variation of either party’s argument not mentioned in the briefs before this court but buried in the briefs before Magistrate Judge Callahan, such argument is deemed waived. At the in-court hearing on appeal, the parties were directed to set forth all of their arguments in the briefs to this court and notified that they would not receive broad review of prior documents. Just as the court is not required to scour the record for evidence creating a question of fact, Hunt-Golliday v. Metro. Water Reclamation Dist., 104 F.3d 1004, 1010 n.2 (7th Cir. 1997), it should not be required to scour the record to find the parties’ arguments.
In his revised brief (Doc. 113), LeBeau lists five issues for appeal: (1) the doctrine of impossibility (both factual and legal); (2) the doctrine of overbreadth; (3) violations of his First Amendment right to free speech and Fifth Amendment right to due process (and “other issues”); (4) Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980); and (5) United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). (Doc. 113 at 3-4.) However, numbers (4) and (5) above are better considered as legal support for issue (3) rather than separate issues.
The court is limiting LeBeau to these issues. While LeBeau’s revised brief on appeal invites this court to review and comment on “[t]he balance of all the other legal argument reserved in Doc 58 and in Docs 28 and 43" (Doc. 113 at 14), this court declines his invitation regarding any matter not addressed in this decision. To the extent LeBeau briefly references additional issues in his revised reply brief (“freedom of choice in medicine under the 9th amendment” and restraint of trade (Doc. 116 at 14, 18)) but did not list them in his revised initial brief (Doc. 113) or properly develop them even if mentioned, this court will not address them. When it ordered re-briefing, this court told LeBeau that he would be limited to what he raised in his revised brief, and that the government should respond.
New arguments in reply are not permitted. United States v. Cruse, 805 F.3d 795, 818 n.7 (7th Cir. 2015); In this instance, this court is functioning as an appellate court and will review legal issues de novo and factual determinations with deference to the magistrate judge. United States v. Snow, 656 F.3d 498, 500 (7th Cir. 2011); see United States v. Gochis, 256 F.3d 739, 742 (7th Cir. 2001).
The Federal Food, Drug, and Cosmetic Act (FDCA) establishes a system of premarketing clearance for drugs. Certain drugs, designated as “new drugs, ” cannot be sold in interstate commerce unless a new-drug application is approved by the FDA. United States v. Marcen Labs., Inc., 416 F.Supp. 453, 455 (S.D.N.Y.), aff’d, 556 F.2d 562 (2d Cir. 1976) (table).
The criminal information in this case charged LeBeau with introducing new drugs into interstate commerce in violation of the FDCA. LeBeau was convicted under 21 U.S.C. § 355(a), which states that “[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug.” See also 21 U.S.C. § 331(d) (prohibiting the introduction of an unapproved new drug through interstate commerce). New drug applications are to be filed with the Secretary of Health and Human Services. 21 U.S.C. §§ 321(d), 355(b), (j). Any person may file an application. § 355(b).
As pertinent here, the term “drug” means an “article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” 21 U.S.C. § 321(g)(1)(B). “New drug” means any drug “the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof.” § 321(p)(1). Thus, the manufacturer or distributor of a product meant to diagnose, cure, mitigate, treat or prevent disease has two choices before distributing that product: show that the product is generally recognized among experts as safe and effective for that use or obtain approval from the Secretary. See United States v. LeBeau, 786 F.Supp. 761, 767 (E.D. Wis. 1992), aff’d, 985 F.2d 563, 1993 WL 21970 (7th Cir. 1993) (table).
Although the FDCA does not define what constitutes general recognition of safety and effectiveness, the Supreme Court has interpreted the new-drug definition to require expert consensus founded upon “substantial evidence, ” which in turn means adequate and well-controlled investigations by experts and responsible expert opinions. United ...