Baker v. U.S.

Decision Date15 January 1991
Docket NumberNo. 90-15009,90-15009
Citation932 F.2d 813
PartiesKenneth M. BAKER, Petitioner-Appellant, v. UNITED STATES of America, Respondent-Appellee.
CourtU.S. Court of Appeals — Ninth Circuit

Terry Admur, Pasadena, Cal., for petitioner-appellant.

Mark Edelman, Asst. U.S. Atty., Fresno, Cal., for respondent-appellee.

Appeal from the United States District Court for the Eastern District of California; M.D. Crocker, District Judge.

Before TANG, BOOCHEVER and NOONAN, Circuit Judges.

BOOCHEVER, Circuit Judge:

OVERVIEW

After a plea of nolo contendere, Baker was convicted of misbranding certain drugs, in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). He moved to vacate his sentence under 28 U.S.C. Sec. 2255, for lack of federal jurisdiction, arguing that the transactions set out in the information charging him were wholly intrastate in nature. The district court found a sufficient nexus to interstate commerce. We AFFIRM.

BACKGROUND

Baker manufactured a drug that was sold as synthetic heroin. As sold, the package contained no labels identifying the drug, its effects, or the proper dosage. Baker and others entered a nolo plea to a seven-count superseding indictment charging them with violating 21 U.S.C. Sec. 331(k) 1 as they

caused an act to be done, and aided and abetted the act being done with respect to a drug, an analog of fentanyl, while such drug was held for sale, after components of the drug were shipped in interstate commerce, which act resulted in the drug being misbranded.

Baker was sentenced to three consecutive one-year terms on the first three counts, and a four-year term of probation in exchange for a suspended sentence on the remaining four counts. Under the plea agreement, Baker reserved his right to appeal the denial of his motion to dismiss for violations of the Speedy Trial Act, the exercise of which was ultimately unsuccessful.

Baker filed a "Petition for a Writ of Error Coram Nobis" in the district court which was construed as a motion to vacate his sentence pursuant to 28 U.S.C. Sec. 2255. The motion was denied and this appeal was taken.

DISCUSSION

Essentially, Baker's argument below and on appeal is that notwithstanding that the component parts of the synthetic heroin traveled in interstate commerce, the manufacture and distribution of the end product all occurred in California, so that the interstate commerce link is missing. In other words, he reads Sec. 331(k) to require that the misbranded drug, the synthetic heroin made from the components shipped in interstate commerce, and not the components alone travel in interstate commerce.

A plain reading of Sec. 331(k) supports affirmance. Reading only the part of the relevant subsection, the question is whether Baker did anything with respect to the drug, while it was held for sale and after shipment in interstate commerce, that results in the drug being misbranded. He did. There was a failure to label, done while or before the synthetic heroin was held for sale, which occurred after a shipment in interstate commerce.

The shipment in interstate commerce, of course, did not involve the synthetic heroin but the ingredients combined to make it. The FDCA defines the term "drug," however, to include "articles intended for use as a component of" a recognized drug. See 21 U.S.C. Sec. 321(g)(1)(A) & (D). Thus, the "shipment in interstate commerce" requirement is satisfied even when only an ingredient is transported interstate. We are, furthermore, guided to this result by the Supreme Court's admonitions that "Congress fully intended that the [FDCA's] coverage be as broad as its literal language indicates," United States v. Bacto-Unidisk, 394 U.S. 784, 798, 89 S.Ct. 1410, 1418, 22 L.Ed.2d 726 (1969), and that courts generally beware the creation of "loopholes" In addition, the better-reasoned cases are consistent with this reading, concluding that the "shipment in interstate commerce" requirement of Sec. 331(k) is satisfied when the misbranded drug held for intrastate sale contains ingredients shipped in interstate commerce. See United States v. An Article of Food, 752 F.2d 11, 14 (1st Cir.1985) ("Because it is undisputed that the potassium nitrate added to the seized beverages was shipped in interstate commerce, those beverages [, although mixed and sold only intrastate,] clearly fall within the scope of statutory forfeiture jurisdiction."); United States v. Dianovin Pharmaceuticals, Inc., 475 F.2d 100, 103 (1st Cir.), cert. denied, 414 U.S. 830, 94 S.Ct. 60, 38 L.Ed.2d 65 (1973) ("The appellants' use of components shipped in interstate commerce to make vitamin K for injection brought their activities within Sec. 331(k)...."); see also United States v. Cassaro, Inc., 443 F.2d 153, 155-56 (1st Cir.1971); Accord United States v. Articles of Drug, 625 F.2d 665, 671 (5th Cir.1980).

that have no basis in statutory language, Kordel v. United States, 335 U.S. 345, 349, 69 S.Ct. 106, 109, 93 L.Ed. 52 (1948).

Baker's whole argument relies on a thirty-year-old case from the Eastern District of Michigan, United States v. An Article or Device Consisting of 31 Units (Gonsertron), 180 F.Supp. 52 (E.D.Mich.1959). There, the district court, in a six-paragraph decision, dismissed the government's motion to seize a misbranded device. Nine component parts, apparently all of which traveled in interstate commerce, were used in manufacturing the device. The court concluded that 21 U.S.C. Sec. 321(h)--defining "device"--"does not attempt to regulate devices solely by reason of the fact that they contain component parts shipped in interstate commerce." Id. at 53.

The government attempts to distinguish Gonsertron on the ground that it "involved a device, not drugs" and that "the Act specifically includes within its definition the components of a drug." (emphasis added). This distinction is of no help as the definition of "device," albeit with slightly different language, also includes components of devices. 21 U.S.C. Sec. 321(h). The better distinction is simply that, as the government points out, Gonsertron was incorrectly decided, and, in any case, does not represent the current state of the law. Indeed, a subsequent case in its own jurisdiction has thrown the result in Gonsertron into doubt.

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  • U.S. v. Varela-Cruz
    • United States
    • U.S. District Court — District of Puerto Rico
    • September 2, 1999
    ...331(k) and 334(a)(1), there is substantial case law supporting a broad interpretation of the entire Act. See Baker v. United States, 932 F.2d 813, 816 (9th Cir.1991) (holding that "wholly intrastate manufactures and sales of drugs are covered by [section 331(k) of the Act] as long as an ing......
  • United States v. Aholelei
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    • U.S. District Court — District of Hawaii
    • December 22, 2017
    ...F.3d 1383, 1386 (9th Cir. 1996) (construing a coram nobis petition by an in-custody petitioner as a § 2255 motion); Baker v. United States, 932 F.2d 813, 814 (9th Cir. 1991) (same). The court turns now to the issue of whether Aholelei meets the timeliness requirement for a § 2255 motion.IV.......
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    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • February 4, 2014
    ...§ 331(k)'s “ ‘shipment in interstate commerce’ requirement is satisfied even when only an ingredient is transported interstate.” 932 F.2d 813, 814 (9th Cir.1991). We therefore hold that, by virtue of its use of doxycycline, the Mixture is within the scope of drugs—and, by extension, biologi......
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    ...held that the “interstate commerce” element is met if any component of that drug moved in interstate commerce. See Baker v. United States, 932 F.2d 813, 816 (9th Cir.1991) (“We hold that wholly intrastate manufacturers and sales of drugs are covered by 21 U.S.C. § 331(k) as long as an ingre......
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1 books & journal articles
  • The optimal scope of FDA regulation of genetic tests: meeting challenges and keeping promises.
    • United States
    • Harvard Journal of Law & Technology Vol. 20 No. 2, March 2007
    • March 22, 2007
    ...a device because it is a "part ... intended for use in the diagnosis of disease." 21 U.S.C. § 321(h). (88.) See Baker v. United States, 932 F.2d 813, 814 (9th Cir. 1991) ("Thus, the 'shipment in interstate commerce' requirement is satisfied even when only an ingredient is transported inters......

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