United States v. Undetermined Quantities of an Article of Device

797 F. Supp. 861, 1992 U.S. Dist. LEXIS 13602, 1992 WL 208003
CourtDistrict Court, D. Colorado
DecidedAugust 28, 1992
DocketCiv. A. No. 91-B-2019
StatusPublished
Cited by1 cases

This text of 797 F. Supp. 861 (United States v. Undetermined Quantities of an Article of Device) is published on Counsel Stack Legal Research, covering District Court, D. Colorado primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Undetermined Quantities of an Article of Device, 797 F. Supp. 861, 1992 U.S. Dist. LEXIS 13602, 1992 WL 208003 (D. Colo. 1992).

Opinion

MEMORANDUM OPINION AND ORDER

BABCOCK, District Judge.

Claimant Metrex Research Corporation (Metrex) moves for its attorney fees and expenses incurred in this forfeiture action under the Equal Access to Justice Act (EAJA), 28 U.S.C. § 2412(d)(1). The issues are adequately briefed and oral argument will not materially aid their resolution. Because the position of the United States was not substantially justified, Metrex’ motion for attorney fees and expenses is granted. However, Metrex claims fees and expenses in excess of those allowed by the EAJA and, therefore, its application will be reduced accordingly.

The United States filed this civil forfeiture action on November 19, 1991 alleging violations of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301, et seq. In its verified complaint, the United States claimed that Metrex’ products were misbranded within the meaning of the FDCA, 21 U.S.C. § 352(o) “in that a premarket notification was not submitted prior to marketing as required by 21 U.S.C. § 360(k) and 21 CFR §§ 807.81 and 807.97.” However, it is undisputed that Metrex had, in fact, submitted a premarket notification (a 510(k) report) on April 25, 1991.

On November 21, 1991, the Colorado Department of Health placed an embargo on Metrex products based on the government’s representations that Metrex’ premarket notification had been rejected. The next day Colorado lifted the embargo after meeting with an FDA official who admitted that the Metrex 510(k) report had not been rejected. On November 25, 1991, the [863]*863government seized Metrex’ complete inventory, again based on the factual allegation in the verified complaint that Metrex had not filed a 510(k) report.

On December 12, 1991, I heard Metrex’ motion to dismiss, which I converted to summary judgment without objection by either party. At the conclusion of that hearing, I granted summary judgment for Metrex, holding there was no genuine dispute that Metrex had submitted a 510(k) report. Indeed, the government conceded that Metrex filed a 510(k) report. Therefore, I held that the products were not misbranded within the meaning of 21 U.S.C. § 352(o) and dismissed the action. I rejected the government’s argument that a 510(k) report must be “approved” before marketing because the plain language of the statute only requires “submission” of the report.

I.

The EAJA provides in relevant part that “a court shall award to a prevailing party other than the United States fees and other expenses ... incurred by that party in any civil action ... brought by or against the United States ..., unless the court finds that the position of the United States was substantially justified or that special circumstances make an award unjust.” 21 U.S.C. § 2412(d)(1)(A). An award of fees and other expenses is mandatory unless the court finds that the government’s position was substantially justified. Estate of Smith v. O’Halloran, 930 F.2d 1496, 1501 (10th Cir.1991).

The government bears the burden of showing that its position was substantially justified. Id. “To do so, the government must prove that its case had a reasonable basis in law and in fact.” Id. The Supreme Court defined “substantially justified” as “justified in substance or in the main—that is, justified to a degree that could satisfy a reasonable person.” Pierce v. Underwood, 487 U.S. 552, 565, 108 S.Ct. 2541, 2550, 101 L.Ed.2d 490 (1988). The Court stressed that substantially justified means more than merely undeserving of sanctions for frivolousness. Id. at 566.

The United States asserted two positions during this action. First, in its verified complaint, the government argued that Metrex’ products were misbranded under 21 U.S.C. § 352(o) for failure to file a 510(k) report. Second, in its pleadings opposing dismissal and summary judgment, the government argued that the FDCA required premarketing approval of the 510(k) submission. Neither of these positions are substantially justified.

The government’s first position has no basis in fact. It is undisputed that Metrex filed a 510(k) report. The government’s second position has no basis in law. Section 352(o) defines a product as misbranded if “notice or other information respecting it was not provided as required by such section or section 360(k) of this title.” Section 360(k), in turn, merely requires each person who seeks to introduce a device into interstate commerce to “report” on certain matters set out in that section. By their plain language, these two sections simply do not require pre-marketing approval of a 510(k) report. Therefore, I conclude that neither of the government’s positions are substantially justified in fact or in law.

Now, for the first time, the government asserts another justification for its seizure and forfeiture action. It argues that Metrex’ 510(k) report was “deemed withdrawn” because FDA requested additional information which Metrex did not provide. 21 CFR § 807.87(h) empowers FDA to request additional information and provides that if the information is not provided within 30 days “the Commissioner will consider the premarket notification denied.” The government relies on a July 24, 1991 letter purportedly mailed to Metrex requesting additional information. Because Metrex did not submit the requested information within 30 days, the government contends that the 510(k) report was withdrawn and, therefore, its action was justified.

This argument fails for two reasons. First, it is hotly disputed whether the July 24, 1991 letter was mailed or even created on the date indicated. The letter is unsigned and it does not request specific additional information but merely references an [864]*864alleged prior request by the Office of Device Evaluation. The government has come forward with no evidence that the Office of Device Evaluation had ever requested such information. Moreover, the letter was suspiciously generated on the last day on which the government could object to Metrex’ 510(k) report. Thus, the circumstances surrounding that letter seem to indicate that it was either created automatically by a computer to preserve any objections or that it was created after the fact to justify the government’s actions. In any event, the government has not met its burden of proof.

Second, a “position” articulated for the first time after dismissal and in opposition to an EAJA application cannot be used to justify the underlying lawsuit. See, Abela v. Gustafson,

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Bluebook (online)
797 F. Supp. 861, 1992 U.S. Dist. LEXIS 13602, 1992 WL 208003, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-undetermined-quantities-of-an-article-of-device-cod-1992.