The Davinci Company, LLC v. United States

CourtUnited States Court of Federal Claims
DecidedAugust 7, 2025
Docket24-1238
StatusPublished

This text of The Davinci Company, LLC v. United States (The Davinci Company, LLC v. United States) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
The Davinci Company, LLC v. United States, (uscfc 2025).

Opinion

In the United States Court of Federal Claims No. 24-1238 (Filed Under Seal: July 31, 2025) Reissued: August 7, 2025 1

) THE DAVINCI COMPANY, LLC, ) ) Plaintiff, ) ) v. ) ) THE UNITED STATES, ) ) Defendant. ) )

Jason Nicholas Workmaster, Miller & Chevalier Chartered, Washington, D.C., for plaintiff.

Kyle Shane Beckrich, U.S. Department of Justice, Civil Division, Washington, D.C., for defendant.

OPINION & ORDER

SMITH, Senior Judge

This case concerns the Department of Veterans Affairs’ (“VA”) decision to disregard a crucial provision of the Trade Agreements Act (“TAA”) when it chose to procure Tamsulosin, a drug that treats a prostate condition. The VA awarded the contract, before and after corrective action on the procurement, to two different companies, whose Tamsulosin comes from India, a non-TAA country. In contrast, the DaVinci Company LLC (“The DaVinci Company”) offered to procure Tamsulosin from Spain, a TAA compliant country.

The VA’s decision prejudiced The DaVinci Company because the organization followed the rules and lost a valuable economic opportunity. Acetris Health, LLC v. United States, 949 F.3d 719, 723 (Fed. Cir. 2020) (describing the TAA’s requirements). In response, defendant, the United States of America, claims the VA’s decision based on the view that the TAA’s obligations can be excluded when the Buy American Act (“BAA”) is invoked. 41 U.S.C. § 8302 (a)(1). The VA categorized this procurement as a BAA small business set-aside, thereby, as defendant claims, nullifying the TAA’s

1 An unredacted version of this opinion was issued under seal on July 31, 2025. The parties were given an opportunity to propose redactions, and none were requested. obligations. 48 C.F.R. § 25.101(b).

Essentially, defendant’s argument has three stages. First, this categorization permits the VA to disregard the TAA’s requirements when there is no readily available domestic supply of the drug. Consequently, the VA may use any procurement source that normally would be excluded by the TAA. Second, the VA believes two waivers— the nonmanufacturing and the nonavailability waivers—nullifies the TAA’s requirements. Third, the BAA allows the government to completely ignore the TAA’s limits.

But defendant’s argument misses the point. The fact that Tamsulosin is insufficiently produced domestically, and the aforementioned waivers allow agencies to procure international pharmaceuticals under the BAA does not permit the VA to avoid the TAA’s statutory requirements.

I

On July 1, 2024, the VA issued Solicitation No. 36C77024Q0292 (the “Solicitation”) to purchase Tamsulosin as a small business set-aside. See Administrative Record at 56, 67 (Tab 7a), ECF No. 29 [hereinafter AR]. The VA did so after conducting a required ‘Rule of Two’ analysis, in which the VA determined that fourteen manufacturers and/or suppliers of Tamsulosin exist. Id. at 12–14 (Tab 4); see also PDS Consultants, Inc. v. United States, 907 F.3d 1345, 1357 (Fed. Cir. 2018) (“The Supreme Court [has] held that . . . [38 U.S.C.] § 8127(d) ‘unambiguously requires the [VA] to use the Rule of Two before contracting under the competitive procedures.’”) (quoting Kingdomware Techs., Inc. v. United States, 579 U.S. 162, 171 (2016)). But none of the fourteen are domestic small businesses manufactures; there are only domestic resellers. AR at 14 (Tab 4). So, on June 25, 2024, prior to issuing the Solicitation, the VA requested and then received a nonmanufacturing waiver from the SBA, thereby allowing the VA, under 13 C.F.R. § 121.406(b)(7), to use a domestic reseller of foreign-origin Tamsulosin “without regard to the place of manufacture.” Id. at 3–4 (Tab 2); id. at 5–7 (Tab 3). In issuing this waiver, the SBA found that the VA provided “sufficient evidence demonstrating that there are no domestic manufacture[r]s . . . and therefore no small business manufacture[r]s . . . as well.” Id. at 6 (Tab 3). Instead, the SBA determined that any domestic reseller would be sufficient to meet the ‘Rule of Two’ domestic-origin requirement. Id. at 3–4 (Tab 2). Based on these parameters, the Solicitation was issued the following month as a small business set- aside subject to the BAA, but not the TAA. Id. at 53 (Tab 7).

The VA received eight proposals to its Solicitation, including one from plaintiff, The DaVinci Company, submitted on July 8, 2024, offering to provide Tamsulosin from Spain, a TAA-designated country. Id. at 561–62 (Tab 18). After submitting its proposal, The DaVinci Company filed an agency protest wherein it argued, as it does here, that the VA should apply the TAA instead of the BAA to its procurement. Id. at 616–24 (Tab 23). On July 19, 2024, the VA dismissed in part and denied in part this protest based on how the agency viewed its ‘Rule of Two’ requirements. Id. at 699–

2 700. However, it failed to explain why the BAA applied over the TAA when no domestic manufacturers of Tamsulosin are available. See Plaintiff’s Motion for Judgment on the Administrative Record at 7–8, ECF No. 32 [hereinafter Pl.’s Mot.].

On July 23, 2024, the VA found Wood International LLC’s offer to be the best value to the government; that offer procures Tamsulosin from India, a non-TAA- designated country. See AR at 561–65 (Tab 18). On July 26, 2024, the VA submitted a BAA nonavailability waiver—essentially a waiver of domestic preference—to the SBA’s Made in America Office because the VA needed to procure Tamsulosin from a foreign country, given, according to the VA, that “[a]ll quotes received in response to the [S]olicitation were for pharmaceuticals manufactured in India.” Id. at 605–09 (Tab 20); id. at 562 (Tab 18). The DaVinci Company stressed this inaccuracy (among others) provided by the VA to the SBA’s Made in America Office. See Pl.’s Mot. at 10. But in an August 2, 2024, letter the Made in America Office made clear that it was unwilling to address The DaVinci Company’s issues unless plaintiff abandoned its pre- award protest. See AR at 612 (Tab 22). On August 7, 2024, the Made in America Office approved the VA’s nonavailability waiver. See Defendant’s Cross-Motion for Judgment on the Administrative Record at 15, 17, ECF No. 37 [hereinafter Def.’s Mot.].

II

On August 13, 2024, The DaVinci Company filed its complaint in this Court alleging four claims against the VA. See generally Complaint, ECF No. 1 [hereinafter Compl.]. First, the VA incorrectly applied the BAA to the Solicitation. Id. at 17–23. Second, the VA failed to apply the TAA to the Solicitation. Id. Third, the VA submitted misleading information to the Made in America Office when requesting a nonavailability waiver. Id. Fourth, the VA failed to apply the correct evaluation criteria to the eight Solicitation proposals. Id.

On August 27, 2024, defendant informed the Court of its intention to take corrective action in this case, and requested the Court stay the matter until the VA finished its process. See generally Defendant’s Motion to Stay Deadlines and Notice of Corrective Action, ECF No. 14. After a status conference the following day, the Court granted this stay—and the VA began to undertake its corrective action on the Solicitation. See generally Order Staying Case, ECF No. 16. On September 25, 2024, the VA reissued the Solicitation and sought new proposals. Def.’s Mot.

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