CSL Plasma Inc. v. United States Customs & Border Prot.
| Decision Date | 16 September 2022 |
| Docket Number | Civil Action 21-cv-2360 (TSC),22-cv-0242 (TSC) |
| Parties | CSL PLASMA INC., et al., Plaintiffs, v. UNITED STATES CUSTOMS AND BORDER PROTECTION, et al., Defendants. HECTOR AMAYA., et al., Plaintiffs, v. UNITED STATES CUSTOMS AND BORDER PROTECTION, et al., Defendants. |
| Court | U.S. District Court — District of Columbia |
Plaintiffs-five companies that collect and sell blood plasma (“Company Plaintiffs”), their employees (“Employee Plaintiffs”), their donors (“Donor Plaintiffs”), and patients who benefit from plasma-derived therapies (“Patient Plaintiffs”)-sued Defendants United States Customs and Border Protection (“CBP”), and Chris Magnus,[1] in his official capacity as CBP Commissioner, in two cases, initially filed separately. Compl., ECF No. 1 (“CSL Plasma Compl.”) CSL Plasma, Inc., et al. v. United States Customs and Border Protection, et al., No 21-cv-2360 (D.D.C. Sept. 7, 2021) (“CSL Plasma”); Compl., ECF No. 1 (“Amaya Compl.”), Amaya, et al. v. United States Customs and Border Protection, et al., No. 22-cv-0242 (D.D.C. Jan. 31, 2022) (“Amaya”). The two cases were consolidated on June 30, 2022. Order of Consolidation ECF No. 42, CSL Plasma; Order of Consolidation, ECF No. 21, Amaya. In both cases, Plaintiffs seek a preliminary injunction enjoining CBP from preventing B-1 and B-2 visa holders from crossing the U.S.-Mexico border to donate their blood plasma at the companies' collection centers. Mot. for Prelim. Inj., ECF No. 7, CSL Plasma (“CSL Plasma Mot. for PI”); Mot. for Prelim. Inj., ECF No. 3, Amaya (“Amaya Mot. for PI”).
Of the four groups of plaintiffs, two-Donor Plaintiffs and Patient Plaintiffs-lack the necessary standing to bring suit, while Employee Plaintiffs have not made a clear showing of irreparable harm. Only Company Plaintiffs have made the clear showing necessary to merit injunctive relief. Therefore, the Amaya motion for a preliminary injunction, will be DENIED, and the CSL Plasma motion for a preliminary injunction will be GRANTED.
The Immigration and Nationality Act of 1952 (“INA”)[2] created the modern statutory framework governing the immigration, naturalization, and nationality of individuals seeking to enter the United States. While the INA primarily encompasses the immigration process, it also includes entry and removal considerations for “certain nonimmigrants,” 8 U.S.C. § 1102, who are exceptions to the broader default status of “immigrants,” and include “an alien . . . visiting the United States temporarily for business or temporarily for pleasure.” Id. § 1101(a)(15)(B).
The State Department administers visa categories and regulates the entry of nonimmigrant aliens under a temporary “B-1” business visa or a “B-2” pleasure visa. 22 C.F.R. § 41.31(a) (2020). “Business” is defined as “conventions, conferences, consultations and other legitimate activities of a commercial or professional nature,” and explicitly excludes “local employment or labor for hire.” Id. § 41.31(b)(1). State Department consular officers are instructed to issue B-1/B-2 visas if an applicant shows they intend to engage in business activities “other than the performance of skilled or unskilled labor.” 9 FAM 101.1-3(b), 402.2-5(A)(a).
State Department regulations allow Mexican nationals to receive either a B-1/B-2 visa for each trip, or a “Border Crossing Card” (“BCC”) that allows multiple B-1/B-2 entries over a 10-year period. 22 C.F.R. § 41.32. Mexican BCC holders are limited to trips no longer than 72 hours and are restricted to a zone 25-75 miles from the border. 8 C.F.R. § 235.1(h)(iii), (v). CBP determines at the port of entry whether individuals seeking admission into the United States are admissible under the B-1/B-2 visa program. 8 U.S.C. § 1201(h).
Human blood plasma is a necessary element of many medical therapies for patients with serious medical conditions and immune deficiencies. CSL Plasma Compl. ¶ 22.[3] Many of those therapies are resource intensive: a year of treatment may require vast quantities of plasma. Id. This has created an industry for the global supply of human blood plasma. Id. ¶¶ 1-2. Companies that sell blood plasma offer payment-around $50-for donations of blood plasma through plasmapheresis, a process in which a donor's blood is drawn, the plasma separated out, and the remainder (red cells, white cells, and platelets) returned to the donor. Id. ¶¶ 23-25. Donors may undergo plasmapheresis no more than twice in a seven-day period, with at least 48 hours between donations. Id. ¶ 24.
For at least 30 years, many blood plasma donors have been B-1 or B-2 visa holders (usually Mexican nationals) who enter the United States solely to donate their plasma. Id. ¶¶ 3334. To accommodate these donations, some blood plasma collection companies-like CSL Behring and Grifols-have built or acquired collection centers along the U.S.-Mexico border. Id. ¶ 4. Employee and Donor Plaintiffs work and donate plasma at these locations, and Patient Plaintiffs benefit from plasma-derived therapies.
Plaintiffs represent that annually, over 30,000 Mexican nationals donated plasma at border-adjacent collection centers operated by Grifols alone. Id. ¶¶ 3-4. They allege that Mexican national blood plasma donation has been common knowledge and accepted custom for decades. Id. ¶ 36; see also CSL Plasma Mot. for PI, Sanchez Decl. ¶ 5-6, ECF No. 7-13. Defendants counter that CBP has “long taken the position” that B-1/B-2 visa holders may not enter the United States solely to donate plasma, and that any exceptions to that position were one-offs attributable to the challenges of enforcing that restriction. Defs.' Opp. to CSL Plasma Mot. for PI ( ) at 4, ECF No. 9.
In March 2020 blood plasma donation-tacitly sanctioned or not-shifted due to the onset of the COVID-19 pandemic. As the pandemic began, the Department of Homeland Security temporarily limited land border travel to “essential travel” only. CSL Plasma Defs.' Opp., Davis Decl. ¶ 12. Ports of entry along the border, including in Arizona and California, deemed plasma donation to be an impermissible activity under the terms of the B-1/B-2 visa classification, and denied BCC holders entry into the United States for that purpose. Id.
In Texas, however, CSL Behring and Grifols issued so-called “safe passage” letters to employees and donors indicating that plasma donors were “essential,” and thus should be allowed to cross the border. CSL Plasma Mot. for PI, Mercado Decl. ¶¶ 5-6; Id. Sanchez Decl. ¶ 7. In response, some CBP port of entry supervisors in Texas coordinated with collection centers to determine whether BCC holders seeking entry to donate plasma were actually coming to collection centers to donate. Id. A system of sorts emerged: collection centers sent appointment lists showing the visa numbers of donors expected the next day to Texas CBP officials, who would then allow those BCC holders to cross the border to donate plasma. Id.
This system eventually came to the attention of CBP's Office of Field Operations, which creates and oversees enforcement policy at ports of entry. CSL Plasma Defs.' Opp., Davies Decl. ¶¶ 6, 13. After a review, the Office issued a guidance memorandum on June 14, 2021 clarifying that plasma donation is considered labor for hire that is impermissible for B-1/B-2 visa holders, regardless of their “essential” classification. Id. ¶ 14; id., Ex. 1, Impermissible Nonimmigrant B-1/B-2 Activities - Paid Plasma Donations (“Plasma Guidance” or “Guidance”). The next day, CBP issued the following statement to the press:
CSL Plasma Compl. ¶ 39. After this statement was issued, CSL Behring and Grifols began contacting members of the executive and legislative branch to “resolve the situation.” Id. ¶ 43.
CSL Behring and Grifols' outreach to the executive and legislative branches to reverse or mitigate the Guidance was unsuccessful. Id. Company Plaintiffs then filed suit in this court on September 7, 2021, alleging that the Guidance violated the Administrative Procedure Act (“APA”) because it was: (1) contrary to law, per 5 U.S.C. § 1101(a)(15)(B); (2) arbitrary and capricious, per 5 U.S.C. § 706(2)(A); and (3) impermissibly promulgated without notice-and-comment, per 5 U.S.C. § 706(2)(D). Compl. ¶¶ 31-32. Company Plaintiffs also moved for a preliminary injunction. After briefing and oral argument, this court denied injunctive relief and dismissed the case. Mem. Op. at *11, ECF No. 28, CSL Plasma. Company Plaintiffs appealed that decision to the D.C. Circuit shortly thereafter. Amend. Not. of Appeal, ECF No. 32, id.
While that appeal was pending, a group of collection center employees, donors, and patients benefitting from plasma-derived therapies filed suit in Amaya, alleging the same causes of action as in CSL Plasma. See Amaya Compl. The Amaya Plaintiffs also sought a preliminary injunction.
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