WASHINGTON (CN) — The U.S. government must face a lawsuit from a group of plasma companies over a regulatory change that threatens their supply chain.
CSL Plasma and other companies like it are in the business of collecting human blood plasma for use by other companies in medicine or biotech. They say up to 10% of all plasma collected nationwide comes from Mexican nationals who earn about $50 per donation. To ensure a steady reserves and take advantage of that donor pool, the companies have invested in infrastructure along the border.
Donors from Mexico historically entered on a combination visa that allows them to enter the United States for multiple limited stays. Around this time last year, however, agents working at Customs and Border Protection received instructions not to allow aliens to enter with B‑1 visas if they were planning to sell plasma. The agency issued a written justification for the policy that said “selling plasma constitutes labor for hire in violation of B‑1 nonimmigrant status."
Chutkan called the companies’ interests merely “coincidental” to the purpose of the Administrative Procedure Act and thus outside the statutory zone of interests, but a three-judge panel of the D.C. Circuit reversed Tuesday, saying "the statutory zone of interests is a merits issue, not a jurisdictional one."
“Moreover, the plasma companies’ claims easily fit within the zone of interests of the B‑1 classification, and therefore they have a cause of action under the APA,” U.S. Circuit Judge Neomi Rao wrote for the court.
Last month during oral arguments, the panel focused heavily on the government’s claim that the noncitizen donors must prove that they have a “some nexus to international trade or commerce” to obtain a B-1 visa.
Baruch Weiss, an attorney for CSL and the other plasma companies, noted that none of the various B-1 qualifying cases that the government cited in its arguments had an international nexus. These included visa approvals for professional athletes to pick up awards and for people to negotiate contracts, to consult with business associates, and to participate in scientific, educational or business conventions.
Weiss also pointed out that the Foreign Affairs Manual, the guide used by immigration officials to determine an applicant’s visa classification, does not explicitly state any requirement for international nexus.
But Assistant U.S. Attorney Lewis Yelin insisted that, even if it is not written in the manual, the need for the international connection is proven by previous B-1 case approvals.
“Every single one of the cases … refer to the need for the activity, that is, the noncitizen’s activity, to have a necessary connection to international commerce,” Yelin said.
The D.C. Circuit rejected that argument, with the Trump-appointed Rao writing that the “government’s limitation of the B‑1 classification is found in neither the text of the statute nor longstanding judicial and agency interpretations.”
The B-1 statutory classification definition includes noncitizens “visiting the United States temporarily for business,” and specifically excludes those “coming for the purpose of study or of performing skilled or unskilled labor or as a representative of foreign press, radio, film, or other foreign information media coming to engage in such vocation.”
“Nowhere does the B‑1 classification use the term ‘international’ or otherwise suggest that the ‘business’ must be of a particular type,” the opinion states.
Rao also undercut the government’s assertion that the plasma companies cannot sue over a policy intended to protect the interests of American workers rather than businesses.
“The B‑1 classification protects the interests of American businesses such as the plasma companies, so they have a cause of action under the APA to challenge CBP’s plasma policy,” the opinion states.
Senior U.S. Circuit Judge Douglas Ginsburg, a Reagan appointee, joined Tuesday’s opinion, as did U.S. Circuit Judge Judith Rogers, a Clinton appointee. The five plasma companies that filed the suit last year are CSL Plasma, CSL Behring, Biomat USA, Talecris Plasma Resources and GCAM Inc.
Weiss told Courthouse News in an email statement on Tuesday that the circuit court's ruling "is a victory not only for the plasma companies and their donors, but for hundreds of thousands of patients who rely on plasma-derived therapies."
A Department of Justice spokesperson did not immediately respond to an email request for comment sent Tuesday.
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