On October 18, 2021, in a 55-page opinion, an Oregon federal district court denied a request for a temporary restraining order (TRO) to prevent the Oregon Health Authority's (OHA) recent orders requiring that educational and health workers and certain state executives obtain the COVID-19 vaccine ("Vaccine Orders") from taking effect.  The 42 plaintiffs included healthcare providers, healthcare staff, teachers, school staff and volunteers, and a state agency employee.  Plaintiffs alleged that a TRO was necessary to block the Vaccine Orders on the grounds they violated both international and constitutional law.  The decision represents an early look at how federal district courts are analyzing such challenges.

History of the Oregon Vaccine Orders

During 2020, several pharmaceutical companies, including Pfizer-BioNTech, began developing vaccines and conducting clinical trials to combat the COVID-19 virus.  In December 2020, Pfizer-BioNTech received its first Emergency Use Authorization (EUA) from the FDA for a two-dose COVID-19 vaccine that had been tested on approximately 44,000 individuals.  Less than two weeks later, the European Medicines Agency approved use of Pfizer-BioNTech's vaccine under the brand name COMIRNATY.  Importantly, the vaccines approved by the FDA and the European Union are physically, biologically, and chemically identical, despite being distributed under different names in different locations.  Over the next several months, the FDA reissued the EUA for the Pfizer-BioNTech vaccine.

In August 2021, Oregon Governor Kate Brown issued Executive Order 21-29 in response to the summer surge of COVID-19 infections and hospitalizations resulting from the highly contagious Delta variant.  In issuing the order, Governor Brown explained that COVID-19 was "imperiling the state health system's ability to manage not just COVID-19 patients, but also those who require specialized medical care after car accidents, heart attacks, and other medical emergencies," and that "employer vaccination requirements have become an important tool for managing the surge."  The executive order required that state Executive-branch employees be "fully-vaccinated" by October 18, 2021.  The OHA subsequently promulgated two more orders that required all teachers, school staff, school volunteers, healthcare providers, and healthcare staff to be fully vaccinated by October 18, 2021.

Plaintiffs' Claims and the Court's Order

In response to the Vaccine Orders, plaintiffs moved for a TRO arguing that the mandates would unlawfully coerce them into taking "experimental" medication in violation of jus cogens, a technical term for customary norms that bind the international community and that cannot be contracted away or preempted by treaty.  The term was recognized in the post-war Nuremberg Code, and prohibits medical experimentation on humans absent voluntary consent.

The court rejected this argument.  First, the court pointed out that the vaccines required under the Vaccine Order are not experimental.  The Pfizer-BioNTech and COMIRNATY-branded vaccines are materially identical, and several months' worth of testing and clinical trials went into their development.  The FDA authorized their use on an emergency basis in December 2020. 

Second, the court found that even if the two vaccines were materially different, plaintiffs failed to offer any support for the argument that "vaccine mandates, particularly during a worldwide pandemic, for an FDA-authorized vaccine that has undergone significant clinical trials and safety evaluation by the FDA [could be] considered a forced or coerced medical ‘experiment.'"  On this point, the court specifically rejected the notion that the Vaccine Orders could be likened in any way to Nazi doctors performing experiments on victims in concentration camps (i.e., the circumstances contemplated by the Nuremberg Code). 

Finally, the court highlighted that plaintiffs remain free to choose whether to obtain the vaccine or, absent a medical or religious accommodation, find employment elsewhere.  In other words, plaintiffs face no coercion to get vaccinated.

The court next considered plaintiffs' constitutional arguments against the Vaccine Orders, namely, that the Vaccine Orders violated due process rights, the Privileges or Immunities Clause, and the Supremacy Clause.  The court extensively analyzed the U.S. Supreme Court's 1907 decision in Jacobsen v. Massachusetts, in which the Court rejected the argument that Massachusetts' smallpox vaccine mandate was an unlawful exercise of police power.  Citing Jacobsen and other more recent cases, the court highlighted numerous public health laws that the general population relies on to ensure the safety and wellbeing of individuals while still respecting personal autonomy. And the court rejected the argument that any federal statutes prohibited the state of Oregon from imposing these requirements.

Plaintiffs raised several other points to which the court gave little credence.  For example, plaintiffs argued that COVID-19 vaccines do more harm than good, relying on the Vaccine Adverse Events Reporting System, or VAERS, in which healthcare providers and individuals can report adverse events following various vaccine administrations.  While 2021 saw an uptick in such adverse events, the court noted that the database does not address causal versus temporal links, nor does it take into account that millions of individual vaccines were administered in 2021.  The court further clarified that its sole function was not to analyze the safety of COVID-19 vaccines or rule on whether the Vaccine Orders were the best policy, but to determine whether the Vaccine Orders were so arbitrary as to not be "rationally related to any governmental interest and therefore shock[] the conscience."

Next, the court determined that plaintiffs failed to show that they were likely to suffer imminent irreparable injury.  Facing the loss of employment was not deemed sufficient, nor were being subjected to the terms of employers' proposed accommodations, including unpaid administrative leave.  The temporary harm associated with losing their jobs, benefits, and income did not rise to the level of imminent irreparable injury that would justify the issuance of the TRO.

Finally, the court weighed the equities and public interest of the Vaccine Orders.  In so doing, the court held that plaintiffs' claims and constitutional arguments could not "overcome the significant public interest in requiring that Executive Branch employees, healthcare workers and providers, teachers, school staff, and school volunteers … be vaccinated."

Ongoing Litigation over Vaccine Mandates

This recent decision from Oregon is one of an increasing number of cases addressing the legality of vaccine mandates. The general tenor of these decisions, from New Mexico, Texas, Minnesota, and elsewhere, is that both state and private employer mandates are lawful. These other courts have addressed many of the same arguments at play in Oregon. Requiring vaccination as a condition of employment does not offend the United States Constitution, federal statutes, or international law.

With that said, courts have taken a more mixed approach to mandates that limit the availability of medical or religious accommodations to employees. Some of these courts have struck down public mandates that allow no religious accommodations while others have closely scrutinized employer decisions to put all exempt employees on unpaid leave.

Thus, while this emerging case law broadly supports the validity of vaccine mandates, companies should consult counsel as they consider imposing and implementing such requirements, and should monitor this new area in the law closely.