Johnson v. Brown

567 F.Supp.3d 1230

Malcolm JOHNSON, Stephanie Kaiser, Jessie Clark, Christina Carmichael, Tara Johnson, Kathleen Sanders, Dr. F, Travis Brenneman, Ms. D, Linda Riser, Chad Dillard, Heidi Hopkins, Glenn Hopkins, Leann Wagerle, Teresa Lynn Karn, Boaz Miller, Candy Barnett, Lane Ewry, Margaret Henson, Melissa Swancutt, Ms. B, Wendy Sumner, Adrian Park, Dr. C, Kimberly Swegar, Kelly Hickman, Ms. E, Gail Giltner, Ms. G, Jennifer Brier, Melanie Crites-Bachert, D.O., Marti Lamb, Mary Gabriele, M.D., Elisabeth Coates, Kori Distefano, Terese Lampa, Jazmin Graff, M.D., Terri Kam, Stephanie Nyhus, Dr. A, David West, Nate Lyons, Jane/John Does 1-100, Plaintiffs,

v.Kate BROWN, in her official capacity of Governor of the State of Oregon; Patrick Allen, in his official capacity as Director of the Oregon Health Authority, Defendants.

Case No. 3:21-cv-1494-SI

United States District Court, D. Oregon.

Signed October 18, 2021

Stephen J. Joncus, Joncus Law p.c., 13203 SE 172nd Avenue, Suite 166 #344, Happy Valley, OR 97086. Of Attorneys for Plaintiffs.

Ellen F. Rosenblum, Attorney General; Marc Abrams, Assistant Attorney-in-Charge; and Christina L. Beatty-Walters, Senior Assistant Attorney General, Oregon Department of Justice, 100 SW Market Street, Portland, OR 97201. Of Attorneys for Defendants.

OPINION AND ORDER

Michael H. Simon, District Judge.

This case presents another instance of individuals seeking to avoid the obligations imposed by a state-ordered COVID-19 vaccination mandate intended to protect the health of the community during a global pandemic. Under an executive order and related regulations, Oregon requires certain employees, not exempt on either medical or religious grounds, to be vaccinated against COVID-19 or face the risk of losing their jobs. Attempting to avoid the well-established constitutional framework for evaluating such a requirement, Plaintiffs invoke the international law doctrine of jus cogens (compelling law or peremptory norm). Plaintiffs, however, fail to show that they satisfy the prerequisites for this powerful, international legal principle, as determined under United States law. Because the applicable constitutional test asks only whether a state has shown a rational basis for its decision and the action challenged here satisfies that test, the Court denies Plaintiffs’ motion for a temporary restraining order (TRO).

Plaintiffs are 42 individuals who are healthcare providers, healthcare staff, teachers, school staff, a school volunteer, and a State agency employee. They allege that they are subject to orders issued by Oregon Governor Kate Brown and the Oregon Health Authority (OHA) requiring educational and health workers and certain executive State employees be vaccinated against COVID-19 (Vaccine Orders). For most persons covered by the Vaccine Orders, they must show both an intent to get fully vaccinated and forward progress, specifically by getting at least one dose of the vaccine, by October 18, 2021, or they must apply for or obtain an exception before that date.¹ Otherwise, they face the risk of having their employers terminate their employment. Plaintiffs sue Oregon Governor Kate Brown, in her official capacity, and Patrick Allen, in his official capacity as Director of the OHA. Plaintiffs assert four claims for relief.² Two claims invoke 42 U.S.C. § 1983, alleging that Defendants violated Plaintiffs’ rights under the Due Process Clause and the Privileges or Immunities Clause of the Fourteenth Amendment of the U.S. Constitution by coercing persons into taking what Plaintiffs allege is "experimental" medication: the Pfizer-BioNTech COVID-19 vaccine. Plaintiffs’ third claim invokes the Supremacy Clause of the Constitution, alleging that a federal statute relating to emergency use authorizations for vaccines requires informed consent and the Vaccine Orders conflict with that law and are therefore unconstitutional. Plaintiffs’ final claim is that Defendants violated Oregon Revised Statutes (ORS) § 431.180. Plaintiffs allege that the Vaccine Orders coerce Plaintiffs into taking experimental medication and thus interfere with Plaintiffs’ choice of treatment for COVID-19, in violation of ORS § 431.180.

Before the Court is Plaintiffs’ motion for a TRO. Plaintiffs argue that because their constitutional rights have been violated and they are in danger of losing their jobs, they face imminent irreparable harm. Plaintiffs also argue that because their right not to be coerced to take experimental medication is "undeniable," they are likely to succeed on the merits of their claims, and that the balance of the equities and public interest factors tip in their favor.

STANDARDS

In deciding whether to grant a motion for TRO, courts look to substantially the same factors that apply to a court's decision on whether to issue a preliminary injunction. See Stuhlbarg Int'l Sales Co. v. John D. Brush & Co. , 240 F.3d 832, 839 n.7 (9th Cir. 2001). A preliminary injunction is an "extraordinary remedy that may only be awarded upon a clear showing that the plaintiff is entitled to such relief." Winter v. Nat. Res. Def. Council, Inc. , 555 U.S. 7, 22, 129 S.Ct. 365, 172 L.Ed.2d 249 (2008). A plaintiff seeking a preliminary injunction generally must show that: (1) he or she is likely to succeed on the merits; (2) he or she is likely to suffer irreparable harm in the absence of preliminary relief; (3) the balance of equities tips in his or her favor; and (4) that an injunction is in the public interest. Id. at 20, 129 S.Ct. 365 (rejecting the Ninth Circuit's earlier rule that the mere "possibility" of irreparable harm, rather than its likelihood, was sometimes sufficient to justify a preliminary injunction).

The Supreme Court's decision in Winter , however, did not disturb the Ninth Circuit's alternative "serious questions" test. All. for the Wild Rockies v. Cottrell , 632 F.3d 1127, 1131-32 (9th Cir. 2011). Under this test, " ‘serious questions going to the merits’ and a hardship balance that tips sharply toward the plaintiff can support issuance of an injunction, assuming the other two elements of the Winter test are also met." Id. at 1132. Thus, a preliminary injunction may be granted "if there is a likelihood of irreparable injury to plaintiff; there are serious questions going to the merits; the balance of hardships tips sharply in favor of the plaintiff; and the injunction is in the public interest." M.R. v. Dreyfus , 697 F.3d 706, 725 (9th Cir. 2012).

In addition, a TRO is necessarily of a shorter and more limited duration than a preliminary injunction.³ Thus, the application of the relevant factors may differ, depending on whether the court is considering a TRO or a preliminary injunction.⁴ Indeed, the two factors most likely to be affected by whether the motion at issue is for a TRO or a preliminary injunction are the balancing of the equities among the parties and the public interest. Finally, "[d]ue to the urgency of obtaining a preliminary injunction at a point when there has been limited factual development, the rules of evidence do not apply strictly to preliminary injunction proceedings." Herb Reed Enters., LLC v. Florida Entmt. Mgmt., Inc. , 736 F.3d 1239, 1250 n.5 (9th Cir. 2013) ; see also Johnson v. Couturier , 572 F.3d 1067, 1083 (9th Cir. 2009).

BACKGROUND⁵

For nearly two years, COVID-19 has presented a serious risk to the health and safety of our community, nation, and world. The COVID-19 infection, caused by the virus SARS-CoV-2, undergoes mutations as it replicates, resulting in variants, some of which are more severe and transmissible than earlier variants. This case mainly concerns the authorization and approval by the United States Food and Drug Administration (FDA) of Pfizer-BioNTech's vaccine against COVID-19, and its interplay with the Vaccine Orders issued by Governor Brown and the OHA in response to dramatically increasing COVID-19 infections and hospitalizations in Oregon, particularly among the unvaccinated, to help respond to the public health crisis.

A. Pfizer-BioNTech Vaccine

1. Early Vaccine Development and Authorizations

In response to the global pandemic, Pfizer and BioNTech,⁶ along with other pharmaceutical companies, began working on a COVID-19 vaccine. To that end, Pfizer-BioNTech developed a vaccine that uses messenger RNA (mRNA), and began conducting clinical trials on the vaccine in April 2020. See ECF 3-1 at 3-4 (describing the background of the clinical trials of the Pfizer-BioNTech Vaccine); ECF 3-4 at 24 (same); ECF 10-1, 10-2 (clinical trials data).⁷ This included a clinical trial with approximately 44,000 participants. ECF 3-1 at 3; ECF 10-4 at 3; ECF 3-4 at 24; ECF 10-1.

On December 11, 2020, Pfizer-BioNTech received its first Emergency Use Authorization (EUA) from the FDA for its vaccine (Pfizer-BioNTech Vaccine or Pfizer-BioNTech COVID-19 Vaccine). ECF 3-1 at 1, 3 (describing the history of the EUAs for the Pfizer-BioNTech Vaccine); ECF 10-4 at 3 (same). This EUA authorized the Pfizer-BioNTech Vaccine as a two-dose treatment for individuals 16 years and older. Id. The EUA relied, in part, on the clinical trial of approximately 44,000 participants, among other clinical trials. EC 3-1 at; ECF 10-4 at; ECF 3-4 at 24.

On December 21, 2020, Pfizer-BioNTech received conditional marketing authorization in the European Union (EU) for its COVID-19 vaccine.⁸ The European Medicines Agency recommended that the European Commission grant the conditional approval in part based on the data from the ongoing clinical trial of 44,000 participants on which the FDA also relied in granting the EUA on December 11, 2020.⁹ On that date, BioNTech explained that its "vaccine will be marketed in the EU under the brand name COMIRNATY®."¹⁰ BioNTech also stated: "With this EU authorization in all 27 EU member states, the COVID-19 vaccine has now been granted a conditional marketing authorization, emergency use authorization, or a temporary authorization in a total of more than 40 countries. ...