A trial court correctly denied a patient advocate’s request for an order directing that ivermectin be administered to her father, who was hospitalized with COVID-19, the Michigan Court of Appeals has decided.

In Frey v Trinity Health-Michigan (Docket No. 359446), the plaintiff’s 68-year-old father, David Frey, was hospitalized with COVID-19. The plaintiff was Frey’s patient advocate. A doctor had previously prescribed Frey ivermectin, a drug that is approved by the U.S. Food and Drug Administration to treat parasitic infections. The defendants, Trinity Health-Michigan/St. Joseph Mercy Hospital, refused to administer the ivermectin, saying it “would be contrary to its policy and against the medical judgment of Frey’s treating physicians.”

The plaintiff filed a complaint in the Washtenaw County Circuit Court, seeking an emergency medical declaratory and injunctive relief. She asked the trial court to issue an order directing the defendants to administer ivermectin to her father. The trial court dismissed the plaintiff’s complaint.

The Court of Appeals affirmed, finding that the plaintiff did not establish the factors required for issuing a preliminary injunction. “Contrary to plaintiff’s position, the mere fact that a doctor - who is not the treating physician and who does not have hospital privileges - prescribes a medication does not mean that a court should direct that it be administered to a patient,” the appeals court said. “The role of the courts is not to overrule the medical judgment of the treating physicians and the policies of the treating hospital.”

Judges Deborah A. Servitto, David H. Sawyer and Michael J. Kelly were on the panel that issued the unpublished opinion.

Judge Kelly concurred in part and dissented in part. “[P]laintiff is unable to show that the failure to administer ivermectin will cause irreparable harm and her motion must fail. As a result, I find it unnecessary to address the remaining factors, so I do not join the majority’s analysis of them.”

Four-Factor Failure

On appeal, the Court of Appeals first observed that the plaintiff’s situation “deserves much sympathy” because she wanted “every attempt be made to preserve her father’s health.”

However, “the law requires plaintiff to show that she is entitled to the injunctive relief that she seeks,” the Court of Appeals continued. “Therefore, our review is confined to the narrow legal question of whether plaintiff has demonstrated the factors required for issuance of an injunction. Under the circumstances, plaintiff has not met her burden.”

In its analysis, the Court of Appeals referenced the procedure for issuing a preliminary injunction set forth in MCR 3.310. That court rule says, in part: “1) Except as otherwise provided by statute or these rules, an injunction may not be granted before a hearing on a motion for a preliminary injunction or on an order to show cause why a preliminary injunction should not be issued. … 4) At the hearing on an order to show cause why a preliminary injunction should not issue, the party seeking injunctive relief has the burden of establishing that a preliminary injunction should be issued, whether or not a temporary restraining order has been issued.”

The Court of Appeals also cited Slis v State, 332 Mich App 312 (2020), and explained that a trial court must consider the following factors when deciding whether to grant injunctive relief: “(1) whether the applicant has demonstrated that irreparable harm will occur without the issuance of an injunction, (2) whether the applicant is likely to prevail on the merits, (3) whether the harm to the applicant absent an injunction outweighs the harm an injunction would cause to the adverse party, and (4) whether the public interest will be harmed if a preliminary injunction is issued.”

Accordingly, the Court of Appeals examined each of these four factors in light of the plaintiff’s request.

“As to the first factor, plaintiff has not shown irreparable harm will occur absent issuance of an injunction,” the Court of Appeals said, noting the plaintiff did not produce “any evidence that, in the absence of a current COVID-19 infection, ivermectin would have any impact on Frey’s condition.” In addition, the plaintiff “failed to provide any affirmation of the use of ivermectin from any doctor who actually has examined and treated Frey, nor has she shown that Frey’s condition will worsen absent the administering of ivermectin. The absence of such evidence is fatal to her request for a preliminary injunction in this case.”

Regarding the second factor, the plaintiff “has not shown a likelihood of success on the merits,” the Court of Appeals stated. “[The] plaintiff must show that she has a likelihood of success of proving that the law permits a court to order a hospital to give treatment that the patient’s treating physicians have not prescribed and do not recommend, and that is contrary to the hospital’s protocols for the patient’s illness. Even accepting that plaintiff has shown that some doctors credit ivermectin as an effective treatment for COVID-19, she still must provide a legal basis for her request for a court order directing the hospital to dispense it to Frey. We reject plaintiff’s argument that the hospital should have recognized her authority as Frey’s patient advocate. Plaintiff ignores the fact that the hospital’s policy against ivermectin would apply even if Frey himself, rather than his patient advocate, requested ivermectin to treat COVID-19. Therefore, this case is not simply a matter of Frey not being able to direct his own medical care, as characterized by plaintiff. Rather, plaintiff is asking this Court to allow her to override the medical opinion of Frey’s treating physicians and direct the hospital act contrary to its own policies. We decline that invitation.”

Addressing the third factor, the Court of Appeals said the plaintiff did not establish that the harm to her father, absent an injunction, outweighed the harm to the defendants. “Plaintiff argues that any harm to defendants if the injunction was granted would be negated by the fact that she has offered to sign a release of liability. But the potential harm to defendants is broader than this one case, because a court directive in this matter could open the door for a flood of similar suits from other patients with COVID-19, not to mention other conditions, suing to obtain care that is contrary to hospital policies.”

As to the fourth factor, the plaintiff argued that hospitals should acknowledge the authority granted to patient advocates to make medical decisions on behalf of incapacitated individuals. The plaintiff “is asking the Court to expand her authority as patient advocate to act in a manner contrary to the current medical practices in the hospital, and in conflict with Frey’s treating physicians, yet she has shown no legal authority for such an expansion of a patient advocate’s role,” the Court of Appeals wrote. “[T]he public interest is best served by permitting physicians and hospitals to follow established procedures and use their professional judgment to determine appropriate medical treatment.”

Accordingly, “we determine that plaintiff has not met her burden to show the four prerequisite elements to merit a preliminary injunction,” the Court of Appeals held. “Plaintiff has not provided legal authority to support her contention that courts should intrude upon a hospital’s medical policies and direct it, contrary to those policies, to administer a drug for an off-label use that the FDA specifically cautions against. Where plaintiff has failed to show the necessary elements for injunctive relief, the trial court did not abuse its discretion in denying her motion.”

Additional Arguments Dismissed

The Court of Appeals also addressed the plaintiff’s additional arguments, including that the defendants breached her father’s rights as a patient under MCL 333.20201.

“Even assuming that Frey is disabled, plaintiff has not overcome the reality that whether ivermectin can be considered ‘appropriate care’ for patients with COVID-19 is disputed,” the Court of Appeals wrote. “Defendants’ policy, established in light of the FDA recommendation, is that it is not appropriate care. … Plaintiff cites materials promoting ivermectin as a treatment for COVID-19, but she has failed to provide a legal basis for this Court to dictate a specific policy to defendant hospital regarding its patients. … The judiciary is charged with interpreting and implementing the law; it does not decide which policies hospitals should adopt regarding the off-label use of medicine, or which medical treatments are appropriate for a patient.”

Further, the Court of Appeals declined to recognize a civil right to treat COVID-19 with ivermectin. “[W]e observe that plaintiff has cited no legal authority for her proposition that the off-label use of a drug, against the recommendation of the FDA, the CDC, the hospital, and the treating physicians, is a civil right. Notably, defendants cite caselaw holding that patients do not have the right to take non FDA-approved drugs. … Although plaintiff maintains that ivermectin is not an experimental drug, its use to treat COVID-19 is not wholly accepted and can be considered experimental.”

The Court of Appeals also rejected the plaintiff’s assertion that the defendants had prohibited her from acting in her father’s best interests, which was her obligation under MCL 700.5509 as his patient advocate. “While plaintiff has the statutory authority to act as an advocate for Frey, nothing in the plain language of the statute bestows upon plaintiff the power to force a hospital to administer medication that it believes would be contrary to a patient’s care.”

In addition, the plaintiff presented a due process argument, claiming the trial court erred by dismissing her complaint sua sponte with no notice and opportunity to respond. “The transcript reflects that both attorneys were given ample time to make their arguments during the hearing, which was nearly an hour in length,” the Court of Appeals said. “Although plaintiff’s co-counsel attempted to make additional arguments after the trial court had made its decision, the fact that those arguments were disallowed did not deprive plaintiff of due process.”

Accordingly, the plaintiff “has not shown error in the dismissal procedure,” the Court of Appeals concluded. “Plaintiff sought a declaration determining the rights of the parties. The trial court determined that plaintiff was not entitled to injunctive relief. On appeal, plaintiff does not illustrate what was left for the trial court to decide. … We therefore are unable to conclude that plaintiff was not afforded due process. Under the exigent circumstances of this case, the trial court acted promptly and properly in resolving this matter.”