By Gretchen Schuldt
A court cannot order a private health care provider to implement a treatment that the provider believes is below the standard of care, the state Court of Appeals ruled this week in a split decision.
The District II Court of Appeals panel, in a decision written by Appellate Judge Lori Kornblum, reversed a ruling by Waukesha County Circuit Judge Lloyd Carter and said that Aurora Health Care did not have to administer ivermectin to a COVID-19 patient. Kornblum was joined in the decision by Appellate Judge Lisa S. Neubauer.
Ivermectin is primarily used as an anti-parasitic in farm animals and is given to humans to treat some parasites and scabies. It has not been approved by the FDA for COVID-19 treatment.
Appellate Judge Shelley A. Grogan dissented, saying that Carter made a reasonable ruling when he issued an injunction directing Aurora to credential a doctor willing to give the treatment to the patient, John Zingsheim.
The suit is one of several similar suits involving New York attorney Ralph Lorigo that have been filed around the country. In the Wisconsin case, Lorigo represented plaintiff Allen Gahl, Zingsheim's health-care representative. Gahl also was represented by attorney Karen L. Mueller, a far-Right candidate for Wisconsin attorney general.
"Requests for injunctive relief must be premised on the existence of a viable legal claim upon which the petitioner can show a reasonable likelihood of success," Kornblum wrote. "Gahl fails to meet this foundational requirement. ... Because Gahl has failed to identify any law, claim, or recognized cause of action under Wisconsin law by which a patient may compel a health care professional to administer a course of treatment contrary to that medical professional’s judgment, the court erroneously exercised its discretion in granting Gahl injunctive relief."
Zingsheim, 60, was admitted to the hospital in September 2021 and placed in the intensive care unit. He was intubated on Oct. 3, but his condition deteriorated. He was offered other treatments, accepting some and declining others.
"Gahl, 'losing hope for [the patient’s] survival,' searched for 'an alternative treatment' and became aware of the proposed treatment" (ivermectin), Kornblum said, adding in a footnote that there is no evidence that Gahl is a doctor "or a medical professional of any kind."
Gahl obtained a prescription for the drug from Dr. Edward Hagen, who did not examine Zingsheim but prescribed a drug for him based on talking to Gahl. The hospital refused to administer the drug, however, because officials believed that doing so would not meet the standard of care.
Gahl went to court in an effort to force Aurora to comply with his wishes.
"Importantly, Gahl initially did not submit an affidavit from Hagen or any other licensed medical professional ...explaining why the proposed treatment was necessary for this patient or within the standard of care," Kornblum wrote.
Aurora argued that there is no legal authority in the state compelling a health care provider to administer a treatment the provider believes to be below the standard of care.
Aurora also said that Hagen did not even have access to Zingsheim's medical records and "raised its concern to the court that the Wisconsin State Licensing Board had previously disciplined Hagen for prescribing medications to a person who was not his patient and whom he had not examined."
Hagen admitted to the state Medical Examining Board that he prescribed drugs, including opiates, to a neighbor for about 1½ years without examining him beforehand. He also said he did not keep medical records on the patient or consult with the patient's physician. The examining board reprimanded Hagen in 2013.
Aurora filed affidavits in support of its position, including one that described the risks that ivermectin posed. They include, according to the affidavits, heart damage, liver damage, stroke, kidney damage, hypotension, loss of bodily movement control, seizures, coma, and death.
At an October hearing, Judge Carter asked for more evidence and gave the two sides until that afternoon to supplement the record. Among the items Gahl submitted was an unsworn, undated declaration from ivermectin-supporter Dr. Pierre Kory "explaining his support for the use of the proposed treatment for COVID-19 patients," Kornblum wrote. "The declaration is conspicuously devoid of any discussion of the patient in this case."
"None of the documents Gahl filed relating to Kory establish that Kory ever examined this patient or spoke with this patient’s treating medical providers. ... At no time did Gahl submit any medical information from any health care professional who had actually examined this patient, reviewed this patient’s records, or who could give a medical opinion to a reasonable degree of medical probability about the benefits of the proposed treatment on this patient at this time," she wrote.
Carter ordered Aurora to administer ivermectin but also set a hearing for the next day to allow Aurora to give reasons why his order should not go into effect.
"While the court cited the criteria for granting a temporary injunction at the hearing, the court never applied those criteria to the facts of the case on the record or in the order," Kornblum said. "The court failed to identify which, if any, legal claim asserted by Gahl in the petition provided a basis for the injunctive relief requested, much less the legal authority supporting such a claim."
Aurora sent a letter to the judge objecting to the order and saying it was "problematic."
"I am not aware of any orders written by Dr. Hagen, but am aware of a prescription written by Dr. Hagen for [the proposed treatment] 66mg to be taken once daily," the letter said. "The prescription does not indicate from where [the proposed treatment] is to be obtained or how the tablets are to be administered to a patient who is intubated and sedated. Finally, the Order provides that Aurora is to administer [the proposed treatment] 'as further ordered by Mr. Gahl.' Mr. Gahl is not a healthcare provider."
At the hearing the next day, Aurora said the patient was improving and no longer tested positive for COVID.
"Gahl’s attorney switched his argument from using the proposed treatment as an emergency treatment for COVID-19 to giving the proposed treatment for 'COVID and the damages that come about as a result of COVID,' ” Kornblum wrote.
Carter modified his order somewhat, ruling that Gahl should find a physician willing to administer the drug and to whom Aurora could grant credentials to practice in its hospital. Once credentialed, that doctor would have permission to go to the hospital and administer the ivermectin to Zingsheim.
"At no point did the court issue an oral or written order explaining whether or how Gahl had established the ... criteria for injunctive relief. The court also did not identify any claim set forth in Gahl’s petition which supported the request for relief, much less the legal authority supporting the claim," Kornblum said.
Gahl effectively acknowledges that ivermectin treatment is below the accepted level of care, Kornblum said.
"He admits that using the proposed treatment for COVID-19 is not approved by the FDA, as it is an 'off-label use of the drug,'" she wrote.
"We do not decide the medical question of what the standard of care should be. We are not doctors. We decide the legal question, as both Aurora and Gahl agree, of whether the court has the authority to order Aurora to provide treatment that is below the currently accepted standard of care for COVID-19," she said.
"The court failed to identify any viable claim upon which the temporary injunctive relief was granted, and as such, Gahl did not show a reasonable likelihood of success on the merits," Kornblum wrote.
Injunctions are used to preserve the status quo, Kornblum said, but "the court’s order neither preserved nor restored the status quo between the parties, but instead altered the status quo and granted much, if not all, of the relief Gahl ultimately seeks in this case."
"Recognizing that he has failed to identify any legal basis for the circuit court’s action, Gahl urges us to ignore the law based on his assertions that the treatment protocols for COVID-19 are wrong. ... These criticisms do not empower us to order a private health care provider to administer a proposed treatment that does not fall within its standard of care when there is no legal authority upon which to do so. Our role is to interpret and apply the law as written. We are bound by the law, and the law in this case does not provide a basis for judicial intervention," she said.
In dissent, Grogan said the issue at hand was not, as Aurora argued, whether a court could order a provider to offer care below the standard of care; it was, instead, whether Carter erroneously exercised his discretion in granting the injunction.
"Based on the record," she wrote, "it is clear the circuit court’s decision was reasoned and based on the record and applicable law."
Patients have rights in Wisconsin, she said, including the right to make their own health care decisions, the right to informed consent, and the right to request and receive medically viable alternative treatments.
"Although Wisconsin law does not afford a patient the right to demand any treatment the patient desires, it does recognize a patient’s right to request and receive medically viable alternative treatments," Grogan wrote. "The fact that the circuit court was presented with differing opinions about what treatment is proper for Zingsheim suggests the jury is still 'out' as to whether there is only one particular and established 'standard of care' in treating this novel virus. Time will eventually reveal what the standard of care or reasonable alternative treatment is for people in Zingsheim’s position. What is important here is that the circuit court had before it information from two independent physicians (one indicating he was the world’s foremost expert on treating COVID-19) who both agreed that a protocol different than that which Aurora had administered, without success, would be proper and could be beneficial to Zingsheim."
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