While issues regarding the treatment of severe COVID-19 have receded from the public’s mind, a Sept. 22, 2022, decision by the Pennsylvania Superior Court, Shoemaker v. UPMC Pinnacle Hospitals, 2022 PA Super 163, addressed the issue of whether a patient can force a hospital to provide treatments the hospital determined to be outside the standard of care. The controversy involved whether a patient had a right to force a hospital to treat the patient with ivermectin which, at the time, was a medically controversial treatment for patients with severe COVID-19. The Superior Court ruled that the patient did not have a right to require a hospital to administer an unapproved form of treatment.

Facts of the Case

Factually, the case began when the primary plaintiff, Glen Cauffman, tested positive for COVID-19 and was hospitalized at UPMC Pinnacle Hospital on Jan. 2, 2022. He was placed under the care of a UPMC attending physician, Dr. Goldman, who explained the hospital’s then-current protocol for treating COVID-19. That protocol did not include use of ivermectin, as the hospital concluded it was not well-studied, and either showed no benefit or potential harm, namely liver damage. Mr. Cauffman received approved treatments at UPMC; however, his condition deteriorated, and he was eventually sedated, intubated, and placed on a ventilator in the ICU on Jan. 10, 2022. Judith Shoemaker, acting under a power of attorney for Mr. Cauffman, requested and obtained a prescription for ivermectin from a physician who was not credentialled at UPMC. Given Mr. Cauffman’s low chance of survival and the fact that UPMC had exhausted all of its treatment options, she requested that the hospital administer ivermectin. The hospital refused, and Ms. Shoemaker sought a mandatory injunction claiming the hospital breached its express/implied contract and violated Pennsylvania and federal law by denying Mr. Cauffman his right to make rational treatment decisions.

The trial court granted Ms. Shoemaker’s ex parte request and ordered that the hospital administer the ivermectin, reasoning that Mr. Cauffman would suffer irreparable injury if the injunction was not granted. At the hearing on the merits, Ms. Shoemaker called Dr. Daniel Wheeler, who testified that there were studies showing the effectiveness of ivermectin in treating COVID-19. He concluded that administration of the drug since the initial ex parte injunction demonstrated that Mr. Cauffman’s condition had improved, and he attributed this improvement to the use of ivermectin. UPMC, on the other hand, through Dr. Goldman, chair of its infectious disease committee who was involved in Mr. Cauffman’s care, testified that the hospital’s protocol was in line with CDC and medical standards concluding that ivermectin was not effective in treating COVID-19. Dr. Goldman did not believe that Mr. Cauffman’s condition was improving as a function of ivermectin, and additional witnesses testified that the medical literature supporting use of the drug was later retracted after it was revealed the authors falsified the data in the study.

The trial court upheld the initial ex parte injunction, granted the motion for preliminary injunction, and directed the hospital to allow Mr. Cauffman’s treating physician, who was not credentialed at UPMC, to continue to administer the drug. It also directed plaintiff’s experts to be available to UPMC for consultation. UPMC appealed. During the time between the granting of the preliminary injunction and the appeal, UPMC was directed by Mr. Cauffman’s physician to administer two to three times the normal dose of ivermectin to Mr. Cauffman. In seeking an emergency stay of the trial court’s order, UPMC, through Dr. Goldman, noted that the patient’s condition was deteriorating and there appeared to be damage to the patient’s liver, which Goldman attributed to the high dose of ivermectin. The Superior Court granted UPMC’s emergency motion to stay the injunction.  Mr. Cauffman passed away Feb. 22, 2022.

Superior Court Decision

The first issue for the Superior Court to consider was whether the appeal was moot given Mr. Cauffman’s passing. UPMC acknowledged that the issue was technically moot but argued that forcing a hospital to utilize an unproven treatment was an issue of public importance that was capable of repetition and would often evade appellate review because the patient would either recover or die. Here, the court agreed that the appeal involved “a broad range of public policy issues involving the standard of care, ethical concerns of healthcare providers, and whether a court may direct a hospital to administer a certain treatment or to allow the administration of a certain treatment against hospital protocol, overriding the advice of medical professionals and hospital accreditation standards.” Thus, it would consider the merits of the appeal.

Moving to the merits, the Superior Court noted that this was a mandatory, as opposed to a prohibitory, preliminary injunction to compel an act and accordingly, subject to a higher standard under Pennsylvania law. As such, the injunction was subject to a more stringent review where the requesting party must demonstrate a clear right to relief. The issue, according to the court, was not whether ivermectin was a suitable treatment, but whether Mr. Cauffman had a legal right in need of protection. Here, the court phrased the issue as whether Mr. Cauffman had a legal right to compel UPMC to administer a treatment that contravened its own policy and to allow an uncredentialed physician to practice at the hospital in violation of hospital protocols. It ruled that Mr. Cauffman did not have such a right.

The Superior Court began its analysis by citing the Pennsylvania doctrine of corporate negligence, where a hospital can be directly liable for its failure to uphold the proper standard of care owed to a patient. By determining that the use of ivermectin would be outside the hospital’s standard of care, it concluded that plaintiffs had no right to force UPMC to administer the drug. The court wrote: “There is no precedent or applicable law to support the proposition that a patient has a legal right to demand a particular medical treatment against the advice of their treating physicians, to compel a hospital to allow the administration of a medical treatment that contravenes its own hospital policy, or to force a hospital to issue credentials to a physician to administer such a treatment.”

Similarly, it ruled that the Pennsylvania regulations cited by plaintiffs regarding the patient’s bill of rights established only that a patient has a right to full information about his medical care and a right to refuse treatment. The regulation did not, however, empower a patient with the right to demand a particular treatment. Similarly, federal regulations that mandate that a patient be allowed to participate in the development of a plan of care and make informed decisions regarding his care did not require that a patient could compel a particular treatment, as the regulation could not be construed as a mechanism to demand the provision of medically unnecessary or inappropriate services. Finally, the Superior Court held that the trial court had no basis to order UPMC to grant credentials to a physician, as this would violate the hospital’s duty to select and retain only competent physicians and to oversee persons who practice medicine at the hospital as articulated in Pennsylvania’s corporate negligence doctrine.

Citing decisions from other states regarding the administration of ivermectin, it noted that “judges are not doctors” and “cannot practice medicine from the bench.” “The judiciary is called upon to serve in black robes, not white coats. And it must be vigilant to stay in its lane and remember its role.” Accordingly, the court reversed the injunction.

While the decision pertains to the use of ivermectin, it may have ramifications to other non-standard treatments in Pennsylvania. Given the court’s historical refusal to substitute its judgment for that of a hospital’s in terms of medical decision-making, the decision is in line with the deference Pennsylvania courts give to hospitals regarding medical issues.