Triaging “Ivermania”: Recent Court Decisions Provide Guidance to Hospitals on Responding to Demands for Debunked COVID-19 Treatment

Despite the fact that the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), American Medical Association (AMA), American Pharmacists Association (APhA), and the American Society of Health-System Pharmacists (ASHP) have each rejected Ivermectin as an approved treatment for COVID-19, lawsuits demanding relief continue to be filed. Most of the cases are resolved prior to a court’s substantive ruling due to the patient’s recovery or failure to recover. 

However, in cases where the patient survives but continues to experience symptoms, the litigation continues. In these cases, plaintiffs have generally relied on two prongs of arguments, both of which have been rejected by the courts.

Standard of Care 

In the first line of cases, the plaintiffs demanded that Ivermectin be administered in order to comply with the community standard of care. See, e.g., DeMarco v. Christiana Care Health Servs., Inc., No. 2021-0804 (Del. Ch. Sept. 24, 2021). Courts have generally defined the standard of care as the degree of care, skill, and learning expected of a reasonably prudent healthcare provider possessing a similar background in the same medical community. 

In these cases, courts have held that physicians are indeed required to meet the prevailing standard of care, but that the requirement does not include administering every medication requested by the patient. Therefore, as Ivermectin’s efficacy remains under scrutiny, courts have held that physicians who refuse to administer the drug are not deviating from the applicable standard of care and no liability arises from their actions.

Constitutional Right of Access

In the second line of cases, the plaintiffs argued that COVID-19 patients have a constitutional right of access to Ivermectin. In one group of cases based on this theory, the plaintiffs contended that their right of access stems from the right to self-determination. A Virginia court, among others, reached the opposite conclusion and determined that, although patients have the right to make choices regarding their care, the right of self-determination is limited to the right to refuse medical treatment.  See, e.g., Marik v. Sentara Healthcare, No. CL21-13852 (Va. Cir. Ct. Nov. 23, 2021). The right does not extend to the demand for a specific treatment or medication.

Other Theories

Courts have also rejected the argument that the refusal to prescribe Ivermectin is a violation of the patient’s right to informed consent, specifically, the patient’s authorization to undergo a specific medical treatment. 

A Texas appellate court recently held that the right to informed consent does not confer upon the patient the right to compel the physician to administer a specific treatment. See Texas Health Huguley, Inc. v. Jones, 637 S.W.3d 202, 217 (Tex. App. 2021). The court stated, “[a]lthough we may empathize with a wife’s desire to try anything and everything to save her husband, we are bound by the law, and the law, in this case, does not allow judicial intervention. Just as we cannot legislate from the bench, we cannot practice medicine from the bench.” Id. at 207. Similarly, courts have also rejected arguments based on the Right to Try Act, which permits patients to request and undergo unproven treatments when diagnosed with life-threatening diseases and who have tried all approved treatments. Courts have described the Act as permissive, clarifying that it does not create an obligation for a physician to prescribe an investigational drug; however, it does protect the physician against liability if choosing to administer an investigational drug.

Hospital Guidelines & Employment Policies

Notably, while most Ivermectin cases have been brought by guardians of COVID-19 patients, at least one case, Marik, discussed above, was initiated by a hospital physician. 

In Marik, the physician was barred by the hospital from prescribing Ivermectin to COVID-19 patients. 

In his complaint against the hospital, he alleged that the hospital’s policies violated the state’s informed consent law as the guidelines prevented him from discussing with his patients Ivermectin as a potential COVID-19 treatment, and therefore fully informing the patient of the available treatment options. Although the court rejected the hospital’s argument that the physician lacked standing to bring the suit, the court held that the physician was not sufficiently impacted by its policy to challenge an alleged violation of the state’s informed consent law. Therefore, it ruled against the physician, holding that the hospital’s guidelines did not violate the patient’s informed consent rights. The court reasoned that the informed consent doctrine does not compel a hospital to provide all potentially available alternative procedures and treatments to patients. Rather, the doctrine requires only that a physician provide a patient with sufficient information to make an informed choice about his or her treatment. Notably, the court also found that the guidelines did not prohibit the physician from informing his patients of the treatment option and recommending other hospitals or facilities for the treatment.  

Conclusion & Takeaways

Prior to the publication of scientific studies disproving the efficacy of Ivermectin as a treatment for COVID-19, several courts ordered certain hospitals to permit the administration of Ivermectin. See, e.g., In re Estate of Nurije Fype, No 2021P000542 (Ill. Cir. Ct, Dupge Cty., Apr. 30, 2021); Yepes v. Long Island Jewish Forest Hills Hosp., No. 0713067/2021 (Jul. 6, 2021); Smith v. West Chester Hosp., LLC, No. CV 2021 WL 4129083 (Ohio Com. Pl. Sep. 6, 2021). Since then, the issue has evolved to the narrow question of whether courts may continue down that path and order the administration of a treatment that is neither approved by the FDA nor prescribed by a physician, and which is contrary to a hospital’s protocols for treating the patient’s illness. In general, courts have answered that question in the negative and sided with hospitals that refuse to administer Ivermectin as a COVID-19 treatment.  

However, Ivermania is spreading beyond the courtroom. Harassment of hospital staff and physicians due to their refusal to administer the drug is significantly disrupting patient care at hospitals and health systems throughout the United States. Taken together, the lawsuits and significant operational interruptions give rise to the need for a best practices pathway for health care providers as they contend with patient (and physician) demand for the administration of Ivermectin. Providers should continue to adhere to the accepted standard of care guidelines in the treatment of COVID-19 patients, especially in the face of the misinformation and threats of violence surrounding the drug. In the event providers elect to authorize the administration of Ivermectin, the providers’ informed consent forms should expressly state that Ivermectin is not approved by the FDA for use in the treatment of COVID-19, and that the patient indemnifies the provider for any harm to the patient arising from the treatment. 

Finally, providers should review their clinical guidelines, informed consent policies, and liability waivers with their medical staffs and legal counsel to ensure compliance with both the prevailing standard of care and the evolving regulatory requirements.