In the face of contrary public health guidance and recommendations, patients and their surrogates have sought to compel medical providers and hospitals to provide specific therapies to treat COVID-19. This article seeks to explore the legal issues raised by requests for injunctive relief to direct the administration of Ivermectin for COVID-19, the ethical issues related to judicial medical directives, and surrogates’ exercise of substituted judgment.
The Evolution of the COVID-19 Response – Treatment Guidance
Over the course of two years, governments, institutions, medical and scientific professionals, and individuals have grappled with this novel disease and attempted to identify its etiology and pathogenesis, contain its spread, investigate and develop treatments and vaccinations, address misinformation, and make appropriate and acceptable policy recommendations and decisions, while attempting to navigate a new normal. To that end, policy recommendations made at the state, federal, and regulatory agency level have provided guidance and recommendations for COVID-19 surveillance and treatment and limited individual rights in the furtherance of the common good and public health protection under the state’s police power.
As treatments became available, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs), and the NIH added the available treatments to the guidance. If it became clear that treatments were ineffective or that the risks outweighed the benefits, the guidance was updated.
Although its potential therapeutic effect on COVID-19 is being investigated, Ivermectin has not received EUA, but has emerged, for some, as an alternative to the standard COVID-19 treatment regimen. has not yet issued a recommendation for the use of Ivermectin as a treatment for COVID-19, although The Panel noted that clinical trials have been conducted and are ongoing.
The Case for Ivermectin
Courts have been asked, often by surrogates, to compel physicians and hospitals to administer this unapproved treatment for COVID-19, often prescribed by physicians who do not have privileges at the hospitals at issue, and often by physicians who have never actually met or examined the patient at issue in contravention of existing public health recommendations. Surrogates of gravely ill patients, having exhausted the avenues available at their respective hospital facilities, beseech judges to quickly balance the patient’s purported individual preference for a specific, unapproved medical treatment and to review the medical judgments of the patient’s treating physicians and the prescribing physician. In Marik v. Sentara Healthcare, a physician sought to enjoin the healthcare system at which he held privileges from prohibiting the application of the “MATH protocol,” which includes the prescription of Ivermectin to treat COVID-19 under a theory of informed consent. The majority of lower courts have denied plaintiffs’ requests to direct the administration of Ivermectin or to require hospitals to grant privileges to providers who would then do so.
Unique Issues when Medical Recommendations and Individual Preferences Conflict
During a continuing public health emergency and pandemic, judges have faced novel applications to mandate a particular course of treatment, the request for which may be the result of misinformation campaigns and politically motivated reactions to perceived increasing infringements on individual rights.that states may restrict individual rights for the protection of public health and safety, specifically upholding a law mandating a smallpox vaccination, noting that for over 100 years, the medical profession generally agreed that vaccination was effective.
Unlike situations such as that in Jacobson in which individuals seek not to be constrained by generally applicable public health inspired mandates, the cases seeking to compel the administration of Ivermectin seek to enforce a right which to date has not been recognized in the context of the physician-patient relationship. Generally, a physician-patient relationship is created when a patient seeks medical or surgical treatment and professional services are rendered or when medical advice is provided to a patient.In contrast, the cases concerning Ivermectin prescriptions issued often involve physicians who have not entered into a typical physician-patient relationship with the involved patient, and the patients tend to be incapacitated and treated in facilities at which the prescribing physician does not have privileges.
Physician Ethics and Moral Integrity
Courts are also being asked to override medical judgment, knowledge, and physician ethics of treating physicians who do not believe Ivermectin will be effective or may believe that its administration will be harmful to their patients.
in which the ethical norms of respect for patient self-determination and fidelity to patients are reiterated, while recognizing the need for physicians to balance their own moral integrity and authenticity across professional and personal beliefs through the freedom to practice in accord with well-considered deeply held beliefs. Although there are limitations to the exercise of physician conscience, the Ethics Opinion recommends that physicians consider their own personal integrity and emotional or moral distress prior to undertaking a particular course of treatment or before entering into the physician-patient relationship and refer a patient to another physician or institution to provide the declined treatment, unless the referral would similarly cause moral or emotional injury to the physician. As judges are asked to compel physicians to administer treatments they do not believe is within the applicable standard of care and/or are not indicated, the application of Ethical Opinion 1.1.7 is clear, and some courts have considered the potential for emotional or moral injury of the involved providers when making the determination whether to compel the administration of Ivermectin.
The legal system should seek to minimize the exacerbation of moral injury by judges compelling medical providers to act contrary to their medical judgment.
A physician’s applicable duty is to provide treatment that is consistent with the standard of care in existence at the time of the provision of the treatment. Although off-label prescribing, i.e., prescribing an approved medication for an indication that is not the original FDA-approved indication, can be consistent with the standard of care, Ivermectin is not considered the standard of care for COVID-19 treatment in any jurisdiction or medical specialty within the United States. Generally, a patient’s choice of treatment is limited to a choice between the risks, benefits, and alternatives recommended by the patient’s treating physicians.In those cases, the courts have recognized the state’s interest in preserving life, protecting the vulnerable from coercion or abuse, and protecting the integrity and ethics of the medical professional, but acknowledged in Washington v. Glucksberg that personal autonomy is limited, and there was no fundamental liberty interest to assisted suicide.
Patients are not generally entitled to dictate a particular course of treatment. In the context of COVID-19, some patients have sought care and treatment at hospital facilities that refuse to administer the patient’s desired course of treatment, and instead of leaving the institution, these patients have requested that providers administer Ivermectin or have sought supplemental medical care from outside physicians who do not have privileges at the hospital and may not even practice within the state. A few trial courts have crafted inventive workarounds to permit the administration of Ivermectin, but the orders have been overturned on appeal.
The professional and ethical impacts for the physicians who have prescribed Ivermectin for COVID-19, an off-label use, for patients they may not have examined or even met are unfolding.
In the context of the Ivermectin lawsuits, however, the actions are generally brought through a surrogate and not directly by the patient, many of whom have been intubated, sedated, and unable to advocate on their own behalf; nor do the lawsuits reference any advance directives.Advance health directives and executed healthcare proxies have been underrepresented in the Ivermectin caselaw, leaving courts to grapple with surrogacy determinations in addition to addressing the underlying merits of the claims. Many jurisdictions apply the substituted judgment for surrogate decision-makers, and the surrogates in the majority of the Ivermectin actions assert that they are exercising substitute judgment and that the patients either requested Ivermectin directly of the hospital or made their preference for the off-label prescription known prior to becoming incapacitated by COVID-19. If a surrogate is unaware of the patient’s instructions or preference, the Uniform Health Care Decisions Act instructs surrogates to make decisions in the best interests of the patient. Unfortunately, research indicates that surrogates do not often accurately predict patient treatment preferences, either because they do not actually know the patient’s preferences or intentionally deviate from the patient’s preferences due to their own values.
Right to Try
which provides expanded access to certain unapproved drugs or biologics to patients who have been diagnosed with serious or immediately life-threatening conditions or diseases who have exhausted all approved treatment options and are unable to participate in a clinical trial. The Act is inapplicable to many of the COVID-19 patients who are generally receiving approved treatments and have not attempted to obtain access to drugs under clinical trial through the FDA’s expanded use program. Manufacturers and sponsors are not required to provide their drugs or biologics to patients under the Act, and given Merck’s clear statement that Ivermectin should not be used to treat COVID-19 and its pending application for approval its oral COVID-19 treatment which was recently approved by the FDA’s Panel, it is unclear whether this or the Pfizer treatment currently pending EUA approval would be feasible alternatives for these desperate families. and especially in the context of treatment which is not generally recognized as efficacious. In the face of lawsuits seeking to mandate treatment in contravention of recognized public health guidance and medical recommendations, courts may recognize the ongoing uncertainty and continually evolving standards, but should defer to the established professional and policy recommendations and the treatment plan developed by the treating physicians.
Multiple legal and ethical issues arise when plaintiffs seek to compel physicians and hospitals to administer a preferred treatment. Courts have focused on whether fundamental rights include the right to demand a specific treatment, whether the physician-patient relationship mandates care beyond the standard of care, and whether physicians or hospitals are harmed. The inquiry as to whether the surrogates are aware of and requesting their ward’s preferences is similarly important, but courts have not had to reach that decision, because the courts have generally agreed with the DeMarco court, that where the standard of care is being met, healthcare decision-making regarding the plan of care should remain at the patient’s bedside, and not moved to the judge’s bench.