An Emerging Litigation Frontier

The Evolution of the COVID-19 Response – Treatment Guidance

Since its emergence as a mysterious new form of pneumonia of unknown etiology in December 2019 and the declaration of SARS-CoV-2 as a public health emergency by the United States Secretary of Health and Human Services on January 31, 2020, SARS-CoV-2 has infected over 47.9 million people and COVID-19 has contributed to the deaths of over 773,339 people in the United States. New hospital admissions for COVID-19 peaked to over 15,000  per day across the United States. 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.

The National Institutes of Health (NIH) published COVID-19 Treatment Guidelines as of April 21, 2020, and has consistently updated the guidelines as additional scientific evidence became known. 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. For example,  hydroxychloroquine was originally recommended on March 28, 2020, but removed after its EUA was revoked on June 15, 2020.

In contrast, Ivermectin is an antiparasitic drug that has been approved by the FDA for use in humans to treat intestinal tropical diseases and as a topical cream to for external parasites, such as scabies.  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. The COVID-19 Treatment Guideline Panel (Panel) 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 Panel cited the significant methodological limitations and incomplete information of the reported studies which included missing information, small sample sizes, varying doses and schedules for the administration of Ivermectin, undefined outcome measures, and unblinded studies in which participants received not only Ivermectin, but additional treatments concomitantly, therefore making it difficult to determine the efficacy of Ivermectin as a treatment for COVID-19.

The Case for Ivermectin

As of August 2021, the Centers for Disease Control and Prevention (CDC) observed that  Ivermectin prescriptions increased exponentially during the pandemic, with a 24-fold increase from the pre-pandemic baseline, ranging from 3,600 prescriptions per week in March 2020, increasing to 39,000 prescriptions by the week of January 8, 2021, and rising to 88,000 prescriptions during the week of August 13, 2021.  In addition to Ivermectin prescriptions, reports of potential poisoning or overdoses due to ingestion of veterinary formulations of Ivermectin have been identified. The  CDC, the FDA, the American Medical Association (AMA), the American Pharmacists Association, the American Society of Health-System Pharmacists, and Merck, the manufacturer of Ivermectin, have issued statements urging individuals not to use Ivermectin to treat or prevent COVID-19.

Despite these warnings, certain patients and their family members still seek Ivermectin as a treatment for COVID-19, some resorting to securing legal representation to bring civil actions for injunctions mandating hospitals and physicians to prescribe and/or administer 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 court found that physicians should not be permitted to compel hospitals to even tacitly approve alternative treatments that the hospital deems to be unsafe. 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.   As early as 1905, the United States Supreme Court held in Jacobson v. Massachusetts 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.  The Court reiterated that a state has a right to ensure the safety of its members in the context of an epidemic disease and that individual rights may be restricted when the unfettered rights are balanced against public safety.

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.  As the AMA’s Code of Ethics Opinion on this issue provides, the patient-physician relationship is a fundamentally moral activity entered into by mutual consent, which is embodied by the clinical encounter, the imperative of which is to care for patients and to alleviate suffering. 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.  Physicians are entitled to refuse to perform, accommodate, or assist with healthcare on moral grounds under federal and certain state laws.

The AMA Code of Medical Ethics has also considered a physician’s exercise of conscience in Ethics Opinion 1.1.7 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.  In DeMarco v. Christiana Care Health Servs., the court acknowledged that compelling the defendant to follow a care plan developed by and administer treatments recommended by a non-treating physician that is inconsistent with the standard of care could potentially cause substantial harm to the physician and to the stability of hospital administration and admitting privileges.

The COVID-19 pandemic has already increased the risk of burnout and emotional upheaval for healthcare providers, especially in the context of everchanging guidance regarding treatment and mitigation strategies, the application of crisis standards of care due to strained resources, and the potential for moral injury.  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.  The right to refuse treatment is generally considered the standard for a patient’s right to self-determination, but a patient does not have a fundamental right to compel a particular course of treatment, and the physician-patient relationship, generally, does not compel a physician to act beyond or contrary to the standard of care. Actions involving the determination of how fundamental liberty rights impact medical decisions tend to relate to the right to refuse treatment or to determine the time and manner of death. 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.  As explained by Chief Justice Sudderth in Texas, in overturning the trial court’s order compelling the hospital to grant privileges to a physician for the purpose of administering Ivermectin to a patient in the ICU, “judges are not doctors…[and] are not empowered to decide whether a particular medication should be administered.”

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. Medical licensing boards have suspended providers’ licenses and commenced investigations in response to Ivermectin prescribing, as well as the spread of misinformation, generally. Hospitals have suspended the privileges of some physicians.

Surrogacy Issues

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.  For example, in Huguley, the patient’s wife was seeking a treatment the patient never requested, and he was too ill to communicate his preferences and did not have an advance directive or healthcare proxy. 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.  Surrogates may project their preferences onto their wards and may have a false sense of confidence in their ability to accurately portray their ward’s values and healthcare wishes.

Right to Try

The courts have also considered the applicability of the “Right to Try Act” 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.  It is clear, however, that there is no fundamental right to mandate a particular drug or treatment, especially for an off-label use, and especially in the context of treatment which is not generally recognized as efficacious.  The Jacobson Court recognized the inherent evolution of and controversy within the medical and scientific fields, noting that “[t]he fact that [a] belief is not universal is not controlling…the possibility that the belief may be wrong, and that science may yet show it to be wrong, is not conclusive, for the legislature has the right to pass laws which, according to the common belief of the people, are adopted to prevent the spread of contagious diseases.” 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.  

Conclusion

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.