When it comes to Ivermectin as a COVID-19 treatment, and litigation enforcing hospitals to administer it, doctors have a duty to use their medical judgement to provide competent care and have no obligation to provide futile or harmful care, write Christopher Robertson and Margaret Houtz from the Boston School of Law in the New England Journal of Medicine.
They write:
As the COVID-19 pandemic wears on, patients have asked courts to compel hospitals to administer unproven therapies, with mixed legal results. Although talk radio hosts, politicians, and social media users have promoted various treatment approaches, they have given particular attention to Ivermectin.
The US Food and Drug Administration (FDA) has approved Ivermectin for use in humans for treating onchocerciasis (river blindness), intestinal strongyloidiasis, certain other parasitic worms, head lice, and skin conditions such as rosacea.
Although this approval facilitates legal off-label use for prophylaxis against or treatment of other conditions, both the FDA and the US Centers for Disease Control and Prevention (CDC) have cautioned against using Ivermectin for COVID-19, citing adverse gastrointestinal and neurologic effects. In addition, a Cochrane review concluded that “overall, the reliable evidence available does not support the use of Ivermectin for treatment or prevention of COVID-19 outside well-designed randomised trials”.
In US hospitals, requests for Ivermectin to treat COVID-19 have generally come as last-ditch efforts by family of critically sick patients.
For example, Jason Jones, a patient in Texas, was on a ventilator and in a medically induced coma for weeks before his wife requested that Ivermectin be administered. When the hospital didn’t provide the medication, Jones’ wife found an unaffiliated doctor who was willing to to administer it. She ultimately lost, but several other patients and surrogates have prevailed in similar suits among the hundreds filed nationwide, according to media reports.
Because these cases are often filed in local courts on an emergency basis and few have been appealed, extensive court records arenʼt always created. In three cases for which legal dockets are available – from Illinois, Ohio, and the Jones case in Texas – the lower court granted the plaintiffsʼ requests for Ivermectin. In the Ohio case, however, the court refused to issue continued injunctive relief after a 14-day period, and in the Texas case, an appeals court overturned the trial courtʼs decision. In three other cases – from Delaware, Michigan, and New York – trial courts refused the plaintiffsʼ requests. In the Michigan case, the decision was upheld on appeal.
This wave of litigation has its roots in legal frameworks related to prescribing medication, the doctor–patient relationship, physician licensing, and hospital-credentialing procedures. Although state laws are fairly consistent, these frameworks are pliable enough that various judges have decided differently on the same issue. As the court in Michigan wrote, the question is “whether the judiciary has the legal authority to compel a hospital to administer a drug, on an off-label use, that the hospital considers may harm its patient, and where that use is not
sanctioned by the FDA and other health authorities”.
However, these lawsuits have also called into question the judiciaryʼs role in medical decision-making.
According to common law, establishing a doctor–patient relationship is typically voluntary for both parties. Once this relationship is formed, doctors have a duty to use their medical judgment to provide competent care and may face discipline or liability for providing substandard care. Physicians have no obligation to provide futile or harmful care; requiring them to do so could cause moral distress.
The provision of futile care can also affect the interests of other patients, even outside the pandemic context of extreme scarcity.
Doctor–patient relationships arenʼt exclusive, however. Patients can establish relationships with several doctors, and they arenʼt confined to a particular hospital when seeking new medical advice. In the recent Ivermectin cases, patients who were stymied by their treating hospitals sought out other doctors to prescribe the medication, including doctors who have become notorious specifically for their willingness to provide this service.
In tension with this philosophy of patientsʼ choice regarding their physicians, hospital bylaws determine the membership of the medical staff and thus who can order medication within the hospital. This system is a function of hospital-accreditation standards, which are required by payers, including Medicare. As courts have recognised, although the practice of medicine is the responsibility of licensed physicians, hospitals are also bound by an independent legal duty to patients. This duty requires hospitals “to use reasonable care in formulating the policies and procedures that govern its medical staff and non-physician personnel, to exercise reasonable care in the selection of its medical staff, and to periodically monitor and review the medical staffʼs competence”.
Traditionally, there have been two workarounds for resolving conflicts between patient choice and hospital independence. First, physicians who have hospital privileges can exercise their own judgment to confirm an outside doctorʼs prescription and order medication for a hospitalised patient.
Second, when a hospital refuses to provide certain care, the patient can be transferred to a different hospital.
In the Ivermectin cases, apparently no hospital physician was willing to prescribe the drug and transfer was infeasible, because of either patient-related risks or the lack of a physician with privileges at a hospital that was willing to accept the transfer.
When the quandary has remained, several courts have sided with hospitals. The judges in these cases havenʼt focused on the medical issue of whether Ivermectin would or wouldnʼt be safe and effective for treating COVID-19 – a question that they arenʼt competent to answer, especially in the setting of an emergency petition with no opportunity for robust fact-finding. Instead, these courts have focused on whether the judiciary has the authority to issue an injunction compelling a hospital to act contrary to its staffʼs judgment.
As the court in Texas wrote, “It would be illogical to impose a duty to use reasonable care upon a hospital, but to deprive the hospital of the ability to implement policies and programmes that it deems reasonable.”
In other cases, trial courts have taken the opposite tack. Arguing that because petitioning patients are near death, and therefore there is little downside to administering Ivermectin, some judges have ordered hospitals to grant prescribing doctors emergency privileges. In the Illinois case, for example, the judge stated, “I canʼt think of a more extraordinary situation than when we are talking about a manʼs life.”
Yet of course having lives at stake isnʼt exceptional in hospitals, and it is all the more reason to ensure that practice is evidence-based. Although a hospital granting emergency privileges is arguably a fine outcome for an individual patient – if treatment with Ivermectin reflects the patientʼs or a surrogateʼs informed choice and the advice of a competent physician – such an ad hoc approach undermines the policy of having independent medical staff oversee the quality of care in US hospitals.
According to this view, hospitals arenʼt accountable institutions, just places where healthcare happens, for better or worse.
Although these decisions may make it seem as if judges are elevating themselves above doctors and hospitals, the judges might see themselves as merely resolving a dispute between two physicians: one in the hospital, opposed to Ivermectinʼs use, and the other outside the hospital, supporting its use. In this case, the tie goes to the patientʼs (or surrogateʼs) preference. But this conflict invites the larger question of why a small minority of physicians should be allowed to promote themselves as practicing in ways not supported by evidence.
In one sense, these court battles are mere echoes of previous controversies involving patients who have demanded treatments that hospitals considered futile or hospitals that wouldnʼt perform abortions or provide drugs intended to hasten death.
However, the present moment represents the strange intersection of a deadly pandemic, the rise of social media sites where treatments are promoted directly to patients, and a decade in which the “right to try” unapproved treatments has been supported by legislatures, Congress, and the White House.
The ground may be shifting, but at the moment, courts are preserving the institutional integrity of both healthcare and the judiciary.
See more from MedicalBrief archives:
Fact File: Making sense of the Ivermectin controversy
Ivermectin meta-analyses highlighted, again, the dangers of fake data
Chequered history of Ivermectin rulings in US court state courts
US court reverses order forcing hospital to treat patient with Ivermectin
US judge rules COVID patient must get Ivermectin
US judge orders administration of Ivermectin to comatose patient