A judge in Ohio ruled on Monday that a hospital in the region must administer ivermectin to a patient very sick with COVID-19 in their ICU, despite the decision by the medical staff, in agreement with recent statements by the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), that ivermectin is not an appropriate treatment, as it has been shown not to work against COVID.
This case tracks a swelling interest, which some ascribe to the efforts of a group called America’s Front Line Doctors, among people for the anti-parasitic medication as both a treatment and prophylactic for COVID-19 — despite warnings from the medical establishment that it doesn’t work, and, if taken in the form normally given to farm animals or at the dosages being suggested, can be harmful.
The Ohio ruling is just the latest of several successful law suits (see similar cases in New York and Illinois) to order hospitals to administer ivermectin to hospitalized COVID-19 patients, despite the objections of the treating physicians.
There is also evidence of a global trend, as evidenced by the order of a court in South Africa to allow the prescription of ivermectin for COVID-19, something that was previously not permitted by the country’s drug regulatory agency.
This trend of courts ordering that treatments requested by hospitalized patients be made available by that hospital — so long as they are prescribed by a physician — opens the door to substantial administrative, legal, and ethical chaos. This post analyzes some of the most pressing legal, regulatory, and ethical concerns.
Is the prescription by the out-of-hospital doctor legal, given that the FDA has issued a statement declaring ivermectin ineffective against COVID-19 and urging doctors not to prescribe it?
Yes. As I explained in an earlier post, just as it was legal for the medical director of a Texas nursing home to prescribe hydroxychloroquine, in this case, ivermectin has already been approved by the FDA. Prescription drugs sit at an uncomfortable intersection between federal jurisdiction, which approves drugs for use in the United States by prescription, and the jurisdiction of individual states, which designate who has authority to prescribe FDA-approved drugs.
Accordingly, because ivermectin is FDA-approved, any state-licensed prescriber can order its use for any patient, for any purpose. Indeed, anecdotal evidence suggests it is being prescribed widely both to patients who request it and to patients, such as those in an Arkansas jail, who have little choice. The drug, which comes in both human and animal formulations, is also available without a prescription in a paste form intended for farm animals. As of the writing of this post, it is in stock at Amazon.com (no link provided).
Licensed prescribers can order the use of a drug even if the drug was approved by the FDA originally for a different purpose in a different population. So, a drug approved by the FDA to treat, for example, high blood pressure in adults could legally be prescribed to treat anxiety in children. This is called prescribing a drug “off-label” because the “label” indicates the uses for which it was approved. As Professor John Aloysius Cogan, Jr. at UCONN Law notes, though, a physician prescribing a drug isn’t the same as an insurance company paying for it.
The only restraint on a licensed prescriber doing this is concern over state medical malpractice liability if the patient experiences harm connected with being prescribed the drug. In most states, medical malpractice laws have been rewritten to heavily favor physicians. In every state, physicians are only held responsible for harm caused by their acts which are “outside the standard of care.” This is always hard to define and is especially so in a situation like treating COVID-19, when care recommendations change so quickly.
In times of emergency, the deference is even greater. At the urging of the American Medical Association, most states, including Ohio, and the federal government have passed short-term laws tied to a declaration of a public health state of emergency that create extensive waivers of existing health laws to shield providers (and just about everyone else) of individual liability for good faith efforts they make in treating patients for COVID-19. If this weren’t shield enough, the PREP Act likely preempts state tort laws on issues regarding treatment of COVID-19 patients.
What does it mean to be “under the care” of a specific hospital — does that limit the direct involvement of doctors not credentialed to practice in that hospital?
Most patients come into the hospital under the care of multiple other physicians, and for the most part, once they are admitted, their plans of care, such as prescriptions for chronic conditions, are re-written by physicians at the hospital and filled by the hospital pharmacy. This report, based on the experiences of Pennsylvania hospitals, details the risks of allowing patients to retain and take the medication they bring with them. The Joint Commission, an organization that sets quality standards for hospitals, provides more specific guidelines on these issues.
Must a hospital administer prescriptions requested by the patient but written by doctors not on the designated clinical care team?
In Ohio, like every other state, patients, or their legally-designated surrogate, have the right to make their own decisions about whether or not they will take a specific medication, unless they are under a specific court order to do so. In this case, the patient’s wife has made a legal request on their behalf. The question is whether the hospital is obligated to offer a medication just because the patient is requesting it. In the Ohio case, the court order mandating that the patient be administered ivermectin describes him as being the “dual patient” of both the hospital and the out-of-hospital doctor. But, while it’s common for patients to have more than one doctor, there has never been a case obligating one doctor to carry out the treatment plan of another. Each provider has independent judgement, and in the end it is the patient who decides whose advice to follow.
Here, there has been no question raised about the patient’s wife’s authority to make health care decisions for the patient — wives are designated surrogate decision makers in every state. But is authority to make decisions the same as the ability to compel compliance with a specific course of treatment? Or is the situation more like that of a passenger, who, having chosen which airliner to fly on, cannot then dictate the route? In general, courts are very deferential to private businesses’, including hospitals’, right to follow their own policies or procedures, up to the point these policies violate a state or federal law.
What are the implications of a court requiring a doctor to administer a drug they do not believe is medically indicated?
In the United States, health care providers have a fiduciary duty to act in their patient’s best interests. Coming from the Latin word for “loyal,” a fiduciary duty is a duty of care based on the superiority of a doctor’s knowledge of medicine than a patient’s.
To directly override the judgement of a treating physician (or team of physicians) to administer a medication prescribed by a doctor who is not part of the treatment team at the hospital where the patient has been admitted is new and frightening ground which raises a host of legal questions. (While there are no details in the order, since the patient is reported as being in a medically induced coma, it seems likely that the drug must be administered intravenously. So, it is probable that the order would require the hospital to mix the drug with fluid and for hospital nurses to connect the bag to a tube running into the patient’s body.)
Do the medical professionals, doctors, and nurses directly caring for this patient have a right to refuse to administer a treatment they think unwarranted and possibly harmful? Would they be protected from doing so by Ohio’s new law that allows health care providers to refuse treatment that violates their conscience? And what about the doctor willing to prescribe ivermectin — is he likely to get in trouble from the state licensure board? Probably not, says NYU bioethicist Art Caplan who opined earlier this month on the larger topic of physicians who “spread false information” about COVID-19 treatments. Moreover, Ohio’s immunity laws specific to COVID include actions by licensing boards, and provide protection, absent gross negligence or “wanton disregard” for patient safety.
When can families require that doctors provide care they do not believe is medically necessary?
It is not unusual for patients’ families to seek outside advice when told by doctors that a loved one is not getting better while being treated with existing medical care, or, more seriously, can no longer benefit from any medical care. What is unusual is for a court to circumvent the medical judgement of the treating physician to administer a course of treatment that, while legal, is vigorously contradicted by the Food and Drug Administration and thought by the vast majority of medical experts to be more harmful than helpful.
This conflict comes up most often in disputes over end-of-life care. In some states, like Texas, when a hospital seeks to withdraw a course of treatment, the issue is framed as refusing to comply with a patient’s legal wishes expressed in an “advance directive” and is explicitly allowed, so long as the hospital follows a series of procedures, including offering the patient’s family an opportunity to transfer to another hospital. Indeed, when a patient is well enough to be moved, that is usually what happens.
The process offered patients squarely does not include the right to judicial review. In other states, there is no such statutory structure, but on a case-by-case basis courts are highly reluctant to interfere with the medical judgement of a treating physician.
Do laws requiring that patients be offered access to unapproved drugs through the FDA’s compassionate use program apply to situations where patients are demanding administration of an authorized drug?
In the case of hydroxychloroquine, another example of an FDA-approved drug shown not to be effective for off-label use against COVID-19, but still sought after by patients, the President of the United States asserted that patients had “the right to try” any drug they thought would make them well.
That concept of “right to try,” and “expanded access” though, is associated with patients seeking to participate in a clinical trial of drugs not yet approved by the FDA. And in Abigail Alliance v. Eschenbach, the D.C. Circuit Court of Appeals held, in a decision that the U.S. Supreme Court declined to review (brief opposing Cert here), that no individual had a right to participate in a clinical trial conducted by a private company.
State and federal laws passed since that case have streamlined the process of requesting access to unapproved drugs if the manufacturer is willing, but no law exists that establishes a right of any patient to have access to any drug — approved by the FDA or not.
Moreover, as I’ve written earlier, a physician making a decision to “experiment” with using an old drug for a new purpose does not fall under the jurisdiction of human subjects research protection laws.
Whatever happens with the individual patient in this specific Ohio case, the broader issues it raises — of patient autonomy, provider fiduciary duty, and accrediting standards intended to protect patients — present cause for concern. Situations where patients or their families seek treatments hospitals are unwilling to provide span the gamut of illnesses, from Lyme disease, to chronic pain, to fibromyalgia, to cancer. Whether any specific case is appealed to a higher state, or even federal, court is a matter of the individual institution’s own decision about how it will manage its resources. But, as these cases proliferate, it is likely that one will be appealed, leaving open the possibility of substantial change in the relationship between patients and the hospitals which treat them.