There have now been scores of cases seeking to compel a hospital to prescribe Ivermectin for COVID-19 patients. Most have been decided in favor of the ill patient. To be sure, these cases are usually heard on an emergency, ex parte basis, meaning without an opportunity for the hospital or doctor to sound in. Generally, the judicial opinion reeks of bald sentiment and judicial activism– the benevolent wish to give the dying patient a “last chance.” Reliance on good old-fashioned “law” is absent.
Are Doctors Indifferent to the plight of their dying patients?
The decisions evidence judicial incredulity over a treating physician’s seeming indifference or callousness for their dying patient, who, in judicial eyes, has no other option other than taking Ivermectin. To effectuate this protocol – opposed by the CDC and FDA and generally the entire medical staff -- courts are adopting the opinion of a doctor who has often never seen the patient, whose specialty bears little or no relevance to COVID, and who is uncredentialled by the hospital where the patient is admitted. Their prescriptions are rendered after a brief telephonic conference with a spouse, who then retains the doctor on behalf of her loved one. The cases usually turn on the refusal of a hospital to allow a non-credentialled physician to practice in their hospital
Judges now second-guess doctors, trespassing on the practice of medicine.
Although Ivermectin’s champions might bemoan the medical establishment’s failure to countenance the possibility the drug may work, these advocates should be equally (or perhaps more) concerned with the legal establishment’s failure to adhere to its own standards – and worry over the message these cases are sending.
The deviation from the standard of legal care when judicial opinions contradict medical judgment becomes manifest when contrasted with the practice requiring judges to instruct juries that their verdicts cannot be based on sentiment or emotion. Triers of fact (judges or juries) must agree to follow the law, whether they agree with it or not.
Scientific evidence and expert testimony, upon which medical malpractice cases turn, are required to be predicated on “sound science” –generally tested according to the multi-factorial Daubert standard [1]. New York, where many of these cases have been brought, still relies on the older Frye test – which only admits scientific (or medical) testimony if it adheres to the consensus of the scientific or medical community (which, prescribing Ivermectin for COVID does not).
Verdicts directing hospital treatment should not be blindly construed as a win for Ivermectin (and patient’s rights) then, but rather as a loss for the legal system, the practice of medicine and the respect that jurists previously demonstrated for the field of medicine .
These “case[s] turns on the role of health care providers versus that of the judiciary.” Judge Bonnie Siddurth
Two weeks ago, an appellate court in Texas rendered a decision on a court-ordered prescription of Ivermectin, reversing the trial court's ruling. While the case may have little precedential power outside of Texas, it may give us direction as to what the law requires instead of what compassion might engender.
“As a society, we not only expect, but require, doctors and hospitals to exercise their independent professional judgment.” Judge Bonnie Sudderth
Like many Ivermectin-seeking plaintiffs, Mrs. Jones demanded the drug for her gravely-ill husband, who had suffered COVID-19 and is now residing in ICU in a medically-induced coma. Her husband’s physician (and apparently the entire hospital staff) refused the demand to prescribe the drug – citing FDA and CDC directives. [2]
Mrs. Jones then located Ivermectin proponent Dr. Mary Talley Bowden online, who claims she has treated hundreds of patients with the drug. The “consult” consisted of an hour-long telephone call between Dr. Bowden, an otolaryngologist, and the patient’s wife. Dr. Bowden never saw Mr. Jones, never reviewed his hospital records, never examined him, and didn’t consult with other treating physicians. Notwithstanding, she prescribed a cocktail of 16 different medications for the ailing man. She did acknowledge “that she did not have a completely accurate picture of Mr. Jones’s medical condition” when she wrote the Ivermectin prescription. Nevertheless, she testified that this did not matter or change her recommendation for Ivermectin “because this man is dying.”
After hearing testimony that Dr. Bowden could meet the credentialing requirements of the hospital, the trial court ordered that she be credentialled and Ivermectin administered. At that point, various procedural legal niceties intervened, ultimately bringing the matter before the appellate court. Ironically, a day before the appellate decision was released, Dr. Bowden was suspended by Houston Methodist, the hospital where she was accredited, for spreading "dangerous misinformation" about Covid-19 on social media. She subsequently resigned.
While theoretically, Dr. Bowden could have obtained credentialing privileges at the Huguley hospital (had she sought them), she would have been prevented from treating or prescribing for Mr. Jones since he was in the ICU and only ICU- credentialled physicians (“intensivists”) are authorized to treat such patients at Huguley hospital. Credentialing ICU physicians at Huguley is dependent on their having obtained Board Certification in critical care, which Dr. Bowden does not possess. The trial court nevertheless ordered administration of the drug.
In an elegant, well-reasoned, but perhaps quixotic decision, Chief Judge Bonnie Sudderth of Texas’ Second Appellate District provided some broad and unequivocal principles of law which she intimates have far greater breadth than the bounds of the facts before her:
“The judiciary is called upon to serve in black robes, not white coats. And it must be vigilant to stay in its lane and remember its role. Even if we disagree with a hospital’s decision, we cannot interfere with its lawful exercise of discretion without a valid legal basis.”
Mrs. Jones’ claims included allegations that the hospital and doctors’ violated the right of informed consent, violated the Hippocratic Oath (to do no harm), violated the standard of care, and constituted a denial of the Right to Try, which applies to drugs currently considered experimental by the FDA.
The appellate court denied all her claims, additionally rejecting waivers of liability and new leniencies in CMS credentialing requirements, noting their use is permissive as a defensive posture if sued, not as an offensive strategy. As far as the Right to Try Act (sometimes called the compassionate use exception), the court noted that using a drug after a phase-one clinical trial while FDA approval is pending is not the same thing as using it off-label:
“[The Act] does not give a terminally ill patient the fundamental right to use a medicine off-label. By its own terms, the Act allows a terminally ill patient to use only an “investigational drug, biological product, or device….”
Credentialing
Perhaps the most significant tack the court took was regarding credentialing.
While the hospital claimed that acceding to Mrs. Jones’s demands would force it to violate state and federal credentialing laws, the court refused to decide the matter on such limited grounds, equating credentialling not with a quasi-ministerial function but with the actual practice of medicine.
“We begin by explaining why we need not address the credentialing issue, because our resolution turns on a more basic, central issue—the role of the judiciary when reviewing the physical and mental health decisions made by physicians or health care providers.
And the question is not (as the trial court asked) “why is it not allowed” for a non-credentialed doctor to be temporarily admitted to the ICU to administer Ivermectin to a dying man. The overarching question is whether the law gives the judiciary the authority to intervene and compel a particular outcome in the hospital’s legal exercise of its discretion to make credentialing decisions.”
Judge Sudderth ruled that unquestionably, it does not.
“[a] hospital’s credentialing of doctors is necessary to …[its] core function [it] …is, therefore, an inseparable part of the health care rendered to patients. It is the hospitals—not the courts—that have the training, responsibility, and discretion to “determine, in accordance with state law and with the advice of the medical staff, which categories of practitioners are eligible candidates for appointment to the medical staff.”
“As the Attorney General has opined, “[u]nder these statutes, the [hospital’s governing board] is the only entity authorized to appoint staff members or grant privileges.”
Judge Sudderth leaves us no doubt of the respective roles of the court, the doctor, and the hospital:
“questions of medical judgment are not subject to judicial review…. [c]ourts have disavowed any attempt to second-guess the propriety or adequacy of a particular course of treatment.” [3]
“Judges are not doctors. We are not empowered to decide whether a particular medication should be administered, or whether a particular doctor should be granted ICU privilege …. Although 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.”
Endnote
A recent case in Delaware, Demarco v. Christiana Care Health Services, demonstrates a similar judicial mindset.
“More fundamentally, it would undermine the “traditional consensual nature of the physician-patient relationship” that undergirds the safe delivery of health care. Granting Plaintiff's injunction would be detrimental to the public policy of allowing and compelling a healthcare provider to deliver the standard of care based on prevailing scientific and ethical norms and regulations.”
[1] Reed v. Granbury Hosp. Corp., 117 S.W.3d 404, 409 (Tex. App.—Fort Worth 2003,
[2] “The doctor explained that he had not prescribed Ivermectin while treating Mr. Jones’s COVID-19 because the Food and Drug Administration (FDA) had issued a warning that the drug should not be used for COVID-19 treatment, and because, likely for the same reason, the drug was not part of Huguley’s [the health system’s] COVID-19 protocol.”
[3] Russell v. Sheffer, 528 F.2d 318, 319 (4th Cir. 1975)
