Ohio Trial Court Decision Denying Ivermectin Injunction

This was decided December 23, but was just posted on Westlaw.

From Franklin County Common Pleas Judge Carl Aveni's decision in Bontell v. Ohiohealth Corp. (note that Ms. Mikalonis apparently died Jan. 1, after this decision was rendered):

The narrow question before this Court is whether a single trial judge can, or should re-write existing Ohio law on a case-by case basis to compel particularized off-label medical treatment in contravention to the collective training, experience, medical judgment, and professional ethics of the physicians and hospital actually providing care.

The Ohio General Assembly has recently answered this question when enacting R.C. 4743.10, expressly reserving such judgments to the informed discretion of the medical practitioners responsible for their patients. This Court lacks a sound basis on these facts to either legislate with a gavel or practice medicine from the bench; capriciously formulating and superimposing its own views on individual infectious disease cases, where the legislature has reserved matters to the judgment of the doctors and hospitals trained, licensed and entrusted to provide such care.

It is entirely understandable that Plaintiff, faced with a devastating disease and limited options, would ask the Court to do whatever it can, and as quickly as possible. But, even from a wellspring of deep sympathy, the Court cannot re-write the laws to compel doctors to act against their judgment, training, and ethics, where the General Assembly has soundly rested that authority….

Plaintiff Lori Bontell is the health care surrogate for her sister, Karen Mikalonis, a patient receiving COVID-19 treatment in the Intensive Care Unit at Defendant's Dublin Methodist Hospital. Since December 16, 2021, Ms. Mikalonis has been on a ventilator, in a medically induced coma. Plaintiff seeks an order requiring Defendant to amend Ms. Mikalonis' ongoing treatment to include a regimen of Ivermectin. Ivermectin is an anti-parasitic drug originally developed for equine use, but now approved for some limited uses in humans as an anti-parasitic under conditions not present here.

The parties agree that this would be an off-label use of Ivermectin, and further agree that Ivermectin has not been approved as an anti-viral treatment by any public medical body. The U.S Food and Drug Administration, the Center for Disease Control and Prevention, American Medical Association, American Pharmacists Association; and the American Society of Health-System Pharmacists have each recently issued statements or advisories against the use of Ivermectin to treat COVID-19. {The Court notes this body of advisories against Ivermectin by various governmental, regulatory, medical, and pharmaceutical bodies not for their substantive conclusion that Ivermectin is contraindicated in the treatment of COVID- 19, but rather as showing that the Defendant hospital's own unwillingness to provide this treatment in the exercise of its own judgment is itself neither arbitrary nor capricious.}

After Ms. Mikalonis was admitted to Defendant hospital, Plaintiff secured a doctor licensed in other states, but not Ohio, who was willing to prescribe Ivermectin. It is undisputed that this physician is not affiliated with Defendant, and holds no privileges at Defendant's hospital. It is equally undisputed that this physician had never previously stood in a doctor-patient relationship with Ms. Mikalonis, practiced medicine in Ohio, or directly physically examined Ms. Mikalonis. There was some indication during argument at the hearing, however, that this physician may have had a remote conversation with Ms. Mikalonis by Zoom or some other video technology, before she was sedated and intubated, and while she was patient at the Defendant hospital.

In any event, it is undisputed that Plaintiff has requested Defendant include Ivermectin in Ms. Mikalonis' course of treatment; and equally clear that Defendant has refused, citing concerns about both safety and efficacy. Finally, the parties agree that it would no longer be safe to transfer Plaintiff to another facility, if one were found that was willing to consider Ivermectin as an off-label treatment for COVID-19….

At the emergency hearing, Plaintiff and Defendant alike came equipped with arguments about whether Ivermectin is an efficacious or safe treatment for COVID-19; either generally, or in the specific circumstances of a sedated patient on a ventilator. Those pharmaceutical and epidemiological questions are beyond the purview of this Court, other than to note that they are very much in debate. This Court would be ill-equipped to parse the developing medical research on those issues. But the merits of Ivermectin, whatever they may or may not be, are not the central issue before this Court.

The central question is whether the Defendant, and its associated physicians, bearing the legal responsibility to care for this patient, should be compelled to act in a way that they believe in their professional judgment may be affirmatively unsafe in addition to being merely unhelpful…. That they do not under Ohio law is dispositive of this matter. As Defendants note, the Ohio General Assembly recently codified the authority of medical professionals to decline such treatment in the exercise of their sound professional and ethical judgment. R.C. 4743.10, effective Sept. 30, 2021, directs that medical practitioners and health care institutions have "the freedom to decline to perform … any health care service which violates the practitioner's, institution's, or payer's conscience as informed by the moral, ethical or religious beliefs, or principles held by the practitioner, institution, or payer."

Here, Defendant has credibly demonstrated that its qualms about treating Ms. Mikalonis with Ivermectin stem not only from its genuinely held doubts about its efficacy, but also about its safety. See e.g., Affidavit of Dr. Joseph Gastaldo, originally filed in Franklin County Case. No 21CV5147, filed herein, at ("[t]aking a drug for an unapproved use can be very dangerous"); accord, id., at ¶¶ 24, 25, passim (noting concerns about safety and efficacy). Again, the question before this Court is not whether these concerns are correct, or might be either borne out or refuted by subsequent research and an evolving body knowledge about this emergent disease. Instead, under R.C. 4743.10(B), the Court is bound simply to examine whether Defendant holds genuine ethical concerns contrary the proposed course of treatment.

At argument this morning, Plaintiff conceded that Defendant is operating out of this ethical concern, and is motivated in good faith by its interpretation of the patient's best interests. That being the case, the law directs the outcome. Per Ohio R.C. 4743.10(B), this Court is not empowered to order the relief that Plaintiff seeks, in supplantation of Defendant's exercise of its professional judgment and contrary to Defendant's professional ethics. {While not controlling, the Court notes that this conclusion is consistent with the Butler County Common Pleas' recent decision in Smith v. West Chester Hosp., LLC (Sept. 6, 2021), Butler CP CV 2021-08-1206, also declining to prospectively compel continued Ivermectin for COVID-19 over the objections of the treating physicians.}