By: Thomas J. Hurney Jr. and Neil C. Brown
An Ohio court attracted national attention when a judge issued a temporary restraining order requiring a hospital to administer ivermectin to a COVID-19 patient. Another judge has now issued an order denying a motion for preliminary injunction, relieving the hospital of the order to administer the drug.
By order dated August 23, 2021, an Ohio Court of Common Pleas judge granted a 14-day preliminary injunction, which directed West Chester Hospital to administer ivermectin to a COVID-19 patient hospitalized and on a ventilator.1 The patient’s wife obtained a prescription for ivermectin from a doctor who was a proponent of the drug as a treatment for COVID-19. The prescribing physician did not have staff privileges at the hospital and had not seen the patient. The hospital started administering the drug as ordered.
Another judge held a hearing on issuance of a preliminary injunction on September 2-3, 2021, and heard testimony from the prescribing physician, as well as from the hospital and other witnesses.
In an order dated September 6, 2021, the judge denied the motion for preliminary injunction, finding, inter alia, that issuing the injunction would not serve the public interest:
[P]ublic policy in this case encompasses a number of broader issues including a hospital’s standard of care decisions, mandating doctors and nurses to provide care they believe unnecessary, ethical concerns of all doctors involved, patient autonomy, fiduciary duty, accreditation standards for patient protections, obligating one doctor to carry out the treatment regimen/plan of another doctor, interplay of RC. 4743.10, and whether a court should medicate or legislate from the bench.
As recognized by the Ohio Court of Common Pleas, ivermectin is not approved for use by the U.S. Food & Drug Administration (FDA) for treating COVID-19. The FDA’s website states it “has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea.” And “[c]urrently available data do not show ivermectin is effective against COVID-19.”
The U.S. Centers for Disease Control (CDC) provides a similar recommendation, stating “[b]e aware that currently, ivermectin has not been proven as a way to prevent or treat COVID-19.”
The drug’s manufacturer has also stated that its analysis of available and emerging studies identifies “No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and; A concerning lack of safety data in the majority of studies.”
While in this case it was ivermectin, a court order to administer any unapproved or off label drug presents a wide variety of issues. For example, what if the hospital or attending provider believes that the administration of such medication is not in the patient’s best interest? To what extent should a court have the power to direct a hospital’s or provider’s practice, especially with respect to off-label medications? To what extent would a hospital/provider be liable for adverse events in such instances? Here, the Ohio Court of Common Pleas clearly stated its desire to not “medicate . . . from the bench,” and to leave such decisions to treating hospitals/providers.
This case also raises questions from the standpoint of hospital medical staff rules and bylaws compliance. In many instances, hospital medical staff rules and bylaws require hospital providers to be credentialed and granted medical staff privileges before they can render treatment to hospital patients. And off-label uses of medication, while potentially permitted, may require supporting clinical studies and literature before being administered. If a court orders the administration of medication in contravention of such medical staff rules and bylaws, what types of repercussions may result from such violations? Would an individual provider be subject to a peer-review action? The Ohio Court of Common Pleas seemingly recognized and addressed this issue by noting that “[the patient] [was] capable of being safely and medically appropriately moved to a hospital where [the prescribing physician] has privileges.”
This case represents a victory for provider-autonomy. Namely, when an off-label, medically unsupported use of a drug is requested by a patient (or a patient’s personal representative), the Ohio Court of Common Pleas held that the ultimate authority to administer that drug belongs to the provider.
The two orders can be viewed online at:
https://s3.documentcloud.org/documents/21051019/j-smith-judgement-order.pdf
https://www.documentcloud.org/documents/21055887-oster-order
1 See Smith v. West Chester Hospital, LLC, Butler C.P. No. CV 2021 08 1206 (Sept. 6, 2021).