A Delaware judge has refused to order a hospital to administer the anti-parasitic drug ivermectin to a man who is seriously ill with COVID-19.
Vice Chancellor Morgan Zurn said in a ruling issued Friday that patients, even if they are gravely ill, do not have a right to a particular medical treatment. She also said a health care provider’s duty to treat is bound by that provider’s standard of care.
“While ivermectin has been approved as safe and effective to treat human parasitic infections, and so is distinct from a wholly unapproved new drug, DeMarco still has no right to compel its use to treat COVID-19 outside the standard of care,” Zurn wrote.
The ruling came one day after a hearing in a lawsuit filed last week by Mary Ellen DeMarco on behalf of her husband, David, against Christiana Care Health Services.
Despite refusing to issue an injunction sought by Mary Ellen DeMarco, Zurn indicated that she was prepared to quickly consider an application for an interlocutory appeal to the Delaware Supreme Court.
According to the lawsuit, David DeMarco checked himself in to Christiana’s Wilmington Hospital on Sept. 9. He was placed in isolation in the intensive care unit after being diagnosed with COVID-19. His wife has been able to communicate with him only by phone.
DeMarco was placed on oxygen and given a variety of drugs, including, remdesivir, but his condition did not improve. Within days, he was diagnosed with severe respiratory failure and on the brink of requiring placement on a ventilator.
Shortly after being hospitalized, DeMarco texted his wife and requested ivermectin, which has been approved by the Food and Drug Administration to treat various tropical diseases. The drug’s antiviral and anti-inflammatory properties also have led to its use by some COVID-19 patients, some of whom have had to obtain court orders to do so, but Christiana Care’s treatment guidelines do not include ivermectin.
Mary Ellen DeMarco discussed ivermectin with hospital staff, including her husband’s treatment team and patient advocacy, but the hospital refused to treat DeMarco with it.
His wife then contacted Dr. Adam Brownstein, a family medicine specialist in Milton, who prescribed ivermectin for her husband despite not having previously treated or examined him. Mary Ellen DeMarco testified that Brownstein spoke with her husband and his doctor before writing the prescription. She got the prescription filled at a CVS pharmacy in Milford, but the hospital refused to authorize or administer it and refused to allow her to give it to her husband.
On Sept. 19, at DeMarco’s request, he was discharged from the hospital against medical advice and transferred to home hospice care so that he could self-administer ivermectin. According to the court ruling, he took one large dose of ivermectin, but his condition deteriorated rapidly after his oxygen mask broke in what his wife described as a “catastrophic equipment failure.”
Mary Ellen DeMarco called 911 and asked that her husband be taken to a different hospital, but he wound up back at Wilmington Hospital because the other hospital did not have any ICU beds. He is now intubated and on ventilator support.
In February, the National Institutes of Health said that there was insufficient evidence for its COVID-19 treatment guidelines panel to recommend “either for or against” the use of ivermectin for the treatment of COVID-19.
“Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19,” the NIH said.
While ivermectin has been shown to inhibit the replication of the coronavirus in cell cultures, studies suggest that doses up to 100-fold higher than those approved for use in humans would be needed to achieve the same antiviral efficacy detected in the lab, according to the NIH.
More recently, the American Medical Association issued a statement earlier this month opposing the use of ivermectin to prevent or treat COVID-19 outside of a clinical trial.
In that context, Zurn concluded that, under the present standard of care, health care providers have no duty to administer ivermectin to a COVID-19 patient.
She also noted that the “right of self-determination” in the health care setting allows a person to accept or refuse treatment, but that there is no legal authority granting the right to compel a particular treatment outside the standard of care.
“Even the terminally ill do not have a constitutional right to procure and use experimental drugs,” the judge wrote.