For the second time in three weeks a court has denied an injunction that would have compelled a hospital to administer ivermectin to a patient seriously ill with COVID-19. We previously reported on the first of those decisions, Smith v. West Chester Hosp., LLC, 2021 WL 4129083 (Ohio Com. Pl. 2021). Today we report on the second, DeMarco v. Christiana Care Health Servs., Inc., 2021 WL 4343661 (Del. Ch. 2021).
By way of reminder, ivermectin’s labeled use in humans is for the treatment of two parasitic worms at very low doses, not the treatment of COVID-19 at very high doses. As both the DeMarco and Smith courts noted, there is no reliable evidence that ivermectin is effective against COVID-19. Not only is there no reliable evidence that ivermectin is effective against COVID-19, there are “many reports from poison control centers and toxicology centers” of “severe adverse reactions related to ivermectin” in people who have taken it. DeMarco, 2021 WL 4343661, at *6. Not surprisingly, the FDA, CDC, AMA, WHO, and other healthcare organizations have strongly recommended against use of ivermectin to treat COVID-19. Id. at *6–7. Nonetheless, there is “a legion of plaintiffs seeking to compel hospitals to treat COVID-19 patients with ivermectin.” Id. at *1.
As in Smith, the patient in DeMarco, the plaintiff’s husband, obtained a prescription for ivermectin from a doctor who “had not previously treated [him], and prescribed the medication without examining him.” 2021 WL 4343661, at *3. And, as in Smith, the prescribing doctor did not have admitting privileges at the hospital caring for the patient. Id.
The hospital caring for the patient refused to administer the ivermectin.
Plaintiff sued, seeking an injunction that would have compelled the hospital to administer the drug. The plaintiff alleged that the hospital’s refusal to administer it violated her husband’s implied contract with the hospital and her husband’s right to self-determination under Delaware state law.
The hospital opposed the injunction, arguing that the patient had no right to receive the drug and that the hospital had no duty to administer it. The hospital further argued that, given ivermectin’s lack of proven effectiveness against COVID-19, the plaintiff could not show that her husband would suffer irreparable harm from the hospital’s refusal to administer the drug. Finally, the hospital argued that compelling the hospital to administer ivermectin to treat COVID-19 despite the drug’s lack of proven benefit and its known adverse consequences based on a prescription written by a doctor without admitting privileges would be contrary to the public interest.
The court agreed with the hospital on each point.
While acknowledging that there is an implied contract between patients and their healthcare providers under Delaware law, the court explained that the duty imposed on healthcare providers by that contractual relationship is “the ‘duty to the patient to render health care that meets the applicable standard of skill and care required of every health care provider within the same field of medicine.’” 2021 WL 4343661, at *8 (quoting Anderson v. Russell, 2012 WL 1415911, at *1 (Del. Super. Ct. 2012), in turn quoting 18 Del. C. § 6801(7)). Moreover, under Delaware statute, “‘a health-care provider or institution may decline to comply with an individual instruction or health-care decision that requires medically ineffective treatment or health care contrary to generally accepted health-care standards applicable to the health-care provider or institution.’” Id. (quoting 16 Del. C. § 2508(f)). Given this legal framework, the court held that a COVID-19 patient has no contractual right to receive ivermectin under Delaware law because “[t]reating COVID-19 with ivermectin is undisputedly contrary to generally accepted health care standards.” Id. at *9.
The court further held that the statutory and constitutional rights to self-determination under Delaware law do not entitle a patient to receive a particular treatment. The “‘statutory right of self-determination’ in the health care setting is,” the court explained, “limited to the right to refuse medical or surgical treatment if such refusal is not contrary to existing public health laws.” 2021 WL 4343661, at *9 (quoting 16 Del. C. § 2502). And the constitutional right to self-determination in the healthcare setting is the right to “‘accept … or  refuse treatment.’” Id. (quoting Matter of Tavel, 661 A.2d 1061, 1068 (Del. 1995)). Neither the statutory nor the constitutional right to self-determination gives a patient “the right to compel a particular treatment outside the standard of care.” Id.
Thus, the court concluded, a hospital “does not have an enforceable duty to treat [a patient] with ivermectin, and [a patient] does not have an enforceable legal right to that treatment.” 2021 WL 4343661, at *8. In so holding, it observed that “[o]ther courts considering patient requests for treatments that fall outside the standard of care have concluded the patient,” even a terminally ill patient, “does not have a right to obtain the medication of her choice.” Id. The court cited various cases to that effect, but not Bexis’s recent post analyzing them.
The court’s determination that a patient has no right to receive ivermectin was by itself a sufficient ground on which to deny the plaintiff’s requested injunction. But the court went on to consider the other factors to be considered when an injunction is sought, i.e., whether the plaintiff had shown that an injunction was necessary to prevent irreparable injury and whether the balance of the equities favored an injunction. The court found that neither factor favored an injunction.
The court’s irreparable-harm analysis was succinct. Administering ivermectin is not the standard of care for treating COVID-19 because there is no reliable evidence that it is effective. “In fact,” found the court, “the weight of authority shows that it is not an effective treatment.” 2021 WL 4343661, at *11. “This,” the court explained, “is why ivermectin is not within the scope of a provider’s duty” and “also why” the plaintiff “cannot show its administration is necessary to avoid irreparable harm.” Id.
Considering the balance of the equities—which encompass not only potential harms to the parties but also public policy and the impact an injunction would have on the public and third parties—the court, citing Smith, concluded that the equities weighed against an injunction that would have forced the hospital to administer ivermectin.
The court found that “[c]ompelling” the hospital “to provide a treatment outside the standard of care—on the prescription of a doctor who did not see the patient, has never treated the patient, and does not have privileges at that hospital—risks substantial harm to [the hospital] and the health care system at large.” 2021 WL 4343661, at *12. It would, said the court, jeopardize “the stability of hospital administration and admitting privileges.” Id.
“More fundamentally,” the court declared, granting the “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.” 2021 WL 4343661, at *12. The injunction would not only undermine physicians’ “ethical duty not to harm their patients” but interfere with the “basis of medical practice,” which is “to deliver evidence-based medicine.” Id.
“Finally,” the court determined, “compelling a provider to operate outside the standard of care would improperly and imprudently move health care treatment decisionmaking from the patient’s bedside to a judge’s bench.” 2021 WL 4343661, at *13.
Reason carries the day.