COVID-19 and Ivermectin Lawsuits

The COVID-19 pandemic has jeopardized the public health, ignited intense tribalism, and disrupted nearly every aspect of our lives, including the judicial and healthcare systems.

In the last few months, courts in several jurisdictions saw a string of lawsuits filed against hospitals by guardians of COVID-19 patients, who sought to force hospitals to administer the controversial drug ivermectin as part of their COVID-19 treatment protocol. The law firm that represented these plaintiffs indicated that many more lawsuits are in the works. See Alex Ebert & Allie Reed, “String of Suits Force Covid-19 Ivermectin Treatment in Hospitals,” Bloomberg Law, Sept. 1, 2021.

While some have lauded ivermectin as a miracle drug, the scientific and medical communities oppose ivermectin’s off-label use to treat COVID-19 because the efficacy and safety of such use remain unclear. Ivermectin tablets are approved by the Food and Drug Administration (FDA) for use in humans at very low doses to treat certain parasitic worms, but the FDA warns that ivermectin is not approved to treat COVID-19 and that larger doses “can be highly toxic” and even fatal for humans. See U.S. Food & Drug Admin., Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 (last visited Oct. 2, 2021). For these reasons, many hospitals consider ivermectin outside of the medical standard of care and refuse to administer ivermectin to treat COVID-19 patients.

Plaintiff guardians who believe they may be out of options have filed at least seven cases against such hospitals in various jurisdictions. In each case, the plaintiff sought declaratory and injunctive relief, arguing that the hospital must treat the respective patient with ivermectin for two reasons: (1) the hospital needs to comply with the patient’s ivermectin prescription and the appropriate standard of care; and (2) COVID-19 patients have a constitutional right of access to ivermectin.

While these cases have reached different outcomes, the better view is that courts should respect the standard of care for COVID-19 treatment developed by hospitals and healthcare providers, and they should recognize that there is no right to try ivermectin for this use.

Cases Supporting the Plaintiffs’ Position

The first ivermectin lawsuit was filed in upstate New York, Kulbacki v. Kaleida Health, et al., Index No. 800259/2021 (N.Y. Sup. Ct., Erie Cty., filed Jan. 8, 2021). Unlike the later cases, Kulbacki involved a patient who had previously received ivermectin treatment from the hospital. The plaintiff requested that the hospital readminister ivermectin after the patient’s condition rapidly declined. The doctors and hospital initially refused, but they ultimately agreed to administer the drug if the patient could obtain a prescription for it. The court then dismissed the plaintiff’s action as moot. Kulbacki, Index No. 800259/2021, slip op. at 1–2 (N.Y. Sup. Ct., Erie Cty., Jan. 19, 2021). The patient received the additional ivermectin treatment and has since recovered. See Dan Herbeck, “After judge orders hospital to use experimental Covid-19 treatment, woman recovers,” Buffalo News, Jan. 15, 2021.

In Dickinson v. Rochester General Hospital et al., another court in upstate New York, in a short, two-page decision, ordered the hospital to “immediately enforce” the patient’s prescription for ivermectin. Dickinson v. Rochester Gen. Hosp., Index No. 47013/2021 (N.Y. Sup. Ct., Orleans Cty., Jan. 21, 2021) (Order to Show Cause).

Similarly, in In re Estate of Nurije Fype, an Illinois court issued a one-page emergency order recognizing the patient’s daughter as the legal guardian and requiring the patient’s hospital to administer ivermectin in accordance with the patient’s prescription. In re Estate of Nurije Fype, No. 2021P000542 (Ill. Cir. Ct., DuPage Cty., Apr. 30, 2021) (Emergency Order). To no avail, the hospital’s attorney argued that “[t]he court doesn’t have the authority to order a medical corporation to use particular medications, particularly when it’s an off-label use.” John Keilman, “DuPage County judge orders Elmhurst Hospital to allow COVID-19 patient to receive controversial medication,” Chi. Trib., May 3, 2021.

The hospital appealed the court’s decision, but the court of appeals ruled that the appeal was moot because the patient had already been discharged from the hospital. In re Estate of Nurije Fype, No. 2021 IL App (2d) 210259-U (July 27, 2021).

Cases Supporting the Hospitals’ Position

However, the other four cases tell a more cautionary tale for future ivermectin plaintiffs.

The first case, Wilson v. Advocate Condell Medical Center, No. 2021MR000957 (Ill. Cir. Ct., DuPage Cty., Sept. 16, 2021), does not provide precedential support for the hospitals’ position, but it injected a word of warning to future plaintiffs. There, the Illinois court granted the plaintiff’s injunction. But after the hospital administered the initial doses of ivermectin, the patient’s heart rate plunged dangerously low, a side effect of an ivermectin overdose. The plaintiff then withdrew all pleadings and asked the judge to terminate the injunction. The hospital attributed the drop in blood pressure to ivermectin, though the plaintiff’s attorney disputed that to local news outlets. John Keilman, “Family drops lawsuit aiming to force Libertyville hospital to provide ivermectin treatment for COVID-19 patient,” Chic. Trib., Sept. 22, 2021.

The remaining three ivermectin cases—Smith v. West Chester Hospital, Motta v. Norton Brownsboro Hospital, and DeMarco v. Christiana Care Health Services, Inc.—are the first reasoned decisions, and they precluded plaintiffs from using the judicial system to interfere with hospitals’ COVID-19 treatment protocol.

In Smith, an Ohio court initially granted the plaintiff’s temporary injunction and ordered the hospital to “immediately administer” ivermectin to the patient, in accordance with his prescription.

After a hearing, however, a different judge reversed course and denied the plaintiff’s preliminary injunction. The court reasoned that the plaintiff failed to demonstrate a strong likelihood of success on the merits because “there [could] be no doubt that the medical and scientific communities do not support the use of ivermectin as a treatment for COVID-19.” The plaintiff, on the other hand, pointed only to limited, inconclusive studies, as well as “a neutral position” by the National Institutes of Health. The court also reasoned that public policy does not support forcing physicians “to try ‘any’ type of treatment on human beings. Rather, public policy supports the safe and effective development of medications and medical practices,” as well as some deference to hospitals’ standards of care. Smith v. West Chester Hosp., No. CV 2021 08 1206, slip op. at 7–8, 10 (Ohio Ct. Com. Pls., Butler Cty., Sept. 6, 2021) (denying plaintiff’s action for a preliminary injunction).

Likewise, in Motta, the Kentucky court initially granted emergency relief, but a different judge reversed that decision. The court highlighted that courts must exercise “great caution” when “asked to tell hospitals what to do,” especially because the medical community’s study and understanding of COVID-19 moves at “warp speed.” Moreover, courts cannot order hospitals to permit doctors without admitting privileges to treat inpatients just as it cannot “direct[] the NCAA to allow” high school referees “to officiate at the Final Four.” Motta v. Norton Brownsboro Hosp., No. 21-CI-003867, slip op. at 2–3 (Ky. Cir. Ct., Jefferson Cty., Sept. 15, 2021) (Order of Clarification).

In DeMarco, the Delaware court denied the plaintiff’s injunction request and emphasized that “[t]reating COVID-19 with ivermectin is undisputedly contrary to generally accepted health care standards.” Thus, “[u]nder the present standard of care, healthcare providers have no duty to administer ivermectin to a COVID-19 patient.” Although patients have a right to accept, refuse, withhold, or withdraw treatment, they do not have a right to “compel a particular treatment outside the standard of care” or to “procure and use experimental drugs.” Further, “[r]equiring a healthcare provider to administer such a treatment harms the stability of hospital administration,” the “traditional consensual nature of the physician-patient relationship,” and hospitals’ ethical and medical standards. DeMarco v. Christiana Care Health Servs., Inc., No. 2021-0804-MTZ, 2021 WL 4343661, at *9–10, *12 (Del. Ch. Sept. 24, 2021).

Standard of Care

As in Smith, Motta, and DeMarco, courts presiding over future ivermectin lawsuits should avoid “improperly and imprudently mov[ing] health care treatment decisionmaking from the patient’s bedside to a judge’s bench.” DeMarco, 2021 WL 4343661, at *13. The outcome-determinative question is whether a hospital’s decision not to treat COVID-19 patients with ivermectin is coterminous with the duty imposed on it under the appropriate standard of care.

Courts generally define the medical standard of care as the degree of care, skill, and learning expected of a reasonably prudent healthcare provider, with a similar background and in the same medical community. Littleton v. Good Samaritan Hosp. & Health Ctr., 39 Ohio St. 3d 86, 93 (1988); Nestorowich v. Ricotta, 97 N.Y.2d 393, 398 (N.Y. 2002). The professional standards that exist at the time are what tests the provider’s conduct. DeMarco, 2021 WL 4343661, at 8*.

Contrary to the ivermectin plaintiffs’ assertions, an ivermectin prescription cannot eclipse the standard of care for treating COVID-19. Courts have shown deference to hospitals, and they typically do not require hospitals to follow prescriptions that exceed or violate the standard of care. See, e.g., Watkins v. Affiliated Internists, P.C., No. M2011-00541-COA-R3CV, 2012 WL 4086139, at *3–4, n.2 (Tenn. Ct. App. Sept. 17, 2012) (medical malpractice claim where prescription allegedly violated standard of care); Pollins ex rel. Estate of Vaccaro-Pollins v. Jones, 263 Va. 25, 29 (2002) (same); Sloan v. Ohio Dep’t of Rehab. & Corr., 119 Ohio App. 3d 331, 337–38 (1997) (same).

As the Smith and DeMarco courts explained, according to the medical and scientific communities, the standard of care for COVID-19 patients does not currently include off-label ivermectin treatment. The FDA, Centers for Disease Control and Prevention, World Health Organization, American Medical Association, American Pharmacists Association, American Society of Health-System Pharmacists, and even the drug’s creator, Merck, all caution that the drug’s efficacy and safety, at higher doses and for this particular use, are unclear. See Press Release, Am. Med. Ass’n, AMA, APhA, ASHP statement on ending use of ivermectin to treat COVID-19 (Sept. 1, 2021).

In DeMarco, Motta, and Smith, the patients’ ivermectin prescriptions could not overshadow this standard of care, especially because the prescribing doctors had never met the patients and were not affiliated with the defendant hospitals.

The ivermectin plaintiffs argue that, even if ivermectin treatment is not part of the COVID-19 standard of care, it should be. They point to several promising clinical trials, as well as research by the Front Line COVID-19 Critical Care Alliance. See Front Line COVID-19 Critical Care Alliance, Ivermectin in COVID-19 (Sept. 2, 2021); J.C. Rajter et al., “Use of Ivermectin Is Associated with Lower Mortality in Hospitalized Patients with COVID-19,” CHEST, Oct. 13, 2020.

But many of the studies on which the ivermectin plaintiffs rely note their limitations, and some studies have even been retracted. See Dr. Andrew Hill, Twitter (Aug. 16, 2021); Sara Reardon, “Flawed ivermectin preprint highlights challenges of COVID drug studies,” 596 Nature 173–74, Aug. 12, 2021. Certain other studies and reports continue to raise questions about the drug’s efficacy and safety in treating COVID-19, particularly at higher doses that have not been thoroughly tested in humans. See M. Popp et al., Ivermectin for preventing and treating COVID-19 (Cochrane July 28, 2021).

For the time being, off-label ivermectin treatment is not part of the COVID-19 standard of care, and courts likely cannot force hospitals to change that.

Constitutional Right to Try Ivermectin

The plaintiff in DeMarco also argued that patients have a constitutional right to ivermectin treatment for COVID-19, stemming from the right to self-determination. 2021 WL 4343661, at *4. Some media outlets have echoed this theory, and the law firm representing the ivermectin plaintiffs endorses this theory on its website. See The Law Office of Ralph C. Lorigo in the News (last visited Oct. 2, 2021). But ivermectin plaintiffs cannot point to any legal authority to support this theory.

Rejecting similar theories, courts have long held that, although individuals have a right to obtain and reject medical treatment, they do not have a fundamental right of access to particular types of treatment, regardless of the treatment’s legality. Indeed, the Supreme Court instructs that “there is no right to practice medicine which is not subordinate to the police powers of the states and also to the power of Congress to make laws necessary and proper.” Lambert v. Yellowley, 272 U.S. 581, 598 (1926) (internal citations omitted); see also Watson v. Maryland, 218 U.S. 173, 176 (1910) (“There is perhaps no profession more properly open to such regulation than that which embraces the practitioners of medicine.”).

In Gonzales v. Raich, 545 U.S. 1 (2005), the Supreme Court rejected an as-applied Commerce Clause challenge to the Controlled Substances Act, as well as the argument that patients have a constitutional right to medically necessary marijuana. Similarly, in United States v. Oakland Cannabis Buyers’ Co-op., 532 U.S. 483 (2001), the Court denied an implied medical necessity exception to the Controlled Substances Act and explained that such a question “is for legislative judgment, not judicial interference.” Id. at 490 (quotations and citations omitted). In United States v. Rutherford, 442 U.S. 544 (1979), the Court held that terminally ill cancer patients could not enjoin the FDA’s prohibition on the drug Laetrile because, “[u]nder our constitutional framework, federal courts do not sit as councils of revision.” Id. at 555.

Federal and state courts throughout the United States have followed suit. They have held that individuals do not have a right to particular treatments under the Due Process Clause, the constitutional right to privacy, the common-law doctrine of necessity, or the common-law doctrine of self-defense. See, e.g., Abigail All. for Better Access to Developmental Drugs v. Eschenbach, 495 F.3d 695, 706–7, 710–11, n.18 (D.C. Cir. 2007) (“No circuit court has acceded to an affirmative access claim.”); Mitchell v. Clayton, 995 F.2d 772, 775 (7th Cir. 1993) (“[M]ost federal courts have held that a patient does not have a constitutional right to obtain a particular type of treatment or to obtain treatment from a particular provider if the government has reasonably prohibited that type of treatment or provider.”); see also Bexis, “More COVID Kookiness—Ivermectin Lawsuits,” Drug & Device Law Blog (Sept. 6, 2021) (string-citing federal and state cases showing that patients do not have a fundamental right to non-FDA-approved drugs).

In sum, the FDA has power over ivermectin’s use, and ivermectin plaintiffs have “point[ed] to no authority granting the right to compel a particular treatment outside the standard of care.” DeMarco, 2021 WL 4343661, at *4. Nor could we find any.

Conclusion

“It is impossible not to feel sympathetic” for plaintiffs who just want their loved ones to get better and are willing to do whatever they can to make that happen. Smith v. West Chester Hosp., No. CV 2021 08 1206, slip op. at 10 (Ohio Ct. Com. Pls., Butler Cty., Sept. 6, 2021) (denying plaintiff’s action for a preliminary injunction). But the law must remain impartial, and no law empowers courts to medicate from the bench by forcing hospitals to administer an off-label drug.