On Monday, Bexis, laboring on Labor Day, blogged about a kooky Ohio decision ordering the off-label administration of an animal drug, ivermectin, to a seriously ill COVID-19 patient over the objections of that patient’s treating physicians and of the hospital in which the patient was being treated. The decision was kooky both medically and legally.
According to the FDA, ivermectin tablets are “approved” for use in humans “at very specific doses to treat some parasitic worms.” Those “very specific doses” are very low—at most, a one-time administration of 200 mcg/kg, which translates into a single dose of approximately 15 mg for a 175-pound person. The Ohio court ordered the hospital to administer 30 mg per day for 21 days—i.e., to administer 42 times (!) the maximum recommended dose. (Recommended, don’t forget, for treatment of two particular diseases caused by two particular parasites, not for COVID-19 caused by the SARS-CoV-2 virus.)
It is true that the FDA has approved use of ivermectin in higher doses, but higher doses in animals, not humans. As the FDA explained in an effort to dissuade use of ivermectin in COVID-19 patients, the high doses appropriate for use in animals (and the inactive ingredients used in animal formulations) “can be highly toxic in humans.” That higher does might be used in animals makes sense because, the FDA notes, “they are used for large animals like horses and cows, which weigh a lot more than we do—a ton or more.” So, as the FDA summed up on Twitter, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
Fortunately, a different Ohio judge has now stopped it, denying the plaintiff’s motion for an emergency injunction after an evidentiary hearing. The decision, Smith v. West Chester Hospital LLC, CV 2021 08 1206 (Butler Cnty. Ohio CCP Sept. 6, 2021) (“Order”), is not—yet, at least—on Westlaw or Lexis, but it is linked here.
Perhaps the second judge read Bexis’s post discussing the decision that had ordered the administration of ivermectin. Describing that decision as “unprecedented,” Bexis noted that “[w]e are unaware of any legal basis for a court to order the off-label use of any medication over the objections of treating physicians and hospitals.” Apparently the second judge wasn’t aware of any legal basis either, concluding that the plaintiff (who asked that the drug be administered to her seriously ill husband) was not entitled to the injunction she sought.
Sometimes, one doesn’t have to look beyond the framing of the issue to know how a court will rule. This is one of those instances. According to the court, the question before it was whether “an injunction should be granted to force a hospital to honor the prescription of a doctor that has not seen a patient and has no privileges at said hospital thus forcing the hospital to give ivermectin to a patient when the hospital’s doctors, the FDA, CDC, and the AMA do not believe ivermectin should be a recommended way to treat COVID-19.” Order 3. Once the court stated the issue in those terms, the only question was how it would explain its decision to deny the injunction.
Rather than taking Bexis’s scholarly approach of analyzing the extensive case law holding that patients—even terminally ill patients—do not have a right to their drug of choice (see, e.g., United States v. Rutherford, 442 U.S. 544 (1979)), the judge focused on the facts of the case in light of the four factors to be considered when deciding whether to grant an injunction: likelihood of success on the merits; whether the plaintiff will suffer irreparable injury absent the injunction; whether third parties would be harmed by the injunction; and whether the public interest would served by the injunction. The plaintiff went 0-3-1.
While it is clear what the plaintiff wanted, it is not clear—from either the initial decision granting the injunction on the pleadings or the subsequent decision denying the injunction after an evidentiary hearing—what the plaintiff’s legal claim was. According to the court, it was not a “right to try” claim. Order 10.
Whatever the plaintiff’s legal claim might have been, the court found that the plaintiff had failed to demonstrate a likelihood of success on the merits. The court noted that “[t]he studies that tend to give support to ivermectin” as a treatment for COVID-19 have not only “had inconsistent results,” but “were of low quality or low certainty, included small sample sizes, various dosing regimens, or have been so riddled with issues that the study was withdrawn.” Order 8. And the doctor who had prescribed ivermectin to the plaintiff’s husband—who, recall, has never seen the husband—testified that he did not know whether continued use of the drug would in fact benefit the husband. Id. The court said that this evidence, the evidence offered in favor of ordering the continued administration of ivermectin, had to “be balanced against” the fact that “the FDA, CDC, AMA, APhA, and the doctors who testified on behalf of” the defendant hospital all “recommend against the use ivermectin” to treat COVID-19. Id. Noting that “no single public health body in the United States supports the use of ivermectin to treat COVID-19,” the court concluded that the plaintiff had failed to show a substantial likelihood of success on the merits.
The court further found that the plaintiff had failed to demonstrate that she would suffer irreparable injury if the injunction were not issued. Given the “current evidence” showing that “ivermectin is not effective as a treatment for COVID-19,” plaintiff could not show that withholding such treatment would cause her (or her husband, the patient) injury. Order 9. Moreover, the court noted, she could have her husband transferred, without court order, to a hospital where the doctor who prescribed ivermectin (again, without ever seeing her husband) has admitting privileges. Id.
The court did not address whether a third party would be harmed by issuance of the injunction because neither party had addressed the question.
The court did, however, find that “[t]he public interest would not be served by issuing the injunction.” Order 10. Although the court said that it understood the plaintiff “wanting to do anything to help her loved one, public policy,” it said, “should not and does not support allowing a physician to try ‘any’ type of treatment on human beings.” Id. “Rather,” said the court, “public policy supports the safe and effective development of medications and medical practices,” through clinical trials, for example. Id. “What is more,” the court recognized, requiring a hospital to administer a drug over the sound medical judgment of its physicians, implicates “a number of broader issues,” including whether doctors can be compelled “to provide care they believe unnecessary” and “whether a court should medicate or legislate from the bench.” Id. In sum, the court concluded, “public policy would not favor the granting of the injunction.” Id.
Just as Bexis said.