Happy Birthday to the Drug and Device Law Daughter. You cannot come home from Kyrgyzstan soon enough. Fall might be the season of mists and mellow fruitfulness, but it is dismal without you. And we hope you have refrained from playing Buzkashi (headless goat polo).
Sometimes we discern patterns in our posts. Last week we wrote about whether comment k applies to horse medicine, and this week we write about whether a patient (a human one) can compel a hospital to give him horse medicine.
Okay, that’s a bit unfair of us. Ivermectin has been called horse medicine in some news accounts, but it is not that, or at least, not only that. We freely admit that in our description above we took a cheap shot. We were exploiting what has become a political as much as medical controversy. Speaking of courting controversy, today’s post is rather like what we scribbled two weeks ago on limiting liability for injuries from administration of a vaccine. It wasn’t the Covid vaccine, but we drew the connection in the hopes of drawing eyeballs to our blogsite. It was all about the clicks. Shame on us.
So this week we will play it straight. (This post also covers an issue addressed in several prior posts, including here and here.) In Cammarano v. Staten Island Univ. Hospital, 2021 NYLJ LEXIS 987 (N.Y. Superior Ct. Sept. 30, 2021), a patient diagnosed with Covid-19 filed a motion for a preliminary injunction forcing a hospital to give him Ivermectin. (The case was actually filed by the patient’s son as an advocate for the patient, but for simplicity’s sake, we’ll talk about the patient.) It was not merely a case of a patient saying ‘I wanna.’ The patient said that both the hospital’s chief of the Intensive Care Unit and the patient’s out of state doctor were in favor of Ivermectin use. But the patient did not supply affidavits to that effect, and, meanwhile, the hospital refused to administer Ivermectin to the patient because it concluded that Ivermectin was not the appropriate course of treatment.
Because the plaintiff sought a preliminary injunction, he had the burden of demonstrating both a likelihood of success on the merits and irreparable harm in the absence of the injunction. The court concluded that the plaintiff failed to meet his burden. Though the court was “sympathetic” to the plaintiff, there was “no admissible evidence submitted that Ivermectin is an effective or approved treatment for Covid-19.” Rather, all that the plaintiff presented was speculation about the effect of Ivermectin. The plaintiff also did not come up with legal authority for the court to order the requested relief. Consequently, the court refused to “overrule the clinical judgment of the patient’s physicians, as doing so may cause severe harm to those physicians” and the hospital.
The Cammarano court did not buy the plaintiff’s argument that he had a fundamental right to the Ivermectin medication. The court was reminded of cases in the 1970s in which cancer patients petitioned for a right of access to Laetrile, a drug made from fruit pits. There was pro-Laetrile publicity, and terminally ill patients were understandably desperate to try it, but courts, including SCOTUS, deferred to the FDA’s determination that Laetrile was not safe and effective in treating cancer.
The FDA had approved Ivermectin for treating intestinal conditions caused by parasitic worms. Administering Ivermectin to treat Covid-19 would be an off-label use. Sometimes off-label uses can be medically appropriate. But the FDA has taken a strong position against use of Ivermectin to treat Covid-19, finding that “currently available data do not show Ivermectin is effective.” Accordingly, the Cammarano court would “not require any doctor to be placed in a potentially unethical position wherein they could be committing medical malpractice by administering a medication for an unapproved, alleged off-label use.”
Though the plaintiff did not explicitly make the argument, the Cammarano court considered options available to the plaintiff via the Right to Try Act and the FDA’s expanded use program. Compassionate use of experimental or unapproved drugs can be available when a patient faces a life-threatening condition and no comparable or satisfactory options are available. But the court held that the plaintiff did not qualify for such compassionate use. The plaintiff did not have an active Covid-19 infection and there was no evidence that the plaintiff tried to obtain drugs undergoing clinical trials. The Cammarano court was bound by precedents that there is no fundamental right to use new or experimental drugs, and declined to “interfere with the regulations of the FDA and order the administration of Ivermectin to the patient over the objection of the Defendants.”
We often hear about the virtues of evidence-based medicine. The Cammarano case shows the virtue of evidence-based law.