Nine lawsuits have been filed recently seeking judicial orders forcing hospitals to administer the controversial drug ivermectin to COVID patients against the medical judgment of their treating physicians. In at least one case, in addition to the hospital, the physicians themselves were named as defendants. Seven have been successful, although one order was superseded by another judge, who ruled in favor of the defendant hospital. Hospitals are appealing other orders. In two lawsuits, the hospital prevailed and the judge refused to order administration of ivermectin.
The rulings are an unsettling development because, as we shall see, patients have no legal right to such a remedy. Indeed, in no case where I was able to review the pleadings and orders (they were not available in all cases) did the plaintiff cite any legal authority for the judge to act nor did their orders cite any authority for doing so.
Today, after a brief review of ivermectin, we’ll take a closer look at the facts of these cases. Then we’ll discuss the their ethical and legal implications.
Ivermectin, the alleged wonder drug
Ivermectin has been extensively covered here on SBM in posts by our own Scott Gavura, DPharm, and Dr. David Gorski (also here and here), as well as in a guest post by Dr. William Paolo. By way of background, here is some basic information from those posts and other sources:
- Ivermectin is approved by the FDA to treat parasites in people and, in a different formulation, is used to prevent heartworm disease and treat parasites in animals. The FDA has not approved ivermectin to prevent or treat COVID, although off-label use for that purpose is not illegal.
- At this time, there is insufficient evidence of ivermectin’s effectiveness as a COVID prophylactic or treatment and a growing body of evidence points to the conclusion that it is not effective for these uses. It can also have side effects. Some people have ingested the animal formulation and become seriously ill.
- The FDA, WHO, the AMA, the American Pharmacists Association, and the American Society of Health-System Pharmacists all oppose the use of ivermectin to prevent or treat COVID outside of a clinical trial. According to the NIH COVID-19 Treatment Guidelines Panel, there is insufficient evidence to recommend its use. The CDC has issued a Health Advisory warning on ivermectin. Even Merck, the drug’s maker, recommends against using it for COVID.
- Despite all of this, and the availability of vaccines and effective treatments for COVID, some physicians, politicians, right-wing media personalities, as well as all-out quacks, continue to promote ivermectin. A group calling itself the Front Line COVID-19 Critical Care Alliance (FLCCC) aggressively promotes ivermectin with cherry-picked evidence and has created unproven treatment protocols that include it.
The nine lawsuits have similar facts so I won’t discuss each individually (for one reason, it would make this post entirely too long). However, before we begin, here’s a list of each patient for whom judicial intervention was sought, with links to more information about their cases, including media reports and documents filed with the courts. (I’ll link to some of these again in referring to particular cases.)
- Randy Clouse (also here), Illinois
- Richard Cyganovich (also here), New York
- Glenna Dickinson (also here), New York
- Nurije Fype (also here), Illinois
- Michael Gangemi (also here), New York
- Pete Lopez (also here), Texas
- Judith Smentkiewicz, New York
- Jeffrey Smith (also here and here), Ohio
- John Swanson, New York
In a typical case, a patient contracts COVID and is hospitalized. In most cases the patient is in the ICU and some are on ventilators. A family member has read about ivermectin online, seen it discussed on Fox News or in other media, and/or discovered the dubious advice of the FLCCC.
Because most of the COVID patients in these cases are incompetent to make their own decisions due to their illness, a spouse or other family member wants one of the patient’s physicians to administer ivermectin. The physician and/or the hospital refuse. Some family members then get prescriptions for ivermectin from physicians who do not have privileges at the hospital, but the hospital still declines either to administer the ivermectin with its own staff or allow the physician without privileges to do so. In the Texas case, the patient had been prescribed ivermectin at a VA Medical Center but was admitted to the hospital before he was able to take it.
The family member then files suit on behalf of the patient seeking to force the hospital to allow administration of ivermectin. In all but one case, the plaintiffs are represented by New York law firm of attorney Ralph C. Lorigo. The plaintiffs seek emergency relief, asking that the court enter an order requiring the hospital to administer ivermectin immediately. The courts have issued such orders before the hospital has had an opportunity to be heard and, in at least one case, before the hospital was served with notice that the action had commenced.
Favorable orders are usually based on documentary evidence filed by the plaintiffs. Plaintiffs have submitted copies of the unproven FLCCC protocols, supporting affidavits from physicians who prescribe or promote ivermectin, studies purporting to show the effectiveness of ivermectin, and news articles about similar cases in which courts have ordered hospitals to administer the drug. In one case, Dr. Pierre Kory, president of the FLCCC and ivermectin promoter extraordinaire, himself supplied an affidavit. In another, there is an affidavit from Dr. Fred Wagchul, one of the FLCCC’s founders. Needless to say, this evidence generally presents a glowing picture of ivermectin’s effectiveness as a COVID treatment.
In the cases won by the plaintiffs, the courts either ordered the hospital to administer ivermectin to the patient (with, in some cases, the family delivering ivermectin to the hospital from an outside pharmacy, which is against hospital protocol) or ordered the hospital to allow a physician who did not have privileges at the hospital to administer the drug. The hospitals have appealed at least two of these cases.
In several cases, according to media reports, patients have improved after being treated with ivermectin, which their families, their attorney, and some doctors interpret as evidence of the drug’s effectiveness.
One doctor said that Nurije Fype had been weaned off a ventilator and discharged from the hospital after receiving small amounts of ivermectin for 20 days. Judith Smentikeiwicz’s family thinks ivermectin saved her life, her son claiming that, in less than 48 hours, his mother was taken off the ventilator, transferred out of the ICU, and was sitting up on her own and communicating. Mr. Lorgio, the attorney who obtained the order, said that Ms. Smentikeiwicz “was on a ventilator, literally on her deathbed, before she was given this drug. As far as we’re concerned, the judge’s order saved this woman’s life.” Mr. Lorgio also claimed, in the case of John Swanson, that after one dose of ivermectin, Swanson was breathing on his own and taken off the ventilator “and was making great progress”.
Fortunately, for balance, some news reports about these seemingly miraculous recoveries also quoted experts cautioning that correlation does not mean causation and pointing out that there is still not enough evidence to support ivermectin’s effectiveness for COVID.
In the case of Pete Lopez, who unfortunately passed away, the family is angry because, they say, the hospital refused to administer ivermectin after being ordered to do so by a court. The hospital has appealed the order and Mr. Lorgio, the family’s attorney, is seeking to hold the hospital in contempt. In the Fype case, Mr. Lorgio tried to get the judge to order the hospital to pay the plaintiffs’ legal expenses and issue a $25,000 fine, but the judge refused, saying the hospital had complied with the court’s order.
Hospitals have had some success in fighting these actions.
In Ohio, a judge, having given the hospital an opportunity to present evidence, ruled that it “bears no duty to honor a prescription” for ivermectin written for COVID patient Jeffrey Smith (also represented by the Lorgio firm), superseding a previous order by a different judge requiring the hospital to do so. Twenty-one days of ivermectin had been prescribed by Dr. Fred Wagshul, who (as was revealed at the hearing) had never reviewed Mr. Smith’s clinical information or discussed treatment with his physicians, is not board-certified in any specialty, and has not worked in a hospital for 10 years. (At the time of the hearing, Mr. Smith had received 13 doses.) Dr. Wagshul said that the pharmaceutical industry and U.S. government have “smeared” ivermectin and “‘censored’ its allegedly undeniable beneficial value”. (An odd claim in light of the fact that the drug’s own manufacturer advises against its use.) He nevertheless testified that “I honestly don’t know” if ivermectin had benefited Mr. Smith.
In an interview, Dr. Wagshul claimed that the science behind ivermectin is “irrefutable”, that the CDC and FDA were in a “conspiracy” against the drug to protect the FDA’s Emergency Use Authorizations for COVID-19 vaccines, that the mainstream media and social media companies had been engaged in “censorship” regarding ivermectin’s benefits, and that the government’s refusal to acknowledge its benefits amounted to “genocide”. In the same article, another physician called the FLCCA doctors “snake oil salesmen” and reviewed the “serious problems” with organization’s research.
A physician testifying for the hospital said that “there is no conclusive evidence to show enough benefit exists to outweigh [the drug’s] risks”. Mr. Smith’s treating physician “disputed any notion that ivermectin demonstrably helped his patient” and said there isn’t enough evidence to support its use. The hospital’s chief of staff testified that a physician who is not board certified would never be admitted to practice there and was concerned that Dr. Wagchul had never seen the patient or reviewed his information.
The court, in ruling in the hospital’s favor, said that:
While this court is sympathetic to the Plaintiff [Mr. Smith’s wife and his medical proxy] and understands the idea of wanting to do anything to help her loved one, public policy should not and does not support allowing a physician to try ‘any’ type of treatment on human beings . . .
The court found that ivermectin
has not been shown to be effective at this juncture. The studies that tend to give support to ivermectin have had inconsistent results, limitations to the studies, were open label studies, were of low quality or low certainty, included small sample sizes, various dosing regiments, or have been so riddled with issues that the study was withdrawn.
In a New York case, last week a judge issued an order (via letter) refusing to force the hospital to treat the patient with ivermectin, although he deferred a final ruling on the petition. The patient’s prescription, written by Dr. Ross Nochimson, who specializes in “Interventional Pain and Regenerative Medicine” and was not one of the patient’s treating physicians, read
Take 5.5 pills by mouth once daily up to 5 days Depending [sic] on clinical symptoms and improvement.
As with the Smith case, there was nothing in the record to indicate that Dr. Nochimson had ever “clinically observed” the patient or “reviewed his medical record” or “what the pills are for; what are clinical symptoms and what would constitute improvement”. On the other hand, “extensive affidavits” from the patient’s treating physicians specified the “possible deleterious impact Ivermectin may have” on the patient.
The record also included an affidavit from Dr. Pierre Kory extolling the virtues of ivermectin, an affidavit to which the judge was apparently referring when he noted that only doctors without personal knowledge of the patient’s medical situation were advocating giving him the drug.
In a third case ruling in favor of a hospital, the prescribing physician, Dr. Alan Bain, was also criticized by the hospital’s attorney for failing to perform an adequate review of Randy Clouse’s medical history prior to prescribing ivermectin and ignoring “widespread medical advice” on its use, charging that Dr. Bain wanted to make Mr. Clouse (also represented by the Lorgio firm) “a guinea pig”. The hospital, in rebuttal to the plaintiff’s description of Mr. Clouse’s condition, filed documents showing that the patient was already improving and that he no longer had an active COVID case. In any event, according to the hospital, the patient’s physicians “believe administration of ivermectin will likely result in kidney and lung damage, which can lead to organ failure and death.”
In a testament to how widespread misinformation about ivermectin has become, the patient’s wife, understandably upset, claimed that a ruling in her husband’s favor “could have helped save the lives of ‘thousands of other people'”, although she said she would not appeal.
Ethical and legal views
Noted bioethicist Arthur Caplan blasted the decisions forcing hospitals and physicians to administer ivermectin in an Ars Technica interview. “There is no standard of care saying you have to use [ivermectin]”, he said, and orders forcing its administration were asking doctors to do something “unethical and illegal”. Calling the original order (now overturned) in the Jeffrey Smith case “absurd”, Dr. Caplan said that if he were these doctors, he “simply wouldn’t do it”.
Unfortunately, from a legal standpoint, as has happened in some of these cases, refusing to follow a court’s order may result in the other side filing a motion to hold you in contempt.
As I said earlier, none of the cases in which I reviewed the pleadings and orders cited any legal right to force a physician or hospital to administer a drug against a physician’s medical judgment. This absence would be notable to any lawyer because it is a basic rule of pleading one’s case, not to mention winning it, that the plaintiff be able to point to some law – whether it be a statute, administrative rule, a constitutional provision, or common law – giving him a right to relief based on the facts of his case. So basic is this principle that I began to wonder if there had been some drastic change in the law since I was in active practice.
Fortunately, this has not happened. James M. Beck, an experienced litigator at the international law firm Reed Smith LLP, and a drug and device law expert, has done the heavy lifting in researching and analyzing the issue and recently wrote about it in a blog post titled “More COVID Kookiness – Ivermectin Lawsuits“, which gives you some idea of his thoughts on the subject.
We 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, whether or not some interloping non-staff physician might have prescribed it.
According to Mr. Beck, “precedent rejecting some sort of constitutional right to ‘medical’ use of unproven treatments goes back a long time”, as do cases rejecting statutory and common law grounds. This includes Prohibition, when a court refused to allow physicians to prescribe large amounts of alcoholic “medicine”, as well as cases rejecting a right to use medical marijuana and the quack cancer drug Laetrile. He also cites the Abigail Alliance case, which, in dispensing with the notion that a patient has a right to access experimental drugs, helped fuel a movement that ended in the “Right to Try” laws. These do not provide a right to access off-label drugs from unwilling physicians either, in part because these laws are “expressly voluntary”. Nor does the FDA’s compassionate use program provide any legal basis for doing so.
Mr. Beck concludes:
If a patient wants to self-medicate against COVID-19, whether by taking ivermectin, injecting bleach, or anything else, we’re not trying to stop them. Just leave a forwarding address for any Darwin Award. Nor would we object to a patient seeking off-label use of ivermectin as a COVID-19 treatment being transferred to a facility willing to provide it. But beyond that, patients have no legal basis to go to court to force unwilling health care providers either to participate in an off-label use they do not believe is therapeutic, or to force hospitals tolerate such a use in their facilities.
Hospitals and physicians would do well to cut and paste his blog post if faced with a lawsuit seeking to force them to administer ivermectin.
I imagine the judges who ordered the administration of ivermectin were greatly influenced by the dire straits of the patients who sought it and the cherry-picked information filed in support of their petitions. Where hospitals and physicians have been allowed to present their own evidence prior to the court’s decision, defendants have generally fared better. And I imagine some of these orders will be overturned on appeal.
However, in the face of overwhelming legal precedent holding that no patient has a right to a particular treatment, and especially in the face of stringent opposition by those who would be forced to provide it, these decisions are indeed troubling.