We’re happy to report on a couple of favorable decisions involving some of the COVID-19-related issues that the Blog has been covering. We have one each on ivermectin injunctions, Shoemaker v. UPMC, ___ A.3d ___, 2022 WL 4372772 (Pa. Super. Sept. 22, 2022), and vaccine mandates, Children’s Health Defense, Inc. v. Rutgers, 2022 WL 4377515 (D.N.J. Sept. 22, 2022).
Eliminating Ivermectin Idiocy
The ivermectin case was particularly gratifying because it: (1) reversed an injunction issued by a misguided trial judge, and (2) was from Pennsylvania, where several of us practice. The Shoemaker case was an appeal from Perry County, Pennsylvania, where the COVID vaccination rate is some 20% below the state average. The appellant was a local hospital, seeking relief from an order that “specifically directed [the hospital] to allow two physicians, who were not credentialed . . ., to administer ivermectin to [a patient], who had been admitted to the Hospital’s Intensive Care Unit (ICU) for treatment of his COVID-19 infection after he became critically ill.” 2022 WL 4372772, at *1. Shoemaker had this to say about ivermectin:
Ivermectin is a medication used to treat certain infections caused by internal and external parasites in various animal species and humans. Although ivermectin received consideration by health care experts as a potential COVID-19 treatment, the U.S. Food and Drug Administration (FDA) has not authorized the use of ivermectin to prevent or treat COVID-19 infections, warns of the drug’s potential risks, and concludes that “[c]urrently available data do not show ivermectin is effective against COVID-19.”
The American Medical Association (AMA), American Pharmacists Association (APhA), and American Society of Health-System Pharmacists (ASHP) issued a joint statement in September 2021 calling for the immediate end to the prescribing, dispensing, and use of ivermectin for the prevention and treatment of COVID-19 outside of a clinical trial. The World Health Organization (WHO) has taken a similar position.
Id. (footnotes omitted).
Nonetheless, the patient’s guardian obtained an ivermectin prescription for the patient, sight unseen, from a local physician, but the hospital refused to administer the drug, as it violated hospital care standards for COVID-19. Id. at *2. So the guardian went to court, seeking a barrage of judicial relief – a declaratory judgment, an “emergency petition,” and a temporary restraining order. Id. The claim was for “breach” of an unidentified “express and/or implied contract” and of the Hippocratic Oath. Id. She hired a lawyer known for bringing these case around the country, and had an affidavit from the same “expert” who, as we mentioned in this post, claims he is “generally considered the foremost expert” on ivermectin as a COVID-19 treatment.” Id. at *3. That “world’s foremost expert” didn’t show for the hearing, but another doctor did. The hospital countered with testimony from its infectious disease chair and director of clinical pharmacy – both of whom testified that ivermectin was ineffective and that the study the opposing expert relied on “was retracted after subsequent peer review revealed that it had relied on data which had been suspected as having been falsified.” Id. at *4.
Unfortunately, the local judge granted a preliminary mandatory injunction, ordering the hospital to allow uncredentialed doctors to administer ivermectin to the hospital’s patient. After receiving the drug, the patient suffered liver damage (a known risk of high-dose ivermectin and died – whether from COVID-19 or ivermectin is unclear from the opinion. Id.
Despite the patient’s death mooting the appeal, Shoemaker decided the appeal because it was of public importance to put an end to this kind of ivermectin traveling road show in Pennsylvania. 2022 WL 4372772, at *5 (“agree[ing] with [the hospital] this appeal involves a broad range of public policy issues”).
The unanimous Pennsylvania Superior Court viewed the court order “compell[ing the hospital]] to allow uncredentialed physicians to practice medicine at the Hospital . . . of the Hospital’s COVID-19 treatment protocol” as “astonishing.” Id. at *6. We thought the same thing – we called it “kooky” − when we first learned of these lawsuits and wrote a detailed post detailing numerous legal reasons why hospitals cannot be forced to permit off-label uses of drugs that they believed beneath the medical standard of care. Shoemaker didn’t even get that far.
First, the trial court abused its discretion in issuing a “mandatory” injunction – “an extraordinary remedy that should only be utilized in the rarest of circumstances.” Id.
Second, the trial court acted in an ultra vires fashion, assuming in had more power to address COVID-19-related issues than it actually did. Id. at *9 (“the trial court failed to cite to any legal basis to justify its decision”).
[T]he trial court’s focus was misplaced as the trial court failed to recognize that the question before it was not whether ivermectin is a suitable treatment option for COVID-19, but rather whether [plaintiff] had identified a legal right in need of protection through a mandatory injunction.
2022 WL 4372772, at *7 (emphasis original). The plaintiff’s purported causes of action did not exist. The claim of an “express” contract was made up from whole cloth. “[T]he record does not contain any evidence of an express contract.” Id. Shoemaker is a case that makes us wish Pennsylvania had a Rule 11. The other implied contract and Hippocratic Oath claims were almost as bad:
[A]ny implied contract between [the patient] and the Hospital would simply require the Hospital to treat [him] according to the applicable standard of care. In addition, [the] allegation that the Hospital violated the Hippocratic oath to “do no harm” is simply a reformulation of its duty to comply with the relevant standard of care, not an excuse to force a hospital to abandon its protocols as well as to require an uncredentialed physician to practice on its premises.
Id.
Third, hospital “corporate negligence,” which was apparently raised for the first time on appeal, was inapplicable, since it applies only to prevent deviations from the medical standard of care – whereas ivermectin itself flunked the standard of care test. Not only did plaintiff concede that ivermectin was “outside the Hospital’s standard of care,” but every reputable medical organization agreed. Id. at *8 (citing “multiple national health organizations, including the FDA, AMA, and WHO”).
Fourth, hospital patients have no “legal right to make rational treatment decisions and choices.” Id. That purported “right” sounds nice, but it’s not the law:
There is no precedent or applicable law to support the proposition that a patient has a legal right to demand a particular medical treatment against the advice of their treating physicians, to compel a hospital to allow the administration of a medical treatment that contravenes its own hospital policy, or to force a hospital to issue credentials to a physician to administer such a treatment.
2022 WL 4372772, at *8 Nothing in the Pennsylvania “Patient’s Bill of Rights,” 28 Pa. Code §103.22(b), gives patients the power to order doctors or hospitals to violate the medical standard of care. 2022 WL 4372772, at *8-9. Any “right to demand a particular treatment or therapy, especially one against hospital protocol and outside the standard of care” is “notably absent.” Id. at *9.
Fifth, courts have no power to override a hospital’s power to credential physicians to practice within their facilities. The “trial court failed to cite to any legal basis to justify its decision to order UPMC to grant credentials to physicians to administer ivermectin.” Id. Shoemaker determined that there was nothing to cite:
Given the importance of the credentialing process, the trial court improperly interfered with the Hospital’s discretion to select, retain, and supervise the physicians who practiced on its premises when it ordered the Hospital to allow uncredentialed physicians to administer ivermectin within the Hospital’s ICU. Hospitals, not courts, have the resources and authority to determine whether a physician has the appropriate medical training, experience, and personal fitness to be eligible for medical staff privileges, especially within an intensive care unit.
2022 WL 4372772, at *9.
Shoemaker then briefly cited unanimous appellate and/or published precedent agreeing that courts cannot order health care providers to administer ivermectin over their objection – five decisions (out of a total of seven that we know of). Id. at *10. For completeness, here are all seven: Pisano v. Mayo Clinic, 333 So.3d 782, 790 (Fla. App. 2022); Gahl v. Aurora Health Care, Inc., 977 N.W.2d 756, 759 (Wis. App. 2022); Abbinanti v. Presence Center & Suburban Hospitals Network, 191 N.E.3d.1265, 1271-72 (Ill. App. 2021); Texas Health Huguley, Inc. v. Jones, 637 S.W.3d 202, 207 (Tex. App. 2021); Frey v. Health-Michigan, 2021 WL 5871744, at *4-5 (Mich. App. Dec. 10, 2021); DeMarco v. Christiana Care Health Services, Inc., 263 A.3d 423, 426 (Del. Ch. 2021); Salier v. Walmart, Inc., ___ F. Supp.3d ___, 2022 WL 3579752, at *4 (D. Minn. Aug. 19, 2022) (pharmacy defendant).
We fully agree with, and endorse, the Shoemaker decision’s bottom line: “[J]udges are not doctors and cannot practice medicine from the bench. The judiciary is called upon to serve in black robes, not white coats. And it must be vigilant to stay in its lane and remember its role.” 2022 WL 4372772, at *10.
Validating Vaccine Mandates
Our second case, Children’s Health Defense, Inc. v. Rutgers, 2022 WL 4377515 (D.N.J. Sept. 22, 2022) (“CHD”), agreed that Rutgers University could enforce a vaccine mandate that “requir[ed] its students to either be vaccinated or obtain an exemption,” id. at *1, and if they refused, to stay the heck away from campus. We commented on an earlier stage of this litigation a year ago, and the lineup of parties is now significantly different. Five individual students, and an antivax organization they joined, claimed the mandate was “unconstitutional” and the COVID-19 vaccines “experimental,” yadda yadda. Id. at *1, 7. They lost. First, because most of the individual plaintiffs got some sort of exemption, their claims were moot. Id. at *5. Their claims of harm, despite getting an exemption, were “conjectural and hypothetical.” Id. We’ll pay them no further mind.
Concerning what was left, the Supreme Court’s Jacobson case (we first discussed that, here), effectively put plaintiffs out of court:
[Jacobson] stated that it would strike down such a [vaccine mandate] regulation only if it had no “real or substantial relation to those objects” or if it amounted to “a plain, palpable invasion of rights secured by fundamental law.” Courts interpret the review applied in Jacobson as “rational basis review.” Despite Plaintiffs’ entreaties to apply a higher level of scrutiny in this case, the Court will again apply a rational basis review, given the continued vitality of Jacobson.
CHD, 2022 WL 4377515, at *6 (citations omitted).
Plaintiffs’ screwy claims were based on the university’s purported ulterior motives – “that Rutgers also had a financial motive . . . because of Rutgers’ “financial ties to all three COVID-19 vaccine manufacturers.” Id. (quoting plaintiffs’ complaints). Whether true or not, “[v]accination requirements are well established in the law,” so subjective motive didn’t matter. Id. The university “undoubtedly has a legitimate interest in protecting the members of its broad community from a potentially deadly disease and in trying to prevent more of the massive disruptions that COVID-19 caused for three semesters.” Id. at *7. That satisfied “rational basis.” Id.
Neither did the remaining plaintiffs have an equal protection right to expose other members of the university community to COVID-19. Rational basis applied to these claims as well. Id. Unvaccinated potential disease spreaders were not a protected class:
Plaintiffs are not members of a protected class. . . . Being unvaccinated does not confer protected status. Once again, [the university] has a legitimate interest in protecting its students and staff from a pandemic-inducing virus that is COVID-19, thus satisfying the standards of rational basis review
CHD, 2022 WL 4377515, at *7 (citations omitted). None of the three policies the antivax students attacked was unconstitutional. First, the university’s masking policy applied to everyone. Id. Second, the mandatory testing policy applied to anyone who was unvaccinated, not just students with vaccine exemptions. Id. Third, “courts have consistently held that higher education policies barring unvaccinated students from on-campus housing are not unconstitutional.” Id.
Next, despite plaintiffs’ “self-serving statement that the restrictions imposed on religiously exempt students” were unsupported by “any further evidence.” Id. at *8. Even if they had evidence, it wouldn’t have mattered. “[E]ven if the Policy did not provide for religious exemptions to vaccination requirements, Plaintiffs could not argue that a vaccination requirement applicable equally to all students and faculty violates their right to free exercise.” Id. Indeed, the university was doing more than was constitutionally required. The university’s policy “supports the right of free exercise of religion because the university has chosen to enable the practice of religion by providing a religious exemption to the vaccination requirement.” Id. (emphasis original).
After failing with the United States Constitution, the CHD plaintiffs also struck out with the New Jersey Constitution. The university countered with a New Jersey Supreme Court case, Sadlock v. Board of Education of Borough of Carlstadt, 58 A.2d 218 (N.J. 1948), which – as we mentioned in our Jacobson post − took “judicial notice . . . that vaccination is commonly believed to be a safe and valuable means of preventing the spread of certain diseases . . ., and that this belief is supported by high medical authority.” Id. at 220. CHD found Sadlock dispositive of the plaintiffs’ state constitutional claims:
In finding that the resolution was not violative of the guarantees of the federal and New Jersey Constitutions pertaining to personal and religious liberties, [Sadlock] noted that “the principle is too well established to require citation that the so-called constitutional liberties are not absolute but are relative only. They must be considered in the light of the general public welfare. To hold otherwise would be to place the individual above the law.”
2022 WL 4377515, at *9 (quoting Sadlock, 58 A.2d at 222).
CHD also disposed of jumble of miscellaneous claims:
- Civil Rights Statutes – Absent any constitutional violation these claims failed. Id. at *9.
- FDCA – The university didn’t require plaintiffs to take “experimental” products. They weren’t experimental at all, and the university didn’t make anybody vaccinate; “it has simply made adherence to the mandate a condition to . . . enrollment.” Id. at *9-10.
- New Jersey State Statutes – Completely contrary to plaintiffs’ claims, the statute in question required the university “to obtain proof from students that they have taken certain immunizations and authorize [it] to require other ACIP-recommended vaccinations.” Id. at *10.
- Breach of Contract – Plaintiffs failed to identify either the contract or the provision breached. At most there was an “offer” that plaintiffs “had an ample amount of time to reject . . . and either unenroll . . ., transfer to a different program, or not apply for admission . . . in the first place.” Id. at *10-11.
- Promissory Estoppel – The one plaintiff whose claim wasn’t moot could simply have enrolled in the university’s online program to be exempt from the mandate, but never did. Id. at *12. Thus, nobody suffered any legal detriment. Id.
In sum, all the claims in CHD were entirely bogus, and all but one of the student plaintiffs had sought and received a religious exemption that the university provided as a matter of grace, not requirement. The one remaining plaintiff simply didn’t take available steps to be exempted through remote learning. To us it looks like an ideological antivax group tried, with notable lack of success, to use the student plaintiffs as pawns in its ill-fated attempt to challenge the university’s vaccine mandate. We hope there is some way for the university to recover its costs of defending this transparently meritless, and politically inspired, litigation.