COVID TREATMENTS AND THE COURT

Cammarano v. Staten Island University Hosp., Date filed: 2021-09-20, Court: Supreme Court, Richmond, Judge: Justice Ralph Porzio, Case Number: 85169/2021:

"HISTORY

This action was brought by Donald James Cammarano, (hereinafter “Plaintiff/advocate”) as the son and advocate for Donald Anthony Cammarano (hereinafter “Patient”) on September 7, 2021, seeking a medical declaratory judgment and emergency order compelling Staten Island University Hospital- Northwell Health (hereinafter “SIUH/Northwell”) to comply with a prescription for Ivermectin to treat the patient’s COVID-19. According to Plaintiff/advocate, his father, the patient, tested positive for COVID-19 on or about July 23, 2021 and was admitted to SIUH/Northwell on July 28, 2021. While in the ICU, the patient received the hospital’s COVID-19 treatment protocol of Remdesivir, antibiotics, and steroids. Plaintiff/advocate stated in his affidavit that on August 11, 2021 the patient, his father, stated that he wanted to be prescribed Ivermectin. The following day, August 12, 2021, Plaintiff/advocate stated that Dr. Michael Chalhoub, the Chief of the ICU at Staten Island University Hospital, agreed to prescribe Ivermectin for the patient. Despite this, the Plaintiff/advocate was subsequently informed that the hospital refused to prescribe and administer the prescription. Instead, Dr. Michael Turner, MD, a doctor from Washington State and not associated with Northwell Health, prescribed Ivermectin for the patient. However, SIUH/Northwell refuses to administer the prescription as they claim Ivermectin is not the appropriate course of treatment for the patient.

SPECIAL PROCEEDING

The Plaintiffs brought this Special Proceeding and Order to Show Cause for a medical declaratory judgment and emergency preliminary injunction on September 7, 2021 asking this Court to compel SIUH/Northwell to administer Ivermectin to the patient. This Court initially denied the interim relief which sought SIUH/Northwell to administer Ivermectin as “ordered by his treating physicians” based upon the failure to timely file an affirmation pursuant to 22 NYCRR 202.7. The Court heard the matter on September 9, 2021, and again did not order SIUH/Northwell to administer Ivermectin. The matter was adjourned for full briefing and oral arguments of the Order to Show Cause on September 14, 2021.

Though the Court is sympathetic to the Plaintiffs, there has been no admissible evidence submitted that Ivermectin is an effective or an approved treatment for COVID-19. The Plaintiffs failed to present any affidavits from Dr. Michael Turner, the prescribing physician, or any other expert, recommending Ivermectin to the patient or attesting to Ivermectin as an effective treatment for COVID-19. Plaintiffs, in support of the application, submitted inadmissible news articles and orders from similar cases, without any statutory or case law authority. This decision will address the preliminary injunction, the fundamental right to medication, the right to try and the compassionate use of medication.

The Preliminary Injunction

In order for the Court to grant a preliminary injunction, the Plaintiff must show (1) a likelihood of success on the merits; (2) irreparable harm in the absence of the preliminary injunction; and (3) the balance of the equities in favor of the Plaintiff. See W. T. Grant Co. v. Srogi, 52 NY2d 496, 517 (1981). “A mandatory injunction, which is used to compel the performance of an act, is an extraordinary and drastic remedy which is rarely granted and then only for unusual circumstances where such relief is essential to maintain the status quo pending trial of the action. Matos v. City of New York, 21 A.D.3d 936, 937 [2d Dept. 2005].

It is the Plaintiffs’ burden to show a likelihood of success on the merits of the case and it must be clear from undisputed facts. See McLaughlin, Piven, Vogel, Inc. v. W.J. Nolan & Co., 114 AD2d 165, 173 [2d Dept. 1986]; Family Affair Haircutters, Inc. v. Detling, 110 AD2d 745, 747 [2d Dept. 1985]. The Plaintiffs have failed to show a likelihood of success on the merits, as they have not shown that Ivermectin would be effective in treating the patient, nor have they shown that the Court has any legal authority to order their requested relief.

Further, Plaintiffs have failed to show that they would suffer irreparable harm in the absence of the preliminary injunction. The alleged harm must be shown by the Plaintiff to be “imminent, not remote or speculative.” See Golden v. Steam Heat, 216 AD2d 440, 442 [2d Dept. 1995]. In this case, Plaintiffs have only speculated that the Ivermectin treatment would be effective for the patient. The Court, on speculation alone, cannot find that the patient would suffer irreparable harm in the absence of the preliminary injunction.

Finally, the Plaintiffs have failed to show a balance of the equities in their favor, as they must show that the irreparable harm will outweigh the harm to the defendants. See McLaughlin, Piven, Vogel, Inc. v. W.J. Nolan & Co., 114 AD2d 165, 174 [2d Dept. 1986]. This Court agrees that “public policy should not and does not support allowing a physician to try any type of treatment on human beings. Rather, public policy supports the safe and effective development of medications and medical practices.” See Smith v. W. Chester Hosp. LLC, 2021 Ohio Misc. LEXIS 103 [Ohio Court of Common Pleas Gen. Div. Butler Cty. September 6, 2021]. The goal of providing assistance to patients during the COVID-19 pandemic should not “overcome thoughtful, evidence-based judgment…” American Medical Association, Prescribing Medications Responsibly in a Pandemic, Code of Medical Ethics Opinion 1.2.11 (August 21, 2021), available at www.ama-assn.org/delivering-care/ethics/prescribing-medications-responsibly-pandemic [last accessed Sept. 20, 2021]. This Court will not overrule the clinical judgment of the patient’s physicians, as doing so may cause severe harm to those physicians, SIUH and Northwell Health.

Fundamental Right to Medication

The news surrounding the use of Ivermectin to treat COVID-19, without any data or peer-reviewed proof, reminds this court of the use of Laetrile, a drug that gained popularity, but was not federally approved for the treatment of cancer. Laetrile, also known as amygdalin, is made from the pits of fruits and is found naturally in plants. The drug was ultimately banned by the United States Food and Drug Administration (hereinafter “FDA”) as it showed no anticancer activity, and the side effects mirror the symptoms of cyanide poisoning. (“Laetrile/Amygdalin (PDQ®)-Health Professional Version,” National Institute of Health, National Cancer Institute, www.cancer.gov/about-cancer/treatment/cam/hp/laetrile-pdq, [last accessed Sept. 20, 2021]). The use of the unapproved drug Laetrile for terminally ill patients was addressed by the United States Supreme Court in United States v. Rutherford.

In 1975, terminally ill cancer patients brought an action to “enjoin the Government from interfering with the interstate shipment and sale of Laetrile, a drug not approved for distribution under the act.” United States v. Rutherford, 442 US 544, 556 [1979]. The question addressed in the Rutherford case was “whether the Federal Food, Drug and Cosmetic Act precludes terminally ill cancer patients from obtaining Laetrile, a drug not recognized as ‘safe and effective’…” Id. at 546. The Court stated, “for the terminally ill, as for anyone else, a drug is unsafe if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit…” Id. at 556. The Supreme Court in Rutherford ultimately held that there was no explicit exception for terminally ill patients to use a drug that was not approved as safe or effective. Id.

The Supreme Court, in analyzing a drug’s effectiveness under the Federal Food, Drug and Cosmetic Act, noted:

“Moreover, there is a special sense in which the relationship between drug effectiveness and safety has meaning in the context of incurable illnesses. An otherwise harmless drug can be dangerous to any patient if it does not produce its purported therapeutic effect. See 107 Cong. Rec. 5640 (1961) (comments of Sen. Kefauver). But if an individual suffering from a potentially fatal disease rejects conventional therapy in favor of a drug with no demonstrable curative properties, the consequences can be irreversible. See, e. g., 42 Fed. Reg. 39768, 39787 (1977) (statement of Dr. Carl Leventhal, Deputy Director of the Bureau of Drugs, FDA, and Assistant Professor of Neurology and Pathology at Georgetown University).” United States v. Rutherford, 442 US 544, 556 [1979].

The United States Court of Appeals for the District of Columbia Circuit addressed drug regulation and the use of unapproved drugs for the terminally ill in its decision in Abigail Alliance for Better Access to Dev. Drugs v. Von Eschenbach, 378 US App DC 33, 495 F3d 695, 702 [2007]. In Abigail the Court noted that the FDA and Congress had programs available for terminally ill patients, to “provide early access to promising experimental drugs when warranted.” The use of investigational drugs by patients not participating in clinical trials may be approved for the treatment of “serious or immediately life-threatening diseases if there exists no comparable or satisfactory alternative drug or other therapy.” The Court analyzed the FDA’s procedure for access to experimental drugs, but in citing Rutherford, stated that someone in desperate need of curative treatments can have their death “hastened by the use of a potentially toxic drug with no proven therapeutic benefit.” Abigail at 713. The FDA’s policy of limiting access is rationally related to a legitimate state interest in protecting patients from “potentially unsafe drugs with unknown therapeutic effects.” Abigail at 713. In Abigail, the Court ultimately held that terminally ill patients had no fundamental due process right to access experimental drugs.

Ivermectin and Off-Label Use

Upon the Court’s research, the FDA has only approved Ivermectin to treat people with intestinal strongyloidiasis and onchocerciasis, conditions that are caused by parasitic worms. (Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, U.S. Food & Drug Administration,_www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19 [last accessed Sept. 17, 2021]). In the instant matter, Ivermectin is being prescribed to treat the patient’s COVID-19 as an off-label use. Unapproved use of an FDA approved drug is often called “off-label” use, meaning that the drug is being used for a disease or condition that it is not approved to treat. (“Understanding Unapproved Use of Approved Drugs Off Label,” U.S. Food & Drug Administration, www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label [last accessed Sept. 20, 2021]). Doctors often have the ability to prescribe drugs to their patients for “off-label use” if they feel that it may benefit a patient. (“What to Know About Off-Label Drug Use,” Medical News Today, www.medicalnewstoday.com/articles/off-label-drug-use#reasons-for-use, [last accessed Sept. 20, 2021]).

Off-label prescriptions are an “integral part of contemporary medicine,” however, these prescriptions can harm patients when “an off-label use lacks a solid evidentiary basis.” (“Off-Label Prescribing: A Call for Heightened Professional and Government Oversight,” J Law Med Ethics, www.ncbi.nlm.nih.gov/pmc/articles/PMC2836889/ [last accessed Sept. 20, 2021]). Responsible off-label prescribing requires physicians to “(1) evaluate whether there is sufficient evidence to justify an off-label use; (2) press for additional information and research when adequate evidence is lacking; and (3) inform patients about the uncertainties and potential costs associated with off-label prescribing.” Id. When uncertainty exists about the benefits of off-label applications, “patients are at risk of receiving harmful or ineffective treatments.” Id. The FDA has not “authorized or approved Ivermectin for use in preventing or treating COVID-19.” (Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, U.S. Food & Drug Administration,_www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19 [last accessed Sept. 17, 2021]). The alleged successes of Ivermectin are merely anecdotal at this time, however, the FDA confirms that “currently available data do not show Ivermectin is effective…” Id.

The Court finds the affidavits submitted on behalf of SIUH/Northwell by its employees, Dr. Neville Mobarakai and Dr. Dany Elsayegh, to be persuasive and notes that the patient is not suffering from an active COVID-19 infection, but rather complications from COVID-19, specifically bacterial pneumonia. Per these doctors, bacterial pneumonia is not treated by Ivermectin. In fact, both doctors claim that since Ivermectin is not clinically warranted for the patient’s current condition, “it would be unethical to provide such treatment to Donald Anthony Cammarano.” See Defendants’ Exhibits A and B. Further, this Court understands that deviation from accepted medical practices is an essential element of medical malpractice and per the FDA, there is no current evidence to justify off-label use of Ivermectin at this time. See Poter v. Adams, 104 AD3d 925, 926, 961 NYS2d 556, 558 [2d Dept. 2013] and (Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, U.S. Food & Drug Administration,_www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19 [last accessed Sept. 17, 2021]). As such, this Court will 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 purpose.

Right to Try and Expanded Access

Though not expressly argued by the parties in this matter, the Court has considered options available to the patient through the Right to Try Act and the FDA’s expanded use program. The “Right to Try Act” was signed into law on May 30, 2018. The law permits patients who have been diagnosed with life-threatening diseases or conditions who have tried approved treatment options and are not able to participate in a clinical trial to access unapproved medical treatments. The FDA allows patients to have access to “eligible investigational drugs” if they meet certain criteria, such as, being diagnosed with a life-threatening disease, they’ve exhausted approved treatment options, and they provide written informed consent. (“Right to Try,” US. Food and Drug Administration, www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try [last accessed Sept. 20, 2021]).

In addition to “Right to Try,” patients may have access to expanded use, also known as compassionate use, of experimental or unapproved medical products outside of clinical trials. This is available when there is “no comparable or satisfactory therapy options” available. Expanded use may be available to a patient when a patient has a serious, life threatening disease or condition; there is no comparable drug or therapy; a clinical trial is not possible; the benefit justifies the potential risks of treatment; and providing the product will not interfere with investigational trials. (“Expanded Access,” US. Food and Drug Administration, www.fda.gov/news-events/public-health-focus/expanded-access [last accessed Sept. 20, 2021]).

After careful consideration, this Court finds that these programs to try medications are not applicable in this case. Per the affidavits provided by SIUH/Northwell, the patient is currently diagnosed with bacterial pneumonia and does not have an active COVID-19 infection. There was no evidence submitted that the patient attempted to obtain drugs undergoing clinical trials, pursuant to the Right to Try Act or under the FDA’s expanded use program. In any event, as the Courts have previously found that there is not a fundamental right for a patient to use new or experimental drugs, this Court will not interfere with the regulations of the FDA and order the administration of Ivermectin to the patient over the objection of the Defendants.

CONCLUSION

This Court is not commenting on whether Ivermectin will ever be an effective or approved treatment for COVID-19, nor will it medicate from the bench. This Court will not order a hospital to provide a patient with an unproven, unapproved treatment that could potentially have detrimental effects on him due to his fragile health. The Plaintiffs have failed to present expert support for the off-label use of Ivermectin to treat the patient’s current condition. Based upon the foregoing, the Plaintiffs’ request for a declaratory judgment and order to compel Staten Island University Hospital- Northwell Health administer Ivermectin is denied."