D.J.C. v Staten Is. Univ. Hosp.-Northwell Health
2021 NY Slip Op 21293 [73 Misc 3d 840]
September 20, 2021
Porzio, J.
Supreme Court, Richmond County
Published by New York State Law Reporting Bureau pursuant to Judiciary Law § 431.
As corrected through Wednesday, January 5, 2022


[*1]
D.J.C., as Son and Health Care Advocate for D.A.C., Plaintiff,
v
Staten Island University Hospital-Northwell Health, Defendant.

Supreme Court, Richmond County, September 20, 2021

APPEARANCES OF COUNSEL

Law Office of Ralph C. Lorigo (Ralph Lorigo of counsel) for plaintiff.

La Salle, La Salle & Dwyer, P.C. (Adam Daniel Kahn of counsel) for defendant.

{**73 Misc 3d at 841} OPINION OF THE COURT
Ralph J. Porzio, J.

Upon the papers filed in support of the application and the papers filed in opposition thereto, and after hearing oral arguments, for the reasons set forth on the record it is ordered that motion No. 001 seeking an order to compel the defendant to comply with the order and prescription of Dr. Michael Turner, MD, to administer Ivermectin to D.A.C. is hereby denied.

History

This action was brought by D.J.C. (hereinafter plaintiff/advocate), as the son and advocate for D.A.C. (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. Michel 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 [*2]

The plaintiff 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{**73 Misc 3d at 842} 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 plaintiff, there has been no admissible evidence submitted that Ivermectin is an effective or an approved treatment for COVID-19. The plaintiff 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. Plaintiff, 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 under unusual circumstances where such relief is essential to maintain the status quo pending trial of the action." (Matos v City of New York, 21 AD3d 936, 937 [2d Dept 2005] [citation omitted].)

It is the plaintiff's 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 v Nolan & Co., 114 AD2d 165, 172-173 [2d Dept 1986]; Family Affair Haircutters v Detling, 110 AD2d 745, 747 [2d Dept 1985].) The plaintiff has failed to show a likelihood of success on the merits, as he has not shown that Ivermectin would be effective in treating the patient, nor has he shown that the court has any legal authority to order the requested relief.{**73 Misc 3d at 843}

Further, plaintiff has failed to show that the patient 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, plaintiff has 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 plaintiff has failed to show a balance of the equities in his favor, as he must show that the irreparable harm will outweigh the harm to the defendant. (See McLaughlin, Piven, Vogel v 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 West Chester Hosp., LLC, 2021 Ohio Misc LEXIS 103, *11 [Ct Common Pleas, Butler County, Gen Div, Sept. 6, 2021, No. CV 2021 08 1206] [internal quotation marks omitted and emphasis added].) The goal of providing assistance to patients during the COVID-19 pandemic should not "overcome thoughtful, evidence-based judgment." (American Medical Association, Prescribing [*3]Medications Responsibly in a Pandemic [Aug. 21, 2021], available at https://www.ama-assn.org/delivering-care/ethics/prescribing-medications-responsibly-pandemic [last accessed Sept. 20, 2021]; AMA Code of Medical Ethics Op 1.2.11, Ethically Sound Innovation in Medical Practice.) 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. (National Institutes of Health, National Cancer Institute, Laetrile/Amygdalin{**73 Misc 3d at 844} [PDQ®]—Health Professional Version, https://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 [Federal Food, Drug, and Cosmetic Act]." (United States v Rutherford, 442 US 544, 548 [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, "[f]or 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 555-556.) 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 and n 13 [1979] [footnote callout omitted].)

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 (495 F3d 695, 702 [2007]). In Abigail the court noted that the FDA{**73 Misc 3d at 845} and Congress had programs available for terminally ill patients, to "provide early access to promising experimental drugs when warranted." (Id. at 698-699.) 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 [*4]no comparable or satisfactory alternative drug or other therapy." (Id. at 699 [internal quotation marks and brackets omitted].) 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 (U.S. Food & Drug Administration, Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19 [last accessed Sept. 17, 2021], cached at https://nycourts.gov/reporter/webdocs/Why-You-Should-Not-Use-Ivermectin-to-Treat-or-Prevent-COVID-19.pdf). 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 (U.S. Food & Drug Administration, Understanding Unapproved Use of Approved Drugs "Off Label," https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label [last accessed Sept. 20, 2021], cached at https://nycourts.gov/reporter/webdocs/Understanding-Unapproved-Use-of-Approved-Drugs-Off-Label.pdf). Doctors often have the ability to prescribe drugs to their patients for "off-label use" if they feel that it may benefit a patient. (Jennifer Berry, What to Know About Off-Label Drug{**73 Misc 3d at 846}Use, Medical News Today, June 30, 2020, available at https://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." (Rebecca Dresser & Joel Frader, Off-Label Prescribing: A Call for Heightened Professional and Government Oversight, 37 JL Med & Ethics 476, 476 [2009], available at https://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 [I]vermectin for use in preventing or treating COVID-19." (U.S. Food & Drug Administration, Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19{**73 Misc 3d at 847} [last accessed Sept. 17, 2021].) The alleged successes of Ivermectin are merely anecdotal at this time; however, the FDA confirms that "[c]urrently available data do not show [I]vermectin 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 [D.A.C.]" (See defendant's exhibits A, B.) Further, this court understands that deviation from [*5]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 [2d Dept 2013]; U.S. Food & Drug Administration, Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, https://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 (Pub L 115-176, 132 US Stat 1372). 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, having exhausted approved treatment options, and providing written informed consent. (U.S. Food & Drug Administration, Right to Try, https://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 alternative therapy options" available. (U.S. Food & Drug Administration, Expanded Access, https://www.fda.gov/news-events/public-health-focus/expanded-access [last accessed Sept. 20, 2021].) 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. (Id.)

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{**73 Misc 3d at 848} 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 defendant.

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 plaintiff has failed to present expert support for the off-label use of Ivermectin to treat the patient's current condition. Based upon the foregoing, the plaintiff's request for a declaratory judgment and order to compel Staten Island University Hospital-Northwell Health to administer Ivermectin is denied.