DeMarco v. Christiana Care Health Servs.

ZURN, Vice Chancellor.

Submitted: September 23, 2021

Theodore A. Kittila and William E. Green, Jr., HALLORAN FARKAS + KITTILA LLP, Wilmington, Delaware; Ralph C. Lorigo, LAW OFFICE OF RALPH C. LORIGO, West Seneca, New York, Attorneys for Plaintiff.

John D. Balaguer, Stephen J. Milewski, and Karine Sarkisian, WHITE AND WILLIAMS LLP, Wilmington, Delaware, Attorneys for Defendant.

OPINION

ZURN, Vice Chancellor.

This Court has been asked to compel a healthcare provider to treat a hospitalized COVID-19 patient with ivermectin. Ivermectin is a safe and effective treatment for parasitic disease. While some providers are administering ivermectin to COVID-19 patients due to its anti-viral and anti-inflammatory properties, it is not part of the standard of care for the COVID-19 virus. Upon admission to the hospital, the patient in this case expressed a desire to be treated with ivermectin. As the patient's health declined, his wife sought out and obtained a prescription from a doctor who never met the patient, and who is not affiliated with the hospital. Consistent with its guidelines, the hospital refused to administer the ivermectin prescription. Because the patient was hospitalized in isolation due to his infectious disease, the only avenues to effectuate delivery of ivermectin were through discharge against medical advice, and through a court order. After trying the first avenue and then returning to the hospital, the patient's wife has joined a legion of plaintiffs seeking to compel hospitals to treat COVID-19 patients with ivermectin.

This precedential opinion denies the requested injunction. The evidentiary proceedings before this Court focused on ivermectin's safety and efficacy, with the hospital explaining why ivermectin is not part of the standard of care and the plaintiff arguing why it should be. But this opinion denies the injunction based on two more fundamental, and reciprocal, precepts. Patients, even gravely ill ones, do not have a right to a particular treatment, and medical providers' duty to treat is coterminous with their standard of care. This court will wield its equitable powers only to enforce a right or duty; in their absence, relief is not available. The patient has this Court's sincerest sympathies and best wishes, but not an injunction.

I. BACKGROUND

I draw the following facts from the record as developed at yesterday's evidentiary hearing (the "Hearing") on the plaintiff's motion for a preliminary injunction (the "Motion"). That record includes seven Hearing exhibits, Hearing testimony from three witnesses, and at least twenty other exhibits and declarations the parties submitted with their pleadings and briefs. I have examined that evidence, giving each document and testimony the weight deserved. I have found the following facts based on the preponderance of that evidence.

Though the plaintiff has not filed a formal motion, the parties and the Court have treated her request in this highly expedited case as one for a preliminary injunction. See Docket Item ("D.I.") 12 at 7 [hereinafter "TRO Hr'g Tr."]; D.I. 8; D.I. 9. Citations in the form "PI Hr'g Tr." refer to the September 23 Hearing transcript, available at D.I. 13.

The parties submitted their Hearing exhibits to the Court electronically, but have not yet filed them on the docket. Citations in the form "PX -" refer to plaintiff's Hearing exhibits; citations in the form "DX -" refer to defendant's Hearing exhibits.

See, e.g., Everett v. Lanouette, 1994 WL 681106, at *4 (Del. Ch. Nov. 10, 1994) (denying plaintiffs' mandatory injunction because they failed to prove their case by a preponderance of the evidence); C&J Energy Servs. v. City of Miami Gen. Empls.' & Sanitation Emps.' Ret. Tr., 107 A.3d 1049, 1053-54 (Del. 2014) (footnote omitted) ("Mandatory injunctions should only issue with the confidence of findings made after a trial or on undisputed facts."); Agilent Techs., Inc. v. Kirkland, 2010 WL 610725, at *13 (Del. Ch. Feb. 18, 2010) (internal quotation marks omitted) ("Proof by a preponderance of the evidence means proof that something is more likely than not. It means that certain evidence, when compared to the evidence opposed to it, has the more convincing force and makes you believe that something is more likely true than not.").

A. David DeMarco Is Hospitalized With COVID-19.

Plaintiff Mary Ellen DeMarco ("Plaintiff") is the attorney in fact for her husband David DeMarco ("DeMarco"). Defendant Christiana Care Health Services, Inc. ("Defendant") is a private not-for-profit corporation authorized to do business in the State of Delaware.

D.I. 1, Verified Complaint for Injunctive and Declaratory Relief ¶¶ 3, 7 [hereinafter "Compl."]; Compl. Ex. A.

Id. ¶ 4.

On September 9, DeMarco checked himself in to Wilmington Hospital, Defendant's Wilmington, Delaware campus (the "Hospital"), where he was diagnosed with COVID-19 and moved to the intensive care unit ("ICU"). While in the Hospital, DeMarco was in isolation and only Hospital personnel had access to him; Plaintiff communicated with DeMarco by phone.

Id. ¶ 8; TRO Hr'g Tr. 29.

Compl. ¶ 12; PI Hr'g Tr. 10-12.

As part of his advanced health care treatment instructions, DeMarco indicated that he did not wish to be placed on a mechanical ventilator or breathing machine.DeMarco persistently stated that he did not wish to be placed on a ventilator. Plaintiff discussed DeMarco's wishes with his doctors at the Hospital on September 10.

Compl. Ex. A at 6. DeMarco's health care directive indicated that it was "only guidance" and his health care agent, Plaintiff, "shall have final say and may override any of my instructions." Id. at 7.

PI Hr'g Tr. 6.

Id. 12.

The Hospital treated DeMarco with heated high-flow oxygen at the maximum setting of one hundred al concerns of all doctors involved, patient autonomy, fiduciary duty, accreditation standards for patient protections, obligating one doctor to carry out the treatment regimen/plan of another doctor, . . . and whether a court should medicate or legislate from the bench.

Smith II, No. 2021 08 1206, at 10.

I find that reasoning persuasive. Compelling Defendant to provide a treatment outside the standard of care-on the prescription of a doctor who did not see the patient, has never treated the patient, and does not have privileges at that hospital- risks substantial harm to Defendant and the health care system at large. Requiring a healthcare provider to administer such a treatment harms the stability of hospital administration and admitting privileges.

Cf. Ass n of Cmty. Cancer Ctrs. v. Azar, 509 F.Supp.3d 482, 502-03 (D. Md. 2020) (weighing the potential effects of a TRO on healthcare providers and doctors' ability to treat their patients and manage their practices when balancing the equities and ultimately granting plaintiffs' request for injunction).

More fundamentally, it would undermine the "traditional consensual nature of the physician-patient relationship" that undergirds the safe delivery of health care. Granting Plaintiff's injunction would be detrimental to the public policy of allowing and compelling a healthcare provider to deliver the standard of care based on prevailing scientific and ethical norms and regulations, as ensconced in the Delaware Code. Dr. Maheshwari explained that physicians have an ethical duty not to harm their patients. He further testified that the proposed injunction could interfere with the "basis of medical practice to deliver evidence-based medicine and offer patients treatment that may be beneficial or is indeed beneficial. And to avoid treatment that is nonbeneficial." Dr. Maheshwari observed that not only has ivermectin "not been shown to have benefit," but it also "has the potential for harm."

See Am. Coll. of Obstetricians & Gynecologists v. U.S. Food & Drug Admin., 472 F.Supp.3d 183, 228 (D. Md. 2020) (granting a preliminary injunction after considering the doctors' ability to exercise their "medical judgement" when treating patients using telehealth, where they complied with all laws and regulations and "plainly promote[d] the public interest in . . . safeguarding public health" (internal quotation marks omitted) quoting Pashby v. Delia, 709 F.3d 307, 331 (4th Cir. 2013))), order clarified sub nom. Am. Coll. of Obstetricians & Gynecologists ex rel. Council of Univ. Chairs of Obstetrics & Gynecology v. U.S. Food & Drug Admin., 2020 WL 8167535 (D. Md. Aug. 19, 2020), and appeal dismissed sub nom. Am. Coll. of Obstetricians &Gynecologists v. Indiana, 2021 WL 3276054 (4th Cir. May 19, 2021); P.I. Hr'g Tr. 99 ("The traditional consensual nature of the physician-patient relationship will be undermined. The autonomy of physicians to make medical judgments about what is and is not in the best interest of their patients will be undermined.").

See Mayor & City Council of Balt. v. Azar, 392 F.Supp.3d 602, 619 (D. Md. 2019) (granting an injunction after considering the public health problems that may result from a rule that would prohibit doctors receiving Title X funding from discussing abortion with their patients because it would "forc[e] doctors to engage in the unethical practice of medicine, thus endangering the lives of patients and residents"), appeal dismissed as moot sub nom. Mayor of Balt. v. Azar, 973 F.3d 258 (4th Cir. 2020), cert. granted sub nom. Cochran v. Mayor & City Council of Balt., 141 S.Ct. 1369 (2021), and cert. dismissed sub nom. Becerra v. Mayor & City Council of Balt., 141 S.Ct. 2170 (2021).

P.I. Hr'g Tr. 57.

Id. 58.

Id. 57-58 ("A. There are multiple case reports currently active as it relates to potential harm with shock, liver failure, and other adverse reactions.").

Finally, compelling a provider to operate outside the standard of care would improperly and imprudently move health care treatment decisionmaking from the patient's bedside to a judge's bench.

Cf. Pharm. Prod. Dev., Inc. v. TVM Life Sci. Ventures VI, L.P., 2011 WL 549163, at *5 (Del. Ch. Feb. 16, 2011) (describing a judicial officer's "law-trained scientific . . . observation" about a drug's efficacy and potency as "oxymoronic"); Del. Bd. of Nursing v. Francis, 195 A.3d 467, 469 (Del. 2018) (noting the Court is comprised of "law-trained judges, not medical professionals").

III. CONCLUSION

For the foregoing reasons, Plaintiff's request for a mandatory preliminary injunction must be DENIED. My decision is animated both by Plaintiff's failure to show she is entitled to the relief she seeks at this procedural stage, and by her more fundamental failure to identify any established right that would serve as a basis for that relief. Despite the finality of my second conclusion, my decision today is limited to the Motion before me, which is one for interlocutory injunctive relief. Because of this procedural posture, I recognize Plaintiff's ability to pursue review of my decision is limited by Delaware Supreme Court Rule 42. As I indicated at yesterday's Hearing, I am prepared to expeditiously consider an application by Plaintiff to certify an interlocutory appeal.

Supr. Ct. R. 42.

Privitera quoted the FDA Commissioner's explanation of the quest for laetrile treatment:

In the Commissioner's opinion, the use of Laetrile in the United States has become a genuine public health problem. Increasingly, doctors dealing with cancer patients are finding that the patients are coming to legitimate therapy too late, having delayed while trying Laetrile. It seems clear that another substantial group of persons afflicted with cancer is avoiding effective therapy altogether and using Laetrile instead. The question has become one of life and death for these patients and for others who may be convinced to use Laetrile in the future.

Id. at 924 (citing 42 Fed. Reg. 39769).