A Delaware Chancery Court case involves Mary Ellen DeMarco, acting as attorney in fact for David DeMarco, who sought to compel Christiana Care Health Services, Inc. to administer ivermectin to David, a hospitalized COVID-19 patient. While ivermectin is recognized as safe for treating parasitic diseases and has some anti-viral and anti-inflammatory properties, it is not considered part of the standard treatment for COVID-19. Upon admission, David requested ivermectin, but when his condition worsened, his wife obtained a prescription from a non-affiliated physician. The hospital refused to administer the drug in accordance with its treatment guidelines.
The court denied the plaintiff’s request for an injunction, emphasizing two key principles: patients do not have an inherent right to specific treatments, and healthcare providers' duty to treat is bound by established standards of care. The court only exercises its equitable powers to enforce recognized rights or duties; in their absence, relief is denied. The evidentiary record included testimony and various exhibits, leading to the conclusion that the plaintiff did not meet the burden of proof required for a mandatory injunction. The court expressed sympathy for the patient but reiterated that an injunction was not warranted under the circumstances.
Proof by a preponderance of the evidence indicates that something is more likely true than not, requiring a comparison of evidence's convincing force. Mary Ellen DeMarco serves as the attorney-in-fact for her husband, David DeMarco, who was hospitalized with COVID-19 at Wilmington Hospital on September 9. During his stay, DeMarco expressed a refusal to be placed on a mechanical ventilator, and Plaintiff communicated his wishes to the hospital staff on September 10. Despite receiving treatment consistent with hospital protocols, including heated high-flow oxygen and various medications, DeMarco's condition worsened, leading to a diagnosis of severe hypoxic respiratory failure by September 16.
At DeMarco's request, Mary Ellen sought alternative treatment with ivermectin, a drug approved for antiparasitic use but not included in the hospital's COVID-19 treatment guidelines, which are based on evidence-based literature and FDA recommendations. After discussions with hospital staff on September 11, the hospital declined to administer ivermectin. Subsequently, on September 16, Dr. Adam Brownstein, a family medicine specialist, prescribed ivermectin without having examined DeMarco. Plaintiff filled the prescription at a CVS Pharmacy, but the hospital refused to allow its administration, and due to isolation protocols, she was unable to deliver the medication directly to DeMarco.
Plaintiff filed a Verified Complaint for Injunctive and Declaratory Relief on September 17, 2021, asserting two counts: Count I demands injunctive relief for the administration of Ivermectin prescribed by Dr. Brownstein, while Count II seeks a declaratory judgment to honor Plaintiff’s power of attorney regarding Mr. DeMarco's medical treatment. Alongside the Complaint, Plaintiff filed a Motion for Expedited Proceedings and a Motion for an Emergency Temporary Restraining Order (TRO), aiming to align with other petitioners who received injunctions for similar COVID-19 treatments. The Defendant acknowledged DeMarco’s durable healthcare power of attorney, which Plaintiff holds, but stated their right to refuse treatments deemed unsafe or ineffective. The Court held an expedited TRO hearing shortly after the Complaint was filed, conducted ex parte due to unsuccessful attempts to contact Defendant's counsel, ultimately denying the TRO for seeking mandatory relief based on disputed facts, while scheduling a hearing on September 23.
On September 19, DeMarco was discharged from the hospital against medical advice to pursue home hospice care and self-administer Ivermectin. Following a significant deterioration in his condition, including a critical equipment failure with his oxygen mask, he was readmitted to the hospital's ICU after an ambulance could not transport him to a different facility due to lack of ICU beds. Upon readmission, DeMarco rescinded his do-not-resuscitate directive and consented to intubation. He remains gravely ill in the ICU. Following the TRO hearing, Plaintiff continues to seek mandatory injunctive relief, and Defendant's counsel entered their appearances on September 17.
On September 21, the Hospital responded to the Complaint, and on September 22, it filed a Brief opposing the Plaintiff’s request for injunctive and declaratory relief. The Plaintiff argues that the Hospital's refusal to administer ivermectin violates the Patient/Physician contract, the Hippocratic Oath, and Mr. DeMarco’s rights under Delaware law and the state constitution. She seeks an injunction to compel the Hospital to honor these obligations. The Hospital contends that it does not have a duty to treat DeMarco with ivermectin, asserting that the Plaintiff has not established a right enforceable by a mandatory injunction and that she would not suffer irreparable harm from the lack of treatment. Conversely, the Hospital claims it would be harmed by acting against established medical standards.
During the Hearing on September 23, the Plaintiff affirmed her belief that DeMarco has the right to receive ivermectin. She provided her own testimony along with that of Dr. Ryan Partovi, a naturopathic doctor who has prescribed ivermectin for COVID-19 patients, although he does not treat them directly and lacks consultation with critical care teams. Dr. Partovi testified that ivermectin could likely benefit DeMarco and improve his survival chances, although most of his experience is with early-stage patients. He cited a literature review by the FLCCC Alliance, which claims that 27 studies support ivermectin's use for COVID-19.
In contrast, the Hospital presented Dr. Vinay Maheshwari, chair of its Department of Medicine, who outlined the Hospital’s treatment guidelines for COVID-19, emphasizing that there is insufficient high-quality evidence to support the use of ivermectin in hospitalized or critically ill patients.
Ivermectin poses significant risks, including liver failure, shock, hypotension, and seizures, with many severe adverse reactions reported, particularly from self-administration outside hospital settings. National clinical authorities have issued warnings against its use for COVID-19 treatment. The NIH, after reviewing thirty-two studies in February 2021, found insufficient evidence to recommend ivermectin for COVID-19, noting methodological flaws and the necessity for doses up to 100 times higher than approved for humans. The AMA, alongside other medical organizations, strongly opposes prescribing ivermectin for COVID-19 outside clinical trials, supported by advisories from the CDC, FDA, and statements from Merck, emphasizing the lack of evidence for its efficacy. The Infectious Diseases Society of America also advises against its use outside clinical trials.
In the analysis section, the plaintiff seeks a preliminary injunction to compel a hospital to administer ivermectin to DeMarco. For such a mandatory injunction to be granted, the plaintiff must demonstrate legal entitlement, imminent irreparable injury, and a favorable balance of hardships. The court may deny this request even with a reasonable chance of success if there is a genuine dispute on essential issues. The plaintiff's request for a preliminary injunction is also her final relief sought, and without extraordinary circumstances, the court is hesitant to grant relief amid substantial factual disputes. The plaintiff did not satisfy the requirements for the injunction; the defendant has no obligation to provide ivermectin, and the plaintiff failed to prove irreparable harm, as the potential harm to DeMarco from not receiving ivermectin is disputed, with the evidence favoring the defendant.
The balance of equities does not favor the requested injunction, as the Plaintiff has not demonstrated entitlement to judgment on the merits. To obtain mandatory injunctive relief, the applicant must clearly establish the legal right or duty at stake, which requires more than a reasonable probability of success. The Plaintiff has failed to show that the Defendant is obligated to provide ivermectin treatment to DeMarco. Although an implicit contractual relationship exists between DeMarco and the Defendant upon seeking treatment, the Defendant's duty is to render care that meets the applicable professional standard, which does not include ivermectin for COVID-19 as its efficacy is disputed.
The Delaware General Assembly allows healthcare providers to refuse treatments that are medically ineffective or contrary to accepted standards. Given that major medical institutions, including the FDA and WHO, do not endorse ivermectin for COVID-19, the Defendant's refusal to administer it does not violate the standard of care. The Plaintiff's assertion of a statutory right to self-determination is limited to refusing treatments that do not conflict with public health laws. The Delaware Constitution recognizes an individual's right to bodily autonomy, allowing for the acceptance or refusal of medical treatment, but this does not compel a healthcare provider to administer a treatment that is not aligned with established medical standards.
Plaintiff lacks the authority to compel nonstandard treatment outside the established standard of care, and no such authority was found. The defendant's patient rights and responsibilities indicate that while patients can participate in care decisions, they cannot demand nonstandard treatments. Judicial precedent shows that patients do not have a constitutional right to specific treatments or to choose particular providers, even in cases involving terminal illness and experimental drugs. Courts have consistently ruled that the right to refuse treatment is protected, but this does not extend to a right to access specific medications against government regulations. The regulation of medical practices falls within state police powers, which prioritize public health, and the appropriate legal standard for reviewing such regulations is rational basis, not compelling state interest. There is no recognized constitutional right to access a particular drug or treatment, and the government is not obligated to provide alternatives to its regulations for dying patients seeking experimental treatments.
Severe illness is a persistent aspect of the human experience, highlighted by historical court rulings in the late 1970s and early 1980s that denied patients the right to use the unapproved substance laetrile for cancer treatment, which was not part of standard medical care. Similarly, while ivermectin is approved for treating human parasitic infections, DeMarco lacks the right to mandate its use for COVID-19 outside established medical protocols. The absence of a defined legal duty or right means that mandatory injunctive relief is not available to the plaintiff.
The right to obtain drugs with unproven efficacy does not fall under the privacy rights recognized by federal or California constitutions. Historical context, including the FDA's stance on laetrile, illustrates the public health risks posed by patients delaying effective treatment in favor of unproven alternatives.
The plaintiff has not shown irreparable harm necessary for a mandatory injunction, as ivermectin's effectiveness against COVID-19 remains unproven and disputed, which disqualifies it from being within a provider’s duty of care. The majority of the plaintiff's arguments regarding potential harm are based on questionable sources, inconsistent with prevailing medical authority. While the plaintiff indicates a preference for ivermectin over standard treatments, there is no conclusive evidence that refusal of ivermectin will lead to significant deterioration in DeMarco's health. The plaintiff's position appears to be driven more by patient choice than by substantiated medical necessity, failing to demonstrate that DeMarco would face irreparable harm without ivermectin.
DeMarco's claim regarding the necessity of ivermectin treatment is contested, with evidence favoring the Defendant, suggesting that denying the injunction does not cause irreparable harm to DeMarco. The analysis emphasizes that the balance of equities supports the Defendant, as Plaintiff must demonstrate that the harm from denying the injunction outweighs the harm to the Defendant if it is granted. Public policy considerations are significant, particularly regarding the impact on medical standards, patient autonomy, and the ethical responsibilities of healthcare providers. A recent Ohio court ruling also supports this view, having denied a similar treatment mandate based on concerns over medication safety and standard care practices. Compelling the Defendant to administer a treatment outside established medical standards could undermine healthcare stability and the physician-patient relationship. Thus, granting the injunction would contravene public policy and potentially cause greater harm to the healthcare system.
Healthcare providers are required to deliver care according to prevailing scientific and ethical standards as outlined in the Delaware Code. Dr. Maheshwari emphasized that physicians have an ethical obligation to avoid harming patients and expressed concerns that a proposed injunction could disrupt the practice of evidence-based medicine, potentially leading to the provision of nonbeneficial treatments. He noted that ivermectin lacks proven benefits and poses risks of harm, which could undermine the traditional physician-patient relationship and the autonomy of healthcare professionals in making medical decisions. The excerpt cites a precedent where an injunction was granted to prevent unethical medical practices that could endanger patients. Ultimately, the court denied the plaintiff's request for a mandatory preliminary injunction due to insufficient grounds for relief and a lack of established rights to support the request. The decision is confined to the current motion for interlocutory injunctive relief, with the possibility for the plaintiff to seek an interlocutory appeal.
