A few months after the end of a legal attempt to dictate his COVID-19 caregiving through the courts – one of many recent such attempts around the nation – Burleson pulmonary critical care specialist Jason Seiden, MD, reflected on the “why” of those situations.
What’s causing COVID-19 patients and their families to involve judges and attorneys in an effort to compel physicians to treat the disease in unproven ways, against their medical judgment?
Dr. Seiden believes stress, fear, and desperation are all part of the equation that’s added up to a perhaps-unprecedented spate of cases pursuing mandated treatment through the legal system.
“It’s a new time in medicine. There are social stressors, there are political stressors, there are stressors in people’s lives,” he said. “[It] creates an environment of chaos and fear, and ‘What can I do?’ and ‘I have to do something.’”
While harboring sympathy for such feelings, he also asks: “Where do we draw the line? Once you utilize the legal system to overcome the best professional opinion of a physician or a surgeon, what’s next? It takes out the whole autonomy, and the didactic structure of medicine – everything that we’re taught and that we lean on.”
Dr. Seiden came away relieved in November 2021, after a Fort Worth appeals court sided with his facility, Texas Health Huguley Hospital Fort Worth South, and against the wife of a man who had suffered two collapsed lungs following a COVID infection.
Unlike the trial court that first heard the case, the appeals court denied her attempt to force the hospital to treat her husband with the anti-parasitic drug ivermectin, which, as of this writing, the Food and Drug Administration (FDA) does not recommend to treat COVID-19.
In its decision, the 2nd Court of Appeals heavily emphasized the proper role of the judiciary, with Chief Justice Bonnie Sudderth writing, “Just as we cannot legislate from the bench, we cannot practice medicine from the bench.”
The case wasn’t the first in Texas or the nation to involve attempted court compulsion of an unproven COVID treatment. And in some similar cases around the country, patients’ families have been successful in getting a court order to do so.
The Texas Medical Association’s Committee on Patient-Physician Advocacy, while not directly involved in such cases, has a keen interest in making sure physicians can exercise their medical judgment.
Committee Chair Majid Basit, MD, says it’s imperative for medicine to stand strongly “against courts dictating what physicians can and cannot do.” (See “Picking the Right Battles,” page 16.)
“The courts are our friend. We want them to have a role in making sure that everyone is safe and to interpret the laws when it’s appropriate,” he said. “But we want to make sure that we always advocate for the best care for our patients.”
Medical judgment prevails
According to court documents, Jason Jones was admitted to Huguley in September 2021. Court filings say Dr. Seiden treated him with steroids and antibiotics, but Mr. Jones’ condition didn’t improve. He suffered two collapsed lungs and was placed on a ventilator and moved to the intensive care unit in a medically induced coma.
Mr. Jones’ wife, Erin, researched COVID-19 treatments online and learned about ivermectin, according to court documents. But when she asked the hospital about the drug, the facility declined to attempt treatment with it.
Ms. Jones found and spoke via telehealth to another physician, who prescribed “four infusions and 12 drugs, including ivermectin” for Mr. Jones, court filings say. According to court documents, the patient did not participate in the telehealth call, and the otolaryngologist did not see him in person or review his medical records prior to writing the ivermectin prescription.
Ms. Jones then sued Huguley, Dr. Seiden, and 10 unidentified hospital workers to force the hospital to administer ivermectin. In the appeals court’s words, the suit alleged they “violated state and federal law by ignoring her ivermectin request, that they violated their implied hospital-patient and doctor-patient contracts with Mr. Jones, and that they violated their Hippocratic Oath to do no harm.”
The trial court’s decision required the hospital to grant the other physician temporary privileges solely to give Mr. Jones the disputed drug. In part, the court cited Texas’ “right to try” law, passed in 2015 to provide expedited access to investigational drugs: “This law confirms the right of terminal patients to use an investigational drug, such as ivermectin.”
But the appeals court took a markedly different view, nullifying the trial court’s decision and stating its intent to stay in its legal lane.
“The judiciary is called upon to serve in black robes, not white coats,” Justice Sudderth wrote. “And it must be vigilant to stay in its lane and remember its role. Even if we disagree with a hospital’s decision, we cannot interfere with its lawful exercise of discretion without a valid legal basis.”
Justice Sudderth’s opinion also called the right-to-try law “inapplicable.” The law, it noted, defines an investigational drug as one that “successfully completed phase one of a clinical trial but has not yet been approved for general use by the [FDA] and remains under investigation in the clinical trial.” While the law gives patients a fundamental right “to request experimental drugs,” it doesn’t “give a terminally ill patient the fundamental right to use a medicine off-label” and “does not require a physician to prescribe investigational drugs,” the appeals court wrote.
Dr. Seiden told Texas Medicine in February that Mr. Jones had been transferred to another facility since the appeals court’s ruling the previous November.
Elsewhere in the U.S., similar attempts to compel ivermectin treatment have had mixed success.
In an Illinois case, a patient’s family won a court mandate. According to a May 2021 Chicago Tribune article, a judge in DuPage County, Ill., ordered Elmhurst Hospital to administer ivermectin to a comatose COVID patient after her daughter filed suit (tma.tips/elmhurst). The hospital appealed, according to an American Bar Association article compiling details of several ivermectin cases. But an appeals court ruled the appeal moot because the patient had already been discharged from Elmhurst (tma.tips/abaivermectin).
In August 2021 in Ohio, a judge ordered West Chester Hospital to treat a COVID patient with the drug after his wife received a prescription and requested the emergency court order. But the following month, Judge Michael A. Oster reversed the decision.
Similar to the Huguley case, Judge Oster’s decision noted judges “are not doctors or nurses. We have gavels, not needles, vaccine, or other medicines.”
But the ruling did take stock of the available science surrounding the anti-parasitic (tma.tips/westchester).
“This Court is not determining if ivermectin will ever be effective and useful as a treatment for COVID-19. However, based upon the evidence, it has not been shown to be effective at this juncture,” Judge Oster wrote. “The studies that tend to give support to ivermectin have had inconsistent results, limitations to the studies, were open label studies, were of low quality or low certainty, included small sample sizes, various dosing regimens, or have been so riddled with issues that the study was withdrawn. As such, based upon these limitations, the medical community does not support the use of ivermectin as a treatment for COVID-19 at this time.”
Judge Oster noted it was “impossible not to feel sympathetic” to the wife, saying she wants her husband to get better, and the hospital wants to make that happen while following what it believes are appropriate medical standards. There are no “bad actors” in the case, he wrote.
“While this court is sympathetic to the Plaintiff and understands the idea of wanting to do anything to help her loved one, public policy should not and does not support allowing a physician to try ‘any’ type of treatment on human beings. … What is more, public policy in this case encompasses a number of broader issues” including “obligating one doctor to carry out the treatment regimen/plan of another doctor … and whether a court should medicate or legislate from the bench,” Judge Oster added.
For Dr. Seiden, the court’s decision in the Huguley case represents a needed line in the sand between legal experts and medical ones. And the need for that line goes well beyond ivermectin, he said.
“I was talking to an orthopedic colleague and friend of mine during [our] appellate case while that was ongoing. And he said, ‘What could happen?’” if ivermectin were given to the patient, Dr. Seiden recalled. “I said, ‘Imagine you tell a patient that they’re obese, they’re not a candidate for a knee replacement, and then they go get a court order for a knee replacement.’”
Dr. Basit, chair of TMA’s Committee on Patient-Physician Advocacy, agrees that fear is a driving force behind many of the court battles that emerged over the past year-plus. And families have access to information “outside of the usual randomized control trials and guidelines that we have,” he said. They want to do everything possible to save their loved ones.
“That’s the case with patients looking for alternative therapies for end-stage cancer or any other disease where traditional medicine has said all the therapeutic options have been used up, and really the only option is end-of-life care,” he said. “That, in itself, is a very foreign phrase for most Americans – that concept of futility and end of life and hospice and comfort. We see that on a daily basis as a physician, but families tend to be very reticent to even think about that, and they look at every option that’s out there, even if it’s not approved.”
But, when patients and families demand something, Dr. Basit added, “the physician always has the right to say no.” And TMA can take action to protect that right.
“Legislatively, we can embolden our legislators to work [on] our behalf of both physicians and patients to make sure that physicians retain their autonomy, and we hold that physician-patient relationship sacred.”
Tex Med. 2022;118(6):44-47
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