The Charted Defense

The Shield That Keeps Growing — Mississippi's COVID Immunity and the Diagnostic Delay That Can't Be Sued

Michael

Use Left/Right to seek, Home/End to jump to start or end. Hold shift to jump forward or backward.

0:00 | 41:51

Send us Fan Mail

A patient recovers from COVID-19 in early 2021. Weeks later, he begins losing strength in both legs. Then he can't urinate. He goes to a hospital, then a clinic, then another provider. For three months, no one connects the dots. When the diagnosis finally arrives — transverse myelitis, a known post-COVID neurological complication — the window for optimal treatment has narrowed sharply. He and his spouse file a malpractice suit. The case never makes it past the first procedural hurdle. In Secrist v. Rush Medical Foundation, the Mississippi Supreme Court affirmed dismissal — not because the care was found adequate, but because a COVID-era immunity statute made the lawsuit legally impermissible. The court never had to evaluate the standard of care.

In this episode, Bryan walks through the clinical timeline and the procedural arc of the case. Sarah unpacks Mississippi's pandemic immunity framework — what it covers, how broadly the courts have read it, and where the outer edges of the shield actually sit for care delivered during and after the public health emergency. And Michael brings the frontline hospitalist perspective: why post-COVID transverse myelitis is so easy to miss in the first weeks of progressive weakness, the leg-weakness-plus-urinary-retention combination that should trigger emergent spine MRI on any shift, and what clinicians who practiced through 2020–2021 should understand about how immunity statutes now interact with the diagnostic decisions they made in real time.

Educational purposes only. Not legal advice. Not medical advice.

Support the show

SPEAKER_01

This podcast episode is produced for educational purposes only and does not constitute legal advice or medical advice. Laws governing healthcare provider immunity vary by jurisdiction and change over time. Case details are drawn from public court records. Physicians should consult with qualified legal counsel regarding their specific circumstances and jurisdiction. Clinical guidance discussed in this episode reflects general principles and does not replace individualized clinical judgment. A patient recovers from COVID-19 in early 2021. Weeks later, he starts losing strength in both legs. Then, he cannot urinate. He goes to the hospital and then to another clinic, and then to another provider. For three months, no one connects the dots. When the diagnosis finally comes, transverse myelitis, a known post-COVID neurological complication. The window for optimal treatment has narrowed considerably. Patient and his spouse file a medical malpractice lawsuit. The case never makes it past the first procedural hurdle. Mississippi Supreme Court affirmed the dismissal of Secrist v. Rush Medical Foundation. Not because the care was found to be adequate, but because a COVID-era immunity statute made the lawsuit legally impermissible. The court never evaluated whether the standard of care was met. It did not need to. This is the Charted Defense. I'm Brian, alongside Sarah and Michael. Today we are examining what COVID-era provider immunity statutes may protect in a case like this one, how far that protection extends, and what the Mississippi Supreme Court's decision means for physicians who provided care during the pandemic in that state.

SPEAKER_02

I want to be upfront about where I am coming from on this case. As a hospitalist, I managed post-COVID patients throughout 2021, but I did not personally see this specific presentation. Transverse myelitis can be challenging to diagnose early, particularly in early 2021, when the literature on post-COVID neurological sequelae was still emerging. We were learning in real time. So when I read these facts, I approach them analytically. I can see the clinical red flags that in retrospect should have prompted an urgent neurological workup. And I can also appreciate the clinical environment in which those red flags may have been harder to recognize.

SPEAKER_00

Before we get to the legal framework, we need to understand the medical condition at the center of this case. Transverse myelitis is a rare acquired neuroimmune spinal cord disorder characterized by inflammation across one or more segments of the spinal cord. The inflammation damages the myelin sheath, the insulation around nerve fibers, and can also injure axons directly. Pathologically, the hallmark is focal collections of lymphocytes and monocytes with varying degrees of demyelination, axonal injury, and microglial activation within the cord. When the inflammation extends across three or more spinal cord segments, it is classified as longitudinally extensive transverse myelitis, which is more typical of post-infectious and autoimmune causes rather than multiple sclerosis. It is rare. The reported annual incidence ranges from approximately one to nine cases per million people. But after SARS-CoV-2 emerged, published case series documented a recurring association between COVID-19 infection and subsequent development of acute transverse myelitis. Transverse myelitis is classified as an uncommon neurological complication of COVID-19, typically occurring days to weeks after the onset of infection. The prevailing theory involves molecular mimicry or a post-infectious cytokine storm. The immune system, having fought off the virus, aberrantly cross-reacts with the body's own neural tissue, leading to demyelination and exonyl injury.

SPEAKER_02

That autonomic piece most commonly manifests as acute urinary retention. One important detail from the literature, in the acute phase, the weakness is often flaccid with diminished deep tendon reflexes, which can initially mimic a peripheral neuropathy like Guyan Baret syndrome. That distinction matters, and it is one of the reasons this diagnosis can be missed early. Additionally, one-third to one half of patients present with localizing back pain or a band-like area of altered sensation at the dermatomal level, which is another clue pointing toward a spinal cord process. So you have a patient who recently recovered from COVID and now presents with progressive leg weakness and the inability to urinate. That combination, no leg weakness plus new onset urinary retention, is what should direct our thinking toward a spinal cord process. The standard of care is emergent MRI of the entire spine with gadolinium contrast. What does the treatment window look like? Treatment is high-dose intravenous corticosteroids, typically methyl prednisolone, one gram per day for three to seven days. The goal is to suppress the inflammatory cascade before it causes irreversible damage to the spinal cord. For patients who do not respond to steroids, the next step is plasma exchange. And the evidence suggests that earlier initiation of plasma exchange is associated with better outcomes. There is also data supporting the use of cyclophosphamide in patients who continue to progress despite both steroids and plasma exchange. In terms of what a favorable outcome looks like, when treatment is initiated promptly, approximately 77 to 80% of patients with post-COVID infection transverse myelitis achieve meaningful neurological recovery. That means gradual return of motor strength and the recovery of spontaneous bladder and bowel function. Recovery typically begins within one to three months and can continue over years with rehabilitation. When diagnosis is delayed and the inflammation goes unchecked, the result can be irreversible. Axonal necrosis, permanent paraplegia, or lifelong dependence on intermittent catheterization and chronic neuropathic pain. Older studies suggest persistent disability in approximately 40% of patients, though outcomes have likely improved with the more widespread use of early plasma exchange.

SPEAKER_01

So the timing of diagnosis directly affects the prognosis. In March 2021, he presents to a hospital with progressive weakness in both legs and an acute inability to urinate. Over the following months, from March through June 2021, he is evaluated by multiple providers across different specialties and facilities. A consulting urologist evaluates him in May 2021, likely referred for the urinary retention symptoms specifically. And that evaluation also documented upper and lower extremity weakness. It is not until June 2021, after a transfer to a different regional medical center, that the patient is diagnosed with transverse myelitis. The diagnosing clinicians at that facility attribute the condition to his prior COVID-19 infection.

SPEAKER_02

The up-to-date guidance is clear on this point. Any patient with a reported or identified sensory level should be considered to have a myelopathy until proven otherwise, and when myelopathy is suspected, urgent spinal imaging of the entire cord is warranted. At the same time, I need to put this in the context of where we were during the pandemic. In 2021, we were operating under emergency orders. The healthcare system was overwhelmed. We were running out of ventilators, running out of supplies, making difficult decisions about resource allocation, decisions about who received ECMO, knowing that choosing one patient often meant another would not survive. Those were the extraordinary circumstances the emergency immunity statutes were designed to address. A patient who recently had COVID presenting with fatigue, weakness, and diffuse complaints, that was not unusual. The differential was wide deconditioning, peripheral neuropathy, post-viral fatigue syndrome, urological causes for the retention. And here is what I will be honest about. When these emergency protections were enacted, I understood them as shielding us from the consequences of practicing in an overwhelmed system. I was not certain those protections would extend to a post-viral complication like transverse myelitis, which is a known sequela of viral illnesses in general. Not something unique to COVID-19. The fact that this statute reached that far is itself a significant legal development.

SPEAKER_01

The patient and his spouse filed a medical malpractice action against the hospital and the specialty practice, where the consulting urologist was affiliated. They alleged a failure to diagnose, a failure to order appropriate imaging, and a failure to refer to neurology.

SPEAKER_02

I want to pause on that for a moment because it illustrates an important clinical teaching point. The urologist was likely consulted for the urinary retention. That is a reasonable referral pathway. But when a urologist encounters a patient with urinary retention who also has bilateral upper and lower extremity weakness, that constellation does not fit neatly within urology. It does not have to be the urologist who makes the neurological diagnosis, but it does require that the urologist recognize the full clinical picture, communicate concerns to the referring provider, and make sure the patient gets routed to the right specialist. This case is a reminder that every specialty has a responsibility to look beyond their own lane when the symptoms do not add up.

SPEAKER_01

The complaint also included a loss of consortium claim. The defendants did not engage on the merits of the standard of care question. Instead, they filed a motion to dismiss under Mississippi Rule of Civil Procedure 12B6, a motion arguing that even if every allegation in the complaint were true, the plaintiffs had failed to state a legally actionable claim.

SPEAKER_00

For our physician audience, a 12B-6 motion is significant because of what it does not involve. There are no depositions, no expert witness reports, no evaluation of the medical records. The court looks only at the face of the complaint, the plaintiff's own words, and asks, assuming everything alleged here is true, does the law allow this claim to proceed? The defendant's argument was that it does not, because of a statutory immunity shield enacted by the Mississippi legislature during the pandemic.

SPEAKER_02

The plaintiff was never able to make their case for breach of duty and causation, but that does not mean they did not have a valid claim. The question of whether the care met the standard, whether the diagnostic delay was reasonable given the clinical circumstances, was never addressed. The court did not need to reach it. The immunity statute resolved the case before any of those questions could be explored. But the legal outcome does not change the clinical reality. This patient had a serious outcome. The takeaway for us is to learn from the delay in diagnosis here, so that we are better prepared to recognize this presentation in the future.

SPEAKER_00

The statute at the center of this case is Mississippi Code Section 1171-7, part of the Mississippi Back to Business Liability, Assurance, and Healthcare Emergency Response Liability Protection Act. The legislature enacted it as Senate Bill 3049, signed by the governor on July 8, 2020, with a retroactive effective date of March 14, 2020. The core immunity provision states that any healthcare professional or healthcare facility shall be immune from suit for any injury or death. And the statute specifies directly or indirectly sustained because of the professional's acts or omissions while providing healthcare services related to a COVID-19 state of emergency. Three features of this statute make it unusually broad. First, the operative phrase is related to, not arising from, not directly caused by, not in response to. Related to is one of the broadest connective phrases available in statutory drafting. Second, the statute includes a liberal construction mandate. Section 11-71-7-2 directs courts to liberally construe the chapter with regard to immunizing healthcare professionals. That is the legislature telling courts, when in doubt, read this in favor of the provider. Third, and this is critical for understanding the sechrist outcome, the statute's definition section expands the scope further. Section 11-71-3A defines COVID-19 not merely as the SARS-CoV-2 virus or the acute respiratory illness. The definition explicitly includes health conditions or threats caused by the virus and conditions associated with the disease. That definitional breadth is what allowed the court to bring a post-COVID neurological complication within the statute's reach.

SPEAKER_01

How does the immunity end? Is there a sunset provision?

SPEAKER_00

The immunity takes effect when the COVID-19 state of emergency is declared and applies to healthcare services performed during the emergency, including any period of renewal. It terminates one year after the end of the emergency. So the prospective immunity window closed on November 20, 2022. But, and this is important, the Act contains what is effectively a savings clause. Civil liability arising from acts or omissions that occurred during the Act's operation remains subject to its provisions permanently. The immunity does not expire for care already delivered during the covered period.

SPEAKER_01

So, how did the Mississippi Supreme Court apply this framework to the sacrist facts?

SPEAKER_00

The majority opinion, authored by Justice T. Kenneth Griffiths, applied a plain language analysis. The court's reasoning followed a clear chain. First, the alleged negligent acts occurred between March and June 2021, squarely within the declared COVID-19 state of emergency. Second, the complaint itself alleged that the patient's transverse myelitis was caused by COVID-19. That allegation was necessary for the plaintiff's theory of damages, but it also supplied the statutory nexus. Because the statute's definition of COVID-19 includes conditions caused by the virus, and because the immunity covers healthcare services related to the emergency, the court concluded that the claim fell within the shield. The court put it directly. COVID-19 caused the COVID-19 state of emergency. Therefore, medical conditions caused by COVID-19 are within the medical conditions causing the emergency. Services provided in relation to those conditions are services related to the emergency. Plain text, broad definitions, liberal construction, dismissal affirmed.

SPEAKER_02

What I find striking is that the plaintiff's own pleading was the mechanism that triggered the immunity. They had to allege that COVID-19 caused the transverse myelitis. That was the ideological foundation of their case. But that very allegation locked the condition into the statute's definition of COVID-19. It is a structural feature of the law. If you are suing over a post-COVID complication, you must establish the COVID nexus to explain the injury, and that nexus is exactly what activates the shield. I also want to note, um, based on what we know about delayed neurological diagnosis cases, they tend to result in significant plaintiff verdicts. This case was not dismissed because the care was found to be adequate. It was dismissed on a statutory procedural shield. The care may still have fallen below the standard. The plaintiff may have had a strong case on the merits, but we will never see those facts evaluated. This is not a clinical victory, uh, it is a legal one. And that raises a question I do not have the answer to. But I think it is worth raising. If the plaintiff had focused on the transverse myelitis as a standalone diagnostic failure and not tried to link it to the prior COVID-19 infection, would they have had a better chance of getting past this statute? I am not certain that the link between COVID and the transverse myelitis was necessary to prove the malpractice claim. The alleged negligence was the failure to diagnose and order imaging, not the failure to prevent a post-COVID complication. It is possible that the very allegation needed to explain the etiology was what handed the defense the immunity shield. That is a strategic dimension worth thinking about.

SPEAKER_00

The plaintiffs tried to narrow the statute. They cited the Mississippi Department of Health's System of Care Plan, which describes COVID-19 primarily as a respiratory disease stressing critical care capacity. They argued the legislature intended the immunity to cover only acute respiratory care during surge conditions. The court rejected that argument.

SPEAKER_02

I will add my perspective on that. When these emergency orders were enacted, I understood them as protecting providers from the consequences of an overwhelmed system. We were making triage decisions about ventilators and ECMO. Decisions where choosing one patient often meant another would not survive. We were protected from litigation because of those extraordinary circumstances. The idea that the same protections would extend to a post-viral neurological complication diagnosed months later. That is a broader reading than I think most of us on the front lines anticipated. Transverse myelitis is a known complication of viral illnesses generally. It was not unique to SARS-CoV-2. Whether the legislature intended this breadth is a question for others. But the court read the statute as written, and the text supports the result.

SPEAKER_01

Were there any dissents?

SPEAKER_00

No. The court was unanimous in outcome. Justice Josiah Coleman filed a special concurrence addressing the legislative history question separately. The plaintiffs had invoked public remarks attributed to the bill's sponsor, describing the legislation as targeted to COVID claims. But that argument was procedurally waived because it was not raised in the trial court. Justice Coleman went further. He argued that even if preserved, individual legislators' public explanations are not part of the enacted law and should not drive statutory interpretation when the text is clear. Section 11-71-11 provides that the immunities in the chapter do not apply if the plaintiff shows, by clear and convincing evidence, that the defendant acted with actual malice or willful intentional misconduct. I want to emphasize what the standard requires and what it does not. This is not a gross negligence exception. Many other states that enacted COVID immunity statutes used gross negligence as their threshold, meaning immunity could be overcome by showing a severe departure from the standard of care. Mississippi chose a significantly higher bar. Actual malice typically requires intent to harm. Willful, intentional misconduct requires a conscious decision to act improperly. And the evidentiary standard is clear and convincing, more demanding than the preponderance of the evidence. Standard that applies in ordinary civil cases.

SPEAKER_02

That distinction matters for understanding the legal landscape. A three-month delay in diagnosing transverse myelitis, however clinically concerning, does not approach actual malice or willful misconduct. Based on the complaint's allegations, the providers evaluated the patient repeatedly across multiple encounters and specialties. They reached the wrong diagnosis or failed to reach the right one in time. That fits the definition of ordinary negligence, which is exactly what Mississippi's statute immunizes. But what matters more for our audience is this. The care and delay in diagnosis here could be legitimate clinical complaints. The immunity statute resolved the legal question, but it did not resolve the clinical one. We need this diagnosis in our differential. We need to know what transverse myelitis looks like, especially in the context of a post-viral syndrome, so that we do not contribute to a similar delay in the future. And I want to be clear about the overall tone here. This was an unprecedented pandemic. These immunity statutes were a legislative response to extraordinary circumstances. Our goal on this podcast is not to judge those decisions. It is to learn from the clinical outcome so we are more informed and less likely to repeat any diagnostic delays that may have occurred. That is not to say these providers practiced bad medicine. It is to say that conditions like transverse myelitis will present, and we need to be prepared to recognize them.

SPEAKER_01

Mississippi is not the only state that enacted COVID-era provider immunity. How does its approach compare to other jurisdictions?

SPEAKER_00

Many states enacted some form of COVID-era health care provider liability protection during 2020 and 2021, but the landscape is a patchwork. The statutes vary dramatically in scope, duration, and exception standards. Mississippi is at the broad end of the spectrum. Compare how courts in two other states interpreted their immunity provisions. In Kentucky, the Court of Appeals examined a case where immunity was invoked for care that allegedly fell below the standard. The Kentucky Court required a causal nexus between the alleged negligence and COVID countermeasures, meaning the negligence had to be connected to the provider's COVID response activities specifically. Ordinary negligence during the pandemic period was not automatically immunized. That is a much narrower reading. In Georgia, an appellate court held that immunity under the state's emergency order framework required a connection to emergency management activity. An elective spinal surgery that happened to occur during the emergency period did not qualify. Again, a nexus requirement that Mississippi statute does not impose. The contrast matters. Under Mississippi's framework, the Nexus is satisfied whenever the underlying medical condition is related to COVID-19, which the statutory definition makes very broad. Under Kentucky's and Georgia's frameworks, the Nexus requires a connection to the emergency response itself. Same pandemic, similar legislative intentions, very different legal outcomes, depending on how the statute was written and how courts interpret the operative language.

SPEAKER_02

That obligation does not change based on geography or on whether an immunity statute happens to cover the care we provided. What is useful is simply knowing that some protections exist for COVID-era care and that they vary from state to state. That awareness is part of understanding the legal environment we practice in, but it should never enter our clinical decision-making.

SPEAKER_01

We have spent a significant portion of this episode on the legal framework. But there is a clinical lesson in the sacrist facts that matters regardless of which state you practice in.

SPEAKER_02

There is. And I want to address it directly, because the legal outcome should not obscure the clinical teaching point. Transverse myelitis is rare, but the red flag pattern that should trigger a spinal cord workup is not rare in the differential. The big theme here is think spine. When you see bilateral lower extremity weakness plus new onset urinary retention, think spinal cord process. That is true whether the suspected etiology is transverse myelitis, cauda aquina syndrome, epidural abscess, compressive myelopathy, spinal cord infarction, or a spinal tumor. The differential for this symptom constellation is broad MS, NMOSD, MOGAD, ADEM, metastatic disease, spinal stenosis, vascular malformations, and more, but the initial diagnostic pathway converges on the same study. Emergent MRI of the entire spine with gadolinium contrast. And I want to emphasize the imaging point because it connects to something we discussed in season three of On the Record. Once you are thinking, spine, order the correct test. An X-ray will not help. A CT scan may not show an intrinsic cord lesion. The literature is clear that a normal CT does not rule out spinal cord pathology. If you order the wrong study and it comes back negative, it can actually bias your thinking away from a spinal cord process. You may think you have ruled it out when you have not. In a malpractice case, that will be framed as the physician was considering a spinal cord process, but chose a study that is well established to not be the appropriate imaging modality for acute spine disease. If you think spine, order the MRI. Document why you ordered it, and if for some reason you decide not to order emergent imaging, document your reasoning for that decision as well. The post-COVID context adds an additional layer that is worth discussing. We now recognize from the published literature that SARS-CoV-2 infection can trigger a range of post-infectious neurological conditions beyond transverse myelitis. The literature on COVID-19 neurologic complications lists Guyan Barrett syndrome, acute disseminated encephalomyelitis, seizures and status epilepticus, autoimmune encephalitis, myoclonus, and various focal neuropathies among the recognized associations. Some of these neurologic complications may not appear until days to weeks after the initial infection, which means a patient can present looking like they are past the acute illness when the neurological complication is just beginning. For those of us who still see patients with COVID infections, and we do, these post-viral complications remain relevant. When a patient who recovered from COVID presents with new neurological deficits, especially motor or autonomic symptoms, that history should heighten your clinical suspicion, not diminish it. And we are now outside the window, protected by these immunity statutes. So any delays or misses for patients with acute COVID infections will be fair game for a malpractice claim.

SPEAKER_01

Michael, what should physicians listening to this take into their next shift?

SPEAKER_02

Five things. First, the clinical red flags. This is the most important point. Bilateral lower extremity weakness plus new onset urinary retention equals think spine, and thinking spine means ordering an MRI, not an X-ray, not a CT, an MRI of the entire spine with gadolinium. Do not let a plausible-sounding alternative diagnosis, deconditioning, urinary tract infection, peripheral neuropathy, delay imaging when the presentation includes both motor and autonomic findings. Some guidance puts it plainly. Any patient with a sensory level should be considered to have a myelopathy until proven otherwise. Second, document your reasoning, not just your plan. If you evaluate a patient with these symptoms and decide not to order emergent imaging, and there may be clinical circumstances where that decision is defensible, document why. What was your differential? What findings supported a non-emergent etiology? What follow-up plan did you establish, and what return precautions did you give? And if you do order imaging, make sure it is the study that will actually answer the question. As we discussed in other episodes, ordering the wrong test can be used against you. The argument will be that you recognized something was wrong in the spine, but chose a modality that is not the standard for evaluating acute spinal cord disease. The immunity statute may protect you in some states, but in most states your documentation is your defense. Third, boxn't educate yourself on the post-COVID neurological conditions that can present after infection. Transverse myelitis, Guillain-Baret syndrome, acute disseminated encephalomyelitis, autoimmune encephalitis, these are recognized post-infectious complications, and we are still seeing COVID infections. These conditions will continue to present. Staying current on what they look like and how they present is part of our responsibility. Fourth, know that care provided during the COVID pandemic, particularly care involving COVID-related conditions, may carry some statutory protections for providers depending on the state. The specifics vary. Some states enacted broad immunity like Mississippi, others used narrower statutes tied to emergency management activity, and some relied on executive orders that have since expired. This is not something that should change your clinical practice, but if you are ever in a situation where it is relevant, discuss it with your attorney. Also note that the statute of limitations is likely approaching or has passed for most care provided during the period covered by these COVID emergency statutes. So we will likely see fewer of these cases being filed. Most are likely already working their way through the legal systems. Fifth, and this is the broader principle, the immunity statute may or may not be available to you, but your obligation to the patient in front of you does not depend on whether a legal shield exists. The clinical standard of care is your responsibility irrespective of liability protections. Approach every patient with the goal of getting to the right diagnosis and let the legal system take care of itself.

SPEAKER_01

The Mississippi Supreme Court's decision in Secrist v. Rush Medical Foundation answered a question that had been opened since the pandemic. Do COVID-era provider immunity statutes cover only acute COVID treatment? Or do they extend to care for conditions caused by the virus? In Mississippi, the answer is clear. The legal landscape across the country remains a patchwork, broad immunity in some states, narrow or expired protections in others, and many statutes yet to be tested in court. For physicians who provided care during the pandemic, the practical imperative is the same. Understand the clinical standards that exist to protect patients and practice to those standards regardless of the legal environment.

SPEAKER_02

It is good to know that some immunity statutes exist for pandemic-era care, but that knowledge should never play a role in the decisions we make as clinicians. Our role is to provide the best care using the evidence available to get to the diagnosis quickly and efficiently. If I were a provider who delayed a critical diagnosis in a post-COVID illness and was protected by this immunity, I would still carry that with me. The statute may resolve the legal question, but it does not resolve the clinical one. So my call to action is this: keep up to date on COVID-related complications, especially those with a high risk of permanent disability. Remember that transverse myelitis, guillon barre, ADEM, these are diagnoses where time matters. And remember that there are certain presentations, like one like the one in this case, where an MRI in the emergency department may be exactly the diagnostic tool that changes the outcome for your patient.

SPEAKER_01

This podcast episode is produced for educational purposes only, and does not constitute legal advice or medical advice. Laws governing healthcare provider immunity vary by jurisdiction and change over time. Case details are drawn from public court records. Physicians should consult with qualified legal counsel regarding their specific circumstances and jurisdiction. Clinical guidance discussed in this episode reflects general principles and does not replace individualized clinical judgment.