The Enemy of Good is Better. The Case for $1 a Day SARS-CoV-2 Testing.

Before we begin, a brief reminder: We provide free consultations specific to COVID-19 operational procedures, staff training, patient consent, and more. Click here to learn how our expert counsel can help your practice stay out of the medico-legal crosshairs. With that said, onward to the piece.

There are two things I don’t understand.

In TSA airport lines, what is the security benefit of spending 5 minutes doing random “enhanced screening” on Grandma, a ninety-year-old woman with a walker who took 5 minutes to advance through the metal detector? We’ve all seen it. I suppose a terrorist organization could equip Grandma with explosives. And we want random checks to be perceived as fair. Still, I don’t get it.

Next, I hear people on TV barking all day about increasing testing and doing contact tracing for COVID-19. Efficient testing – yep, great idea. Contact tracing? How does one do that with 50,000 to 70,000 cases reported a day? Transmission occurs mostly via asymptomatic or pre-symptomatic patients, well before any presumed test would be read. Some tests are taking up to 8 days to be read. Even if all Americans downloaded an app on their phones to send 24/7 geolocation information to contact tracers, I don’t see how public health would improve.

I also don’t understand some of the paradoxes of quantum physics, but that’s a story for another day.

Onward to discussing a brilliant suggestion I heard on This Week in Virology (“the podcast about viruses, the kind that make you sick” – its bona fide tagline). Michael Mina, a public health expert at Harvard, explained why a daily rapid home-based test for SARS-CoV-2 could tame the pandemic.

Our current testing regimen is clinical-grade. It’s designed to be extremely sensitive. Mina co-authored a paper arguing that test sensitivity only needs to be surveillance-grade. When testing at the population level, we are mostly interested in whether one person will transmit an infection to another person.

After infection, individuals undergo a period of incubation during which viral titers are usually too low to detect, followed by an exponential growth of virus, leading to a peak viral load and infectiousness, and ending with declining viral levels and clearance…. These results demonstrate that effective surveillance, including time to first detection and outbreak control, depends largely on frequency of testing and the speed of reporting, and is only marginally improved by high test sensitivity. We therefore conclude that surveillance should prioritize accessibility, frequency, and sample-to-answer time; analytical limits of detection should be secondary.

More on that shortly.

Patients infected with SARS-CoV-2 take a while to develop clinical symptoms, if they ever do. The virus multiplies. Once it reaches a critical threshold of virus concentration, that patient can transmit the infection to another. The “gold standard” for clinical testing is quantitative real-time polymerase chain reaction (qPCR). qPCR remains expensive, and even in the best of situations, has a sample to result time of 24-48 hours. These assays have analytical limits of detection that are usually within around 103 viral RNA copies per ml (cp/ml). qPCR typically uses a primer to bind to the nucleic acid (in this case RNA). Binding is associated with a fluorescent signal. The exercise is repeated (amplified) multiple times (cycles). An important term is Ct which is known as “cycle threshold.”

The Ct (cycle threshold) is defined as the number of cycles required for the fluorescent signal to cross a threshold (i.e. exceeds background level). Ct levels are inversely proportional to the amount of target nucleic acid in the sample (i.e. the lower the Ct level the greater the amount of target nucleic acid in the sample).

Ct < 29 is a strong positive reaction – indicative of abundant target nucleic acid in the sample.
Ct of 30-37 is also a positive reaction – indicative of moderate amount of target nucleic acid.
Ct of 38-40 is a weak reaction – indicative of minimal amounts of target nucleic acid which could represent an infection state or environmental contamination.

In other words, the more cycles PCR needs to detect a threshold fluorescent signal, the lower the RNA concentration in the initial sample. This sample is less infectious.

And vice versa. The fewer cycles needed to detect a threshold fluorescent signal, the higher the RNA concentration in the initial sample. This sample is more infectious and of greater interest for surveillance.

Golf provides a helpful, if strained, analogy. A low golf score is a positive test of you being a good golfer. A low Ct is evidence the initial RNA concentration of the sample is high and more infectious.

As I stated before, 103 viral RNA copies per ml (cp/ml) is the limit of detection with clinical-grade qPCR.

There are cheaper and faster assays with higher thresholds of detection (i.e., around 105 cp/ml) such as point-of-care nucleic acid LAMP [loop-mediated isothermal amplification] and rapid antigen tests.

Patients with low virus concentrations are presumed to not be contagious.

Since filtered samples collected from patients displaying less than 106 cp/ml contain minimal or no measurable infectious virus, either [of the cheaper and faster assays] should detect individuals who are currently infectious. The absence of infectious particles at viral RNA concentrations < 106 cp/ml is likely due to (i) … abundant subgenomic mRNAs, leading to overestimation of the number of actual viral genomes by 100-1000X, (ii) technical artifacts of RT-PCR at Ct values > 35 due to limited template, and (iii) the production of non-infectious viral particles as is commonly seen with a variety of RNA viruses.

In other words, if you use a less sensitive test, (one with a lower target Ct) you will still be able to answer the question, is this patient infectious. What if on the day you test a patient, the result is negative but (had it been measured by qPCR), you would have found some copies of viral RNA? It should not matter. If the patient is getting “worse”, and you are testing daily with your $1/day test, the virus will multiply and you’ll pick it up tomorrow, before or while they are contagious. At the population level, that is the important question you want to answer. If the patient is getting “better”, then the viral kinetics are trending favorably. The patient will still test negative on your $1/day test. The patient will still not transmit the disease.

Like a home pregnancy test, surveillance quality SARS-CoV-2 testing would be frequent, cheap, and could be performed anywhere. Instead of ramming a swab into the middle turbinate, you could rely on anterior nares sampling or even saliva. Before sending kids off to school, spit in a tube and test. Before walking in to work, spit in a tube and test. Want to get into a restaurant or bar? Get the test done by the maître d or the bouncer.

Is a $1 day home-based test a pipe dream? Michael Mina suggests it’s doable with off-the-shelf technology today. He argues the federal government could apply the Defense Production Act to manufacture and distribute such tests. It would be far faster and easier than the research and development required for therapeutics and vaccines.

As a resident, I scrubbed in on a meningioma resection. For hours, the attending surgeon meticulously dissected and removed the tumor. We were almost done. The attending wanted to get it all out. This meant dissecting the remaining strands from the sagittal sinus. The sagittal sinus is a large high-flow draining vein for the brain. You do not want to injure that vessel. If you do, the operative field turns into a bloody mess. Potentially a lethal bloody mess. Well, in our zeal to do a total resection, we got into the sagittal sinus. Several hours later, all was well. A happy ending. But, remember, the tumor was a slow-growing mass. It wasn’t clear this patient would have ever benefited from the additional resection. But once we committed to the plan, the risk went up. The attending concluded with words I’ve never forgotten. “The enemy of good is better.” Sometimes good enough is just fine.

A $1 a day, at home SARS-CoV-2 test may be good enough. Thoughts? Anyone? Anyone? Ferris? Anyone? Comment below.

Meritless disputes propelled by COVID-19 continue to harass doctors. For example, you might have had to change surgicenters for your scheduled patient. You bent over backwards to help the patient. New expenses. Patient gets angry. Those with access to medico-legal counsel are prepared to face the emerging challenges. Those without are struggling.

Here’s something else we know: Each state is different, but practices everywhere share the same responsibility: Keep staff and patients safe.

But with protocols changing on a weekly basis, knowing what to do is half the battle. What’s the solution? Easy. Don’t panic. And ask for help.

Contact us to schedule counsel specific to COVID-19 safety procedures and operational processes. We provide counsel specific to re-opening your practice, staff training, patient consent verbiage, and more. Medical Justice is equipped to keep your practice out of the COVID-19 crosshairs.

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We’ve been protecting doctors from medico-legal threats since 2001. We’ve seen it all. Here’s a sample of typical recent consultation discussions…

  • Former employee stole patient list. Now a competitor…
  • Patient suing doctor in small claims court…
  • Just received board complaint…
  • Allegations of sexual harassment by employee…
  • Patient filed police complaint doctor inappropriately touched her…
  • DEA showed up to my office…
  • Patient “extorting” me. “Pay me or I’ll slam you online.”
  • My carrier wants me to settle. My case is fully defensible…
  • My patient is demanding an unwarranted refund…
  • How do I safely terminate doctor-patient relationship?
  • How to avoid reporting to Data Bank…
  • I want my day in court. But don’t want to risk my nest egg…
  • Hospital wants to fire me…
  • Sham peer review inappropriately limiting privileges…
  • Can I safely use stem cells in my practice?
  • Patient’s results are not what was expected…
  • Just received request for medical records from an attorney…
  • Just received notice of intent to sue…
  • Just received summons for meritless case…
  • Safely responding to negative online reviews…

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Our Executive Team walks with our member doctors until their medico-legal obstacles are resolved.

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.

To Mask or Not to Mask. That is the Question.

For decades, surgeons have performed elaborate rituals to minimize risk of infection to patients. We wash our hands. Don gloves and gowns. Cover our hair. Avoid reaching over our heads or below our waist (except to adjust the light – yes, I know, the rituals are imperfect). It’s a familiar exercise. And it works.

Surgical infections are uncommon. Operating suites are not clean rooms. Patients are still exposed to bacteria. We try to lower the potential inoculum to an amount most patients can handle with a functioning immune system.

I cannot recall a single surgeon ever making a libertarian argument it’s his choice whether to adhere to these rituals.

That was not always so.

Ever heard of Dr. Ignaz Semmelweis? He was a Hungarian physician. His key innovation – cutting the incidence of puerperal fever (“childbed fever”) in obstetrical clinics by using hand disinfectants. Puerperal fever was common and often fatal. Semmelweis’ radical proposal in 1847 was washing hands with chlorinated lime solutions. At the time, the doctors’ wards had three times the mortality of midwives’ wards. When implemented, hand washing crushed the mortality rate. It worked.

During 1848, Semmelweis widened the scope of his washing protocol, to include all instruments coming in contact with patients in labor, and used mortality rates time series to document his success in virtually eliminating puerperal fever from the hospital ward.

How did the medical community react?

Semmelweis was treated as a pariah.

He could offer no acceptable scientific explanation for his findings, and some doctors were offended at the suggestion that they should wash their hands and mocked him for it. In 1865, the increasingly outspoken Semmelweis supposedly suffered a nervous breakdown and was committed to an asylum by his colleagues. He died 14 days later after being beaten by the guards, from a gangrenous wound on his right hand which might have been caused by the beating. Semmelweis’ practice earned widespread acceptance only years after his death, when Louis Pasteur confirmed the germ theory, and Joseph Lister, acting on the French microbiologist’s research, practiced and operated using hygienic methods, with great success.

Certainly, harsher than having to present at a peer review committee meeting.

Semmelweis paved the way toward wide acceptance of infection control.

I trained at Baylor College of Medicine. There, urban legend had it a visiting professor from another country was watching a famous cardiac surgeon operate. The professor stood next to the anesthesiologist, peering over the drape. His glasses supposedly fell into the wound. The surgeon removed the polluting object and returned it to the visiting professor. (Was it first washed? I have no idea. This is an urban legend.) Although the cardiac surgeon had a famous temper, he kept his cool. The same hour, the visiting professor’s glasses fell into the wound again. The surgeon merely looked up and said, “Why don’t you take your pants down and defecate in the wound?” Urban legend has it he used a synonym for defecate.

Onward to masks. In May, Lancet published an article on the history of the surgical mask.

Covering the nose and mouth had been part of traditional sanitary practices against contagious diseases in early modern Europe. This protection was primarily about neutralising so-called miasma in the air through perfumes and spices held under a mask, such as the plague doctors’ bird-like masks. Such practices, however, had become marginal by the 18th century. 

Masks

Following a hiatus of several centuries,

Johann Mikulicz, head of the surgery department of the University of Breslau (now Wroclaw, Poland) started working with the local bacteriologist Carl Flügge, who had shown experimentally that respiratory droplets carried culturable bacteria. In response to these findings, Mikulicz started to wear a face mask in 1897, which he described as “a piece of gauze tied by two strings to the cap, and sweeping across the face so as to cover the nose and mouth and beard”. In Paris, the surgeon Paul Berger also began wearing a mask in the operating room the same year…

However, masks became increasingly widespread. A study of more than 1000 photographs of surgeons in operating rooms in US and European hospitals between 1863 and 1969 indicated that by 1923 over two-thirds of them wore masks and by 1935 most of them were using masks.

It was mainly the use of the mask to cover the mouth and nose (and beard) during the Manchurian plague of 1910–11 and the influenza pandemic of 1918–19 that turned the face mask into a means of protecting medical workers and patients from infectious diseases outside of the operating room. During the 1918–19 influenza pandemic, wearing a mask became mandatory for police forces, medical workers, and even residents in some US cities, although its use was often controversial. Yet in cities like San Francisco, the decline in deaths from influenza was partly attributed to the mandatory mask-wearing policies. At this point, the rationale for wearing masks moved beyond their original use in the operating theatre: they now also protected the wearer against infection.

Medicine moved from reusable to single use protective equipment.

Medical masks started to be replaced by disposable paper masks during the 1930s and were increasingly made of synthetic materials for single use in the 1960s. By the early 1960s, there were advertisements for new kinds of filtering masks made of non-woven synthetic fibres in nursing and surgery journals. These filtering masks were all disposable.

Industry-sponsored studies found the new synthetic masks to be superior to traditional reusable cotton masks. More frequently, however, reusable masks were omitted from comparative studies. In 1975, in one of the last studies to include an industrially manufactured cotton mask, the author concluded that the reusable mask, made of four-ply cotton muslin, was superior to the popular disposable paper masks and the new synthetic respirators. He noted that “cotton fabrics may be as effective as synthetic fabrics when incorporated in a good mask design.” Some studies have suggested that washing reusable masks might increase their bacterial filtering efficiency, perhaps by tightening their fibres. In the absence of commercial cotton masks, more recent studies have only compared artisanal or homemade masks with industrially produced disposable masks, finding the latter to be superior. These results to some extent reinforced the idea that reusable masks were potentially unsafe, partly discouraging further research into well designed and industrially manufactured reusable masks.

The Lancet article concludes:

Perhaps one day it might again be possible to say about protective face masks what medical researchers wrote in 1918: “A mask may be repeatedly washed and used indefinitely.”

My take on the mask wearing debate conforms to what most physicians are advising as we reopen our economy during the COVID-19 pandemic. Just wear a mask.

If I were king, I would mandate this until we have better therapeutics or vaccines: (a) No super-large gatherings. (eg professional football games, rock concerts, Mardi Gras); (b) face masks; and (c) hand washing (ubiquitous alcohol-based goop). That’s mostly it, although as king I’d probably have to fill in some details. We can still have a functioning economy. 

My measures as king require some sacrifice. But, let’s admit it, are they really that big a deal? People should just do that stuff anyway. Sorry to be crude – I wash my hands after I have a bowel movement. No law needed. I don’t go on TV crying about freedom to not wash my hands after I wipe my bottom. It’s just good sense. And I’m sure people around me are glad I take THAT minor act seriously. I don’t consider the choice to wipe or not wipe my bottom an act of libertarian deliberation. Of course, once I buy the Toto I’ve had my eye on, I WILL have a choice. That’s a story for another day.

There are analogous public health measures we already accept; for example, related to driving under the influence. The vast majority of times a person has a blood alcohol over 0.08%, he is able to make it home without crashing into a tree or killing riders in other cars. That statistic does not inform our laws. We agree that because we don’t know when some drunk driver will be lethal, we just ban all driving while under the influence. Because we don’t know when some asymptomatic or pre-symptomatic COVID-19 petri dish may infect a vulnerable person, we consider mandating measures (such as wearing a mask) to prevent a bad outcome. 

The effort required to wear a mask is minimal. The inconvenience slight. The potential benefit great. It’s always a balancing act. We know more now. We still have much to learn. Not everyone will agree with me. What do you think? Comment below.

Medical Justice provides free consultations to doctors facing medico-legal obstacles. We have solutions for patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief) and a meritless litigation. We also provide counsel specific to COVID-19. If you are navigating a medico-legal obstacle, schedule a free consultation with our CEO, Jeff Segal, MD, JD.

Learn how Medical Justice can protect you from medico-legal mayhem… 

Take Advantage of Our Review Monitoring Service

We provide qualified applicants with free review monitoring for 6 week. Reports delivered bi-weekly.

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Request a Consultation with Our Founder

Medical Justice Founder and CEO, Jeff Segal, MD, JD, provides consultations to doctors in need of guidance. 

Meet the Experts Driving Medical Justice

Our Executive Team walks with our member doctors until their medico-legal obstacles are resolved.

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.

The Ethics of Vaccine Efficacy Trials Using Prisoners Challenged with SARS-CoV-2

The race is on to create and distribute a safe and effective vaccine against SARS-CoV-2 for the world. Historically, a vaccine’s efficacy against dangerous agents is tested by seeing whether vaccinated subjects in endemic areas have lower incidence of the disease than the surrounding population. Alternatively, if there’s a reasonable treatment for the condition, then those subjects might be exposed to the agent.  

A thought experiment. 

What if the FDA learns the best vaccine candidate was tested overseas using prisoners challenged with SARS-CoV-2 exposure? Assume the safety profile and evidence of efficacy are excellent. Should the FDA allow the compound to be marketed and distributed in the US? 

Now assume the submitted data package is unchanged but the trial investigators overseas made no mention of using prisoners. That fact is only learned from leaked documents exposing the details. What now? Should the vaccine, if approved, be withheld from the US market? 

The reason I bring this up is because of a position taken by virologists on a podcast I’ve been listening to: This Week in Virology. The panel’s consensus opinion seems to be challenging a patient with SARS-CoV-2 exposure after they’ve been vaccinated with a test vaccine would be unethical. They argue that a patient could get sick and die because there are no known highly efficacious treatments. That point is true. But, let’s step back a moment.  

First, there are thousands of people ready, willing, and able to participate in vaccine trials including being challenged with virus exposure.  

Next, Phase 1 preliminary safety studies are not without risk. Normally, such studies get the green light only after animal studies have demonstrated a reasonable safety profile. Nature does not always cooperate. Ever heard of BIA-2474 (sponsored by a company called Bial)? Most people have not. In 2016, that compound was tested in a Phase 1 safety trial. BIA-2474 was a FAAH inhibitor.  

To refresh

Drugs which enhance the activity of endocannabinoids such as cannabinoid receptor agonists, agents modifying cannabinoid transport or inhibiting their metabolism have the capacity to be used as analgesics, hypnotics, antiemetics, antihypertensive, antiasthmatics, antiepileptics, neuroprotectives, immunomodulatory, anti-inflammatory, alcohol withdrawal, and eating disorders.

One of the major advances in this field was the generation of fatty acid amide hydrolase (FAAH) inhibitors. FAAH hydrolyses the endocannabinoids with amide bonds including anandamide (AEA). Inhibition of FAAH would lead to extended endocannabinoid activity at its site of synthesis resulting in tissue selective activation of CB receptors. This enhanced endocannabinoid activity is suggested to be useful in the treatment of several clinical conditions. At present, a lot of research is being carried out to establish their role in the management of neuropathic pain. 

FAAH inhibitors are being researched extensively, but none of them has reached market yet. Other clinical trials that are conducted on FAAH inhibitors are Merck’s MK-4409, Pfizer’s PF-04457845, and Vernalis’ V158866. None of these trials had reported any adverse effect with this group of agents, and they were considered safe in humans. 

[Prior to human trials with BIA-2474], Bial performed studies on four animal species: rat, mice, dog, and monkey.

What happened? 

A total of 128 participants were enrolled in this trial, out of which ninety were dosed with compound, and the others were given placebo. Volunteers who were subjected to multiple doses of test drug were adversely affected, five of them were admitted to hospital, out of which one of the volunteers was declared brain dead and other four, were said to have irreversible brain damage. The magnetic resonance imaging (MRI) of the affected patients showed evidence of deep cerebral hemorrhage and necrosis.

In short, a disaster. With the benefit of hindsight, much was learned and recommendations were made to update future trial designs to enhance safety.  

Still, the point is that even Phase 1 safety trials pose risk. A Phase 1 safety trial for SARS-CoV-2 would similarly pose some risk. We just don’t know how to quantify that risk. 

Is there a reason to foreclose informed volunteers from participating in Phase 2 vaccine efficacy trials where the subject is challenged with exposure to SARS-CoV-2? Is it really unethical?  

Assume the test vaccine does nothing to protect. We have a reasonable idea of what the mortality and morbidity risk of COVID-19 is to various subjects. By selecting the right demographic, that risk can be controlled, but not eliminated.  

Assume the test vaccine makes the clinical course of SARS-CoV-2 worse than baseline. It’s possible. We don’t know how to quantify that risk. That risk is the same whether the patient is intentionally challenged with virus exposure or exposed to SARS-CoV-2 “in the wild” over time. The only difference is how soon we’ll know that vaccine is a dud.  

If subjects are informed of the risks, whether we can quantify them fully or not, and they volunteer to participate in a vaccine challenge trial, is it noble or unethical? I think the former. All sorts of people volunteer for risky activities that benefit society as a whole. Firefighters, policemen, Navy SEALs, ER and Critical Care Physicians, nurses, and many, many more. This list goes on and on.  

Further, we all accept some risk in our everyday life. We drive in cars. If we wanted to cut the risk of death from driving, we could mandate helmets and flame proof clothing. We could then cut the speed limit to 25 MPH. We don’t.  

We cannot eliminate all risk.

Back to SARS-CoV-2. If we adopt the traditional approach testing vaccinated subjects in endemic areas to learn whether they have a lower incidence of COVID-19 than the surrounding population, the rest of the world may not wait. Some societies may force those who cannot provide informed consent to be challenged with the virus. Then we’ll have a Faustian choice to make. 

Perhaps we’ll have better therapeutics available when Phase 2 and Phase 3 vaccine trials get started. If so, this discussion is academic.  

One statistic that is growing as fast, if not faster, than the US mortality rate from COVID-19. The list of people willing to test a vaccine and be challenged with exposure to SARS-CoV-2. 

What do you think? Let us know in the comments below.

When navigating unprecedented challenges, access to salient, seasoned experts is invaluable. Medical Justice has devised a collection of templates and guidelines that will see you through the emergent medico-legal challenges presented by COVID-19. These resources address obstacles related to informed consent, reopening your practice, and staff issues specific to COVID-19.

Members of Medical Justice: Access these resources by visiting your Members Only page. Need help? Call us: 1-877-633-5878.

Not a member? For a limited time, we are making these templates and protocols specific to COVID-19 available. Click here to learn how to access these resources.

Learn how Medical Justice can protect you from medico-legal mayhem… 

Take Advantage of Our Review Monitoring Service

We provide qualified applicants with free review monitoring for 6 week. Reports delivered bi-weekly.

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Request a Consultation with Our Founder

Medical Justice Founder and CEO, Jeff Segal, MD, JD, provides consultations to doctors in need of guidance. 

Meet the Experts Driving Medical Justice

Our Executive Team walks with our member doctors until their medico-legal obstacles are resolved.

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.

Trial Bar’s Bonanza: COVID-19

Here’s a formula for the trial bar’s wet dream.

A high frequency, high severity condition where no consensus standards are fully accepted or in place.

High frequency means the “triggering event” is common. COVID-19: Check.

High severity means the damages are significant. COVID-19: Check.

A pandemic causing hospitalization, disability and death satisfies both conditions.

“If you or a family member has become seriously ill or someone has died from coronavirus due to someone else’s negligence or fault, you should seek legal advice to see if you have a coronavirus malpractice lawsuit.” Says Brown, Moore & Associates PLCC. Yep, a real advertisement.

As we’ve written earlier, if you are taking care of a COVID-19 patient using established “countermeasures”, you likely have qualified immunity from litigation (under the PREP Act) for anything other than wrongful conduct.

What if your patient GETS COVID-19 while treating him for another condition? This will be even more salient as the country slowly opens up, and more routine care for conditions other than COVID-19 is delivered. You know, the usual stuff.

What happens then?

Did you take reasonable precautions to prevent this from happening? Did you follow the standard of care? How can you be sure the patient was not incubating a pre-symptomatic case of COVID-19 when you took him to the operating room and the trauma of surgery caused a much more horrific post-op course?

These are the questions a plaintiff’s attorney will ask in your deposition.

The playbook on how to prevent COVID-19 is being written as I write this. And it will go through many revisions before all is said and done.

How much, if any, testing for COVID-19 via PCR should be done before surgery? What about timing? How about antibody testing? Any blood markers to see who might be at extra risk? Do we treat those over age 65 differently? Diabetics? I can keep going.

What makes this virus more legally problematic is the variation in incubation period. Some have suggested it can even be 3 weeks, even if the window from exposure to clinical disease is shorter most of the time.

Plus, there are reports of patients testing positive, then negative, then positive again.

How to manage?

One way would be to create a national fund (and process) that addresses COVID-19 illness. If you have a beef, take it up with the fund. That would first require federal legislation. Whether it would be able to sidestep state tort law remains to be seen.

Next, all patients about to undergo a procedure should sign a consent form, similar to the consent for the actual procedure, acknowledging that there is a pandemic in the background. (Of course, they already know that.) They understand there is a risk that they already have pre-symptomatic COVID-19, may get COVID-19, or have a more difficult clinical post-op course if they develop COVID-19. Such a template is available to Medical Justice members. Just email us at info@medicaljustice.com.com.

Not a member, but want access to this template? Click here to learn how to gain access to this resource – and many other critical guidelines specific to COVID-19. 

We have other thoughts to stay out of the crosshairs and will be presenting them over the next several weeks.

What do you think? Let us know your thoughts in the comments below.

Learn how Medical Justice can protect you from medico-legal mayhem… 

Take Advantage of Our Review Monitoring Service

We provide qualified applicants with free review monitoring for 6 week. Reports delivered bi-weekly.

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Request a Consultation with Our Founder

Medical Justice Founder and CEO, Jeff Segal, MD, JD, provides consultations to doctors in need of guidance. 

Meet the Experts Driving Medical Justice

Our Executive Team walks with our member doctors until their medico-legal obstacles are resolved.

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.

A Deal is a Deal

Senator Ron Johnson’s April 23rd op-ed was a buzzkill. Even if it has zero chance of being implemented into law. More on that shortly.  

Unless you’ve been living under a rock for the past two months, the federal government launched the largest economic stimulus package in history (CARES). Included in that behemoth was the Paycheck Protection Program (PPP), a godsend to small businesses. PPP is a loan designed to keep employees in small businesses on its payroll as opposed to shedding them onto the unemployment rolls. If small businesses kept their end of the bargain for 8 weeks, the loan (with some caveats) would be forgiven. Remember, most small businesses were told to shut down. And even if they could formally remain open, with the COVID-19 pandemic in the background, most small businesses were hemorrhaging cash.  

Many healthcare practices took advantage of the offer. Candidly, with the pandemic still in gear, the PPP (rounds one and two) may not be enough. But the program was popular and well-intended.  

Back to Senator Johnson’s op-ed

But the minimal requirements for loan qualification, designed to speed relief, have allowed employers to obtain PPP loans even if they aren’t in financial distress and have no need or intention to lay workers off. Loan applications granted on a first-come, first-serve basis quickly depleted the $349 billion fund, and many deserving small businesses were crowded out, unable to obtain financial relief. On Tuesday the Senate passed a bill that provides another $310 billion for PPP. It places no further limitations on loan forgiveness, and the self-certification of economic harm required by applicants remains a nebulous statement that “current economic uncertainty makes [the] loan request necessary to support the ongoing operations” of the business. 

OK, so less than 100% of small businesses needed the help. No surprise that a bill crafted and implemented in a few days didn’t nail down every detail. Some of the details have been filled in by the Small Business Association which has issued a number of rules. Those are mostly clarifications. They do not change the substance of what Congress passed.  

Back to Senator Johnson: 

It may be too late to limit access to PPP loans to those who truly need to borrow, but it isn’t too late to limit forgiveness. I have begun working on a separate bill to accomplish that objective. 

Here’s his plan: 

My initial proposal—subject to feedback from my colleagues and the public—would allow no forgiveness for businesses whose 2020 taxable income exceeds that of 2019. Full forgiveness would be available only to those businesses whose 2020 gross receipts are less than 60% of the preceding year’s. 

Those in between would be eligible for forgiveness on a sliding scale: 10% of the loan if 2020 gross receipts are 90% or higher of 2019’s; 30% forgiveness for 80% to 90% of 2019 gross receipts; 50% forgiveness for 70% to 80% of 2019 gross receipts; and 75% forgiveness for 60% to 70% of 2019 gross receipts. In no case would forgiveness exceed the loan amount less after-tax income. 

Yes, it would be a good idea to get feedback from colleagues and the public.  

The proposal is a horrible idea.  

The small business community was asked to pitch in. We did. The small business community was told no one knows how long shutdown will last. We understood. The small business community was asked to hang onto its employees in the hopes that the country will be back to business in short order. We did.  

This may be an academic discussion as most small businesses will not have revenue in 2020 exceeding 2019. Still, many still standing at year end WILL have revenue exceeding 60% of what they brought in in 2019. Further, most businesses will not know what that number is until the end of this year.  

Small businesses signed documents with banks describing the terms. The forgiveness provision was the main reason most businesses kept some or all of their employees during the economic cataclysm. A do-over is unconscionable. The federal government got precisely it wanted. Keeping the published unemployment numbers below that of the Great Depression and avoiding bankrupting the states.  

I hope Senator Johnson’s proposal is dead on arrival. 

Otherwise, I’d like to get a second chance to pick my PowerBall numbers after they’re announced.  

What do you think? Let us know in the comments below…

Learn how Medical Justice can protect you from medico-legal mayhem… 

Take Advantage of Our Review Monitoring Service

We provide qualified applicants with free review monitoring for 6 week. Reports delivered bi-weekly.

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Request a Consultation with Our Founder

Medical Justice Founder and CEO, Jeff Segal, MD, JD, provides consultations to doctors in need of guidance. 

Meet the Experts Driving Medical Justice

Our Executive Team walks with our member doctors until their medico-legal obstacles are resolved.

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.

Doctors, Divorce, and COVID-19

“I think it’s not fair, it’s cruel to ask me to choose between my child and the oath I took as a physician,” Dr. Theresa Greene said. “I won’t abandon my team at work or the patients who will increasingly look to me to save their lives in the coming weeks, but it’s torture.

Dr. Greene is an ER physician in Miami.

Greene and her ex-husband have been divorced for two years. They have a daughter and split time with her evenly.

The ex-husband challenged the custody order. Circuit Court Judge Bernard Shapiro ruled that the child should stay with her father, Eric Greene, to limit the risk of exposure to coronavirus. Dr. Greene is appealing the emergency order granting full custody to her ex-husband.

Her ex-husband’s attorney produced an eloquent statement when this became a media story.

“We recognize and genuinely appreciate the sacrifices that she and all healthcare workers are all currently making to save lives and prevent further illness in Florida and around the world. The Greenes’ temporary timesharing dispute was presented before the Court based upon the specific facts of this individual family and a decision was reached based upon the best interests and safety of a minor child, limited to the temporary circumstances presented by COVID-19. The Court’s ruling was not intended to serve as a blanket rule, nor should it. Pursuant to Mr. Greene’s request and as ordered by the Court, Dr. Greene is to be provided future make-up timesharing for each day missed during this challenging time and daily video communication with the child. We will continue to pursue ways to resolve this delicate situation and believe that a result can be achieved safely and fairly.”

Well, that was nice, wasn’t it?

Greene uses personal protective equipment at work. She’s no stranger to the challenges and necessary precautions. Like most ER physicians, she disrobes in the garage or carport. She washes her hands religiously. And a gazillion other things she’s turned into muscle memory.

The court stated it based its decision on the welfare of the child.

Did it?

There are thousands of families where one or both spouses are treating COVID-19 patients. Their kids are not forced to live elsewhere. Some have, of course. But that is a choice. And the one demographic that seems to do OK is children.

In an ideal world, ex-spouses would cut each other some slack during a unique stressful time – like now. The Greenes managed to share custody without any ostensible headaches for two years. If this could haven been worked out without the courts, that would have been better. Now, this drama is playing out in the public eye. That can’t help.

Or can it?

No one really knows with certainty what goes on behind closed doors in any relationship. But now is not the time to throw salt on open wounds.

What do you think? Let us know your thoughts below.

Learn how Medical Justice can protect you from medico-legal mayhem… 

Take Advantage of Our Review Monitoring Service

We provide qualified applicants with free review monitoring for 6 week. Reports delivered bi-weekly.

w

Request a Consultation with Our Founder

Medical Justice Founder and CEO, Jeff Segal, MD, JD, provides consultations to doctors in need of guidance. 

Meet the Experts Driving Medical Justice

Our Executive Team walks with our member doctors until their medico-legal obstacles are resolved.

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.