Hospital Liability for Ventilator Shortages


If a hospital runs out of ventilators to treat its patients, will it be liable when patients die as a result?

Courts have at times imposed malpractice liability when a hospital failed to provide a service that might have benefited a patient. For example, in Herrington v. Hiller, 883 F.2d 411 (5th Cir. 1989), the plaintiff alleged that a baby was born with brain damage as a result of a hospital's failure to provide 24-hour-a-day anesthesia services, and the court found admissible earlier discussions among hospital personnel about whether such services might be needed. More generally:

Hospitals and other institutional providers have a duty to provide adequate staff and services to deal with unexpected medical problems. Hospitals, like physicians, are expected to keep up with an evolving standard of medical practice, particularly if its cost-benefit ratio is high. The failure of a hospital to maintain adequate services to deal with medical emergencies can create liability.

Barry R. Furrow, Enterprise Liability and Health Care Reform: Managing Care and Managing Risk, 39 St. Louis U. L.J. 77, 91 (1994) (footnotes omitted). Also:

Both hospitals and hospital management companies have been found negligent for failure to exercise reasonable care in the maintenance of the hospital's facilities and equipment. The duty to maintain adequate facilities and equipment requires hospitals to have the facilities and equipment necessary to safely carry out the medical treatment it offers.

Mindy Nunez Duffourc, Repurposing the Affirmative Defense of Comparative Fault in Medical Malpractice, 16 Ind. Health L. Rev. 21, 28 (2018) (footnote omitted).

Hospitals, of course, would argue that they have an obligation to maintain sufficient equipment for ordinary times, not for pandemics. Assuming a hospital maintains a typical ICU capacity for hospitals, it would have a strong argument to having met the community standard of care.

If a court in its instructions emphasizes custom, hospitals may mostly be free of liability. But if a court instructed juries to apply the Hand formula, or instructed juries in a way that would implicitly allow them to consider cost-benefit type considerations, the result might well be different. A pandemic was not unpredictable, and a likely cost-benefit analysis would likely suggest that ventilators should have been purchased. If a ventilator costs $25,000, then at a value-per-life of just $5 million, the purchase would have been cost-justified if there were a 1 in 200 chance that it would be necessary--or an even lower chance if a single marginal ventilator might be used for more than one patient.

Stephen Gillers has noted that although the Hand Formula is often treated as black-letter law, jury instructions rarely mention it, but nor do they forbid the jury from applying similar considerations:

[A] puzzle lies in the gap between the authoritative blackletter status of the Hand Formula and the standard instructions given to juries in negligence cases. The proposition that negligence means creating an "unreasonable risk," defined as one whose expected costs exceed the costs of avoiding it, has been explicitly endorsed by the Restatement of Torts, by the leading treatises, and by courts in most states. Indeed, despite the vigorous normative debates over cost-benefit analysis among legal academics, no modern decision to my knowledge squarely rejects the Hand Formula interpretation of negligence. Yet, rather than telling juries to balance the costs and benefits of greater care, courts ordinarily instruct them to determine whether the actor behaved as a "reasonably prudent person" would have under the circumstances. Even on appeal, many courts make surprisingly little use of cost-benefit analysis in reviewing negligence cases. Often, the only question on appeal is whether a reasonable jury could have found a party negligent under the reasonable person standard.

Some scholars claim that these practices demonstrate that the actual meaning of negligence in American law is defined by a reasonable person standard that marginalizes or even supplants the Hand Formula. Although these accounts vary in important particulars, their common theme is that the determination of negligence rests on a noneconomic conception of practical reasonableness that looks to community values and norms rather than to any form of cost-benefit analysis.

But the crucial feature of the pattern jury instructions on negligence is that they explicitly adopt neither of these competing theories -- nor any other. Juries are told neither that a reasonable person is one who complies with community values and norms nor that a reasonable person is one who balances costs and benefits (or behaves "as if " balancing them). Instead, the reasonable person standard is given to the jury without elaboration.

A jury would not likely engage in explicit cost-benefit balancing. But it seems to me plausible (though I would welcome comments from those with more immediate experience) that a jury might well conclude that hospitals should have recognized the need to purchase enough ventilators to handle a surge in patient capacity. A plaintiff's case might be especially strong if a hospital had time between when an emergency loomed and when a patient died to purchase a ventilator that would have saved the patient. Juries, meanwhile, would likely be more sympathetic to hospitals that, early in the emergency, contracted to purchase ventilators (at least simple models) as soon as they were available.

Normatively, I am not sure whether hospitals should be liable. There is a strong argument that if one opens a 1,000 bed hospital, one should not be liable for not opening a 2,000 bed hospital. Liability might create a disincentive for small hospitals to open in the first place. On the other hand, it is difficult to identify an actor in a better position to anticipate potential needs for emergencies or to identify an actor that now will have strong incentives to provide demand for ventilators.

A related but separate question is whether doctors and medical professionals should be held to a lower standard of care during emergencies:

[I]n the wake of events like Hurricane Katrina and the H1N1 pandemic, there have been proposals to change the ordinary standard of care during declared emergencies. This idea is called "altered standards of care," and suggests that there should be different standards that health care workers are held to during an emergency. Broadly, a public health emergency exists when a health situation's "scale, timing or unpredictability threatens to overwhelm routine capabilities." There has been significant research into, and creation of, altered standards of care for volunteers and Good Samaritans who help during emergency situations. Many of these regulations provide immunity to these individuals.

Rebecca Mansbach, Note & Comment, Altered Standards of Care: Needed Reform for when the Next Disaster Strikes, 14 J. Health Care L. & Pol'y 209, 209 (2011) (footnotes omitted). One would not want to discourage a doctor from working during the emergency because the doctor cannot provide care of the same quality as the doctor would ordinarily provide. But that is a different question from whether health care institutions should anticipate emergencies and stock up.

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  1. After SARs, California Governor Schwarzenegger had a stockpile of masks and ventilators established for the next epidemic. Governor Jerry Brown got rid of them in 2011 to save about $5-6 million a year in maintaining the the stockpile. That was about 0.25% of the budget. The hospitals used the masks instead of buying new and most of the ventilators were used as parts or whatever - no one seems to know.
    Culpability, anyone?

    1. Sovereign immunity. Governments can screw up pretty much all they want, with impunity.

    2. If you are trying to make a partisan point - at least get the numbers correct. The 2018/2019 California budget was $190.3 Billion. The $5.1 million to maintain them is not even a rounding error.

      But that's besides the point that BOTH Republicans and Democrats throw out disaster funds during any budget crisis. And then conveniently forget about them when the crisis is over. Just look at Trump's administration and not filling the necessary roles for handling such issues. Or eliminating them entirely. If you want culpability - just look at the leader of your cult.

      1. It's also ignoring that politicians of every stripe take credit for everything and blame for nothing. Trying to hold politicians culpable is an exercise best left to the ballot box.

      2. "If you are trying to make a partisan point "

        I didn't read anything partisan in his post. Unless you're assuming that merely naming the governors in question (without part affiliation) was enough to count?

      3. "But that’s besides the point that BOTH Republicans and Democrats throw out disaster funds during any budget crisis. And then conveniently forget about them when the crisis is over. "

        And, as any 12-year-old can tell you "those other guys do it, too!" is a complete excuse for wrongdoing.

  2. If a hospital can't expand to add more beds without a certificate of necessity from the state, does that add an element to what a Reasonable Person (as hospital executive) might do? Granted that certificates of necessity aren't required for all types of hospital equipment -- lets assume for argument that they are not required for ventilators -- but the number of beds in the hospital would have some bearing on the number of ventilators they might need in extremis.

    1. It would likely at least for a few. It should for any hospital that had actually applied and been turned down by the state. This is by analogy to preemption about claims a device/drug manufacturer should have issued different risk warnings when law/regulation had said "no you can't change that warning". See many posts at the Drug and Device law blog for elaboration on the many variations of that.

  3. If, as NYS Governor Cuomo claims, ventilators are no longer available at any reasonable price, it might be hard to fault a hospital if it runs out and patients die as a result.

    Moreover, as the Washington Post noted, even if ventilators were somehow to become available, many hospitals, cities, and even states may be reluctant to purchase enough ventilators, at about $50,000 each, to cover the worst case ventilator-shortage scenario, since they will soon no longer be needed of the crisis period is over and they will have to be put into storage.

    But the story with CPAP and similar breathing machines may well be a different story.

    The FDA has just recommended and authorized CPAP and similar breathing devices to be used for those COVID-19 patients who need breathing assistance, but do not necessary need the full power and sophistication of hospital ventilators.

    This is very important because there are millions already in use for less serious problems, such as snoring and sleep apnea, which could be acquired immediately from users who volunteer them, or are induced to do without them for several months for a financial reward.

    It also appears that there are many thousands in warehouses, and therefore immediately available from medical supply companies. Thus many could also be made available very quickly, and at far lower cost (~$850/each), than ventilators.

    Unlike conventional hospital ventilators - CPAPs has been called "poor man's ventilators" - they are simple and very inexpensive, and are produced by dozens of different manufacturers.

    Thus production from these companies could be increased quickly if testing indicates that they can be lifesavers for at least some COVID-19 patients.

    CPAPs and similar breathing devices could also be produced more quickly and easily by other companies than much more complicated and expensive ventilators.

    In addition to the FDA's validation and legal authorizations to use CPAPs and similar breathing devices to treat some COVID-19 patients, there is medical evidence explaining how and why they can be valuable.

    There is also an abundance of anecdotal evidence suggesting the same, including the experience of a physician skilled regarding ventilation issues who told me that he successfully used a CPAP machine, with a simple oxygen concentrator, to help an individual with COVID-19 to recover.

    At a time when some are seriously contemplating dealing with ventilator shortages by forcing 2 to 4 patients to share one ventilator despite major concerns about “the inability to monitor the impact on each individual; the potential for cross-contamination of infectious pathogens; and the possibility that instead of one person receiving lifesaving treatment, multiple patients would get dangerously subpar therapy,” [NY TIMES - ‘The Other Option Is Death’: New York Starts Sharing of Ventilators] at least testing other alternatives, especially those without those many risks, and where the tests can be conducted at much lower costs, would seem to be an appropriate alternative.

    Thus a failure to at least try using CPAP and similar breathing machines is more likely to result in liability if a patient died than if a shortage of ventilators led to the same result.

    1. That seems to fall under the "lowered standards of care" and should be possible without being held liable and without needing government permission. But I don't know the legal practicalities of that; I seem to remember that good samaritans who screw up used to be liable until laws were passed exempting good faith efforts.

    2. Something like 3.3 million people have just applied for unemployment. Almost every one of them has two things that can be used to ventilate patients: hands. Ambu bags and endotracheal tubes (ETs) are not in short supply. Things to cause air to flow through the ETs are. It's a lot less specialization than brain surgery to teach someone how to squeeze and ambush bag, and it requires surprisingly little strength to do it. If three people/8-hour shift were hired--and adequately protected with PPE--the cost would be small.

      As for hospitals reasonably anticipating a pandemic, the reasonable question is "what type of pandemic?" This one seems to be respiration-related, so we'd need to have--how many??--extra ventilators. The $25k cost figure ignores too many variables: 1) maintaining them in working order, which means testing them every so often; 2) making necessary repairs; 3) discarding them when the next great model comes along that fills still other functions that will be deemed necessary; 4) hiring people to maintain them--along with the overhead costs, like insurance, etc.; 5) having available people to run them--same extras as #4; 6) paying rent for air-conditioned humidity-controlled (they have soft gasket seals that can't be allowed to dry out) space to store them.... The list goes on and on. It ain't $25k a pop.

      A better cost-benefit analysis would reason that the average life of a ventilator is maybe 10 years if it's not being used. To address this particular crisis might require 1 million ~excess~ ventilators. If you have to replace them every 10 years, then every century (if that' show often the excess are going to be needed), that's now $250k/ventilator--just for the devices--plus maintainers and operators. And the operators for the excess aren't even needed unless there is a respiratory crisis.

      Next up: a myocardial-attacking bug [heart muscle]. How many cardiac ICUs does a hospital have to be able to have for that crisis? How one that attacks the GI tract preferentially? What extra supplies, etc. are needed for that?

      To quote Monty Python, "no one expected the Spanish inquisition."

  4. If a ventilator costs $25,000, then at a value-per-life of just $5 million, the purchase would have been cost-justified if there were a 1 in 200 chance that it would be necessary–or an even lower chance if a single marginal ventilator might be used for more than one patient.

    Only true if the hospital has an unlimited budget, and I'm not aware of any hospital that does.

    The purchase of a marginal ventilator should be weighed against alternative uses of available funds. If you can spend the $25K on something that, in expectation, will save more lives than the ventilator, then buy that other thing instead. If the hospital gets a $25K windfall just the fact that spending it on a ventilator will save some threshold number of lives doesn't mean that spending it some other way wouldn't be better.

    Basically, the (abstract) rule should be that each dollar should be spent in the way that saves the most lives (or QALY's or something else if you prefer) at the margin.

    1. More broadly, if we are evaluating the purchase of life-saving equipment, the business about value-per-life is irrelevant.

      The cost of the ventilator is the number of lives that could have been saved by spending the $25K another way. That's the true opportunity cost here.

      The value-per-life approach is useful when considering policy that imposes costs, though of course there will generally be other factors involved as well.

  5. There are over 6000 hospitals in the country. How can one hospital be blamed in a civil suit for having more people come to its doors than it was designed to accommodate? Like a lot of things, the ventilator shortage will be one of geographic distribution. Ample ability to ventilate patients here in fly-over land, at least for the moment. And in all likelihood there will never be a point in time where the number of patients needing vents within the country will exceed the total number of vents; simply will be an issue of regional supply-demand imbalance.
    Its sort of like the chronic situation with donated vital organs. New York is perpetually supply deficient for the number of people on the waiting list. For whatever reason people in that area of the country choose not to donate at the necessary rate; so not much different than the ventilator situation.

  6. Here is something that single payer medicare proponents are not saying. If we go to government single payer socialized health care that would no longer allow for suing the doctors and hospitals for malpractice, It would be the federal government that would control what the doctor and hospital could or the cost of medical services would still be high. How could the doctor or the hospital supply all the latest equipment if the government does not allow high enough payments for the service rendered to provide all best equipment. If the doctors and hospitals cannot afford to have the latest medical equipment then why should they have to foot the bill if there is a failure because of the lack.

  7. Are hospitals better positioned than the CDS to predict pandemic
    demand? But suppose they are. By the logic here, why can't they then approach any other random person or company and say: "We've identified that spare ventilators are worth the cost, but we'd rather not pay for them - instead you should pay instead because, now that you (like us) know about the issue, it will be YOU that will be also liable in case of a pandemic if there aren't enough and you didn't take the cost-benefit required action."

    After all, the hospital doesn't create or control the pandemic hazard. (If anyone even can influence it, why not go for airlines and cruise ships first?) The argument that a 1000-bed hospital shouldn't need to provide 2000 beds (or whatever a pandemic based calculation might suggest) IS strong and applies with equal force to ventilators.

  8. A liability that one can more easily connect the dots from duty to causality to injury is the hospitals lack of personal protective equipment. Whereas hospitals do not know what patients, or how many patients will come in the door tomorrow, next week, or next month, they do know exactly who their employees and contractors are. They know what size N95 mask each person wears (documented annual fit testing and training is mandatory), as well as gown size and glove size. And their infection control officer also knows that every non-pandemic day the need for this equipment is twice what is actually used, because they know provider compliance rates for PPE use for 'routine' isolation practices. They also know and once or twice a decade plain old flu seasons experience 2 or 3 times as many isolation patients. So they have to always be prepared for at least that much surge in demand, plus a reasonable reserve to cover other other foreseeable contingencies.

    Hospitals have a duty to provide a safe workplace, with specific mandates in health care for specific use of PPE in defined situations. The risks to employees is amply documented (hence the safety regs.) and causality is easy to infer by a preponderance ('how many people cough in your face at work a day, dozens, versus at home, just the dog). And the harm, anything that follows from the health effects of the communicable illness.
    I am documenting daily each instance when I am unable to receive from my hospital necessary PPE, and date/time, and location (no patient identifiers to avoid HIPAA violations), which should be quite sufficient for the lawyers to backtrack within the EMR which patient's chart note corresponds to that date/time/place.

  9. "...If a court in its instructions emphasizes custom, hospitals may mostly be free of liability. But if a court instructed juries to apply the Hand formula, ..."

    I have a general suggestion: In your article, you refer to the "Hand formula" many times. I quoted your first use, directly above, but you use it over and over in your article. Maybe include a short description before your first usage? Or include a link to a description. I doubt any non-lawyer has the slightest inkling what the Hand formula is...and likely that many many lawyers also do not know this.

  10. Reality is Jury Nullification and similar fun things.

    Reality is that this will be a political question and not a legal one -- when we come out of this, the attitude of the public towards the hospitals will decide this -- not the law. If Joe Sixpack and Suzy Sweatpants feel that they were under the boot of authority (which we increasingly are), there's going to be a "get evenism" in response and it will show up in jury decisions/awards.

    Yes, "get evenism" -- it will happen...

    1. The other thing -- and this applies to malpractice suits in general -- is that how the patient and/or patient's family feel they were treated is far more important in the question of if a malpractice suit is filed or not than the actual medical facts.

      If they feel that the hospital did its best, they likely won't sue -- but if they feel it didn't, you'd best get ready for a suit...

      1. True. There's been a bunch of research on this. If a doctor (nurse, etc.) screws up, it actually helps if he or she goes into the room, apologizes, is sincere, etc.. You'd think that this sort of admission would lead to more malpractice suits. But no . . . as Dr Ed says, it's very very very common for such a patient (or the patient's family) to mostly want acknowledgement that a mistake was made, that the person responsible feels remorse, and that there is some indication that the mistake won't be repeated in the future.

  11. Interesting that courts have stated that the government/law enforcement community has no liability to protect a citizen from violent criminals, but now we are to consider that hospitals, which already have liability for failure to protect from common disease states, also are liable during a once-a-century pandemic. One that may have been predictable in general, but as stated previously, happens to affect the lungs and so ventilators are in short supply. The next one may affect the heart, as suggested, but why not kidneys with a severe shortage of dialysis machines? This does not even get into the problem that these devices are not plug-and-play, but require highly trained physicians, nurses, and technicians to run them. You can, with enough money, store enough equipment for most crises. Where will you find the people?

    1. In an emergency, you can teach well-intended people with average intelligence enough to be moderately competent at almost anything.

      It may be "keep the needle there and turn this dial to do so" but you'd be amazed at what bystanders can accomplish when told to "hold this", "do that."

      1. Dr Ed-
        You are correct in what you write, but you know that when mistakes are made and patients die, the hospital will be held responsible, "You had all these machines because you knew they would be needed some day. You are liable for not maintaining staff to run the machines."
        I wish I were wrong.

  12. re: "Hospitals, like physicians, are expected to keep up with an evolving standard of medical practice, particularly if its cost-benefit ratio is high."

    What is meant is the opposite: "Hospitals, like physicians, are expected to keep up with an evolving standard of medical practice, particularly if its cost-benefit ratio is low."

  13. I would think in a world wide pandemic, no one was prepared for, and no one saw coming, the courts would see the issue somewhat differently, something akin to wartime.

  14. At some point, if you impose too much liability on people for not foreseeing things nobody else foresaw even though, in hindsight, it seems perfectly reasonable that they should have been foreseeable, the only way to avoid liability will be to exit the field.

    In general private markets handle rare events very badly.

    The standard in most states is the reasonable person standard. The reason why it’s in the jury instructions is because it’s what the law is. And properly so. Ordinary people simply don’t follow the formula. Nor are many elements of the formula reliably estimable.

    The idea that we know the proabability of a future epidemic occurring, let alone its future death rate, with any precision is simply ludicrous. Formulas that simply assume omniscience as a given - assume we know things beforehand we don’t in fact know beforehand and can only know after the fact - are rarely workable or lead to just results, or an orderly or effective society, in practice.

    Where the future is radically unknowable and unknown, or at least unknown in advance rather than in hindsight, all that people can be required to do is what an ordinary person would do.

  15. Here's an added complication.

    I have seen elsewhere, the claim that these ventilators require skilled technicians to operate because they can themselves cause injury to a lung that is already not healthy.

    This source was claiming that we will run out of ventilator technicians before we run out of ventilators.

  16. If such lawsuits ever start to become a thing, Congress should pass a law that no court shall entertain such in this case, or however that's put.

    Of course, the reality is Congress, and states, will throw out money to build up (or re-build-up-this-time-we-really-mean-it) reserves.

  17. If there is liability, impossibility will still be a defense. the hospital can produce evidence showing that they tried to increase capacity but were unable to acquire any, assuming these are true.

  18. The New York Times has run a story claiming that the CDC, foreseeing that a future epidemic would require a large stockpile of ventilators, had established a program to create cheap portable ventilators after the SARS epidemic. They contracted with a company called Newport to make 40,000 of them at $3000 each. Newport has supplied prototypes in 2011. But before they could ramp up production, Newport was bought by a much large ventilator manufacturer called Covidien. The NYT reports that Covidien promptly shut the project down, allegedly to avoid competition with its existing bulkier and more expensive ventilator line. It suggests that this had been the purpose of buying Newport.

    If the NYT story is true, and if there is to be liability for a ventilator shortage, Covidien’s behavior In deliberately preventing the availability of previously planned for Cheaper and more portable ventilators would appear to much more deserving of liability than anything hospitals have done.

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