Strict Liability in Medicine


In law there is a doctrine called strict liability.

Strict liability means that no matter what you do to protect someone from an injury, if the person suffers an injury, you are liable for the consequences. You could have taken every possible precaution. Doesn’t matter. Injury = liability.

Usually strict liability is reserved for inherently dangerous activities, such as raising pet alligators or demolition. You want to blow things up? You better make darn sure that no one could possibly get hurt. Strict liability also applies to manufacturers who create products for human use. If someone gets harmed using the products, the manufacturer is liable for the injuries. Otherwise, manufacturers would feel comfortable putting potentially dangerous products on the market.

Now some insurance companies and our own federal government want to impose strict liability on hospitals. I started thinking about this the other day when we had a rash of patients who came in with injuries after slipping and falling. According to Medicare and to a growing number of insurers, falls are one of the growing list of “never events” that are not worthy of reimbursement. For example, see this January 7 article in American Medical News.

Here are a few more articles about insurers refusing to pay for the never events:
WSJ Article — Insurers Stop Paying for Care Linked to Errors
AM News — No Pay for “Never Event” Errors Becoming Standard
Group Calls on Hospitals to Waive Payments for “Never Events”
Don’t miss Happy Hospitalist’s “fairy dust” post about “never events,” either.

The National Quality Forum has identified 28 medical errors as “never events.” In other words, these 28 events should “never” happen. Some of them I agree with. For example, leaving an object in a patient after surgery should probably never happen. Operating on the wrong body part or performing the wrong surgery on the wrong patient should probably never happen.

But the list starts to get a little hazy the more you read it.

According to the NQF, patients should never die or have a “serious disability” associated with the use of contaminated drugs, devices, or biologics. First, notice how the hospitals are being put on the hook for products that the manufacturers provide to them. According to the NQF, if hospitals use a product in good faith and there is a “bad outcome” because of contamination of that product, the hospital doesn’t get paid. No matter what. Flu vaccine wasn’t packaged appropriately and someone gets sick from it? Doesn’t matter, hospital, you’re not getting paid to take care of the consequences. You are completely liable for the damages.
Applying this concept to the everyday world would mean that … contamination should never happen. If my kid pukes from spoiled milk in the refrigerator, the milk manufacturer should have to pay for all the medical treatment necessary to make my kid feel better.

According to the NQF, patients should never die or have a serious disability if a device is “misused” or “malfunctions.” If a poorly designed (but FDA approved) device is used in a hospital and the device malfunctions, the manufacturer who made the device bears no responsibility for the patient’s care. It only matters where the injury occurs. Because the device was used in a hospital and the injury occurred in the hospital, the hospital should have to pay for all of the care related to the malfunction. Makes a lot of sense.
Applying this concept to the everyday world would mean that … if the turn signal in my car malfunctions, I get into an accident, and I hurt my back, the city in which I am driving the car should have to reimburse me for my injuries. Doesn’t matter who manufactured the car, it only matters where the injury occurred when I was using the car.

According to the NQF, patients should never attempt suicide resulting in serious disability. Great idea. Impose strict liability on a hospital to ensure that no one has unexpressed suicidal tendencies on the inpatient wards. Maybe we can have a dream analyzer and personal psychotherapists for each patient. Every patient who is admitted should have a 24 hour sitter just to catch that one patient who wakes up from surgery craving a handgun, seeing flashbacks from the movie “Saw,” and saying, “Well, the surgery went OK. Rats. That didn’t work. Maybe I’ll try to hang myself to get out of paying the hospital bill.” Wonder if Glenn Beck’s insurers paid for his inpatient detox because of his suicidal thoughts after his hemorrhoid surgery.

Patients should never have a serious disability associated with a drop in blood sugar. Diabetics know that hypoglycemia “never” happens. Blood sugar drops … patient gets out of bed … patient drops … patient’s head bounces off floor … hospital pays. Strict liability.

The best one is that the NQF asserts that there should be strict liability when a patient suffers death or serious disability associated with a fall in the hospital. Falls should never happen. Everyone always ties their shoelaces. Old people always use their walkers. Dizzy people don’t exist. The unsteadiness and shuffling gait seen in Parkinson’s Disease? A figment of our imagination. If someone falls in the hospital, the hospital is liable.
Well, we can restrain demented patients who are fall risks, right? Wrong. Medicare rules only allow for the “least restrictive method” of restraint and must be discontinued at the “earliest possible time.” Restraint orders are good for a total of 24 hours.
Hospitals could have sitters watch old people who try to climb out of bed. As if the nurses aren’t overworked enough. Hey, now you have to dispense meds, clean patients, chart, feed patients, talk to families, talk to doctors, try to find some time to pee once per shift, be nice, AND watch all of your patients all of the time so they don’t fall out of bed. Why didn’t I think of that sooner?
Suppose a hospital believes that sitters are necessary to comply with these silly rules. Who is going to pay for the sitters? Won’t be the insurers. Won’t be the government, either. Enter the ABN. You have a sick relative who might fall in the hospital? YOU or your family might be stuck paying for these extra services to prevent these “never events” – even if they are unlikely to occur. If you refuse the services, maybe you’re going to be paying for any costs related to falls out of your own pocket. Insurance companies won’t pay for them – they’re “never events.” Hospitals will say that they gave you the opportunity to prevent the fall by paying for a sitter and you refused. Get ready for a jump in the cost of care.
Insurance companies allege that they have “patient safety” in mind when they implement these rules. Perhaps that is true. Are the costs associated with achieving 100% patient safety worth it when there are so many people in this country who can’t get basic health and dental care?

I think there’s another reason for these “safety rules.” With all the money that insurance companies save by by refusing to pay for these “never events,” does anyone actually think that the premiums for health care insurance are going to go down?

Charge more for premiums, pay less for medical care. Insurance companies have it made.

Soon even those with insurance could be in danger of bankruptcy due to hospital charges.

But that would “never” happen, would it?


  1. White Coat.

    Twice in two days I had a patient pass out while on the shitter and fall to the floor.

    Vasovagal syncope.

    Tell me this, Do we need a pervert standing in every bathroom wiping the ass of every old person that decides to take a crap in the bathroom for fear that they may fall down and break their hip?

    Using the rational of these “Never Event” organizers, it is the hospitals fault that a sick patient on the shitter fell off and broke his hip.

    You can’t have a never event for something that is considered a part of living.

    Old people fall. They will always fall unless you strap them to a gurney.

  2. I’m scared you are going to set off an explosion with this post, Dr. WhiteCoat. There are plenty of us legal-types running around here these days, you know. And “strict liability” is such a predatory sounding term.

    Rather than dip my toes in the debate as you have framed, I offer a tiny bit of insight into what many people (including me) thinks is a pretty interesting question:

    Would a strict liability model for medical torts actually change the result of very many suits compared to a negligence model? I know that sounds like crazy talk, but the truth is that in most cases (controlling for all other variables) analysis under strict liability and negligence yields the same ultimate result — e.g., the same plaintiffs recover, and the same do not, no matter which model is imposed. Different outcomes, if they happen, tend to take place only in “fringe cases!”

    Most people agree that whether to impose strict liability (like in most consumer products) or negligence (like in most service industries) can be thought of as a policy decision about where the initial distribution of costs should fall. Many people feel it makes more sense for the manufacturer of, say, Coca-Cola bottles to control production, calculate risks, and price their bottles to cover that cost than it does for consumers to engage in that analysis with respect to every single thing they buy. Unlike manufacturers, consumers generally are not in a position to know the details of the products they consume, and further, they often depend on products, and thus have not bargaining power.

    Negligence, on the other hand, makes more sense when people have an opportunity shop around, or when they enjoy fairly unfettered access to information about the service they are purchasing. Most people, the theory goes, can recognize when a mechanic has failed to fix their car. They are less likely to recognize when Coca Cola has improperly pressurized a bottle.

    The strict liability argument for medical care is an interesting. Although I have a legal and medical background, I think the answer is far from clear and I just don’t feel comfortable either way. But I will offer this observation: some versions of a strict liability regime might do a lot to stabilize damage awards (and attorney’s fees) in medical care related suits:

    Fall off the and scrape your pelvis? Automatic award of X dollars. Break an arm, too? That’s 2(x). Or whatever.

    That kind of model would stabilize the insurance industry, cut out a lot of the lawyers, and encourage settlement of cases. On the downside, it would also distribute the liability of crappy doctors, nurses, radiologists, and hospital janitors evenly across the board. Including to you. The malpractice premiums in each of those professions, totaled in sum, would be calculated to be exactly equal to the sum total cost of injuries that take place in hospitals/dr. offices.

    I’m rambling. But you can see at least I think it’s pretty complicated. I wouldn’t believe anyone who claims the answer is clear — It’s one of those systems where you change one piece, and the whole picture shifts . . . .

    Okay, flame away!

    No flames from me. The whole reason I posted this was to encourage discussion.
    A rose by any other name would smell as sweet” – Romeo. Whether you want to call these changes “safety mechanisms” or “patient care advancements,” you can’t get around the fact that they still amount to strict liability.
    What you propose is a worker’s compensation model to medical injuries. No fault. Injury = award. I don’t think that would be so bad, but people would have to get over the notion that they won’t receive jackpot malpractice awards. Plaintiff’s attorneys would take a hit in income. I would bet that the AAJ would be against such a system.
    The problem with medicine is that it is not a “free market system” in most cases. Cosmetic things such as plastic surgery and Lasik surgery are two exceptions. Everything else is driven by what insurance companies will pay rather than what market forces dictate. HUGE problem with care in the current system. Can’t compare healthcare with the manufacturer model.
    Thanks for your insight!

  3. My favorite on that list, which is applicable to ER, is “patient death or diability due to disappearance (elopement)”. I hope that doesn’t apply to ERs/outpatient areas, at least for non-suicidal patients.

  4. Well…you people just confirm the exact gripe about people who end up in a caring institution who don’t have the proper training or background to affectively mediate what it is you are supposed to be doing. I have never heard such complaints about ‘In house’ matters like you are summarily casting to the world, while making your selves and a reputable tradition of caring vocations look like total crap…personally, attendants see to patients in between for routine tasks and are trained for it…if your not hiring enough well trained people I suggest (and adamantly) that you turn it over. The problem with you people from not following proper procedures not only in the OR by autoclaving instruments for at least 20 minutes…is the same kind of malfeasance that you blame on other people while you yourself go walking room to room with out washing your hands properly…let alone the attendants and other staff walking outside in their bootees for a smoke break or whatever, and coming back into the hospital with the same crusty garments…I realize being around people who need aid is very difficult in the lack of the effective trained skilled personel…I suggest maybe considering some other form of employment or opening your own business…and all your sheik friends who are enjoying their lifestyle about taking in house problems to the public, can sit around and decide exactly how to spend all that overtime pay…make a car payment house payment…and the other amenities of life and thing s that make you happy and manage still to get a membership in the country club…but the truth is “your not good enough”.

  5. A not so minor point to correct – ” you asserted ” the manufacturers who make [a malafunctioning] the device bears no responsibility. In fact, their liability is not extinguished if there is a defect in manufacture, etc. And excluding what the patient chose or chose not to do with litigation, the hospital might have an independent claim as plaintiff against the manufacturer.

    You are correct. That sentence was not clear and I corrected it. Thanks. I intended to say that the manufacturer bears no responsibility for providing the care to the patient who was injured.
    You are also correct that hospitals might have an independent claim against the product manufacturer. Drag hospitals into court and sue manufacturers so that they can recoup money that has been paid to a third party. The attorney’s fees would be overwhelming. That system would not decrease litigation, it would increase litigation. Then the parties settle, sign a non-disclosure agreement, and go about business as usual, waiting for the next bad outcome.
    I guess if you’re an AAJ member, this would be a good thing for you and your brethren. Not a good thing for hospitals or patients.

  6. And the spoiled milk analogy seemed to contradict your position – If a packaging plant sells good milk, and your bad storage or use beyond expiration date makes it go bad – and you feed it to your kid and he gets sick…who’s to blame, again?

    Just like the hospital administering influenza vaccines – how do you tell where/when the contamination occurred? Why make the hospital liable for the bad outcomes 100% of the time when the hospital may not have been at fault 100% of the time? Even if there is a manufacturer recall due to contamination, the hospital is still liable for all of the costs of caring for patients who have been injured.

  7. Exactly!

    In light of the fact that medicine is so far removed from a free market, a strict liability model actually makes sense. I think everyone agrees that if A is injured through no fault of her own, while under the care of B, then A deserves to recover for her injury. What is NOT always clear is that B should be the person who pays. The injury may well have been the fault of neither party. There this odd moral catch-22 in tort, where we want to compensate deserving plaintiffs, even though sometimes the defendant doesn’t deserve to pay.

    That is (to me) a pretty compelling argument for some version of a strict liability model. The point would be to account for all the costs of medical injury, and distribute them in a stable, predictable manner.

    It would be bad for med-mal plaintiffs attorneys, but the (supposed) point of malpractice litigation is to protect plaintiffs, not their attorney’s. Ditto insurance companies — the point is to protect the interests of policy holders, not rack up profits in the health insurance cartel, err, “industry.”

    Cutting insurance profits, and transaction costs from litigation from the picture might be a significant step in reducing healthcare costs. And frankly, I don’t see that kind of model hurting society as a whole any more than the current model. I do see it hurting individual docs who are good care providers, however, because they would have to shoulder the cost inflicted by all the shitty docs out there.

    Like you said, the AAJ (and also the AMA) would lobby like hell to prevent any such change. So the whole analysis is probably just a wishful exercise in blah, blah, blah . . .

    I don’t think that model would hurt society, either. Except if there is an issue with authorizing care as there is now in the worker’s compensation system. It would keep attorneys from only taking the multimillion “bad baby” cases and would fairly compensate patients who suffered lesser injuries.
    The fly in the ointment is the fact that all medical malpractice payments have to be reported to a central repository called the National Practitioner Databank. Settle too many suits and you become unemployable. Doctors would rather fight a questionable case than agree to a small payout because they don’t want to get listed in the Databank. We fear the bad outcome not only because of jackpot jury awards, but also because too many bad outcomes can end up costing you your livelihood.
    This type of system doesn’t happen in any other business model in the US that I am aware of – not even with attorneys. An attorney can totally screw up your case and land you in jail, then can sue you for fees for his “representation.” Companies settle suits, admit no wrongdoing, and insert confidentiality clauses into the settlements all the time. No one litigant finds out about all the other people who have been injured by the company’s products.

  8. Many opinions on the post I see. I think you have a great topic for a round table. You might need some flack jackets but still good prose. After being in healthcare for some twenty years myself I do see the impetus for wanting to improve quality and safety for patients, who wouldn’t. As usual with our society, those who have control are in a position to make things punitive in nature for the rest of us, which I really don’t think is the best course of action always. Healthcare today is very demanding on several plains, and as longevity increases so will demands for resources relative to healthcare. Even with the best laid plans I don’t think healthcare is every going to appreciate a zero defect environment. Healthcare is a human undertaking like most everything else in our world. Humans are fallible – some very much so. I think the best we can hope for is to make sure that we don’t as you say, cut off the wrong body part, or operate on the wrong patient. It is reasonable to expect that these types of errors would never happen. The rest although they may be costly in terms of dollars, pain, time, etc., all we can do is to try an minimize them as best we can given the number of constraints built into the system.

  9. destroy what system is left on

    I don’t know what is more scary. This concept of “never” events or that there are people as actually clueless as Frodo441.

  10. I agree with some of your opinions such as hospitals shouldn’t be liable for malfunctioned equipments, but I do disagree with your opinion on how hospitals should not be responsible for people who fall.

    In actually, its not just hospitals that are being put in this situation. I used to work at a store back in high school and my job required me to be responsible for all clean ups or spills. Now if someone was to fall, it would be most likely due to something in the area that caused one to fall ie slippery floor, petruding object, etc. The store manager made it clear that the store is responsible for all persons who come in regardless of what caused the injury.

    Getting back to the topic of hospitals, the NQF was probably assuming that people don’t fall for no reason at all. They probably think that there must have been something there that the hospital placed improperly that is th cause.

  11. Although I work in an OR as an RN, this is my first time reading the list of the 28 “never” events. The way the events are written makes me question who’s writing them. A large number of these “nevers” seem to be aimed at the OR. While it’s obvious why the wrong site and wrong patient “nevers” are on the list, some of the other “nevers” such as wrong procedure or the “ASA I” statement are poorly written. If a physician is performing an left bowel procedure, and sees a right bowel perforation, should he repair it? Or should he leave it the way it is, to avoid the potential of of a “wrong surgery” lawsuit brought by a personal injury attorney? And the ASA I requirement will only inspire anesthesia providers to find every possible reason to change healthy patients to ASA II’s.
    And a reply to Frodo:
    The surgical team changes their “crusty” clothes when they come back to the OR.
    We use gravity or prevac sterilizers that sterilize instruments in 10 minutes. If they needed 20 minutes, we would use 20 minutes, but we know we don’t because of a crazy thing called research. Some items are sensitive to heat and get chemical or gas sterilization.
    If you think you can do surgery better than the people doing it now, open an OR yourself.

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  14. The lawsuit has all the features of a product. It is inherently harmful in its ordinary use. I suggest strict liability apply to all weak cases.

    Appellate decision are based on judge errors in the law and not on errors of facts. All reversed decisions are never events. The reversed judge should not get paid for any reversed outcome.

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