Good medicine: It’s time for doctors and lawyers to work together to reduce the risk of medical error

Two months ago, physician Richard Horton, editor-in-chief of The Lancet, a United Kingdom-based medical journal, published a piece called “The rule of law: an invisible determinant of health.” In it, Horton says that “Public health advocates do not typically see the law as a critical influence on health. They are wrong.”

Horton’s Exhibit A in support of his thesis might well be its application to medical error.

Earlier this month a couple of physicians from the Johns Hopkins University School of Medicine in Baltimore, published a landmark analysis of medical care gone wrong, concluding: “If medical error was a disease it would rank as the third leading cause of death in the United States,” behind only heart disease and cancer.

Law & medicine, united, could be a formidable team

Law & medicine, united, could be a formidable team

Yet the astronomical 251 000 deaths a year they attribute to medical error “probably underestimates the scope of the problem,” say the authors, because (1) they used conservative numbers in their analysis (2) they counted hospital figures only, thus excluding doctor’s offices, ambulatory care centers, nursing homes, and so on (3) harm less than death was not counted, and (4) the problem is worldwide; Canada and the UK were specifically singled out as likely to be on par with the US.

There’s also a certain slight-of-hand going on with respect to medical error: it’s not just that over 250 000 such deaths aren’t being reported each year — it’s that virtually no such cases are being reported. And for one very good reason: death certificates do not have a category for human or systemic error. In other words, statistically speaking, medical error simply does not exist.

The failure to admit medical error is driven by something else too — fear of lawsuits. Martin Makary, MD, professor of surgery at Johns Hopkins and lead author of the report on error, says fear of the law drives discussion of error underground into “locker rooms, doctor’s lounges, and nursing stations … where they live in the form of stories and not in epidemiological numbers … We have created this wall of silence where we don’t talk openly and honestly about the problems … and that’s why we haven’t even begun to recognize the third leading cause of death in the United States.” (My emphasis)

To better appreciate just how, in Makary’s words, “vastly underappreciated and not even recognized” medical error is, imagine, for example, that every time there was an airline crash we refused to discuss it or, worse, we simply pretended there was none. That’s basically where we’re at with medical error today. The way out, Makarey says, is to address error the way the airline industry addresses pilot error:

“We don’t have a standardized system like aviation. When a plane crashes there’s an investigation. And the entire pilot community worldwide learns something from the crash. But yet in health care the same mistakes happen again and again, and many of them are never investigated … We need solid legal protections for a reporting system … that allows clinicians, coroners, and ME’s, to say this [medical error] was the true cause of death … [to] allow us to finally measure the problem.” (My emphasis)

The “solid legal protections” Makary is asking for already exist in a rule of evidence called “subsequent remedial measures.” It says that when measures are taken that would have made an earlier harm less likely to occur, evidence of the subsequent measures is not admissible to prove fault in a civil lawsuit.

For example, suppose the National Transportation Safety Board investigates an airline crash and determines that a faulty rudder mechanism is responsible. It then submits a report to the Federal Aviation Authority saying so. In turn, the FAA issues a directive to airline companies mandating a change in all aircraft with that kind of rudder. In response, the airlines comply.

Applying the remedial measures rule to this case would mean that in a lawsuit brought against the airline company whose plane crashed, the following could not be used as evidence to prove fault: the fact that there was a NTSB investigation; the NTSB investigative report; the FAA directive based on the report; the subsequent remedial measures taken by the airlines in response to the directive, i.e. replacing the faulty rudder with a safe one.

The reason for the rule is grounded in public safety: in balancing the need to remedy a problem that can affect us all, against the need of a plaintiff in a lawsuit to have all relevant evidence at his disposal, the courts have long since decided that the need for public safety is more important.

That’s what Makary is asking for with respect to medical error: to be able to openly investigate it, truthfully document error when they find it, especially on the death certificate, and to have these things off limits to the courts.

Reducing medical error benefits everyone

Reducing medical error benefits everyone

The reason to truthfully document — to measure — medical error, Makary emphasizes, is because you need good data. Imagine, for example, if there were no category for deaths caused by cancer. If that were so then no government policy, research efforts, or dollars, would flow to fight it. That’s what we have with medical error: since it seemingly doesn’t exist (outside of the domain of lawsuits) the government has no reason to address the error-driven 250 000-plus deaths a year by way of policy, research, or the allocation of funds.

But to begin to honestly measure this error, doctors and hospitals need the “solid legal protections” that Makary is asking for. These legal protections would be local, not federal, and so each state or province would want to draft their own.

This has already been done in many jurisdictions with what’s called the “law of apology.” When a doctor or nurse makes a mistake they can admit it to the patient and their family, and apologize for it, without those statements being used against them in a subsequent lawsuit. Again, we have the threat of suit preventing people from doing the right thing. Yet, nicely, it was the law itself that was used to remove that threat. (Another reason for the rule is that it significantly reduces the number of suits to begin with.)

Notice one more thing: These rules of exclusion (of documents recording error and doctor’s statements) are based on the rules of evidence. They are not based on “tort reform,” a politically charged, divisive topic that seldom leads to anything productive. Rules of evidence, on the other hand, almost by definition invite rational discussion and, more importantly, can be narrowly tailored to fit the facts at hand.

Law and medicine share a bedrock principle: they are both evidence-based professions. That implies a shared way of thinking, and a shared way of practicing their respective professions. Makary’s plea necessitates that these two like-minded professions finally unite to tackle a problem that doesn’t have to exist, at least to the extraordinary degree that the evidence says it does.

The following audio is Dr. Makary’s interview with the British Medical Journal, from which the above quotes have been taken. It’s a rare insider’s account of medicine gone wrong from someone at the top of their profession:

Medical error is the third leading cause of death in the United States — but it’s not something that health care workers feel free to discuss

If medical error was a disease it would rank as the third leading cause of death in the United States, concludes a study just published in the British Medical Journal.

The report pegs the number of deaths at 251 000 a year, a full 100 000 deaths ahead of respiratory illness, which is next in line. Moreover, as high as this number is, it probably underestimates the scope of the problem: “That’s using some of the most conservative numbers in the literature,” says lead author Martin Makary, MD, MPH, and professor of surgery at Johns Hopkins University School of Medicine in Baltimore.

Others agree. Jim Rickert, MD, who was not involved in the study, is an orthopedist in Bedford, Indiana, and president of the Society for Patient Centered Orthopedics. He told Medscape Medical News he was not surprised medical error came in at number 3 and that even those calculations don’t tell the whole story. For example, he notes that the 251 000 figure “doesn’t even include doctors’ offices and ambulatory care centers.” “That’s only inpatient hospitalization resulting in errors,” he says.

And then there’s this: Medical error causing patient death is apparently medicine’s dirty little secret. In an interview with the BMJ, Dr. Makary says: “These are issues that have lived in locker rooms and doctor’s offices and nursing stations where people talk about [these] stories. And it’s almost as if everyone knows of examples they’ve witnessed or know of. But they live in the form of stories and not in epidemiological numbers.”

Notice something else, too: the 251,000 figure refers to medical error causing death. Medical error also causes patient harm that falls short of death. For example: a needlessly prolonged illness, multiple hospital readmissions, the need for surgery, placement in the ICU, further physical and emotional suffering, and so on.

The following chart is taken from the study:




Makary defines medical error in the traditional sense, for instance: a misdiagnosis, a medication mistake, bad judgment, inadequate skill, poorly coordinated care, or a communication breakdown. But he notes that these traditional categories are expanding to include, for example, preventable factors and events, i.e. acts of omission, such as the failure to treat.

So in this emerging category of acts of omission causing harm, consider this fairly typical example of failure to treat in the context of infectious illness. Do you think it constitutes medical error today, and if not, should it?

Imagine, then, you’re in charge of a patient who you know to be colonized with the “superbug” methicillin-resistant staphylococcus aureus (MRSA). Your patient’s name is Sue, a 40-year old single mother of three, aged 7, 10, and 12. She’s been successfully treated for a pneumonia and is about to be discharged. She’s not infected by the MRSA but you’re aware of an important study reported in Clinical Infectious Diseases that says there’s a 1 in 4 chance that she could become infected. And you know that infection leads to the type of harm described two paragraphs above, i.e. multiple hospital readmissions, the need for surgery, etc., which, aside from her own suffering, would jeopardize her income and thus her ability to care for her children. Further, you’re aware of another study that says there’s even a 1 in 7 chance your patient will die if, in fact, she were to become infected with MRSA. So you’re faced with a question: Do you “decolonize” her? That is, do you get rid of the MRSA residing on her skin or in her nostrils, where it’s typically found, thereby removing the foreseeable risk of infection and consequent harm?

The obvious answer would be to decolonize. However, and surprisingly, that is actually not done in most jurisdictions. And here’s the thing: should Sue become MRSA-infected and get sick, or perhaps die, your decision not to treat would not (yet) be considered medical error — at least by health care providers — because non-treatment is the standard of care throughout the land: i.e. that’s how most providers handle a case like this. (But whether a court of law would see it as medical error — as medical negligence — is quite another matter: If your mechanic knew that your car had somewhat faulty brakes and failed to fix them, or failed to even tell you about them, and you crashed as a result, you would have an actionable claim against your mechanic.)

Makary says that “most people underestimate the risk of error when they seek medical care,” calling it a problem that is “vastly underappreciated and not even recognized.” Sue’s case may very well fall within the scope of these statements. If so, her plight is yet further proof of the “vastly underappreciated” nature of this problem.

Ultimately, though, how much harm we can attribute to medical error is unknown, and to some degree probably unknowable. Nevertheless, “the same mistakes happen again and again,” says Dr. Makary, in his interview with the BMJ; and, what’s more, “they’re never investigated.” Which leads us to what he considers the most surprising thing about medical error, what he calls the “Wall of Silence”: the fact that “We haven’t even begun to recognize the third leading cause of death in the United States.”

Makary is right, of course: We haven’t publicly recognized it. But inside those locker rooms, doctors offices, and nursing stations that he mentions above, are a host of dedicated people who, my guess would be, want to give voice to the issue, either within their ranks or publicly. But they operate inside what’s been called an “environment of fear.” And so the question becomes: What will it take to change that culture to permit a much-needed open and honest exchange about an issue that one way or another affects so many of us?

What do you think?











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