Medical Errors Happen (and Much More Often Than You Would Think)

Medical Error Is a Leading Cause of Serious Injury and Death in the U.S. (and Perhaps the Leading Cause)

Although medical professionals often give competent care, there are times when they do not. When that happens, the results can be devastating for the patient and his or her family. Unfortunately, medical errors happen much more often than you would think. A recent study published in a leading medical journal (discussed below) suggests that 440,000 people die each year in U.S. hospitals due to medical errors. To place these numbers in context, 440,000 deaths per year is the equivalent of 20 jumbo jets full of people crashing every week for a full year, or almost 3 full jumbo jets per day. And, serious injuries (but not death) caused by medical errors in hospitals are 10-20 times as high as the number of deaths.

These figures are, to say the least, startling.

Studies on Medical Errors

Many medical books and journal articles have been written on the subject of medical errors. Probably the most famous (and most widely known to the public, due to its coverage by the media) is the 1999 report by the U.S. Institute of Medicine entitled, To Err Is Human: Building a Safer Health System (hereafter “IOM Report”). (Full citation: Committee on Quality of Health Care in America, Institute of Medicine (Kohn L, Corrigan J, Donaldson M, eds). To Err Is Human: Building a Safer Health System, Washington, DC: National Academies Press; 1999.)

By way of background, the Institute of Medicine (“IOM”) is an independent, nonprofit organization created under a Congressional charter to provide unbiased and authoritative advice to decision makers in government and to the public. It was founded in 1970 and is the health arm of the U.S. National Academy of Sciences. Members are elected on the basis of their professional achievement and their willingness to participate actively in IOM’s work without recompense. Many of the studies that IOM undertakes begin as specific mandates from Congress, while others are requested by federal agencies and independent organizations.

The 1999 IOM Report concluded that 44,000-98,000 Americans die each year in hospitals due to medical errors. (See IOM Report, at pp. 1, 31.) These figures placed death caused by medical errors in hospitals ahead of deaths caused by motor-vehicle accidents, breast cancer, and AIDS. (Id. at 1.) As eye-opening as these numbers were, the IOM Report also noted that its figures did not include outpatient care, and if outpatient care were included, the true number of deaths in America from medical errors would be even higher. (Id. at 2.)

In 2013, a new study was published in the Journal of Patient Safety that updated the older IOM Report numbers by using more up-to-date research techniques. (See James J. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Safety. 2013;9(3):122-128.) This new study showed that the actual number of deaths in hospitals due to preventable medical error is 440,000 per year. (Id. at 127.) And, the number of cases of serious harm to patients (but not death) due to medical errors in hospitals is ten-to-twenty times the number of deaths. (Id. at 122) Like most studies, the Journal of Patient Safety study did not evaluate non-hospital medical care (that is, outpatient care, like at doctors’ offices and medical clinics), and so the true death toll from medical errors undoubtedly is much higher once you add in deaths due to medical errors in the outpatient setting, as is discussed below.

As might have been expected, when the 1999 IOM Report originally came out, some doctors criticized the numbers, suggesting that the number of deaths were too high. (See, e.g., (a) McDonald CJ, Weiner M, Hui SL. Deaths due to medical errors are exaggerated in the Institute of Medicine report. JAMA. 2000;284(1):93-95; (b) Hayward R, Hofer T. Estimating hospital deaths due to medical errors: preventability is in the eye of the reviewer. JAMA. 2001;286(4):415–420.) However, these criticisms were in turn themselves criticized as being inaccurate. (See, e.g., (a) Leape L. How many medical error deaths are there really? Anesthesia Patient Safety Foundation Newsletter. Fall 2001; (b) IOM Quality of Health Care in America Committee. The Institute of Medicine Report on Medical Errors: Misunderstanding Can Do Harm. Medscape General Medicine. 2000;2(3); and (c) Leape LL. Institute of Medicine medical error figures are not exaggerated. JAMA. 2000;284(1):95-97.)

In any event, the American Hospital Association now appears to have accepted the 1999 IOM estimate of 98,000 deaths per year in hospitals due to medical errors, and so that figure is the absolute minimum number of deaths in U.S. hospitals that most everyone now agrees on. (See Allen M, How Many Die From Medical Mistakes In U.S. Hospitals? ProPublica Website. Sept. 19, 2013.) And, the newer, higher figures in the Journal of Public Safety study in fact appear to be accurate. According to ProPublica (an independent non-profit newsroom that produces investigative journalism of public interest), it asked three prominent patient safety researchers to review the new study, and all said that the methods and findings of the new study were credible. (Id.)

One of those prominent patient safety researchers is Dr. Lucian Leape, a Harvard pediatrician who is referred to the “father of patient safety” and who was on the IOM committee that wrote the To Err Is Human report. Dr. Leape said that members of the IOM knew at the time that their estimate of medical errors was low, and he said that the new study’s methods and findings are credible. (Id.) Another of the patient safety researchers is Dr. David Classen, who is one of the leading developers of the Global Trigger Tool.  Dr. Classen said that the Journal of Public Safety study was a sound use of the tool and a “great contribution.” He said that it is important to update the numbers from the IOM’s To Err Is Human report. (Id.) The third patient safety researcher is Dr. Marty Makary, a surgeon at Johns Hopkins Hospital whose book Unaccountable calls for greater transparency in health care. Dr. Makary said that the new estimate of deaths caused by medical error shows that eliminating medical errors must become a national priority. (Id.) Drs. Leape, Classen, and Makary all said that it is time to stop citing the 98,000 number. (Id.) Dr. David Mayer, the vice president of quality and safety at Maryland-based MedStar Health, said that people can make arguments about how many patient deaths are hastened by poor hospital care, but that’s not really the point. All the estimates, even on the low end, expose a crisis: “Way too many people are being harmed by unintentional medical error, and it needs to be corrected.” (Id.)

True Rate of Medical Harm Probably Much Higher

While IOM Report and Journal of Patient Safety numbers are eye-opening enough, it turns out that they almost certainly are overly conservative, and that the true rate of death and serious injury from medical error likely is much higher. This is because (1) the studies fail to capture (for various reasons) many of the medical errors that occur in hospitals, and (2) the studies do not count outpatient medical errors (that is, medical errors that occur outside of hospitals, for instance, at doctors’ offices, medical clinics, etc.).

As noted by the U.S. Institute of Medicine (“IOM”):

In other words, the “shocking” numbers in the IOM Report are too low, because (1) lots of medical errors and injuries are not recorded in the patients’ charts, and so they are never discovered, and (2) the numbers include hospital patients but omit the vast numbers of non-hospital patients, like patients who go see their doctor at their doctor’s office or medical clinic.

An Estimate of Total Preventable Medical Error in America

Using the known available data, an estimate of total preventable medical error in America can be calculated that includes outpatient visits to doctors’ offices and medical clinics.

An Estimate of Total Preventable Medical Error in America

Using the known available data, an estimate of total preventable medical error in America can be calculated that includes outpatient visits to doctors’ offices and medical clinics.

• Deaths:

Based on the Journal of Patient Safety study, a conservative estimate of deaths in U.S. hospitals due to medical error is 440,000 patients per year. (See James, J. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Safety 2013;9(3):122-128, at p. 127.) According to the U.S. Centers for Disease Control and Prevention (“CDC”), there are about 35 million hospitalizations per year (note that this is for nonfederal short-stay hospitals, and the number would be higher if federal short-stay hospitals were also included). (See National Center for Health Statistics. National Hospital Discharge Survey; 2006 Annual Summary. 2010;13(168).) According to the CDC, there are about 1.1 billion outpatient visits per year (which is about 31 times the number of hospital admissions). (See National Center for Health Statistics. Ambulatory Care Visits to Physician Offices, Hospital Outpatient Departments, and Emergency Departments: United States, 2001-02. 2006;13(159).) According to the IOM, there is every reason to believe that the rate of medical error outside of hospitals is at least equal to the rate inside of hospitals, if not higher. (See IOM, Quality of Health Care in America Committee. The Institute of Medicine Report on Medical Errors: Misunderstanding Can Do Harm. Medscape General Medicine. 2000;2(3).)

Because (as noted above) the rate of medical errors outside of hospitals probably is equal to the rate inside of hospitals (if it’s not higher), it is tempting to simply take the ratio of total hospital deaths to total hospital visits and multiply it by the number of outpatient visits, to arrive at the overall number of outpatient deaths due to medical error. However, that would be erroneous and would overstate the number of outpatient deaths due to medical error. This is because every hospital admission results in the patient having multiple encounters with healthcare providers (that is, seeing multiple doctors and nurses, having their lab work analyzed by multiple lab technicians, being dispensed multiple drugs, etc., all usually over multiple days). This results in multiple opportunities for medical error. On the other hand, a single outpatient visit usually results in the patient having far fewer healthcare provider encounters (typically, the patient will encounter one doctor and one nurse, with perhaps some lab work ultimately being evaluated by a lab technician or x-rays being reviewed by a radiologist, etc.). This results in less opportunity for a medical error to occur. So, unless we know the number of healthcare provider encounters that the average patient in a hospital has versus the number that the average patient at a medical clinic has, we cannot apply any ratios. And, as far as we know, at present this data does not exist.

However, one fairly recent medical study does give guidance as to the overall amount of medical error occurring outside of hospitals. The study looked at the National Practitioner Data Bank and performed a retrospective trend analysis and cross-sectional comparison of malpractice payments for adverse events occurring in the outpatient and inpatient settings, from 2005 to 2009. (The National Practitioner Data Bank, or NPDB, collects and discloses to authorized users certain negative information on health care practitioners, including adverse malpractice awards, adverse licensure actions, criminal convictions, and exclusion from participation in Medicare or Medicaid. The information in the Data Bank is not available to the general public.) The study used the number and dollar amount of malpractice cases that concluded with an award for the plaintiff as a crude indicator of the prevalence and seriousness of adverse medical events, based on prior research showing that malpractice data can be used to identify problem-prone clinical processes and to suggest interventions that may reduce negligence. The study found a fairly even split between the overall number of malpractice cases in both the outpatient and hospital settings. (See Bishop T, Ryan A, Casalino, L, Paid malpractice claims for adverse events in inpatient and outpatient settings. JAMA. 2011;305(23):2427-2431.) This suggests that the overall number of deaths from medical error in the outpatient setting is probably about equal to the overall number of deaths in the hospital setting, and the same for serious injuries. (In our own personal experience, we have seen more outpatient medical malpractice cases than inpatient malpractice cases, but in order to be conservative, we’ll assume that the overall number is equal.)

If we assume that the overall number of people killed by medical error in the outpatient setting is roughly equal to the overall number of patients killed by error in the hospital, then that would add another 440,000 to the numbers. Thus, on a fairly conservative basis, there are about 880,000 deaths per year that are caused by preventable medical error. That would place medical error as the leading cause of death in the U.S., well ahead of heart disease (597,689), cancer (574,743), chronic lower respiratory diseases (138,080), stroke (129,476), accidents/unintentional injuries (120,859), Alzheimer’s disease (83,494), diabetes (69,071), nephritis, nephritic syndrome, and nephrosis (50,476), and influenza and pneumonia (50,097). (See National Center for Health Statistics, Centers for Disease Control and Prevention. FASTATS. 2010.)

• Serious injuries (but not death):

In the context of the medical studies, a “serious injury” is a medical injury that requires a prolonged hospital stay, inflicts permanent harm, necessitates life-sustaining intervention, or contributes to the death of the patient. (See James J. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Safety. 2013;9(3):122-128, at 124.) As noted earlier, the number of serious injuries (but not death) caused by medical error in hospitals is 10-20 times the number of deaths. (Id. at 122-26.) If there are 880,000 deaths per year from medical error, then there are 8.8 million to 17.6 million serious injuries per year from medical error (that is, 10-20 times the number of deaths).

The leading nonmedical causes of injury in the U.S. are:

• Falls (13.4 million injuries per year);
• Overexertion (4.9 million);
• Being struck by a person or object (3.8 million); and
• Transportation (car, truck, train, airplane, etc., accident) (3.7 million).

(See Centers for Disease Control and Prevention. FastStats. 2012, at pp. 20-21.)

At 8.8 million medically caused injuries per year, this would make medical error the second leading cause of injury in the U.S. At 17.6 million, it would make medical error the leading cause of injury in the U.S.

However, the relative statistics may actually be even worse for medically caused injury. This is because the nonmedical injury statistics include any injury, no matter how minor, for which medical care by a doctor or nurse was rendered. (Id.) In other words, if someone strained their knee and saw a doctor, it was counted as an “injury,” even though it may have been quite minor and required nothing more than some Advil and not engaging in sports for a week or two. If those minor injuries are taken out to leave only serious injuries (and permit an apples-to-apples comparison with medically caused serious injuries), then the number of nonmedical injuries would undoubtedly decrease, probably significantly. In other words, it is likely that hospitalization (which is required to constitute a “serious” injury) was not required for at least half of the 13.4 million yearly injuries in the U.S. from falling. If so, then the number of falls that would qualify as being a “serious injury” would decrease to 6.7 million. Under these circumstances, even the lower range of medically caused injuries (8.8 million) would mean that medical error is the leading cause of serious injury in the U.S.

In any event, regardless of whether medical error is a leading cause, or the leading cause, of death and serious injury in America, the number of patients killed or seriously injured by medical error is far too high. Click here for some suggestions on how the number of medical errors can be reduced. Click here for additional interesting medical literature on the U.S. healthcare system.

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