Using the National Practitioner Data Bank, Makary's researchers found malpractice judgments and settlements for surgeries associated with retained foreign bodies, wrong sites, wrong procedures, or wrong patients. They identified 9,744 paid malpractice judgments and claims over 20 years, with payments totaling $1.3 billion. Death occurred in 6.6% of patients, permanent injury in 33%, and temporary injury in 59%. Using published rates of surgical adverse events resulting in a malpractice claim, the researchers estimate that 4,044 surgical never events occur nationally every year. More serious events involved costlier settlements.
"We've never really had a way to measure this on a national level," Makary says. "Until now we have relied on estimates from voluntary reports from hospitals, and we know that is haphazard." The NPDB is a good source for malpractice claims data for never events because it filters out frivolous lawsuits, he says.
While the study's findings may appear to be alarming, Makary believes they are low-balled. "Although we believe the cases we identified are real, we don't know what the upper end of the range is. We are simply describing the lower end of the range. We believe these are accurate and true cases because hospitals don't pay money for frivolous lawsuits."
"The problem could be three to four times larger than the cases we identified in our study," he adds. "If 60% to 75% of retained objects are never detected and those that are may not necessarily result in a hospital payment, we know that the one-in-seven, one-in-eight, or one-in-nine that we are seeing in the data represent only a fraction of the true scope of the problem."
The study found that surgeons between the ages of 40 and 49 were responsible for one-third of the never events, compared with 14.4% of surgeons over age 60. "That was an interesting finding. I don't have the real explanation for that finding. It may be that once you are a high-volume surgeon you are at the most risk," Makary says. "But it disproves or at least lends less credence to the idea that younger surgeons and very old surgeons are the ones who have the most events associated with them."