CHAPTER TWELVE
IS THERE A BETTER WAY?
If the American malpractice system is so arduous and expensive and is unavailable to the vast majority of patients who’ve experienced errors, it’s fair to ask whether there might be a better way. How do other countries handle medical error?
Whether it’s self-assembled furniture, aerodynamically soled shoes, prison reform, recycling, saunas, or just plain old happiness, Scandinavia strikes many as the land of the sensible. So perhaps it’s no accident that some of the most thoughtful ideas about handling medical error originate from the latitudes that require industrial-strength thermal underwear.
Denmark is an intriguing case study, because although it has the polar opposite system of healthcare coverage (national health insurance versus the largely private US system), it actually started with a similar malpractice system, although on a far smaller scale. Prior to 1992, patients who felt they’d been harmed in the medical system had to take their case to court. They faced the same hurdles that American patients face—tough to get the case litigated if damages weren’t financially compelling enough and even tougher to prove actual negligence. In practice, the majority of patients who’d experienced error had no recourse.
In 1992, the country decided to fall in line with its Nordic neighbors and adopt a no-fault compensation system.1 The idea of this system is to award a modest compensation to any patient whose care wasn’t as good as it should have been or to any patient who experienced a rare or severe complication. Whether the bad outcome happened because of an error or because of negligence or from plain-old bad luck is irrelevant.
By eliminating the burden of proving negligence, far more patients can benefit. And by taking out the adversarial component, doctors aren’t on the defensive. This Patient Compensation System, as it came to be called in Denmark, eliminated the major hurdles that patients faced in the old malpractice court system. It’s much easier to access because you don’t have to find a lawyer willing to take your case. It’s also simpler, because there’s only one sheet of paper to fill out. It’s also free, so there’s no financial barrier to patients. Doctors and hospitals can even file on behalf of patients, and often do.
The cases are adjudicated by an administrative panel similar to the American workers’ compensation board. The panel is made up of legal and medical experts who review the details of the patient’s case, along with a response from the doctor or hospital involved. The patient is awarded compensation if the medical care is deemed to have been substandard (compared to the standard-of-care from a highly trained professional in that field) or if the poor outcome is considered “more extensive than a patient should reasonably have to endure.”2 Typically, about one-third of the cases are deemed worthy of compensation. There is an appeals process for patients who are turned down, though very few patients go that route.
Because patients don’t face the daunting burden of proving negligence, a much higher percentage of injured patients in Denmark receive financial compensation (about four times as many as American patients, when adjusted for population size). Danish patients usually receive payment within seven or eight months, compared to an average of five years for American patients who file lawsuits.
The payouts are quite modest by American standards—$30,000 on average—but monumental settlements aren’t necessary because nationalized healthcare ensures that Danes never face the mountains of medical bills that Americans do. And even for patients whose cases don’t prevail—or for patients who don’t bother filing a claim—most Danes won’t be bankrupted by their injuries because social services are more readily available. Unemployment and disability benefits, in particular, are generous. All Danes receive a pension after retirement. They don’t accrue debt from big-ticket items such as daycare and college, since those are all free. And of course Danes, unlike Americans, never worry about losing health insurance if they lose their jobs because healthcare is guaranteed for all.
You might not be surprised to learn that Denmark ranks as one of the happiest countries in the world. They invented Legos, after all, and boast the world’s oldest amusement park—in operation since 1583. But if you are booking your tickets to Copenhagen as we speak, just remember that in the dead of winter, the sun sets by early afternoon. And there’s always Kierkegaard or Hamlet to put you in a gloomy mood.
In the summer of 1997, a few years after the Patient Compensation System debuted, Dr. Beth Lilja and her family took a vacation in Carriacou. For a busy obstetrician, a remote island in the Caribbean seemed an ideal place to unwind—nothing but pristine beach in its twelve square miles of territory. But remoteness has its downsides. When Lilja exhausted her reading material, she learned that there weren’t any bookstores on the island where she could restock. So when her colleague arrived from New York to join her on the vacation, she quickly pounced on the bulging Sunday edition of the New York Times that he’d thoughtfully stowed in his carry-on.
The cover story of the magazine section immediately caught her eye with the arresting title: “How Can We Save the Next Victim?”3 The article profiled two-month-old Jose Martinez, a baby with a congenital heart defect who was treated with intravenous digoxin for the symptoms of congestive heart failure. Digoxin, originally extracted from the bell-shaped foxglove flower, has an exceedingly narrow safety margin—meaning that there is not much daylight between treatment doses and toxic doses. (Among the side effects of digoxin—besides nausea, vomiting, cardiac arrhythmias, and death—are seeing unusual yellow-green halos. Some historians believe that van Gogh was taking foxglove—he’d painted his own physician holding the flower—and that this side effect might have been responsible for the striking yellow swirls in The Starry Night.)
Because of the narrow safety margin—especially in children—the dose of digoxin is based on weight, calculated as milligrams per kilogram. The resident and the attending taking care of Jose did the calculations together and came up with the correct dose of 0.09 milligrams. The resident then wrote the medication orders in the chart but inadvertently moved the decimal point and wrote 0.9 milligrams instead of 0.09 milligrams. Baby Jose died from receiving a dose of digoxin that was ten-fold too high.
Lilja found herself both horrified and engrossed. It was like an opera where you know the tragic ending in advance but can’t stop the characters from blundering down the fatal pathway. The article ran through all the steps in minute detail, steps that were meant to provide protection but consistently malfunctioned. The attending, for example, was required to review the resident’s orders as part of the standard oversight, which he did. But his eyes didn’t catch the subtle decimal-shift error. A pharmacist who was concerned about the dose paged the resident, but had no way of knowing that the resident had left for the day. A backup order was later received by a pharmacy technician who didn’t know about the other pharmacist’s hesitation and so filled the order. The nurse who received the medication was concerned about the dose and so appropriately asked a covering resident to recheck the calculation. The resident redid the formula on his calculator, but when looking from the calculator with the correct answer of 0.09 milligrams to the vial of 0.9 milligrams didn’t notice the decimal difference. As a last check, the concerned nurse asked a second nurse to recheck the vial and compare it to the order; the second nurse saw 0.9 on both and confirmed that this was correct. The fatal dose was administered.
What especially fascinated Lilja was that the analysis focused on the problems of the system rather than the incompetence or negligence of the medical staff. In fact the staff seemed quite conscientious, putting in extra efforts at every step of the way in attempt to avoid error. Yet the incorrect dose nevertheless barreled its way through all the layers of protection, just as Bob Wachter witnessed two decades later when Pablo Garcia received 38½ tablets of Bactrim.
In Denmark, the general perception of the medical field was that the practice of medicine was basically safe, apart from the occasional mistakes of individuals. Even though the new Patient Compensation System did not focus on finding fault, the emphasis was still on identifying the bad apples and helping them mend their erroneous ways. This was the first time Lilja had read of researchers explicitly strategizing about how to make the system safer for the next patient, not which doctors or nurses to fire.
Lilja packed the article along with her sunscreen and took it back to Denmark with her. As it happened, she was embarking on a new job as a senior obstetrician, and would shortly be facing the obligatory meeting with the medical director, who would be asking the obligatory question about her research interests. Now she had a ready answer.
For decades, the British Medical Journal, or BMJ, had always graced its covers with the weekly table of contents. High art it wasn’t, but it served its purpose. Medical journals aren’t elbowing for space with Cosmopolitan and People on grocery store magazine stands. They don’t need surgically sculpted movie stars or sordid infidelity headlines to entice readers to pick them up. The fixed readership of doctors and researchers are generally simple folk in this regard: they just need to know which studies they have to be up on and which page to turn to. A dutiful list of articles on a utilitarian blue background has long sufficed.
But on March 18, 2000, the BMJ ditched its reserved presentation and covered its journal with a picture of a plane crash. It was an issue devoted to patient safety, inspired by the 1999 report To Err Is Human from the Institute of Medicine in the US. (The medical-error-as-third-leading-cause-of-death article came sixteen years later in the very same BMJ.) The media had been having a field day with jumbo jet metaphors for medical error ever since Lucian Leape coined that analogy in 1994. For this special issue on patient safety, the BMJ borrowed that riveting imagery. Its other not-so-subliminal message was that medicine should learn from the aviation industry’s efforts to understand and reduce plane crashes.
Beth Lilja remembers the issue vividly and read it cover to cover. Every article was focused on fixing the system, not just reeducating the bad apples. It coincided with an international conference on patient safety where she got to meet Leape and many of the pioneers of the patient-safety movement.
Inspired by—or rather, horrified by—the IOM estimates that some one hundred thousand Americans died because of medical error each year, Lilja and her colleagues undertook their own study to assess the state of medical error on their home turf. Everyone regarded the Danish medical system as exemplary, with the highest standards of care. But in fact, Lilja’s study revealed an error rate comparable to what had been cited by the IOM. Her report was set to upend the status quo in Denmark, just as To Err Is Human had done in the US. But as events turned out, the report was published on the morning of September 11, 2001.
Because of the time difference, the 9/11 terrorist attacks in the United States did not make the front page of the Danish newspapers until September 12. So on September 11, the Danish medical-error study was on the front page, but it was quickly buried. Lilja was scheduled for a TV interview the following week, but she remembers being told that her appearance was conditional, “depending if we do or don’t have a war.”
Lilja was eventually interviewed by the television station, but international terrorism dominated everyone’s attention in the weeks and months that followed. “The report didn’t get much press,” Louise Rabøl, a public health physician, told me, “but this turned out to be an advantage.” In the hushed atmosphere following 9/11, the nascent patient-safety community in Denmark was able to sift through the report without much interference from politicians or the press. The somberness of the international mood combined with the innate pragmatism of Danes led to a sober search for solutions without any grandstanding or petty grievances. It just didn’t feel seemly.
The report slowly gained traction in the medical community. For Danes who are used to being applauded for their efficient solutions to nearly every societal ill, the recognition of a high medical-error rate “was a real wakeup call,” according to Rabøl. Within a few months, the main stakeholders in the healthcare system created the Danish Society for Patient Safety, which included representatives from every group with skin in the game—doctors, nurses, midwives, hospitals, research institutions, patient organizations, pharmacies, and drug companies. Away from the geopolitical tumult of the day, the group began to draw up a framework to address medical error by seeking to improve the system as a whole.
Being largely ignored by the preoccupied outside world allowed the various parties to work together with less than the usual friction. Their goal was to have the medical system be open and transparent about errors, and that no one would be afraid to report adverse events. This reporting would provide a road map for future improvements. But in order to achieve this, there would have to be a law setting out the terms.
When Lilja approached the minister of health with the idea of a Patient Safety Act, he said, “If you can guarantee that no main organization will block it, I’ll do it.” Lilja set about, as she described it, going door to door, talking to everyone she could find with any vested interest in medical error. Most doctors she spoke to had mixed feelings about owning up publicly to an error. They supported it in theory, but when it came to the actual practice, they were hesitant.
One of Lilja’s colleagues—whom she described as “very conservative”—was initially opposed to the idea. But then he related a story to Lilja. One day, when he was a trainee, he was paged to administer an IV antibiotic to a patient. He’d been on his way out the door to go home, but he returned to the ward as instructed. He was told which patient needed the antibiotic and set about injecting the medication. Just as he was reaching the end of the injection, the patient said, almost offhandedly, “You know, I’m allergic to penicillin.” The doctor froze, because in his hand sat a nearly empty syringe of penicillin.
The young doctor was too afraid to say anything—to the patient, to the nurses, to his colleagues. Instead, he stayed at the patient’s bedside for the next two hours, taking her blood pressure every five minutes so that he might detect the very first signs of an allergic reaction or potentially fatal anaphylaxis. Two hours went by, and nary an itch nor a rash nor a welt emerged. The blood pressure and pulse hadn’t budged a wink. Like so many people, she’d probably had a minor side effect with penicillin as a child and been told, incorrectly, that she was allergic. Over the years, this “fact” solidified into her medical history.
The doctor-in-training went home that night, relieved that he hadn’t harmed the patient but fraught with discomfort. “I could have told the patient that she actually didn’t have an allergy,” he said to Lilja. “That would have been valuable information for her.” But this would have meant owning up to his error—something that was shameful and uncomfortable. He’d be blamed by his colleagues, even laughed at. He would have to endure the bureaucratic medical-error gauntlet, getting beaten down with blame at every step of the way. It was easier just to keep quiet, especially since no harm had been done.
“That patient probably still thinks she has a penicillin allergy today,” he observed ruefully. He knew he’d done a disservice to the patient—what if she needed a penicillin-related antibiotic in the future and ended up using a less effective or more toxic one instead? This thought haunted him for years. His lasting regret over that situation ultimately converted him to Lilja’s point of view. Transparency about medical error would ultimately be better for everyone.
When the recommendations for the Patient Safety Act were presented to the public and to politicians, every sector of Danish society interested in patient safety was on board. And when the bill came before Parliament in 2003, the law was passed with a unanimous vote.
The main accomplishment of the Patient Safety Act was the creation of the National Incident Reporting System. Anyone working in healthcare could report any adverse event. The sole goal of this repository of data would be improving the healthcare system; nothing reported to this system could be used for compensation, disciplinary action, complaints, or litigation. The law explicitly stated that doctors could not be sued based on information reported to the Incident Reporting System. “We were very careful with the wording,” Lilja said, because doctors wouldn’t report adverse events if they thought they’d be incriminating themselves.
If an adverse event is separately reported to the Patient Compensation System—by a patient, for example—then the doctors’ actions might be investigated. But anything reported to the Incident Reporting System is legally cordoned off. Incidents can even be reported anonymously, but it’s a credit to the trust in the system that this only happens in 3% of reported cases.
“We all go to work trying to do our best,” Rabøl observed. “So if something goes wrong, we want to know how we can improve it.” The goal of the Incident Reporting System is to encourage all healthcare workers—the ground troops who see what’s actually going on—to inform the system of any problems. “For that reason,” Rabøl said, “we don’t call it filing a report. It’s just reporting a problem.” The law was later extended to allow patients and families to report incidents as well.
These accumulated reports add up to a critical mass of data. Researchers can then identify problem areas and direct efforts toward improvements. Rabøl cited the example of pressure ulcers (also known as decubitus ulcers). In the past, these ulcers were considered an inevitable outcome in hospitalized patients who were stuck in bed for days or weeks at a time; they weren’t even considered adverse events. For most healthcare workers, pressure ulcers were in the same mental category as the black-and-blue marks patients got from IVs and blood draws.
Starting in 2004, medical staff were told not just to report problems but to report every single thing that was not part of the intended treatment. Suddenly it seemed as though there was an epidemic of pressure ulcers in Denmark. Of course there was no such epidemic; it was just that now these ulcers were being reported.
Once the scope of the problem became clear, the medical system began an aggressive prevention effort. Within a few years, the ulcer rate plummeted. Now, advanced pressure ulcers (stages 2, 3, and 4) are hardly ever seen in Denmark. Only stage 1 ulcers are seen, and even these have become much less common. “When we pay attention,” Rabøl said, “we can eliminate them. But if we take our eyes off them, they come back!”
The whole approach to medical error in Denmark impressed me. It all seemed so level-headed, so reasonable, so downright Danish. “It works because we trust our state,” Rabøl said with a laugh. “We don’t sue each other. We have a high degree of trust in society. There’s very little corruption. We pay our taxes gladly because we know they are used well.”
Could such a system possibly work in the US? Obviously the stark difference between national healthcare in Denmark and privatized healthcare in the US makes direct translation tricky. Additionally, there is the notable difference in scale: the population of Denmark is just a smidge larger than Brooklyn and Queens put together (5.5 million people) versus the US population of 325 million. And then there is the vast imbalance in the sums of money involved. The US spends almost 18% of its GDP on healthcare, about $3.3 trillion. Denmark, by contrast, spends only 10% of its GDP on healthcare, about $3 billion—less than what Americans collectively spend on dental floss and tattoos.4
So is there any possibility that sensible approaches from the land of hygge coziness could make it in the Wild West of brash capitalists? The muscular leitmotif of American individualism makes it unlikely that the adversarial legal approach to medical error will recede any time soon. However, there are some small experiments that offer tantalizing possibilities. But none of these arose from Danish-style sober, unanimous, collaborative decision-making. Rather, these American experiments arose from knife-to-the-jugular public health emergencies.
In the 1970s and ’80s the number of malpractice cases and the size of payouts in the United States were rising rapidly—especially for injuries related to childbirth. The cost of insuring obstetricians grew so extravagant that many insurers stopped offering malpractice coverage, especially in Virginia and Florida. In the space of five years, twenty insurance carriers in Florida pulled out, leading to a contagion of price hikes by the remaining carriers. Doctors’ premiums quadrupled. In some areas of Florida, obstetricians faced insurance bills that were as much as seven times higher than those of their colleagues in New York or California, and they threatened to close up shop. A growing sense of crisis ensued, with the looming specter—fed perhaps by an overzealous media—of women in labor being turned away from hospitals, left to deliver babies on the sidewalk with hapless taxi drivers assuming the bulk of obstetrical care.
The state legislatures had no choice but to intervene. They decided to focus on the high-profile birth injuries that cause neurological damage, injuries loosely gathered under the umbrella term of cerebral palsy. Traditionally, cerebral palsy was thought to be due entirely to lack of oxygen to the baby during delivery (i.e., it was the fault of the doctor) but newer research suggested an array of complex factors including genetics, environmental exposures, and interrelated medical conditions. The difficulty in sorting out the causal factors made these cases particularly expensive to pursue, with extensive pretrial research and swarms of expert witnesses. Moreover, the need for intensive, long-term medical care for these infants resulted in exorbitant payouts. This combination made these lawsuits singularly expensive to litigate, resulting in a snowball effect on the whole medical ecosystem.
Toward the end of the 1980s, Virginia and Florida set up state-run compensation funds for birth-related neurological injuries. The thinking was that if this chunk of costly cases was pulled out of the courts, then the malpractice system for everything else would stabilize. Insurance premiums for doctors would level out, doctors wouldn’t retire in droves, and taxi drivers could focus on changing lanes without signaling rather than tying off umbilical cords with jumper cables.
On the federal level, the National Vaccine Injury Compensation Program was created under similarly turbulent and perilous circumstances.5 Lawsuits against vaccine manufacturers had soared during the litigious 1970s and ’80s. In particular, lawsuits related to the (ultimately discredited) theory of vaccine-induced autism terrified manufacturers. Because the profit margin on vaccines wasn’t very large to begin with, many companies undertook a brass-tacks analysis and decided it simply wasn’t worth the effort. One by one, manufacturers ceased producing vaccines. There was the very real threat of complete loss of childhood vaccines.
Like the image of pregnant women being turned away, the image of thousands of children newly paralyzed by polio or stricken by the illnesses of generations past did not play well in the public arena. Congress was forced to act and created the National Vaccine Injury Compensation Program. This allowed families to get compensated for injuries related to childhood vaccines, though only for those side effects that had scientific documentation. Shielded from bankrupting lawsuits, manufacturers could resume producing vaccines. (A number of companies, however, did not return to the field. The legacy remains today, with many vaccines produced by only one or two companies, leaving the public susceptible to both shortages and price inflation.)
Like the Danish system, these American programs are no-fault systems—the patient does not have to prove negligence. The case is adjudicated by an administrative panel and if the injury is felt to be related to the birth or the vaccine, there is a payout. In general, these programs have been considered reasonably successful in that costs were controlled, injured patents received compensation, and the respective insurance and vaccine emergencies were stabilized. While the Danish system is funded by the public, the vaccine fund is financed by a small fee on all vaccines (which, it could be argued, is the public). The birth-injury funds come from fees on doctors, hospitals, and insurers.
So, could this model work on a more comprehensive scale? Could the United States take the Nordic plunge and move from the litigation system to a no-fault compensation system? Michelle Mello is a legal scholar at Stanford University who spent years investigating this possibility, an idea that has come to be called “health courts.”6 Like worker’s compensation, this injury compensation system—despite its moniker—would exist outside the courts, using specially trained administrators. Rather than having to prove negligence, patients would only have to show that an injury would have been avoidable (preventable) if best practices had been in place. Using guidelines for common medical errors and injuries, a significant portion of cases could be adjudicated quickly and without the need for lawyers.
When I asked Mello what the biggest barrier to health courts is, she laughed and said, “Trial lawyers.” Removing these cases from the regular courts and reducing the need for legal representation would remove a significant slice of income for lawyers.
In 2010, when a consideration for health courts was floated as part of the Affordable Care Act, a spokesperson for the American Association for Justice stated: “Health courts would involve the creation of an outrageously expensive new bureaucracy to handle the very few medical negligence claims that exist today. . . . It will do nothing to eliminate the 98,000 people who die every year from preventable medical errors.”7 You will not be surprised to learn that the unassumingly named American Association for Justice used to be known as the Association of Trial Lawyers of America.
A major advantage of health courts is that they would introduce a measure of consistency: comparable injuries would be treated in a standardized way. There would be accepted standards both for which kinds of injuries should be compensated and how much should be paid out. This stands in contrast to settlements negotiated by lawyers (or decided by juries), which vary wildly.
Moreover, the health courts, in Mello’s opinion, “would be tied to patient safety as well as cost savings.” Because they have the potential to bring a broader and more representative sample of patient injury to light—not just the catastrophic cases that malpractice suits highlight—the healthcare system would receive more accurate signals about what needs to be improved.
But the strongest selling point of health courts—and the driving force behind the Danish switch—is simple fairness. It would allow many more patients to get compensation and get it faster than in our current litigation-based system, even if the payouts are lower.
However, the perception that a jury of one’s peers protects the average person is tightly woven into the American fabric, even if few people are actually able to get their day in court. Mello observes, “Congress always says, ‘We need juries to protect the little guy,’ but 80% of the time the little guy loses jury trials.” Of course, this romantic attachment to juries might just be a fig leaf for underlying financial interests. After all, Mello notes, “many lawmakers used to be trial lawyers.”
Given that the malpractice system remains the primary construct for addressing patient harm, at least in the US, one question is whether it might be reformed in such a way that its objectives could be better aligned with the wider goal of patient safety. Michelle Mello and her colleague Allen Kachalia have proposed a number of intriguing reforms that might help the malpractice system improve overall safety, while still addressing the needs of the individual patient who brought the suit.8 One example is holding the institution liable in addition to (or instead of) the individual clinician. This acknowledges the fact—as Lucian Leape forcefully pointed out—that there’s almost always a systems problem that enabled a human to make an error. Besides forcing institutions to keep more skin in the game financially, settlements would also include mandates to fix the systems issues (in addition to whatever payout the individual patient might receive).
Another suggestion involves the malpractice insurance that doctors and hospitals must hold. As we saw in Florida and Virginia, the spiraling cost of insurance—which is steeper for high-risk specialties—can make healthcare less safe, especially if all the doctors quit practice! But perhaps insurance rates could be subsidized by the government for institutions that meet certain patient-safety goals. This could channel the threat of malpractice into more productive avenues that have the potential to improve the entire system.
Then there is the larger question about whether the legal system—either through malpractice suits or with administrative health courts—is the best place to resolve medical errors. Might it be possible to handle errors entirely within the medical system itself? Rather than have patients and doctors duke it out as opposing teams, could there be a way for patients to obtain the information they need, receive a payout if appropriate, and have doctors be able to acknowledge and apologize for the error without everyone having to be dragged through the coals?
Over the course of several years, Michelle Mello’s research led her to something called Communication and Resolution Programs (CRPs), which I’ll discuss toward the end of the case I present in the next chapter. Like Mello, this family eventually found its way to CRPs, but via a more convoluted—and far more painful—route.