Patient Safety in the United States

Patient Safety and Medical Malpractice

SURGEONS AT MERCY HOSPITAL IN SCRANTON, PA., threatened to walk off the job (in December 2002) to protest rising malpractice insurance costs. President George W. Bush later met privately with doctors in the area and heard their complaints about the stress of working in a hostile legal environment. One doctor criticized a recent $7 million settlement in a malpractice case against the hospital’s Wilkes-Barre affiliate. After the meeting, the president gave a speech that kicked off his push to put federal caps on punitive damage awards. He said that the medical liability system was “broken” and was driving away good doctors. Bush railed against lawyers and “junk lawsuits,” citing the Wilkes-Barre case.

Bush couldn’t have picked a better example to illustrate the flaws in his proposal. In August 2000, doctors at the Wilkes-Barre hospital were preparing to anesthetize the 73-year-old Frank Thornton before a scheduled surgery. While connecting him to a ventilator, Dr. Esther McKenzie, an anesthesiologist who had flunked her board certification exams five times, mistakenly put the breathing tube down his esophagus instead of his windpipe. The surgeon, Dr. Walter Boris, failed to correct the error, and Thornton was deprived of oxygen for 6 to 10 minutes. A retired welder, church deacon, and veteran, Thornton suffered irreversible brain damage and died a few weeks later.

Dr. Boris refused to meet with Thornton’s wife of 53 years after the mistake. Other hospital doctors who briefed her on her husband’s condition also refused to talk about what happened in the operating room. Broken-hearted, she sued.

In a deposition, Dr. Boris claimed not to recall any of the events that took place that day. He said that he had never told anyone that there might have been an error in the O.R., according to one of Thornton’s attorneys. But the hospital’s risk manager, charged with limiting the institution’s exposure to lawsuits, said in a deposition that Boris had come into the office within hours of the incident and said he thought the breathing tube had been misplaced. Two nurses also testified that they knew that Thornton’s breathing tube was misplaced. Three days into the trial, the hospital offered to settle.

THE DEATH OF A 17-YEAR-OLD PATIENT who was given an organ transplant of the wrong blood type at Duke Medical Center in February was headline news. But between 44,000 and 98,000 Americans die each year because of medical errors, according to a study released in 1999 by the Institute of Medicine. Even using the lower estimate, medical errors are the eighth-leading cause of death in the United States. The IOM study, entitled “To Err Is Human,” found that such mistakes cost between $17 billion and $29 billion a year. Medical errors kill more people each year than do motor vehicle accidents, breast cancer, or AIDS, the study concluded; those deaths are the equivalent of a jumbo jet full of patients crashing every other day.

The IOM proposed making it mandatory for doctors and hospitals to report errors to a national, government-run database. Determining what caused such errors was supposed to make the health care system safer. The Federal Aviation Administration, for example, has made American air travel the safest in the world by analyzing reported errors to identify and correct gaps in safety systems.

Within two years of the report’s publication, states introduced about 100 bills based on the IOM’s recommendations and enacted 23 of them, according to the National Academy for State Health Policy. Congress followed suit, and national medical error bills were introduced in both the House and Senate. Despite that initial flurry of activity, real progress has been slow, in large part because of antagonism between doctors and lawyers. Doctors complain that they are being driven out of the profession by the insurance premiums they pay to protect themselves from lawsuits. Lawyers maintain that they are holding dangerous doctors accountable and winning needed compensation for injured victims and their families. The stridency of the debate has obscured the more fundamental problem: what to do about the casualties of modern medicine.

EVEN WITH THE REGULAR INTRODUCTION of new and better technology, medicine remains an imperfect science. And yet the American health care system places the burden of avoiding errors and paying for them on individual doctors, and not on the institutions where they work or the government that purportedly regulates such institutions.

Most physician organizations, including the American Medical Association, have opposed a mandatory reporting system like the one recommended by the IOM. They say that they are not about to hand over evidence of their lapses to the government only to have lawyers use the information to sue them. (Trial lawyers have already seized on the IOM report to market their litigation services. Several malpractice lawyer referral websites now proclaim, “Medical malpractice errors are responsible for 98,000 deaths each year!”) Dr. James Bagian, the director of the Veterans Administration’s National Center for Patient Safety, explained the resistance this way: “If you know that what you say is going to be rammed down your throat, what incentive do you have to speak up?”

Lawsuits threaten doctors’ livelihood and their sense of autonomy. They challenge doctors to justify their decisions and clinical judgment, an especially painful reckoning for a profession that prides itself on its infallibility.

Recognizing that the fear of litigation is a serious impediment to reducing medical errors, the IOM recommended that Congress pass legislation to extend peer-review protections to reports of errors. Peer-review laws shield doctors’ mortality and morbidity conferences—where doctors talk about cases that have gone awry—from legal discovery. The committee suggested that information about less serious errors (those that do not result in deaths or serious harm) should be protected as well.

The AMA has offered its own solution: a voluntary reporting system that would be confidential, anonymous, and shielded from discovery in lawsuits. It has also pledged $15 million this year to help lobby for the president’s effort to cap medical malpractice awards. The Bush Administration claims that tort reform will encourage doctors to report errors.

Trial lawyers counter that lawsuits make medicine safer by providing a strong incentive for hospitals and doctors to avoid errors. Any reporting system must be mandatory and public, they contend, because doctors will rarely disclose their errors to anyone, let alone patients. As evidence, they point to the AMA’s long-running efforts to prevent the public from accessing the federal National Practitioners Data Bank, which records settlements and judgments against physicians as well as disciplinary actions from state medical boards across the country. Physicians’ groups convinced Congress that the public is too unsophisticated to understand the raw information. On its website, the AMA even has a section entitled “How to evade a report to the NPDB.”

Americans have long given the medical profession tremendous leeway to regulate itself on the grounds that the Hippocratic Oath gives medicine a moral underpinning not found in other professions. As a result, government has played a minimal role in maintaining the quality of American medical care. Doctors police themselves through their own licensing boards, and hospitals are largely regulated by voluntary industry groups like the Joint Commission on Accreditation of Healthcare Organizations.

But self-regulation hasn’t worked, and the public’s faith in the medical profession has seriously eroded over the past decade. Testifying before Congress shortly after the IOM issued “To Err Is Human,” one of its authors, Dr. Donald Berwick, explained why a voluntary reporting system wouldn’t respond sufficiently to the public’s concerns about accountability. “We find widespread distrust by the public in the health care system today,” he said. “The public thinks we are hiding our flaws from them, and, in some ways, we are.”

Doctors are tremendously reluctant to discipline each other, even in egregious cases, and the law doesn’t force them to do so. If a doctor witnesses malpractice or negligence by another physician, he or she has no legal obligation to report it. (Lawyers, on the other hand, are required to report any instances of unethical legal conduct they witness, and they seem to relish the job, as more than one lawyer has noted.)

Take the case of Dr. James Burt, the notorious Ohio gynecologist who subjected hundreds of women to a bizarre operation he called the “Surgery of Love,” which involved cutting out the skin around their clitorises and “reshaping” their vaginas, often after the women were knocked out by an anesthetic for another surgical procedure. Dr. Burt practiced for years, and other doctors in the area knew about him. At least 10 women had tried to sue Burt for their injuries, but all the cases were dismissed because no doctors would testify against him. When one doctor finally felt obligated to report Burt to the state medical board after treating one of Burt’s victims, he was ostracized by the local medical community for breaking rank.

The medical community’s loyalty to Dr. Burt was extreme, but doctors are often reluctant to discipline their own. Public Citizen, an advocacy group that tracks the performance of state medical boards, examined Florida’s disciplinary system for physicians last fall and discovered that the state had 1,555 doctors who had been disciplined by state boards—for incompetence, for prescribing the wrong drugs, for sexual misconduct, for criminal convictions, for ethical lapses, and for other offenses. Most were not required to stop practicing, even temporarily. Of the 23 Florida doctors that Public Citizen found to have 10 or more malpractice judgments and settlements against them, only 12 had ever been disciplined by the Florida Board of Medicine.

Florida’s board is so lax, according to Public Citizen, that the state has become a refuge for doctors with troubles in other states. Esther McKenzie, whose mistake led to Frank Thornton’s death, is now practicing in Florida, after flunking her board certification exam a sixth time. Florida’s record reflects a nationwide problem. Public Citizen reports that fewer than one-half of 1 percent of the nation’s physicians face any serious state sanctions each year.

The Joint Commission on Accreditation is a rubber-stamp institution closely affiliated with the hospitals it is supposed to regulate. The commission requires hospitals to install exit signs properly, but it doesn’t check more meaningful safety factors such as infection and mortality rates or the licensing of surgeons. Its voluntary reporting system vastly underestimates the number of avoidable patient deaths, according to a recent investigative report by The Chicago Tribune. For instance, the group documented just 12 cases of preventable hospital-borne infections since 1995, whereas The Tribune uncovered about 75,000 such deaths in just one year from state and government files.

TRIAL LAWYERS HAVE STEPPED IN where government has refused to tread. They enable victims to seek compensation for their injuries and provide a financial incentive for safety improvements. Litigation has prodded hospitals and doctors into doing a better job of case documentation. It also has inspired “informed consent,” the practice of telling a patient about the risks of a procedure before obtaining his or her consent to perform it.

But the law is an imperfect tool to regulate health care. Lawsuits may prompt hospitals to implement risk-management programs, which attempt to reduce an institution’s exposure to lawsuits by training doctors not to admit errors to patients, among other things. Those programs are not designed to protect patients from injury. Malpractice suits also tend to cluster around the most profitable victims, even when those areas of medical practice may not be the most accident prone.

The law uses a cold calculus to determine the value of a life. Calculations that factor in lost wages and other income don’t work especially well for people who don’t have much of an economic future—the old and the impoverished, for instance. Criminals, drunks, and drug addicts don’t draw a lot of interest from lawyers either, given their lack of appeal to a jury. These factors explain why trial lawyers are so attracted to obstetrics rather than, say, geriatrics. Newborn babies are the perfect victims: innocent, full of potential, and deeply sympathetic.

The prospect of punitive damages can moderate this calculus. As a retired man, Thornton wasn’t worth much by traditional measures of economic losses, but he was a sympathetic victim. The malpractice on him was so egregious that his wife’s lawyers gambled that a jury would make up the difference with damages. But cases like his are few and far between, even though the elderly are more vulnerable to medical errors than younger patients.

Lawsuits also have a limited effect on institutional safety, because malpractice claims are filed for only a small percentage of injuries. A recent Public Citizen study of data released by a Florida state agency estimated that for every six adverse incidents that hospitals reported to the state authorities—such as amputating the wrong leg or leaving a medical instrument in a patient after surgery—only one malpractice claim is ever filed. Similar numbers have been found in other studies nationwide. “Safety is not part of the legal system,” says the V.A.’s Bagian. “The whole philosophy is that you only look at safety when something bad happens. [Litigation is] like closing the barn door after the cow is gone.”

DESPITE ITS SIGNIFICANT SHORTCOMINGS, the right to sue over medical mistakes is deeply cherished by Americans, including physicians themselves. A recent survey conducted by the Harvard School of Public Health and the Kaiser Family Foundation found that more than a third of 831 doctors polled had been victims of medical errors. A series of questions put to the doctors revealed the stubborn paradox at work in the debate over fixing medical errors.

Pollsters asked physicians to identify the most pressing issue facing health care today. Doctors pointed most often to the cost of malpractice insurance and the frequency of lawsuits. When presented with an array of options for reducing medical errors, few doctors chose “more lawsuits.” Yet minutes later, the same doctors were presented a hypothetical scenario in which a surgeon orders an antibiotic for a patient whose medical record says he’s allergic to it. The patient wakes up gasping for air, the mistake is noticed, and the antibiotic is stopped, but the patient stops breathing and dies. When asked what they thought should happen to the surgeon, more than half the doctors said the surgeon should be sued for malpractice.

Litigation also serves another function: compensation. Few measures under consideration throughout the country, particularly tort reform, offer any alternative vision of how to pick up the tab for the costs of death and disability caused by medical errors. As Dr. Lucian Leape, a surgeon who is the nation’s leading expert on medical errors, explained, “Unless we have a fair compensation scheme—which we should because it’s the right thing to do—people will still have an incentive to sue.”

Litigation answers a deep need in all of us for justice. Though likely to save thousands of lives, a national database like the one proposed by the IOM fails to provide for personal accountability. As Jackson Williams, a researcher at Public Citizen, noted, “The medical error reporting system is not designed to punish people.”

DOCTORS AND LAWYERS HAVE REACHED A STALEMATE over how to report medical errors. But there are other, less divisive reforms that can improve patient safety. Hospitals can computerize their drug ordering, reducing errors caused by physicians’ bad handwriting and providing a system of checks to avoid mix-ups. Equipment can also be redesigned to safeguard against common mistakes. Anesthesiology has built safety protocols into its procedures, which is one reason why Thornton’s death was so tragic. His doctor’s error stemmed from a well-known risk.

Better-funded state medical boards, reconfigured to include more nonphysicians, would help to weed out the bad actors. This is no small matter: Public Citizen’s study of the NPDB determined that less than 5 percent of all doctors account for more than half of the malpractice judgments and settlements logged there.

In the tort area, Troyen Brennan, a doctor and a lawyer at Harvard University’s School of Public Health, proposes that the current adversarial system be replaced with a no-fault system similar to workers’ compensation. He argues that holding hospitals and health care organizations strictly liable for patient injuries would shift the responsibility from individual doctors to the institutions where they work.

The U.S. Veterans Health Administration has managed to stake out some common ground between doctors and lawyers. After losing two large malpractice cases in 1987, paying out a total of $1.5 million, officials at the V.A. medical center in Lexington, Ky., changed its risk management strategy. The officials realized that patients frequently sued doctors not because the doctors made a mistake, but because they tried to cover it up—a strategy often dictated by hospital’s risk managers.

Adopting a different approach, the Lexington V.A. started requiring all doctors to disclose their mistakes promptly to a committee, which would then contact the affected parties. The hospital would compensate the patients or their families for the errors, including funds for pain and suffering. Administrators even advised injured patients of their rights to sue the government in cases of malpractice or accidental injury.

Rather than prompting a rash of lawsuits, the V.A.’s full-disclosure policy produced the opposite experience. The hospital’s liability payments have been moderate, and litigation costs were kept to a minimum. As it turned out, according to Steve Kraman, the doctor who started the program and has since left the hospital, being honest defused situations that would otherwise have lead to litigation. Kraman discovered that “you don’t necessarily need to go to court to resolve these things. Most people are decent, and that includes people injured by medical errors.”

A few patients even turned down money offered by the hospital. “We have cases where we’ve had to insist they take it,” said Kraman. In the 17 years the system has been in place, he reported, the hospital failed to settle with only one patient, who sued the hospital and won slightly more damages than the hospital had offered.

The hospital also discovered that plaintiffs’ attorneys were quite cooperative. Once they verified the accuracy of the information provided by the hospital about the substandard care, lawyers were willing to negotiate settlements on the basis of monetary losses that could be calculated rather than on the potential for large judgments. The full-disclosure approach was accepted because it fairly compensated patients for their injuries. The system worked so well that the V.A. adopted it in most of its hospitals. They are now considered some of the safest in the world, and the V.A. managed this without a single change to the tort system.

By Stephanie Mencimer