An ugly truth of 21st century medicine is that episodes that hurt and kill patients get hidden from public view in the name of patient privacy, to the great detriment of all of us.

Medical errors and misdiagnoses occur far too often, with debilitating and deadly consequences. Medications get mixed up. Surgeries are bungled. Doctors decide patients aren’t sick and they are, or they fail to treat them for illnesses and injuries and patients suffer bad results.

Yet doctors, hospitals — and even some malpractice lawyers — hush up the damage.

This silence about preventable injuries and deaths hurts the quality of medical care in two big ways: It hinders close study of bad events and thus prevents care from getting better and safer. And it makes it hard for patients to know which doctors and hospitals they should steer clear of because of a high rate of injuries.

Leaders in medical care have campaigned for years to get doctors and hospitals to fess up to mistakes and to fix their causes. But excuses, myths, and fears keep putting patients at substantial risk. Hospitals, recent news reports show, are using legal tactics to gag patients and their loved ones after grievous medical mistakes occurred. We all need to know more about what has become — largely under the radar — a leading killer.

That list omits a big killer: medical errors. That’s according to researchers at Johns Hopkins University medical school. They estimated in 2016 published research that “more than 250,000 people in the United States die every year because of medical mistakes, making it the third leading cause of death after heart disease and cancer.”

The researchers looked at deaths in the U.S. for eight years, finding that the nation’s system for reporting these was flawed. It missed the dire effects of medical error, as CNBC News reported:

“Currently the CDC uses a deaths collection system that only tallies causes of death occurring from diseases, morbid conditions, and injuries,” the study’s lead author stated in a letter urging the CDC to change the way it collects the nation’s vital health statistics.

As CNBC reported, the Johns Hopkins research “defined a death due to medical error as one that is caused by inadequately skilled staff, error in judgment or care, a system defect, or a preventable adverse effect. This includes computer breakdowns, mix-ups with the doses or types of medications administered to patients and surgical complications that go undiagnosed.”

Critics have questioned the startling numbers about medical errors. But a quarter-century ago, patient safety advocates at the Institute of Medicine published a landmark work, To Err Is Human, decrying the “silence that has surrounded medical errors and their consequence.” Institute investigators reported this in 2000:

“Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That’s more than die from motor vehicle accidents, breast cancer, or AIDS — three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems.”

The toll of misdiagnoses

Despite multiple reforms launched after the Institute research, medical errors persist as a significant patient peril, as do other quality and safety problems. Researchers, also from the Johns Hopkins medical school, dug deep into in a specific type of error-prone practice, publishing a study in 2021 that found misdiagnoses were a major cause of patient harms:

“An estimated 795 000 Americans become permanently disabled or die annually across care settings because dangerous diseases are misdiagnosed. Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined.”

As the news release from the Johns Hopkins Armstrong Institute Center for Diagnostic Excellence and partners from the Risk Management Foundation of the Harvard Medical Institutions reported:

“Vascular events, infections and cancers, dubbed the Big Three, account for 75% of the serious harms … Five conditions causing the most frequent serious harms account for 38.7% of total serious harms: stroke, sepsis, pneumonia, venous thromboembolism and lung cancer.”

David Newman-Toker, M.D., Ph.D., and the lead investigator in this study, was quoted: “Reducing diagnostic errors by 50% for stroke, sepsis, pneumonia, pulmonary embolism and lung cancer could cut permanent disabilities and deaths by 150,000 per year.”

The campaigns to make medical care safer, however, took a big hit as the coronavirus pandemic overwhelmed the U.S. health care system. Hospitals have been urged to recommit to reducing the recent spike in what the Joint Commission, their independent accrediting agency, calls “sentinel events.” These are voluntarily — and likely under-reported — “patient safety events resulting in death, permanent harm or severe harm,” the industry newsletter Fierce Healthcare has reported, adding:

“Covid 19 continued to present challenges to health care organizations throughout 2022, and we saw the number of sentinel events increase above pre-pandemic levels,” Haytham Kaafarani, M.D., chief patient safety officer and medical director at The Joint Commission, said in a [news] release accompanying the report, which also noted a 78% increase in reported events from 2020 to 2022.”

They also don’t discuss their errors or shortcomings with patients, or even colleagues. As Dr. Manoj Jain, an infectious disease specialist, wrote in an Opinion article in the Washington Post:

“Like me, many of my colleagues were never taught how to disclose errors in medical school. Errors were considered incidental lapses and used as teaching points among residents; we were not to discuss them with patients unless absolutely necessary. When I joined a private practice 18 years ago, our hospital and malpractice lawyers told us never to admit guilt. Risk managers were clear that we were to contact them in the event of an error. If patients’ families had questions, we were to be vague with our responses, essentially brushing them off.”

He also noted this: “Gradually, such attitudes and practices have been changing. First, policy makers, doctors and other providers have realized that medical errors are often systemic problems rather than incidental lapses.”

Doctor groups and hospitals, he wrote, slowly have made it a professional, ethical obligation to speak up about medical errors because doing so can significantly benefit patients. State lawmakers also have tried to offer doctors some legal shield if they admit errors, apologize to patients, and try to help fix or pay for them.

But doctors are not taking responsibility for problematic care. They aren’t apologizing and helping to fix errors or helping patients with the cost of added care, research shows. As lawyer and psychologist Jennifer Robbennolt wrote in a published medical journal article:

“Physicians, like patients, are profoundly affected by medical errors; physicians worry about harm caused to patients; are anxious about the consequences of error for their reputations, fearing that patients and colleagues will no longer trust and respect them; experience distress, feelings of guilt, and loss of self-confidence; and are anxious about the possibility of a lawsuit. Indeed, physicians describe the ‘sickening realization of making a bad mistake’ and the sense of dread on realizing that one has made an error.

“Many physicians express the desire to apologize to patients when an error has occurred. However, there is a disconnect … In contrast to the desires and expectations of patients for disclosure and apology, there is evidence many physicians tend to provide minimal information about what happened, what led to the error, or what might be done differently in the future; to choose their words carefully so as to avoid being explicit about the error; and to believe patients who want more information will ask for it to be provided. Similarly, there is evidence that providers are reluctant to make any offers of compensation for medical errors unless and until a lawsuit is filed.”

Unfounded fears

This newsletter has covered the malpractice myths that haunt doctors. They wrongly think that small, simple mistakes will be costly. They fear that knowledge about one error on their part will be career-ending and that the world is full of lawsuits and greedy patients.

In fact, the number of malpractice cases is small and their number steady. Research shows that a handful of misbehaving doctors amass not one, not two, but multiple cases with settlements. They move around to take advantage of the country’s weak, state-by-state licensing system and its ineffectual medical boards and hospital credentialing committees. These bad doctors change practices, ending up in solo situations without colleagues to raise questions about their shoddy work.

The profession should put them out of practice. This would require doctors themselves to do something they do far too infrequently — to stop their silence and speak up about bad colleagues. They know which doctors they would never let anywhere near their own friends and loved ones. They stay mum, partly because they think they will get entangled in messy legal situations. But an array of other reasons also keeps them quiet, reported ProPublica, the Pulitzer Prize-winning investigative site:

“[D]octors depend on each other for business. So, a physician who breaks the code of silence may become known as a tattler and lose referrals, a financial penalty. Or maybe they aren’t sure exactly what happened to the patient and don’t want to take the time to try and unravel it. In some cases, issues related to cultural differences, gender, race, and seniority come into play.”

Patients, as this news article points out, pay the price for doctors’ no-tell practices: “Too often doctors aren’t learning from errors … Nor are patients getting the information they need to receive proper treatment or compensation when the outcome is harmful … Failing to divulge another doctor’s mistake undermines the doctor-patient relationship.”

Another ugly truth: Patients cannot rely on hospitals to do the right thing when dealing with bad doctors and medical error.

A handful of cases that have received widespread media coverage show that doctors and hospitals will stay silent about negligent, abusive, and poor-performing doctors, hoping that with professional nudging the bad actors will just move on.

Besides providing peer oversight, doctors also are supposed to be scrutinized by hospitals granting them practice privileges. But hospitals can be too lax in investigating doctors. At the same time, they also get bogged down in laborious processes that administrators hope will shield them from lawsuits by patients or doctors over “negative credentialing,” news reports on ghastly serial malpractice cases have shown.

This may be surprising. But when hospitals know that patient harms have occurred, they aren’t necessarily required to report the incidents to any regulators because of a patchwork of spotty local, state, and federal rules.

Programs like Medicare and Medicaid give federal regulators some oversight of hospitals. But much of the oversight of quality and safety matters in hospitals has been taken over by industry-supported accrediting groups like the Joint Commission.

The commission tracks serious incidents involving error, misbehavior, and the like, which it calls sentinel events. But hospitals report these voluntarily and commission staff assist institutions in determining appropriate responses.

Pursuing big money

Further, hospitals have become mammoth examples of how profit maximization and the corporatization of medicine has run roughshod over patients. Here is how a sociologist-journalist named Eyal Press reported this crisis in the New York Times Magazine:

“[I]n recent years, despite the esteem associated with their profession, many physicians have found themselves subjected to practices more commonly associated with manual laborers in auto plants and Amazon warehouses, like having their productivity tracked on an hourly basis and being pressured by management to work faster. Because doctors are highly skilled professionals who are not so easy to replace, I assumed that they would not be as reluctant to discuss the distressing conditions at their jobs as the low-wage workers I’d interviewed. But the physicians I contacted were afraid to talk openly … Some sources I tried to reach had signed nondisclosure agreements that prohibited them from speaking to the media without permission. Others worried they could be disciplined or fired if they angered their employers, a concern that seems particularly well founded in the growing swath of the health care system that has been taken over by private-equity firms.”

Giant enterprises have gobbled up parts of the medical system in this country, including physician practice groups, and have leveraged them to maximize profits, according to a recent investigation by Stat. The medical and scientific news site zeroed in on United Health, which it described as now being a medical colossus that has sway over as many as 1 in 10 doctors in this country.

The once small insurer now uses “tactics [that] have transformed medicine in communities across the country into an assembly line that treats millions of patients as products to be monetized,” Stat found, adding: “Doctors said the company had a fixation with medical coding to generate more revenue — encouraging clinicians through bonuses and performance reviews to identify more health problems in patients, even if those conditions seemed dubious.

“By controlling doctors, UnitedHealth can lean on them to practice in ways that benefit the insurer, and use its insurance arm to funnel cash back to its clinicians — similar to how Standard Oil amassed power as both the buyer and seller in oil refining. Through these efforts, and by adeptly navigating the Medicare Advantage payment system, UnitedHealth has squeezed potentially tens of billions of extra dollars from taxpayers over the past decade.”

As hospitals consolidate into a few chains, both nationwide and in select markets, they have wheeled-and-dealed with insurers, Big Pharma, and others in the medical system. Hospitals, like other profit-hungry enterprises, have bought up physician practices. In 2021, the American Medical Association reported that most of its doctor-members for the first time no longer worked for private, physician-owned practices but for others. By 2022-23, according to Fierce Healthcare, “a new high of 77.6% doctors [were] employed by hospitals or other corporate entities.”

What do these mega-economic trends in medicine mean to patients? It means folks in suits and ties with MBAs, but who may or may not have any background in medicine, now decide for doctors such crucial issues as how many patients to see in a given time (20 minutes or less), what kind of tests they might perform, whether certain procedures and medications are cost-effective and permitted — or not — and more.

If doctors seem more harried than ever and angry, flustered, and burned out, do they have the time and energy to risk careers by telling big corporate employers about medical errors they make or to take on poor-performing colleagues? Must they double-check their professional contracts to see if they will violate clauses that bar them from disparaging their workplace or peers, or will they find they have signed nondisclosure agreements that keep them silent altogether about serious professional concerns? Will it be easier than ever before for doctors and hospitals just to say nothing about medical errors, misdiagnoses, and bad doctors — unless unacceptably bad situations occur, become public, and force disclosure?

The story caught the public off guard. But the tactic wasn’t exactly new.

Doctors and hospitals try many different ways to hush up medical errors and practitioners with problems.

NBC News recently investigated a major public hospital system and found that it had used a legal mechanism that has received considerable public attention recently to keep millions of dollars of malpractice settlements out of sight. From 2015 to early 2023, the University of Washington Medical Center and other UW-affiliated hospitals and clinics used nondisclosure agreements, aka NDAs, to gag patients and their lawyers in 70 of 89 negotiated settlements. As NBC News reported:

“As a result, the public has been kept in the dark about allegations of egregious medical mistakes and serious misconduct at Washington’s largest taxpayer-funded hospital system. Payments to settle cases that included confidentiality requirements ranged from as low as $2,000 to as high as $14 million.”

Because the UW system is a public institution, state open-records laws allowed reporters to obtain documents about multiple cases that medical officials wanted to hush up, including, as NBC News found:

§ A newborn who suffered severe brain damage because doctors allegedly failed to properly monitor his heart rate during childbirth ($14 million).

§ A man who died after doctors allegedly misdiagnosed and improperly treated a cancerous mass in his face and neck ($6 million).

§ A girl left with permanent cognitive disabilities after a doctor who operated on her face allegedly left bone fragments behind in her skull, causing a catastrophic stroke ($11 million).

NDAs abound

The same legal tactics have been employed elsewhere, as NBC News found with hospitals in Kansas and Texas. These cases raise even more questions about NDAs, which the investigation described in this way:

An “NDA [is] a legal tool widely used by major corporations and wealthy celebrities to make accusations go away … Nondisclosure agreements can keep sensitive details out of the public eye, but they have come under attack in recent years for shielding bad actors and allowing misconduct to persist. Critics say they allow prominent people to keep sexual assault allegations under wraps, for instance, and businesses to silence would-be whistleblowers.”

Corporations, particularly those in tech or in fields in which product research and development is vital (including in medical devices and pharmaceuticals), have made common NDAs and “noncompete” agreements. They argue that enterprises must protect proprietary information and developments to stay competitive and keep others from hiring away employees to obtain trade secrets.

The use of NDAs in medical malpractice cases puts in focus what legal specialists call “secret settlements” — attempts, typically by defendants, to keep out of public view all or parts of cases involving medical error, negligence, misbehavior, and poor practice by doctors and hospitals.

The NBC News investigation highlighted a critical concern about keeping malpractice cases secret: What happens to doctors involved in them, especially if judges or juries found their practices so dubious as to result in settlements? Many things went wrong with the UW system’s legally required reporting to a nationwide database about doctors and their performance, such that state licensing authorities may not have learned that a surgeon central to one of the cases had lost a sizable malpractice judgment. This is supposed to be a factor considered in allowing a doctor to practice in a given state.

NBC News also raised key issues for Washington taxpayers — did they know that their hospital system had problems and spent big sums to settle suits over them? Did the doctors and hospitals determine if systemic problems existed and needed to be remedied?

Despite the falsehoods that circulate about avaricious plaintiffs, malpractice lawyers can testify that their clients make difficult decisions in suing doctors and hospitals.

Unlike what audiences see on TV shows, the civil justice system can be daunting, and its actual workings can be overwhelming for plaintiffs unfamiliar with the courts and the law. Malpractice cases can take years to resolve, and they involve an adversarial process that can be troubling to lay people.

Those who pursue these lawsuits know that much is at stake. The plaintiffs and their loved ones believe not only that they have suffered injury but also that they may need medical care and other support beyond their resources for as long as a lifetime. Does it make sense to stuff all the information, courageously mined in malpractice cases into sealed, secret files? Does it make sense to keep the parties involved from discussing cases? Sometimes, the pressure to settle and allow the injured to go forward with their lives can be powerful.

Why our law firm says no to secret settlements

I have long opposed secret settlements, and have written and talked to many lawyer groups about why they’re bad for clients and bad for our law practices. As I have written:

“We oppose these provisions and work hard to avoid having them imposed on our clients by defendants who want to hide their wrongdoing from public scrutiny. Our reasons:

“§ The civil justice system exists to help make the world safer and to prevent injuries. Many of our clients come to us saying, ‘It’s not so much the money. I just don’t want this to happen to someone else.’ Secrecy provisions in settlement agreements undercut this important goal of the civil justice system because they don’t let lawyers like us and our clients talk about the safety lessons we learned from a case. Secrecy also lets the same thing happen to other victims when the problem gets buried rather than fixed. Witness the Ford Explorer rollover cases and the clergy sex abuse scandals.

Ҥ Confidentiality clauses in settlement agreements make it harder for future injury victims to find qualified lawyers to represent them, because the lawyers cannot talk about specific cases they have experience with. For that reason, several ethics committees of bar associations, such as the D.C. Bar, have issued ethics opinions saying that confidentiality agreements are unethical when they have this effect. See the D.C. Bar ethics opinion on secret settlements here.

Ҥ Confidentiality language also makes it harder for future injury victims to prosecute their cases, because the secrecy language prevents prior victims from coming forward and sharing their stories and specific evidence they turned up in their cases. This is another reason that such agreements have come under ethics fire.
Ҥ Injury victims who agree under pressure to confidential settlements sometimes live to regret that. It means they can never openly discuss what happened, and if they inadvertently violate the secrecy agreement, a vengeful defendant can pursue them.

“We make one exception – if secrecy benefits an injured person who wants to keep the amount of a settlement from prying eyes, or who wants to keep embarrassing facts about them quiet, then we will agree to confidentiality of specific terms, such as the dollar amount or the name of the injured client. But we don’t agree to keep the facts of the case or the name of the defendant confidential.”

While doctors and hospitals have become expert at trying to keep a lid on medical errors, they have been losing the battle with nefarious actors who rob institutions of critical medical information through a rising onslaught of cyberattacks.

Patients give up a bonanza of personal data when seeking medical care, including basics like their age, addresses, Social Security and Medicare numbers, credit information, and more. Loss of this material opens wide avenues for criminals for further identity thievery and “fishing” attacks to rip off gullible parties, not to mention the havoc that malevolent parties can cause with highly personal details about patients’ injuries, illnesses, treatments, and medications.

Efforts to recover pirated information can cost doctors and hospitals four times as much as might comparably be spent by financial services or other institutions. News organizations have reported that some victims have paid tens of millions of dollars to criminals in hopes of ending ransomware attacks.

The U.S. medical system has huge vulnerability to cyberattacks, experts say. Doctors and hospitals were dragged only recently into the computer age, notably by sizable financial incentives offered under the Affordable Care Act for electronic medical record systems.

As the medical system has sought to keep pace with patients — who have leaped far ahead with their adoption of online services — doctors and hospitals too often have relied on technology that gets out of date fast, links together too many people and services in flawed ways, and leaves open “back doors” exploitable by crooks, experts say.

This year alone, news media have reported on giant cyberattacks against the 140-member Ascencion Hospitals system, as well as a long, paralyzing assault against Change Healthcare, the large United Health Group billing and payment unit. The Lehigh Valley Health Network was attacked. The New York Times has reported on the 2022 cyberattack on the One Brooklyn Health system, and the newspaper noted that “a wave of cyberattacks hit about a dozen hospitals in the fall of 2020, disrupting care.”

The newspaper reported this in 2023: “CommonSpirit Health, which has more than 140 hospitals and more than 700 care sites nationwide, was the target of a cyberattack last year that led to postponed surgeries, doctor visits and other delays in care, NBC reported. And in 2020, Russian hackers launched a ransomware attack on United Health Services, which has at least 400 facilities, making it the largest attack of its kind at the time.”

The 2023 news article also reported on attacks on Prospect Medical Holdings, which “operates 16 hospitals and more than 165 clinics and outpatient centers in Connecticut, Pennsylvania, Rhode Island and Southern California …”

Banks, retailers, and other businesses already have invested in heightened security measures, and experts say doctors and hospitals also must do so.
The next administration, Congress, and federal regulators may have to prod them to take this step and provide taxpayer assistance to ensure it occurs.

A health care journalists’ group has posted online a few tips patients can use to try to protect themselves against medical cyberattacks, including: “Use strong passwords or employ a password manager. Adapt when offered multifactor authentication, a process used by banks and other industries that require more than just your username and password to access information. This means you input your username and password, then must also enter a six-digit code provided in a mobile app on your phone.

“Never open attachments or click on links embedded in suspicious emails or texts. Install all updates to software and programs. Monitor credit to look for any suspicious activity. If you get a call that sounds suspicious, hang up and call the person back” to ensure their identity and foil scammers. “Do not pay ransomware or send gift cards or other forms of payment requested by hackers.”

A bonus tip: Patients also would be wise to fight through the hurdles to ensure they have their own copy of their medical records. If doctors and hospitals insist the material can only be provided electronically, consider getting a quality thumb-drive and keeping a secure copy of the records on it – and not just in a personal computer file, which might be hacked.

Critics in recent years have assailed federal regulators for their chummy oversight of the multibillion-dollar medical device industry. The failure to safeguard the nation, and the allowing of a “Wild West” in the flourishing business of devices, has led to serious harms to big numbers of patients, advocates like journalist Jeanne Lenzer have said.

As she observed: “About 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices. These devices have helped countless people, and some have saved lives. But many others are harmed — and doctors and patients are at the mercy of manufacturers’ claims about the safety and efficacy of the devices. Medical interventions are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic.”

The federal Food and Drug Administration resisted ideas on how to improve patients’ safety, critics say. A newly published New York Times investigation will only infuriate those frustrated with the agency’s medical device oversight, reporting one an open secret in Washington, D.C.:

“For 15 years, Dr. Jeffrey E. Shuren was the federal official charged with ensuring the safety of a vast array of medical devices including artificial knees, breast implants and Covid tests. When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.

“But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.

“One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.”

The newspaper found that ethics requirements that were supposed to seal off a regulatory leader from matters involving his wife’s firm were slight to start with and little enforced. And the couple’s interests, even by appearance, crossed in highly public instances involving LASIK vision surgery, breast implants linked to cancers, and the highly publicized implosion of the blood-testing start-up Theranos. The details of these specific cases should raise serious questions for the FDA.

The Shurens, in the meantime, have done well for themselves, the newspaper found, examining financial disclosure statements:

“Ms. Shuren earned from $1 million to $5 million, according to her husband’s financial disclosure form in 2018, the only one that estimated her income. Dr. Shuren’s F.D.A. salary is $400,000 a year. Dr. Shuren led an office with about 2,500 staff members and a budget of about $790 million. He oversaw thousands of devices, ranging from tests to detect blood-lead levels to IV infusion pumps to ventilators.”

The newspaper reported that the FDA official, during his tenure, started a nonprofit organization that pledged to assist the agency in improving the quality and safety of medical devices. He got an ethics waiver to do so. Critics said the group was packed with industry figures and led Dr. Shuren to grow closer — too close — to those he was charged with regulating.

The FDA official’s tenure is getting more scrutiny, especially as the agency seeks a successor, the newspaper said:

“Last year, the American Medical Association, the nation’s largest physician group, raised “serious safety concerns” about medical devices, highlighting secrecy around reports of device-related injuries and a system that allowed many devices onto the market with little to no testing in humans …

“[S]afety issues multiplied on his watch. The most urgent FDA recalls of devices that can cause serious injury or death have ticked up, to nearly 100 so far this year, from 29 in 2012, the first year such measures were tracked in an agency database. In March, a heart device was recalled after 49 deaths were linked to a specific concern. Reports of device-related injuries soared to 900,000 in 2023, up from about 190,000 in 2012, according to Device Events, a company that makes FDA data user-friendly for subscribers.”

Dr. Shuren, who has a contract to assist his successor in transitioning into the agency leadership role, has been cautioned that he must “exercise greater caution in matters concerning his recusal obligations and will be provided additional administrative support to better ensure future compliance,” the FDA told the newspaper.