DC Medical Malpractice & Patient Safety Blog

Hundreds of patients appear to have received cardiac stents that they didn't need from Dr. Mark Midei, a cardiologist at St. Joseph's Hospital in Towson, Maryland. So why did no one at the hospital blow the whistle? And why did the patients not realize that Midei was rushing them into unwise and risky surgery?

Heart surgery is highly profitable, and there are no incentives for doctors or hospital administrators to rock the boat by raising questions when one cardiologist is putting stents into far more patients than his colleagues.

As for the patients, we Americans have a bias toward dramatic action. If one doctor tells us we need a stent to prop open the coronary arteries in the heart, and another doctor says all we need to do is take a pill every day, most of us will tilt toward the big intervention. Which can be a big mistake, because we then get a piece of metal permanently implanted in a blood vessel, and we have to take medicines anyway for the rest of our life to avoid getting blood clots from the metal that could cause a devastating stroke or more heart damage.

Recently in this blog, I pointed readers toward an excellent review by the Harvard Medical School of the scientific evidence on who should -- and shouldn't -- get the balloon and stent treatment for opening their heart arteries. Many studies have found that unless a patient is having repeated symptoms, the stent treatment does nothing to extend his or her life, even if an artery looks dramatically narrowed.

In the case of Dr. Midei, it appears that outright fraud might have been involved. You have to have a significant narrowing of the artery, 70 percent or more, to even start to qualify for stent treatment, and Midei aggressively over-read his own X-ray studies of the heart's blood vessels to make it seem that patients had much worse narrowing than they really did, according to the published allegations about his practice.

This raises a Fox/Henhouse issue: How is it that a cardiologist can do his own testing to see if someone needs treatment, and then be the one to profit mightily if the decision is yes, they need it? Should second opinions be mandatory on any patient with blood vessel narrowing?

Dr. Bob Wachter, a patient safety pioneer at UCSF medical school in San Francisco, wrote a thoughtful blog on this topic. I'm reprinting part of it below, and urge readers to read the whole article here.

Dr. Wachter writes:

Obviously, the Mideis of the world could be caught by requiring that every cath [blood vessel X-ray] undergo an independent second reading. Some insurers in New Jersey now require such readings before they authorize a stent, and at least one SoCal Kaiser hospital mandates that each cath be presented at a conference before a treatment decision is rendered, analogous to what many tumor boards do for cancers.

Such required peer review might have benefits beyond simply preventing the rare case of fraud. If done well, it might also ensure that other conflicts of interest and non-evidence-based decisions are avoided to the degree possible. For example, a meta-analysis in last month’s Annals of Internal Medicine illustrates the limited value of percutaneous coronary interventions – whereas older studies found that PCI was more effective than medical therapy in treating angina, more recent studies show that these differences have narrowed or even vanished. I’d guess that, when recommending a treatment for a patient with mild angina and a 60% LAD lesion, a peer review group is more likely to pay attention to this kind of evidence than the average cath jock – who may not only be staring at his kid’s private school tuition bill but also at a patient whose bias is to see a stent as a more intuitively satisfying solution than “just medications.”

Some will argue that mandating second opinions for every cath is the equivalent of hitting a nail with a sledgehammer, and they might well be right. However, I do favor at least random over-reads of a sample of catheterization studies. Something like this already happens in a few specialties. In many teaching hospitals, a random sample of pathology studies is reviewed by a second provider. In a few forward-thinking practices, radiologists re-read a sample of x-rays, looking for discrepancies. In response to this case, in fact, St. Joseph’s now requires that 5% of its cath cases undergo a random and blinded re-review. Random audits won’t catch every case of fraud, any more than IRS audits catch every tax scofflaw. But they do help keep people honest, particularly if the audits are coupled with a culture in which the docs welcome feedback and strive for continuous improvement.

Speaking of which, the Midei case made me wonder about the institutional culture at St. Joseph’s. Was Midei a rogue interventionalist working in isolation? Perhaps so – it's common for no other doc to be looking over the shoulder of a cardiologist and his cath readings. But cardiologists don’t perform caths on desert islands – they are assisted by cath techs and nurses. In my experience, these folks become as adept at reading cath films as any physician. If the allegations against Midei are true, it strains credibility to think that no one in the lab knew that inconsequential lesions were being read as tight stenoses and treated with stents.

And what about the hospital administrators? Stents are big business. When Johnson & Johnson first launched their drug coated Cypher stent in 2003, Dr. Midei told the Baltimore Sun, “This is the hottest thing in cardiology in years.” And it was: Maryland hospitals chalked up nearly $250 million in stent business in 2009, and St. Joseph’s stent revenues were $38 million, up more than 50% in 5 years. Before the case broke, St. Joseph’s advertised itself as the busiest cath hospital in Maryland, averaging nearly 20 interventional cases daily. While it is possible that no St. Joe’s leader knew precisely what was happening, I'm guessing that some did but chose to look the other way: the pressure to steer clear of the golden-egg-laying goose must have been intense. Perhaps the fact that the hospital’s CEO and two other senior executives resigned after the case broke provides a clue as to who knew what when.

Cases like this one are terribly troubling, not just because they harm individual patients but because they do violence to the trust that is so fundamental to the physician-patient relationship. Part of the solution must be more robust oversight procedures, such as mandatory second readings of randomly selected cath films.

But these cases also force us to consider the kind of culture that could allow such a fraud to take root and go on for years – a culture that likely prized the hospitals’ and physicians’ financial health over the clinical health of their patients. If the allegations are true, the penalties should be severe, not only for Dr. Midei but also for leaders who knew – or should have known – what was going on, yet remained silent.

Patients need to know that this is not just an issue of a few rogue bad apples. Medicine's fee-for-service payment system pushes doctors toward advocating for more aggressive and profitable interventions. The only way to find out what your body really needs is to shop for second and third opinions, every time. I have more on this subject in chapter 9 of my book, "The Life You Save."

The chapter title says it all: "The Second Opinion: Always Your First Choice."

It's helpful to look at the actual facts, not supposition, about so-called "tort reform" and medical malpractice, because so many medical leaders persist in arguing that curbing victims' rights to accountability for medical injuries would make the health care system better.

The following discussion is courtesy of Joanne Doroshow, the head of Center for Justice & Democracy, and based on a submission she made to the Medicare payment review board.

No serious economist believes that medical malpractice litigation is a major driver of health care costs. In over 30 years, medical malpractice premiums and claims have never been greater than 1% of our nation’s health care costs.

Senator Orrin Hatch asked the Congressional Budget Office to look into the cost issue. CBO responded in an October 9, 2009 letter, trying to determine health care cost savings if Congress enacted a menu of extreme tort restrictions advocated by the medical lobbies, the insurance industry and a lot misinformed doctors. CBO could go no further than to find an extremely small percentage - about 0.5% - of health care savings by wiping out most litigation, legitimate and otherwise (which is what these measures would do – see the Texas example, below). This is far lower than the highly exaggerated numbers thrown around by those who would like to restrict patients’ rights. Alexander C. Hart, “Medical malpractice reform savings would be small, report says,” Los Angeles Times, October 10, 2009;

To reach the 0.5% savings figure, CBO determined that 0.3% was specifically due to defensive medicine. That’s it. Moreover, CBO found little evidence of this “defensive medicine” phenomenon except in studies of Medicare, not studies of private managed care systems. Obviously doctors operate under the same liability rules no matter the system of payment or the age of the patient, so the explanation for this disparity cannot lie with the legal system. Rather, according to CBO, the problem is Medicare’s emphasis on “fee-for-service” spending, whereas private managed care “limit[s] the use of services that have marginal or no benefit to patients (some of which might otherwise be provided as ‘defensive medicine’).” In other words, CBO suggests that to the extent defensive medicine exists at all, it can be controlled through simply managing care correctly as opposed to taking away patients’ rights and possibly killing and injuring more people.

As far as medical malpractice premiums, CBO attributed 0.2% to this cost. This insurance industry continuously fights its own figures on this, but I think they speak for themselves. (See, e.g, a New York Times article.) And here’s what the figures say:

• Medical malpractice premiums, inflation-adjusted, are nearly the lowest they have been in over 30 years. The periodic premium spikes that doctors experience, as they did from 2002 until 2005, are not related to claims, which have been steady or dropping for many years, but to the economic cycle of insurers and to drops in investment income. In fact, medical malpractice claims, inflation-adjusted, are down 45 percent since 2000.

• Medical malpractice insurer profits are higher than the rest of the property casualty industry, which has been remarkably profitable over the last five years.

• Many states that have resisted enacting severe restrictions on injured patients’ legal rights experienced rate changes (i.e., premium increases or decreases for doctors) similar to those states that enacted severe restrictions on patients’ rights, i.e., there is no correlation between “tort reform” and insurance rates for doctors.

All the data backing up these statistics can be found here: For more information, contact the study’s main author, actuary J. Robert Hunter, former Federal Insurance Administrator under Presidents Carter and Ford, former Texas Insurance Commissioner, and now Director of Insurance for the Consumer Federation of America.

Finally, you may be familiar with the widely-read and cited June 1, 2009, New Yorker magazine article by Dr. Atul Gawande, “The Cost Conundrum; What a Texas town can teach us about health care,” which explored why the town of McAllen, Texas, “was the country’s most expensive place for health care.” The following exchange took place with a group of doctors and Dr. Gawande:

“It’s malpractice,” a family physician who had practiced here for thirty-three years said. “McAllen is legal hell,” the cardiologist agreed. Doctors order unnecessary tests just to protect themselves, he said. Everyone thought the lawyers here were worse than elsewhere.

That explanation puzzled me. Several years ago, Texas passed a tough malpractice law that capped pain-and-suffering awards at two hundred and fifty thousand dollars. Didn’t lawsuits go down? “Practically to zero,” the cardiologist admitted.

“Come on,” the general surgeon finally said. “We all know these arguments are bullshit. There is overutilization here, pure and simple.” Doctors, he said, were racking up charges with extra tests, services, and procedures.

This is true for all states that have enacted "caps" and other restrictions on patients' rights. Moreover, CBO noted that “imposing limits on [the right to sue for damages] might be expected to have a negative impact on health outcomes” and cites one study finding such tort restrictions would lead to a 0.2 % increase in the nation’s overall death rate. If true, that would be an additional 4,853 Americans killed every year by medical malpractice, or 48,250 Americans over the ten-year period CBO examines. This should be unacceptable to us as a nation.

The free meals, trinkets and other goodies now lavished on doctors by the prescription drug industry will soon be a matter of public record for each doctor in the United States, under a provision of the new health care reform law. A searchable database goes into effect in 2013 that will let anyone plug in a doctor's name and find out how much largesse that doctor received in the past year. This is a positive development for patient safety in the United States.

Readers of this blog know from past reports that even small "gifts" from manufacturers are highly effective in influencing doctors' prescription writing habits. The industry spends about $1 billion a year in free meals for doctors and many more dollars in countless free pens, scratch pads, textbooks and other trinkets branded with the names of various drugs being promoted. (As we reported in another post, deep-sea fishing trips and golf junkets are also part of the blandishments.)

Do small gifts matter? Yes, as the Pew Prescription Project points out in an excellent fact sheet that summarizes the studies on how doctors' decisions about drugs are influenced by manufacturers. As the Pew researchers write:

[T]he evidence is clear: gifts, even small ones, change behavior. Such marketing drives up drug costs and sometimes puts patients at risk. Social science research ... shows that a gift of any size imposes on the recipient a sense of indebtedness. This need for reciprocity is a deep-seated human reaction. It creates in the recipient, whether consciously or not, a sense of obligation to repay favors, gifts, invitations, etc. Research shows that it takes extraordinarily little to bias an individual’s interpretation and processing of information. Such bias is both subtle and unintentional.

Now, that's "subtle and unintentional" bias on the part of the doctor receiving the gift. Most doctors will deny heatedly -- and honestly -- that drug freebies have any role in how they prescribe medicines. The manufacturers, who study this closely, know otherwise. There is nothing "unintentional" about the way they spend money on seemingly innocuous trinkets like pens.

The new reporting law requires the drug manufacturers to report to the government everything of value given to any doctor or teaching hospital, starting January 1, 2012 (and the government web site has to be up by September 30, 2013).

Manufacturers do not have to report gifts worth less than $10, but if the total of those gifts in one year to any doctor reaches $100, then all gifts have to be reported. There are a few other exemptions and other details worth reading in this "Sunshine" fact sheet from Pew.

Free samples of drugs also will be covered by another part of the law. As I have reported before, thoughtful doctors don't even accept free samples because that can bias their prescriptions away from "tried-and-true" medicines toward newer drugs with uncertain safety records.

I have a chapter in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, educating consumers on how to use prescription drugs safely. One of my key points is that people need to realize that the first few years a new drug is on the market -- during the time of its heaviest promotion by the manufacturer -- is also the most dangerous time for the patient to try the drug, because early users are basically guinea pigs.

This new law infringes no doctor's freedom to accept gifts from industry, and doesn't impact any patient's freedom to patronize such doctors. But with education and "sunshine" about how these gifts create conflicts of interest for the doctor, we can hope that the torrent of freebies will start to slow. All patients will be better off if the education doctors get about new drugs is not influenced by industry gifts.

That question is now on trial in a small west Texas town, where a nurse stands accused of a felony for reporting a doctor whom she thought was guilty of malpractice on patients. Even if the nurse is acquitted, the case could have a chilling effect on nurses' willingness to act as whistle blowers when they see sub-standard medical care.

The defendant, Anne Mitchell, R.N., was indicted for "misuse of official information," a felony, because she reported to the state medical board her concerns about the quality of care delivered by Dr. Rolando G. Arafiles Jr.

Nurse Mitchell worked in quality of care issues for the Winkler County Memorial Hospital where both she and Dr. Arafiles worked.

The case is being followed closely by the Texas Nurses Association, which raised money for the defense of Ms. Mitchell. Click here for case updates.

When the indictment was first reported last summer against Ms. Mitchell and a second nurse (whose charges were recently dropped by the local prosecutor), the American Nurses Association also spoke out strongly.

“ANA wants Winkler County to know the world is watching – we will be monitoring this case closely in the hope that the apparent abuse of prosecutorial discretion will be corrected,” said ANA President Rebecca M. Patton, MSN, RN, CNOR. “It is outrageous to file criminal felony charges against these nurses based on allegations that they raised concerns over a physician’s actions. This undermines one of the basic tenets of the nurse’s Code of Ethics – nurses have a duty to advocate for the health and safety of their patients, and that is what these nurses were doing.”

The New York Times detailed Ms. Mitchell's concerns with Dr. Arafiles' practices in a recent article by Kevin Sack, which also discusses the bigger picture for quality of medical care.

Nurses are traditionally seen as patient safety advocates. That role needs to be nourished, not threatened, for the sake of all patients.

The best measure for understanding what Americans spend on health care is the health care share of GDP (Gross Domestic Production). When that share crossed the 10 percent thershold in the early 1980s, plenty of economists sounded the alarm that ruin was ahead if we couldn't somehow make that share stable, so the rise in health care spending kept pace with the economy but didn't take a bigger and bigger piece of the pie.

So how are we doing? Health care's share of the economic pie went up to 17.3 percent of GDP in 2009, according to a new report in the respected journal Health Affairs. It's the biggest single-year increase since 1960.

The Wall Street Journal's Health Blog crunched some numbers and reported:

The U.S. spent $2.472 trillion on health care last year, according to a paper out today in the journal Health Affairs. That’s $282 million an hour.

Health spending as a percent of GDP — a key metric that shows how much of all U.S. spending goes to health care — rose from 16.2% in 2008 to 17.3% in 2009, far higher than any other industrialized country. That’s the largest one-year increase since 1960, when the feds started closely tracking national health expenditures.

The figure went up so much because health spending continued to rise, even as the overall economy shrank. The aging population accounted for a small part of this rise, but two other factors were more important: rising prices and increasing use. Health-care prices rose by 3.2% in 2009, according to the Health Affairs paper, significantly faster than prices rose for the overall economy. Utilization, which includes both volume and intensity of health-care services, rose by 1.5%.

The share of health-care spending paid for by the government (through programs such as Medicare and Medicaid) is also rising, and is projected to cross the 50% threshold soon.

The share of the economy for health care will be close to 20 percent within the next 10 years, according to government forecasters.

These sobering numbers show the urgency of "bending the cost curve down," as the pundits like to say. Unfortunately the urgency of reforming the safety and quality of health care has taken a far back seat to the money discussion. They actually are compatible goals. One thing we've learned in the health care reform debate is the huge overspending in health care caused by widespread use of new technologies before their benefit is proven, driven in part by conflicts of interest by those pushing the new technologies.

Measured by results -- preventable deaths and injuries due to malpractice, medical errors, preventable infections, misdiagnosis and other events that shouldn't happen -- American health care has a lot of problems. Millions of patients are injured every year, and upwards of 200,000 patients die annually from preventable errors and hospital-acquired infections. The United States also lags far behind other developed countries in basic health outcome measures like life expectancy and infant death rates.

But when U.S. hospitals measure themselves with a different yardstick -- the "process" measures of how often certain important things get done for commonly treated diseases -- the results are astoundingly good. An annual report from the Joint Commission, the agency that inspects and accredits hospitals, finds steady improvement in the "process" quality measures that it looks at -- with most hospitals now performing in the 99% range on things like how often heart attack patients get standard treatments in the ER like aspirin and beta-blocker drugs.

The Joint Commission now measures 31 quality indicators. They cover the most common hospitalizable conditions: heart attack, heart failure (when the pump isn't pumping effectively), pneumonia, surgical care, and children's asthma. You can go to this website to look up information about a particular hospital.

The problems with the report are:

* Data is reported voluntarily by the hospitals, with no independent audit from anyone other than the Joint Commission. The Joint Commission says it's independent from the hospital industry but is often seen by critics as a cheerleader.

* Outcome measures -- deaths and injuries -- are not included in the report. Even infection rates, which could have required reports if Congress ever passes health care reform, are not yet reported.

Consumers Union has a Safe Patients Project. CU says it's high time for the U.S. health care industry to be required to report its results. Patient advocates like me agree wholeheartedly.

The deadly MRSA infection, estimated to kill 19,000 Americans every year (more than the toll from AIDS), has been virtually wiped out in Norway, with three simple steps:

As described in a recent Associated Press article:

Norway's model is surprisingly straightforward.

-- Norwegian doctors prescribe fewer antibiotics than any other country, so people do not have a chance to develop resistance to them.

-- Patients with MRSA are isolated and medical staff who test positive stay at home.

-- Doctors track each case of MRSA by its individual strain, interviewing patients about where they've been and who they've been with, testing anyone who has been in contact with them.

Step No. 1, ratcheting back on antibiotic prescriptions and relying more on the old tried-and-true ones, won't go over well in America, where the prescription drug industry pushes all of us into a newer-is-better and more-is-better approach.

But step No. 2 -- test and isolate -- has been proven to work by itself to virtually wipe out the spread of MRSA once it gets into a hospital, by isolating people who are carriers.

The problem is that people can carry the bug on their skin without harm; a deadly infection only happens when it gets into the body of an already vulnerable patient. The answer: do nasal swabs of all incoming patients when admitted to the hospital to see if they are carriers, and if so, isolate them in special units.

Does your hospital do this? If not, you should ask why not. The safest hospitals in the United States do nasal swabs of all incoming patients at the time of admission. It's for their safety and everyone else's.

Actor James Woods' brother Michael died of a heart attack three years ago in an emergency room hallway in Rhode Island because no one was paying attention. Now, something good will come from Michael Woods' death, thanks to a settlement reached between the Woods family and Kent Hospital in the middle of a jury trial.

The settlement creates a new institute to help teach hospital staff how to pay better attention to patients and develop a more "human-centered" standard of care.

An impasse between the two sides in the trial was broken when the president of the hospital, Sandra Coletta, called James Woods the night before the actor was going to testify about his brother's death. As reported in the Providence Journal:

In that call, he said he heard something he’d never heard from Kent Hospital before, someone saying she was sorry for his family’s loss. ... Woods said the family’s peace of mind about the agreement was helped when Coletta met his mother, Martha.

“Sandra and my mother had a very personal moment, a mother-to-mother conversation,” Woods said, calling it a “sweet and dear way to express sorrow.”

“It was all I ever needed to see in my life,” Woods said, “one human being saying to another human being ‘I’m sorry for your loss.’ ”

In announcing the new Michael J. Woods Institute, which will be funded by $1.25 million of the hospital's money, hospital president Coletta said:

"We know we're not perfect at Kent Hospital. Mistakes were made. We can do better. The Michael J. Woods Institute will help establish a leadership role in promoting patient safety and developing new ways to improve the patient experience and clinical outcomes."

This is one often-overlooked benefit of the civil justice system: producing positive safety reforms to try to reduce the toll of medical error. An actor's celebrity helped make that a reality in Rhode Island. On a quieter level, similar positive events happen at the end of many lawsuits, where families who have lost a loved one insist that part of the settlement go toward education and system reforms to make hospitals safer places. Patient safety advocates like me believe this is one of our highest callings.

How is our medical care system like American agriculture before the era of modern food-growing practices? Pretty similar, argues Dr. Atul Gawande in the New Yorker. Both were expensive, wasteful of human resources and completely fragmented. And the cures for their problems could be similar too.

What reformed American farming and turned it into a world leader in producing low-cost food was the "extension" system that the government set up for teaching farmers, one county at a time, what worked and what didn't work.

Dr. Gawande argues that the 2,000-page health care reform bill now in Congress has an optimistic prospect for using many pilot projects in funding health care to figure out what works to lower costs and increase safety and quality. It's a fascinating argument, and I hope he is right.

I only differ from Gawande on one thing: he takes swipes at malpractice attorneys and the lawsuit system as contributing to the waste. That has not been borne out by careful studies. Moreover, patients need a robust system of advocacy for when preventable injuries have occurred. So far, no better system has been developed for getting to the bottom of what happened, to try to prevent it from happening again, and to give the patient fair compensation.

A piece by a doctor in Salon.com puts the lie to claims from the medical industry that a dose of "tort reform" to curb medical malpractice lawsuits will lower medical costs and make for safer health care. Quite the opposite, as pediatrician Rahul K. Parikh, M.D. explains. Two short excerpts below from his article, which is worth reading in its entirety:

Their refrain [of the AMA leaders] is familiar to anybody following the healthcare reform debate. The only problem is that it's not true. There's nothing "sure or quick" about changing medical liability laws that will improve healthcare or its costs. Defensive medicine adds very little to healthcare's price tag, and rising malpractice premiums have had very little impact on access to care.

...

Tort reformers neglect the fact that malpractice reform won't save one extra life. To make that difference, insurers, doctors and their lobbyists like the AMA need to find ways to improve patient safety. So for those who push tort reform as a panacea for a sick healthcare system, working to prevent injuries is a much more noble pursuit than writing up baseless arguments for the back pages of a newspaper [in this case, the Wall Street Journal].