Vol. 11, No. 2,553 - The American Reporter - January 5, 2005

First Person

by Dan Walter
American Reporter Correspondent

ANNAPOLIS, Md. - I have been reading recent stories about malpractice problems at Johns Hopkins Hospital with great interest. I took my wife there for a relatively low-risk procedure two years ago and through a series of astonishing mishaps, she almost died. Since then, I've spent a lot of time trying to figure out how such things can happen in one of the best medical facilities in the world.

On Feb. 24 of this year, on the same day Hopkins settled a lawsuit in the death of two-year-old Brianna Cohen, the Maryland Office of Health Care Quality issued a report citing numerous safety lapses at the Johns Hopkins Home Care Group. The report concluded that Brianna Cohen died because an unqualified pharmacist supplied a deadly intravenous solution.

Another case involved a seven-month-old who went into a coma after she was given the wrong formula. Last month a patient sued Hopkins because an intern cut an artery in her neck and then fled the room at the sight of blood. Other cases in the past few years include two deaths from contaminated bronchoscopes, two children getting overdoses of chemotherapy, and a volunteer who died in an asthma study.

Then there's U.S. News and World Report naming Johns Hopkins "The Best Hospital in America" for the 13th consecutive year. After what we went through there, I contacted the person at U.S. News who makes these decisions and asked him how he arrived at such a conclusion. He described a fair and analytical process, then added, "For what it's worth - very little to patients and their families who have had bad experiences - there isn't a hospital in the country that hasn't screwed up and/or treated patients callously."

True enough.

When Johns Hopkins Hospital is named "Hospital of the Year" by U.S. News, the hospital's P.R. staff enlarges a copy of the magazine's cover to the size of a movie poster, which is then proudly displayed in the main corridor along with U.S. News covers from previous years. It gives a prospective patient a lot of comfort to walk by all those declarations of excellence.

My wife and I felt reassured. I took her there for a procedure to treat irregular heartbeats. Called a pulmonary vein ablation, it involves maneuvering a catheter through a vein and then up inside the heart chamber.

We were told it was a relatively new procedure, and that there were risks involved. But the risks were minimal, they said, and my wife was in the best of hands. They had done plenty of these and we had every reason to feel confident. (I later discovered that New York's Cornell Medical Center still considers pulmonary vein ablation to be an investigational procedure.)

We were told what to expect through the entire process and given glossy brochures that described the procedure. There was a picture of a woman who'd just undergone one; she was recovering in a pleasant room, smiling and watching television.

Administration at Hopkins is very efficient. We were told to show up very early in the morning. It was still dark outside when my wife was admitted. She was given an admission bracelet and put in a wheel chair. We were briskly processed through various checkpoints, filled out forms and answered questions.

The next to last stop was a brightly-lit cubicle. It was here, under harsh lights in the early morning hours, that my wife and I were handed clipboards with pages and pages of very fine print to sign and initial - routine documents, we were assured. And then, whoosh, she was gone behind the double swinging doors. It looks to me now as if we signed papers stipulating that if anything went wrong it would be our fault.

To his credit, the doctor was very forthcoming later about what happened. While the tip of the catheter was inside my wife's heart, he'd turned away momentarily. Basically, there was a fish hook floating around inside my wife's beating heart, and no one was watching. The tip of the catheter got sucked into her mitral valve apparatus, a complex web of muscle which resembles parachute strings, and with every beat of her heart the little hook became more and more entangled.

Printed in bold letters on the carton for the BiosenseWebster Mapping Lasso Catheter the doctors were using, there is this warning: "Careful catheter manipulation must be performed in order to avoid cardiac damage ... it is contraindicated for the catheter to be in the left ventricle ... do not pull on catheter if resistance is encountered... ."

Another doctor was called in to help. He pulled on the catheter. It sliced through the muscles that open and close the valve. Her valve was "in complete flail," as they described it, and her heart not pumping much blood at all. They had to wait several hours for her to come out of sedation to get her permission to put her under again, crack open her chest and install a new man-made mitral valve.

I will never forget the look on my wife's face when she came out of the first procedure. Insteady of leaving the hospital, I had to tell her that not only had the procedure failed, but her mitral valve was destroyed in the process and they were going to have to open her up and operate on her heart to replace the mitral valve.

At first, she couldn't believe it. It took me a while to convince her that it was true. Surgeons came in and told her that while this was an elective procedure, if she didn't have it done right away, she would die.

After the operation to insert the valve, the doctors were anxious to get her up and about. A little too anxious, as it turned out, because she wasn't ready to be weaned off of life support. So, when she started to die again from acute congestive heart failure, they had to re-intubate her and place her back on life support, a mechanical ventilator. It is an extremely difficult thing to have a breathing tube shoved down one's throat - difficult to undergo, and difficult to watch.

She ran a fever, had a stroke and went into a coma. She spent three weeks in the Intensive Care Unit. I repeatedly asked the nurses if her eyes should be treated somehow, because she could not blink, and stared vacantly at the harsh overhead lights for hours at a time. I was told to not worry. The result was scratched corneas from a syndrome called Exposure Keratopathy, a condition the eye experts at Hopkins' Wilmer Institute later shrugged off as being something they "see a lot of " in the ICU.

As she came out of the coma, there were long stretches of time when she was drugged, scared and disoriented. She was agitated and thrashed about. The nurses tied her to the bed. Her right elbow rested on the bed rail for so long that it damaged a nerve in her arm. For months afterward her right hand felt as if it were on fire and she still cannot fully use it.

One morning I went into her room very early. She had been semi-conscious for days. The nurse said that she'd had a difficult night and was very restless. While straightening out her bed sheets, I found the reason she was "restless." I felt under her back and found a pair of curved forceps was she had apparently been laying on through the night.

Of course, the people who work at the hospital try their best to prevent such things, and despite the pressure and hardships they generally do. Most hospital administrations are usually vigilant and looking for ways to improve their system.

Studies were commissioned, surveys were done. One team of Hopkins researchers who were studying ways to better the odds for intensive care patients recently came out with revolutionary new findings. They determined that patients have a better chance of surviving the ICU if doctors and nurses and everyone else involved communicate and set specific goals for each patient's recovery.

I think those guys are onto something. Soon after surgeons had permanently removed my wife's pacemaker during the open-heart surgery to replace the the destroyed valve, a man in scrubs came in the room and began moving her bed sheets around and pulling on wires. The nurse and I looked at each other. I asked him who he was, but he ignored me and kept poking around. The nurse became alarmed and demanded to know who he was and what he was doing. He was there, he said, to adjust the settings on her pacemaker.

Last year a Hopkins resident complained that the hospital was pushing him to work more than 80 hours a week, violating new rules designed to promote patient safety. The hospital lost medical school accreditation over it for a time.

The resident, I can assure you, was right to complain. During my wife's stay, the doctor in charge was a hard person to find. When I finally spoke to the frazzled and obviously overworked resident about my wife's deteriorating condition, he told me, more or less, that he was a very busy guy with lots of very sick patients, and he had a family, too.

I went to the chief surgeon's office. I waited a long time in his outer office while he wooed a financial donor. Finally I was granted an audience. I told him that if my wife were to die, it wouldn't be good for anybody and he'd better get down there and fix it. He did.

The Big Guy himself glided down the gleaming escalators from the world of oak paneling and strode the halls to the ICU. The staff was all abuzz. The man in charge had made a rare appearance. My wife's care immediately improved.

But I firmly believe that if her family had not been there to insist on proper care, my wife would be either dead or the next thing to it in a long-term nursing facility. As it is, she has loss of equilibrium, short-term memory deficits and general cognitive problems.

Before her stay at Hopkins, she was a relatively healthy R.N. and entrepreneur who ran two businesses. Post-Hopkins, she can neither run a business nor practice nursing and has been officially classified by the Social Security Administration as disabled.

Under the large ugly scar on her chest, a titanium valve can be heard clicking away. The prosthetic valve means that she must take warfarin - a blood thinner - for the rest of her life, and, according to a well-known pharmacologist, "patients who take warfarin walk a tightrope between bleeding and clotting, and a hundred things can tip the balance; it's a difficult drug to use". She still suffers from the irregular heartbeat that brought her to Hopkins in the first place.

The hospital's view is that the damage my wife suffered is the result of "previously unreported complications". Oddly, I have found three previous reports of this "previously unreported complication," that is, a catheter tip becoming entangled in a mitral valve apparatus.

The earliest report I found dates back to 1994. The hospital maintains that what happened to my wife did not violate their "standard of care." We are left to assume, then, that the standard of care at Hopkins rises to the level of a drawn-out, agonizing, near-death experience that leaves one disabled.

In a new book, "Internal Bleeding: The Truth Behind America's Terrifying Epidemic of Medical Mistakes," Robert M. Wachter, MD, Chief of the Medical Service at the University of California at San Francisco Medical Center, ascribes such mistakes to "an epidemic of medical progress - the technology is miraculous, but we have outstripped our ability to deliver it safely."

I believe my wife's misfortune fits that category. I traced the technological development of devices used to treat arrhythmia and began to understand the amount of trial-and-error involved. It was kind of a startling realization for a layman. Reading the journals and case studies, I usually skipped to the section on risks and complications.

Although the doctors had learned much and helped many people, there were always a few patients who had complications. One died, two had strokes, one had damage to the heart structure, and so on. In the next round of clinical trials, the physicians can to try to avoid these complications.

It is the learning curve for the procedure, and generally it means medical progress. But that's little consolation to patients like my wife who wind up as footnotes at the bottom of a clinical journal. You start to feel like a guinea pig. I

n her case, the evolving technology is a mapping catheter. It is used to determine the origination point of improper electrical impulses in certain sections of the heart chamber. Improved versions of the device are continually introduced. Electrophysiologists from around the world gather at conferences every year to report how this or that procedure or device is working.

In 2000, the FDA approved a new type of catheter developed by a division of Johnson & Johnson, a Decapolar Lasso Catheter. As the name implies, there is a loop at the end. The new version has 10 sensors located on the loop. Ideally, the loop can be placed in the area where the pulmonary vein opens into the heart chamber. The flexible loop is designed to straighten when it's pulled back into the sheath that delivers it into the heart.

In my wife's case, the loop got tangled in a complex set of muscles that operate the mitral valve. When the doctor pulled on it, it did not straighten and glide neatly back into its sheath as it should have. When significant force was applied, it sliced right through the muscles. Things went downhill from there.

Knowing little and expecting much from modern technology, I assumed the operator of the catheter would have a clear view of precisely where the catheter tip is at all times. I imagined some sort of high-resolution video image. But they use is fluoroscopy, and the images resemble the colorful Doppler radar splashes you see on tv when a weatherman is talking about severe thunderstorms.

With cloudy vision like that, it seems to me you'd need lots of skill and have to be mighty careful when maneuvering a tiny wire inside a beating heart. Yet, one electrophysiologist told me, in essence they are almost flying blind, feeling their way around. They're able to do it, though - most of the time.

As far as technology outstripping the ability to deliver it safely, it appears to me that in my wife's case there was a "leapfrog effect" which caused the doctors to implement one advance in technology without a corresponding advance in imaging technology.

The American College of Cardiology and American Heart Association issues "Clinical Competence Statements" for various procedures. There is a telling sentence in its statement on invasive electrophysiology studies, catheter ablation, and cardioversion:

"Some Technical Skills Needed : Knowledge of potential complications and management of such complications. Manual dexterity to safely place and manipulate electrode catheters in the appropriate chambers for the arrhythmia under study.... In any event, it remains increasingly critical that the practicing physician acquire and maintain an understanding of relevant first principles of electrophysiology. Although it is exciting, it should be kept in mind that the technology facilitates the application of those fundamental principles of electrophysiology only for the benefit of arrhythmia patients."

"Exciting," indeed.

One last newspaper story about Hopkins: Years ago a doctor there wrote an article about what to do when medical errors are made. His said his hospital should come clean right away, admit its errors and offer to compensate the victim.

Besides being the right thing to do, he wrote, it would ultimately cut down on malpractice payments because victims and their relatives are not immediately thrust into an adversarial role, with all the attendant bad feelings and personal-injury attorney fees. Plaintiff's attorney fees can be anywhere from one-third to one-half of a settlement.

High-profile cases such as the death of a child are generally settled quickly and quietly for unknown sums, but most cases take years to resolve. The head risk manager (i.e., defense lawyer) at Johns Hopkins, Richard Kidwell, wrote an article entitled "The Malpractice Lottery" for an in-house newsletter that claimed "once people see juries making the big awards to patients, the number of claims often increases. It's like the theory of sharks being attracted to blood in water."

My wife doesn't feel like she won the lottery.

When these things were happening to her, I told administrators that I couldn't afford to fly relatives in from around the country, and did not have the money to put them or myself up in local hotels for the duration.

I was told that the hospital's "risk managers" would not allow any such disbursements because it might indicate some sort of culpability in the unfolding tragedy.

The best they could do was validate parking and offer me a voucher for a free cup of coffee[, adding] insult to injury from "America's Best Hospital." Dan Walter is a writer living in the Annapolis area. There is no malpractice suit pending in this case. He can be contacted at DanWalter@annapolis.net

Copyright 2005 Joe Shea The American Reporter. All Rights Reserved.