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Large malpractice, fraud verdict against hospital, doctor

2012-02-02T20:02:00Z

A jury acted decidedly in a recent medical malpractice case concerning botched weight-loss surgery in a Jacksonville, Florida, hospital.

The hospital's prepared statement that, "We provide excellent care and are committed to the quality care we provide our patients" was clearly at odds with the evidence presented during trial. The jury was clearly swayed by the facts that emerged and made its view manifestly apparent by awarding the plaintiff a $178 million judgment against the hospital and a physician, one of the largest malpractice verdicts ever in the region.

]]> The gastric bypass surgery performed at Memorial Hospital was fraught with irregularities and complications. For starters, the surgeon lacked the proper credentials to perform it, which resulted in a jury finding of fraud and misrepresentation by the hospital. Second, and although the hospital and a number of surgeons marketed themselves as a team, evidence emerged to indicate that patients signed documents following their surgeries that denied any connection between the facility and the surgeons. This was read as an attempt by the hospital to deny responsibility for any surgery that went wrong.

In the plaintiff's case, the jury found that sloppy post-operative follow-up treatment and misdiagnoses directly caused the patient to suffer from sharply adverse consequences, including near blindness and an inability to speak.

The jury first found the hospital and doctor liable for $168 million in compensatory damages. Jury members subsequently tacked on an additional $10 million in punitive damages.

Source: The Tennessean, "HCA hospital loses $178M judgment in Fla. negligence case" Getahn Ward, Jan. 24, 2012

Feds: Pharmacies picked up, resold drugs to nursing home patients

2012-01-31T20:02:00Z

The term "double dipping" is commonly used in the context of extortion and other white collar crimes. Less seldom is it seen in regard to pharmacies.

That practice, though, is exactly what several pharmacies in the metropolitan Seattle area are being accused of by the Food and Drug Administration. Specifically, FDA investigators say that, until the agency's probe put a stop to it, the pharmacies were picking up unused drugs from various nursing homes around the area -- many of those drugs having been collected on behalf of patients who had already died -- and then reselling them to patients in other homes without their knowledge.

Those drugs were repacked and sold as new products. Aside from obvious issues concerning potential errors in medication (the FDA stating that such drugs could easily have been tampered with, stored improperly or even have expired), investigators say that the practice is a clear violation of multiple laws and regulations, and the FDA's criminal investigation division is intent on following through aggressively on the matter.

]]> 'Why would you?" asked one inspector. "Not only does this potentially place the patient at risk, but this type of activity places both the repacking pharmacist and the pharmacy in violation of state and federal laws."

Several pharmacy owners are also stated to have refilled prescriptions on their own volition, without any doctor's order to do so.

Investigators raided several pharmacies earlier this month. The probe is ongoing, with no charges having yet been filed in the case.

Source: Seattle Post Intelligencer, "Feds: Pharmacies gave 'used' drugs to W. Washington nursing homes" Levi Pulkkinen, Jan. 25, 2012

J&J in hot water -- again -- for selling unapproved medical devices

2012-01-26T20:04:00Z

Johnson & Johnson (J&J) is the largest pharmaceutical company and medical device maker in the world, with drug and equipment sales made across the globe that reap the company billions of dollars in profits annually.

Sometimes, though, and especially regarding its relationship with U.S. federal regulators, J&J appears to be more like a kid in school who is constantly caught and reprimanded by the teacher for cheating and taking unapproved shortcuts.

That can -- and has -- led to mass litigation concerning medical malpractice against the company and doctors that use its products, in a number of instances.

]]> Readers might well remember some of J&J's recent woes. A manufacturing plant run by one of its subsidiaries -- McNeil Consumer Healthcare -- was closed outright by the FDA last year for irregularities regarding Tylenol products.

And then there is, of course, the celebrated DePuy hip-replacement litigation. J&J's product -- the ASR XL Acetabular Hip Replacement System -- has been found to be defective and resulted in thousands of patients suffering undue pain and subsequent surgeries.

And now DePuy is yet further embroiled in problems with government regulators for its failure to obtain the requisite approval on more than a dozen products it markets in the United States.

The FDA has just sent a warning letter to J&J concerning that, stating that the company did not get pre-market clearance on 14 orthopaedic devices it makes, primarily knee- and hip-system replacements.

Johnson & Johnson says it didn't require approval, because the products were custom devices made for particular patients.

The FDA rejects that claim out of hand, noting that the products could easily be sold to any physician. Moreover, the agency contends that J&J has failed dismally in complying with quality-control regulations concerning the products or implementing any system to review user complaints.

A J&J spokesperson says that the company 'has responded to all concerns raised in the Warning Letter."

Source: Asbury Park Press, "FDA says Johnson & Johnson subsidiary DePuy sold orthopaedic devices without approval" Jan. 18, 2012

Medical commentator: Doctors, apologize for medical mistakes

2012-01-24T20:04:00Z

Say that you're a doctor who is concerned about the repercussions of a medical malpractice error -- both in human and economic terms -- and wondering what to do about it.

Here's some solid advice: Think hard before meekly following the dictate of your insurance company, which is likely telling you to keep mum about the matter and avoid any personal discussion with the patient or the patient's family.

Try this instead: Own up and apologize.

]]> Although that might seem a bit radical, one practicing physician and member of USA TODAY's Board of Contributors says that it is precisely what needs to be done in more instances, both to avoid litigation and to improve the quality of medical care.

In fact, Kevin Pho is quite blunt concerning the matter. "Physicians should disclose their mistake," he says, "apologize and, when appropriate and through mutual agreement, compensate injured patients."

And that act -- one of contrition that fosters trust, seeks to explain and helps patients feel respected and even empowered -- should be adopted nationwide, with a law in all states that bars doctors' apologies from being used against them in court.

Not every bad patient outcome owes to medical error. Those that do, of course, justifiably end up in a court of law, with recompense to the victim being both fair and necessary. But those that don't are often more easily noted and dealt with by all parties involved through candor and open lines of communication.

There is strong and confirming evidence that only in a very few cases do patients bring malpractice claims that lack merit. In cases where a doctor is honest and open with a patient and the latter can see that an outcome did not owe to the doctor's mistake, litigation can often be avoided.

And that, in turn, can lead to systemically better medical treatment, says Pho.

"There's no panacea for eliminating mistakes, but a starting point is clearly communication," he says.

Source: USA TODAY, "Column: How doctors can reduce medical errors, lawsuits" Kevin Pho, Jan. 18, 2012

AMA report: Electronic patient records "linked to errors and harm"

2012-01-20T19:02:00Z

Although researchers involved with a recently issued report by the American Medical Association (AMA) focusing upon electronic health records (EHRs) say that they take no official position one way or the other on EHRs, their report manifestly indicates a number of wide-ranging problems with the evolving hospital technology.

Is it glass half full or half empty concerning the nexus between EHR systems and patient harm? In other words, are the relatively new systems being implemented at a constant pace in hospitals and clinics across the country improving patient safety or, in some cases, actually undermining it by precipitating or contributing to acts of medical malpractice and hospital negligence?

]]> The report cites a litany of broad-based problems that have accompanied the emergence of EHR systems, including these: poorly designed systems with software that is far from user friendly; a data-entry process that encourages copying and pasting data and that contributes to what researchers call "automatic behavior" rather than meaningful analysis; and assorted problems that result in "generating new types of errors."

In fact, says Dr. David Classen, a consultant on the AMA report, "There is still very limited evidence that EHRs improve the safety of care in the average doctor's office."

Classen adds that, notwithstanding the glitches in EHR processes, electronic patient records are here to stay and that they have special utility in measuring performance in large studies and across voluminous amounts of data.

Much still remains uncertain regarding the future of EHRS, though, in terms of the type and timing of their implementation on a truly comprehensive scale.

As the AMA report notes: "It is not yet clear how many providers will adopt these systems, nor the extent to which health IT will improve patient safety in ambulatory care versus generating new types of errors."

Source: Information Week, "EHRs linked to errors, harm, AMA says" Ken Terry, Jan. 13, 2012

Researchers: Medical study data must be widely, routinely shared

2012-01-18T17:02:00Z

The ability of scientists or research teams to replicate or otherwise test and evaluate the results of scientific studies authored by other parties is critical for a number of reasons.

For starters, alleged truth must be tested and confirmed before it can be universally recognized and applied, in fields ranging from science to medicine. Moreover, errors that are allowed to remain in scientific work because others do not have meaningful access to third-party research bring about danger in real-life contexts.

Consider a study that has implications for spinal cord injuries, anesthesia errors, the misdiagnosis of an illness or some other medical topic of concern. It might have uncovered a revolutionary new truth or, conversely, contain a deadly flaw in its logic, but neither of those outcomes can be known or acted upon in the wider world without complete releasing of the data upon which the work is based that provides for its ready replication.

]]> That, say researchers Victoria Stodden (Columbia University) and Samuel Arbesman (senior scholar at the Ewing Marion Kauffman Foundation), is far from being a common outcome. Scientists frequently do not exchange or publish research results, and that, the researchers state, "is making verification of published findings all but impossible and crating a credibility crisis in computational science."

So, for example, a team of surgeons relying on less-than-detailed knowledge of the work done by researchers at another institution -- even an eminent institution -- could visit serious medical harm upon a patient, because they were not apprised of all the relevant information underlying that research.

Stodden and Arbesman call for stricter transparency requirements in the publishing of scientific findings. In their view, that centrally means letting others know the details related to the findings -- the steps taken, the processes followed, the formulas in play. In other words, share the actual work.

Doing so routinely, they say, will "help ensure that public policy is based on sound science."

Source: Bloomberg, "Scientists, share secrets or lose funding: Stodden and Arbesman" Victoria Stodden and Samuel Arbesman, Jan. 9, 2012

An "Anecdotal Complaint" About An ICU EHR

2012-01-16T14:01:28Z

"An "anecdotal complaint" (see health IT-specific definition of 'anecdotal' at this link) from a practicing medical informaticist on an EMR system being rapidly rolled out - in a neonatal ICU, where a single slip is an ended life or lifelong crippling injury, and a multimillion dollar lawsuit, in the making..."

Read full blog at An "Anecdotal Complaint" About An ICU EHR

Federal judge rules VA hospital negligence in veteran's lawsuit

2012-01-12T21:02:00Z

The argument made by government attorneys recently in a medical malpractice lawsuit brought against the Veterans Administration alleging negligent treatment of infection apparently struck the judge as being patently unpersuasive and clearly unsupported by striking evidence to the contrary.

]]> The case involved a then-64-year-old man -- a construction manager and former military veteran -- who sought treatment in 2006 at the Memphis Veterans Medical Center for what was ultimately determined to be a colon infection called diverticulitis.

The man came to the hospital's emergency room in great pain, but was not thoroughly examined or treated by doctors.

Instead, he was sent back home, where, a few days later, his colon ruptured. He suffered infection throughout his body.

Defense attorneys argued at trial that the man's actual injuries and damages owing to the infection were not commensurate with his claims, and that he was greatly overstating their extent.

United States District Court Judge Jon McCalla found that claim to be eminently underwhelming and awarded the Vietnam-era combat veteran $5.7 million in damages for what he deemed the facility's negligent medical treatment.

The veteran's ruptured colon resulted in his need to undergo additional surgeries. He also lost several toes due to the development of gangrene, and his attorneys noted that he is in a permanently weakened condition and in chronic pain.

The damage award included amounts for pain and suffering, medical care, lost earning capacity and lost future wages, and loss of the man's enjoyment of life.

Source: Memphis Commercial Appeal "Judge awards $5.7 million to veteran in medical negligence case" Lawrence Buser, Jan. 4, 2012

Dismal record in hospitals of noting, reporting patient harm

2012-01-09T20:02:00Z

Federal investigators and a team of independent doctors say that, while the primary reasons for medical facilities' underreporting of medical errors -- including medication errors and hospital-induced infections -- might have changed over the years, the end result is the same: Adverse events are being visited on patients in far too many instances, and medical practice and policy is not being changed to prevent them.

]]> That is the stark and straightforward conclusion of a report just issued by the inspector general's office of the Department of Health and Human Services (DHHS), which relied in turn on the scrutiny of researchers looking at hundreds of cases of Medicare patients being harmed.

Their conclusion: Only one out of seven medical errors suffered by patients ever sees the light of day. As a result of that, patient harms typically occur over and over again. In fact, and according to DHHS Inspector General Daniel R. Levinson, about 130,000 Medicare beneficiaries suffer one or multiple adverse events in medical facilities each month.

Why such an appalling rate? According to the researchers, it owes less to a fear of reporting by hospital employees than it does their failure to recognize what equates to patient harm. Additionally, workers sometimes think that widespread abnormalities are isolated, or that other employees are reporting them, or that an event is so common that it doesn't even qualify for reporting.

Whatever the causes, the situation is untenable, say government regulators. Medicare officials state that they will create and distribute to hospitals a list of "reportable events." They say, too, that hospital administrators must work more closely with their employees, providing them with "detailed, unambiguous instructions on the types of events that should be reported."

Source: New York Times, "Report finds most errors at hospitals go unreported" Robert Pear, Jan. 6, 2012

ER departments: Overcrowding, medical errors, a need for change

2012-01-06T20:02:00Z

It is no secret to many people who have gone to an emergency room for treatment in the past few years that ERs have become increasingly frantic and busy places.

The situation that often prevails in emergency departments -- too many patients, too few beds, insufficient staffing to meet patient needs -- leads to an assortment of negative outcomes, ranging from long waits at one end of the spectrum to errors in prescribed medication, misdiagnosis of illness and surgical errors at the other extreme.

]]> What can be done about that? Emergency rooms are in fact more crowded than ever before. A Philadelphia-based hospital lobbying group states that ER admissions rose in Southeastern Pennsylvania by more than 30 percent over a recent decade. Such increase has occurred at the same time that ERs are closing throughout the country. Estimates are that fully one-fourth of all ERs nationally have closed their doors since 1991.

Increasingly more hospitals are looking hard at things like process and flow -- that is, flowcharts explaining when and why patients are converging on ERs, how to optimally staff for them, and how to best integrate ERs with other departments in a hospital

One finding is that ERs are typically overrun on one or two select days each week, on the days that surgeons come in for scheduled surgeries.

Inefficient scheduling of ER surgeries is a major culprit in creating ER congestion and delays downstream. It needs to be changed, say experts who work at adjusting ER flow to be more rational and economical

Eugene Litvak, a Harvard University professor and former Soviet industrial engineer, works with many hospitals to smooth out their ER flow of patients. Litvak recommends scheduling surgeries throughout the week.

Change will need to come, say ER directors and hospital administrators, despite objections that will certainly come from many ER surgeons and others disinterested in a new model.

The stakes and potential rewards are high. All the outlays associated with adding one hospital bed to an emergency room can add up to $2 million. Litvak says that if all hospitals in New Jersey -- where he has been awarded a grant to study and recommend changes -- adopted his methods, they could save as much as $6 billion a year.

Source: Philadelphia Inquirer, "Engineering a cure for hospital inefficiencies" Mark Taylor, Dec. 30, 2011

Caregivers' "alarm fatigue" dulls effectiveness of heart monitors

2012-01-04T19:02:00Z

Here is a bit of decided irony increasingly playing out in American hospitals: In much the same way that too many vitamins or too much exercise can actually be bad for a person, so, too, can too many heart monitors being routinely hooked up to patients bring about unintended medical harm.

Death, in fact, and in growing numbers. In an interesting twist on medical malpractice, patients are dying because of nurses' and other caregivers' failure to respond to monitors that blare out warnings regarding heart rates, abnormal heart rhythms and other irregularities.

]]> The reason for this growing problem is rather sample. Care providers are becoming desensitized to the alarms, which has led to what medical experts are calling "alarm fatigue."

The bottom line in many hospitals is that far more patients than ever before are being routinely wired to cardiac monitors. The reasons vary, but coalesce around a few standard beliefs, chiefly that monitoring is a noninvasive process that does provide for added safety, that it helps to ease emergency room congestion, and that it frees up nurses to do other things.

The unanticipated side effect is that, with alarms sounding off with regularity, a sense of urgency is sometimes lost. Moreover, as and noted by one professor at the Yale University School of Nursing, "More monitoring means more alarms, and more alarms means more false alarms."

Thus, nurses sometimes believe that an alarm is not signaling anything important when ii fact it is.

It is notable when some medical centers -- such as Tufts Medical Center in Boston -- have monitors installed at every bedside.

There is far from universal agreement with that move. Researchers in a recent NIH study state that more than a quarter of all patients being monitored do not meet the medical criteria for being monitored.

Caregivers rely too often on the monitors "as a kind of babysitter," says the Yale professor. "That's not a good use of a monitor," she adds.

Source: Boston Globe, "Wide heart monitor use tied to missed alarms" Liz Kowalczyk, Dec. 29, 2011

Medical error leads to hepatitis C virus for organ, tissue donees

2011-12-30T19:04:00Z

A misreading of a nucleic acid test performed on a deceased donor's tissue has turned out to be a costly misdiagnosis resulting in at least four instances of donees becoming infected with the hepatitis C virus.

The donor died earlier this year after a motor vehicle accident left him with a fatal traumatic brain injury. His father told medical personnel that his son had no previous involvement with intravenous drugs, but the donor actually turned out to have had a history of substance use.

]]> The man's organs and tissue were tested prior to being transplanted in donees, but the tests were ruled negative. The man's organs were tested for antibodies in the bloodstream that would indicate an infection, while the tissue was subjected to both a blood test and the nucleic acid test.

The misreading of that latter test was not discovered until six months after various persons had received organ transplants and tissue. Those infected with the hepatitis C virus included a 41-year-old male who received an infected kidney; a 46-year-old woman who also received a kidney; a 51-year-old man who received a liver; and a child who received tissue for a cardiopulmonary patch.

Owing to the hepatitis C transmission, a tissue sample from the donor was retested and confirmed to be positive for the virus.

Officials from the Centers for Disease Control note that the case underscores the need for systemic improvements regarding organ and tissue transplants, including, centrally, better communication among all parties involved in transplantation.

Source: Washington Post, "CDC reports hepatitis C transmission via transplants" Jenifer LaRue Huget, Dec. 22, 2011

Researchers using "virtual models" for medical testing

2011-12-28T16:02:00Z

If there is one thing that this blog makes readily clear about the practice of medicine, it is this: Notwithstanding the great advances in medicine and the professionals who practice it, mistakes do occur, for a number of reasons.

Doctors, too, are human, and surgical error is committed many times every day in American hospitals. Illnesses are misdiagnosed, doses and types of medicine are incorrectly prescribed, and wrong body parts are operated upon.

]]> To the profession's great credit, effort has never ceased to improve patient health care and outcomes, and great promise is now being seen in one special and highly singular tool being employed by scientists and medical researchers.

Increasingly, "virtual patients" are being refined and used as computerized models for testing medical devices and procedures, without the obvious downside that is a constant potential for human patients in clinical trials.

Dr. George Xu has been developing and using virtual models for more than two decades, with Karl, described as "a faceless, puffy-colored" prototype, still sitting in his lab. Karl now contrasts mightily to new-generation models that look increasingly like humans, replete with skin, bones, fat and organs that mimic the human body as closely as possible.

Dr. Xu leads a team of experts at Rensselaer Polytechnic Institute in New York. In his lab, and in a few select other labs across the country, researchers expose virtual models to radiation to check for exposure from CT scans. They block blood flow into the heart to test images for detecting and measuring blockages. They use the new technology in conducting cost-benefit analyses, such as measuring the benefits to a mother in getting a CT scan versus potential risks to a fetus.

A central hope in the research is that it might allow doctors and students in the future to train for specific surgical procedures while using real tools and actually seeing and feeling organs that are nearly identical with those in humans.

Source: Wall Street Journal, "Scientists find safer ways to test medical procedures" Dec. 20, 2011

Critics question premise, results of medical work-hour restrictions

2011-12-23T19:04:00Z

The Joint Commission -- an independent and not-for-profit organization that accredits and certifies nearly 20,000 health care institutions across the United States -- is not impressed by the remarks of critics who disagree with its assessment that medical professionals work overly long hours that lead directly to acts of hospital negligence and patient errors.

In fact, the Commission cites to several studies that it states conclusively confirm an error rate three times higher for medical staff members who work shifts exceeding 12.5 hours.

]]> Based on such numbers, the Accreditation Council for Graduate Medical Education (ACGME) has, over a period of several years, progressively introduced rules that limit the hours and shifts that medical residents can work. For example, changes implemented in 2003 provided for a limit of 30 hours for a work shift and 80 hours for a work week.

A main rationale cited for the changes was the need to ensure a safe and smooth transition among medical staff when patients were handed off at the end of a shift.

Many medical professionals take issue with that, and say that imposing duty-hour restrictions -- especially for surgical specialists -- actually results in undermined patient care.

"It puts you on a slippery slope where the commitment to the patient may not be the same," says Christian de Virgilio, MD, a surgery professor at the UCLA School of Medicine.

The argument often made by critics is that patients with serious medical conditions are not optimally placed to be simply handed off from one person to another at specified times. A condition might be especially acute, or a patient unstable, at shift's end.

Says Virgilio: "If I were the patient, I would want the person who did the operation on me, who knows the details of my care, be the one taking care of me in a critical condition."

Practitioners of many surgical subspecialties also contend the that ACGME restrictions undercut and compromise resident training that steels doctors to perform at a high level even over many consecutive hours of work

Source: Medscape News, "Joint Commission recommendations address extended-shift fatigue" Nancy A. Melville, Dec. 14, 2011

Distracted doctoring increases medical harm and patient risks

2011-12-21T21:02:00Z

A phenomenon called "distracted doctoring" is alarming a growing number of doctors and hospitals for its propensity to result in medical errors and even outright instances of medical malpractice, as some physicians are becoming fixated more on the technological devices in front of them than they are on their patients.

]]> The underlying impetus for introducing ever more technology into clinics and hospitals is not objectionable in itself and, in fact, has been lauded for its ability to help medical professionals minimize patient errors and other mistakes.

The problem is with the unintended and largely unforeseen side effects, namely, that the professionals themselves are on occasion falling under the spell of the devices they are supposed to use as aids in treating their patients.

"You walk around the hospital, and what you see is not funny," says the director of care at one New York hospital. He states that he has observed doctors and other medical staff members focusing closely on their laptop computers, smartphones and other devices when they should be paying attention to their patients.

"My gut feeling is lives are in danger," he says, adding that, "We're not educating people about the problem, and it's getting worse."

That begs the question of how bad it is actually getting. One recent peer-review survey of more than 400 technicians who monitor bypass surgery found that about half of them admit to talking on cell phones or texting during surgery.

Many physicians and medical doctors readily concede a great worth in the ability of new technologies to reduce medical risks.

"But the last thing we want to see, and what is happening in some cases now, is the computer coming between the patient and his doctor," says Dr. Charles G. Prober, a dean at Stanford Medical School.

Source: New York Times, "As doctors use more devices, potential for distraction grows" Matt Richtel, Dec. 14, 2011