Posts Tagged ‘standard of care’

The Unexpected Killers: Hospital-Acquired Infections

February 24, 2010

According to an article published by NPR, a recent study found that as many as 48,000 people die each year in the U.S. from hospital-acquired infections. Researchers say that this is the first truly national study of its kind, involving 69 million cases of hospital-acquired infections in 40 states.

This study, unlike its predecessors, specifically isolated cases of hospital-acquired infections from cases involving patients  with possible existing infections at the time of admission. In part, this was accomplished by focusing on patients admitted to undergo elective surgery.

The researchers found the death toll from avoidable pneumonia and sepsis is bigger than from traffic fatalities. It’s more than three times higher than that for AIDS, and roughly twice as much as annual deaths from firearms.

Examples of hospital-acquired infections include: pneumonia, sepsis (infection of the blood), urinary tract infections, gastroenteritis, clostridium difficile (c-diff), tuberculosis, and staphylococcus-related infections.

Most hospital-acquired infections can be effectively treated with the proper choice of antibiotics.  There is simply no justification for such an incredibly high mortality rate  to be associated with a series of preventable and treatable medical conditions. For this reason, the results of the study are truly disturbing.

Contributing author: Jon Stefanuca

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Tort Reform – Tennessee Style: ER doctors back bill ‘redefining’ malpractice – NO KIDDING!

February 21, 2010

As I was going through the listings and hashtags on my TweetDeck yesterday, I came across this tweet from a report in a Tennessee online publication – Emergency doctors back bill redefining malpractice | tennessean.com | The Tennessean. While I don’t practice in Tennessee, any trend in legislative changes affecting a patient’s right of access to the legal system is on my watch list.  

Here’s the essence of the proposed legislation according to this article:

Under the bill filed last month, the definition of medical malpractice would be changed from “negligence” to “gross negligence,” which would raise the bar for mistakes that could trigger a lawsuit.

To put this in context, Maryland and the District of Columbia, where I am licensed to practice, have many times defined “gross negligence.”  Those definitions are precisely what caused a chill to run up and down my spine when I saw the proposed change to Tennessee’s malpractice law.

In Maryland there is legislation called the Good Samaritan Act and the Fire and Rescue Company Act, which essentially provides in relevant part that in an emergency setting, only extraordinary or outrageous conduct by a person giving assistance or medical care in an emergency, or by a member of a fire company or rescue company, can be termed “gross negligence.”  For the lawyers among you, see, e.g. McCoy v Hatmaker, 763 A2d 1233 (2000).

In the District of Columbia, one case that gives multiple but somewhat common definitions for  ‘gross negligence is D.C. v Walker, 689 A2d 40 (D.C. 1997):

[Gross negligence is] [t]he failure to exercise even slight care,” and “such negligence as would shock fair-minded men.”Shea v. Fridley, 123 A.2d 358, 363 (D.C.1956).  Similarly, the United States Court of Appeals for this circuit has stated that “gross negligence implies an ‘extreme departure from the ordinary standard of care.’ ” Wager v. Pro, 195 U.S.App. D.C. 423, 428, 603 F.2d 1005, 1010 (1979).  We have applied Maryland law to define gross negligence in the driving context as “a wanton or reckless disregard for human life or for the rights of others,” and “indifference to the consequences … [which] implies malice and evil intention.” Hall v. Hague, 257 A.2d 221, 223 (D.C.1969).  * * * And our federal court of appeals, applying what it apparently perceived to be District law, has said that, “[t]o constitute willful or wanton negligence, the police actions must involve ‘such reckless disregard of security and right as to imply bad faith.’ ”      

And just what is the alleged justification for this ‘gross negligence’ in ER’s standard being proposed?  Well here you go:

“In my personal practice, if I knew that I couldn’t be sued except for things that I truly believe I should get sued over, I could eliminate half of my lab tests, two-thirds of my X-rays and 90 percent of my CT scans because all of those tests are done for my protection, not the patient’s,” said Dr. Andy Walker, a local emergency physician and vice president of the Tennessee chapter of the American Academy of Emergency Medicine. “For TennCare patients, of course, the Tennessee taxpayer is paying for that.”

Yeah – that’s my emphasis added to the above quote.  Is this doctor kidding?  He does twice the number of labs, three times the number of x-rays and ninety percent of the CT scans he orders – to protect himself, not the patient?  And his litmus test for getting sued is what?  – “… things that I truly believe I should get sued over.”  Maybe when the Senate Committee is done investigating the ‘stents controversy’ at St. Joseph Medical Center in Maryland, they can take a look at what’s going on in Tennessee!

Using this wonderful test – “I should only get sued for what I believe is malpractice” – I am pretty confident that  there won’t be much medical malpractice litigation concerning ER care in the state of Tennessee should this wonderful piece of legislation go through.

Perhaps I should also make you aware that there is also pending in the legislature of this state a cap on non-economic damages.   If you are wondering at what amount they want such damages capped – it’s $1,000,000.  Apparently, however, the lobbyists for the medical profession really would like to see such damages capped at $300,000 since they believe such a low figure would “take away the profit motive of trial lawyers.”

I wonder if this double-pronged legislative initiative isn’t a variant on the old shell game.  Throw enough legislation out there and negotiate to get at least one of them passed.

Tell you what – I won’t be moving our firm to Tennessee any time soon.

FDA and International Serious Adverse Events Consortium Complete Third Data Release

February 20, 2010

Do you know what ‘adverse event reporting’ is all about?  Well, in case you don’t, here it is – as defined by the Food and Drug Administration (FDA):

The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products.

Yesterday, February 19, 2010, the FDA issued a news release –Regulatory Science Update: FDA and International Serious Adverse Events Consortium Complete Third Data Release – concerning data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs).  This consortium report was the product of the combined efforts of the U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC).

The concept behind their efforts is the identification of genetic factors  in a subset of patients and thereby assist researchers to better predict an individual’s risk of developing these serious complications.

Drug-induced liver injury occurs in a small subset of patients and is often associated with a drug that is an unpredictable liver toxin, and may be the cause of acute liver failure in some patients. Although the exact mechanism behind drug-induced liver injury is unknown, research suggests that a person’s genes contribute to their likelihood of developing this injury.                                                                                    

Drug-induced SSRs, such as Stevens-Johnson, present as allergic-like skin reactions (blistering and peeling of the skin) and are considered serious enough to discontinue treatment with the medication. These reactions can be fatal if the signs and symptoms are not quickly recognized.

“FDA is pleased with the Consortium’s progress,” said ShaAvhree Buckman, M.D., Ph.D., director of the Office of Translational Sciences in the FDA’s Center for Drug Evaluation and Research. “The continued accumulation of scientific information on the genetic basis of adverse drug events provides researchers with invaluable tools for understanding why some people respond to medicines differently than others.”

If you have ever seen or read about a person suffering from a condition such as Stevens-Johnson Syndrome (SJS), you can well appreciate the significance of this research project.

Debating the Unknowns in Obesity Surgery for Children – NYTimes.com

February 16, 2010

Bariatric surgery – commonly referred to as weight-loss surgery, is apparently on the rise in the pediatric population.  A New York Times article – Debating the Unknowns in Obesity Surgery for Children – NYTimes.com – reports that these surgeries are on the rise in the United States.      

“I honestly believe that in 5 to 10 years you’ll see as many children getting weight-loss procedures as adults,” said Dr. Evan Nadler, co-director of the Obesity Institute at Children’s National Medical Center in Washington.

For those who may not be familiar with exactly what a surgeon does to the intestinal tract, there are numerous videos available on the internet that provide a good overview of this surgery – for example, here is an example showing one form of such surgery known as a by-pass.   There are a number of types of bariatric surgery, including two of the most common – Roux-en-Y gastric bypass and gastric banding procedures.

While such surgeries of often medically necessary and truly constitute a life-saving measure for some, they are not just an alternative to diet and exercise – that is, they are not without substantial risks no matter what form of bariatric surgery is being considered.

Here’s a list of just some of the potential complications -depending on the type of surgery – that are recognized risks of this surgery:

  • Bleeding
  • Complications due to anesthesia and medications
  • Deep vein thrombosis
  • Dehiscence (wound breakdown)
  • Infections
  • Leaks from staple line breakdown
  • Marginal ulcers
  • Pulmonary (lung) problems
  • Spleen injury
  • malabsorption
  • nutritional complications
  • death (reported as less than one percent)

On the other side of the equation, there is no doubt that when indicated, this surgery can certainly provide much needed restoration of health and longevity to these juvenile patients:

Obese children can suffer from a long list of problems better known in adults: insulin resistance, high blood pressure, fatty liver, a thickening of the left side of the heart, and even depression.

So far, the studies have found that the body starts to repair itself as the weight falls. For example, two years after gastric bypass, the left side of the heart has started to return to normal in most adolescents, according to cardiologists at Cincinnati Children’s. Research also suggested that for at least as long as the children have been followed, the procedure appeared safe, and about 85 to 90 percent of adolescents maintained their initial weight loss, Dr.  (Thomas H.)Inge [director of the surgical weight loss program at Cincinnati Children’s] said.

Those on the other side of this significant debate are not so confident in the long-term effects/benefits of having children undergo weight-loss surgery:

Some physicians, including Dr. Edward Livingston, chairman of gastrointestinal and endocrine surgery at the University of Texas Southwestern Medical Center at Dallas, say advocates could be drawing conclusions too early. No one can say whether the changes will translate into a health advantage later on. Dr. Livingston noted that a third of the children in the Australian gastric-banding study had to go back to the operating room over concerns about the device — and that even the children in the group that did not have surgery showed respectable improvements in blood pressure, insulin resistance and other measures. With or without surgery, he said, “both groups got better.”

The NY Times article reports: “No one knows exactly how many adolescents are turning to surgery to get thinner. One of the few studies, published in 2007, reported that bariatric surgery in teenagers was relatively rare but rising fast: from 2000 to 2003 (the last year examined), the number of operations tripled, to about 800.”

In one article, it is estimated that 220,000 bariatric procedures were performed in 2008 with an estimated increase of approximately 20,000 in 2009.

There is also an ongoing debate as to which form of weight-loss surgery is indicated for adolescents – bypass or banding.

Nor do surgeons agree on which of the two procedures used most — banding or bypass — is more appropriate for youths. Dr. Nadler, of Children’s National Medical Center, prefers banding, saying it is less radical and can be more easily undone if need be. In November, in The Journal of the American College of Surgeons, he described a study finding that among 41 teenagers followed for two years after gastric banding, their excess body weight had dropped by about half, on average, and other measures of their health had improved.

There is no doubt the debates will rage on for years to come.  What is evident, however, to those of us who have litigated many cases involving bariatric surgery performed on adults, is that this is not to be considered a ‘quick fix’ for being overweight.  It is not a form of cosmetic surgery.  This is serious stuff and reasoned considerations must be made: (1) is it medically indicated?; (2) what are the alternatives?; (3) who are the surgeons skilled in these procedures?; (4) is the adolescent properly being screened and counseled before undergoing surgery?; (5) what post-operative follow-up is needed?; (6) is the facility where the procedure is to be performed truly recognized as being capable of dealing with such patients and potential post-operative complications?; and (7) does the child and his/her parent(s) truly understand the risks associated with such procedures? – just to name a few of the many issues that must be addressed.

Patient dies in hospital after ‘do not resuscitate’ form is mistakenly put in his files | Mail Online

February 10, 2010

Well apparently we don’t have a corner on the market for committing malpractice.  This deadly incident -reported on February 7, 2010 – occurred in Derbyshire, which is in the north midlands of England.

What occurred?  I truly can’t recount this any better than the reporter, who wrote the article:

A patient who suffered a heart attack on a hospital ward died because clerical staff had mistakenly inserted a ‘Do Not Attempt Resuscitation’ form into his medical notes.

Peter Clarke was not treated by doctors after going into cardiac arrest as a nurse had spotted the form in his files and, even though it was blank and had not been filled in, told other ward staff he should not be revived.

The blunder emerged at an inquest into the incident at Derby Hospitals NHS Trust, where bosses revealed staff had been ‘routinely’ placing the forms alongside medical records before they had been correctly signed and witnessed by senior doctors.

Before you wind-up having ‘no say’ in whether you get to live or die should catastrophic injury strike, you should consider (a) having a living will/advance directive and (b) at least discussing with your loved ones what you want done by way of medical intervention, if anything, should you wind-up in a state such a coma or a persistent vegetative state – to name just a few. – truly opt for the former but don’t be afraid to engage in the latter.

An order for DNR (do not resuscitate)is an extraordinary measure.   Think clearly and long about your decision, but once made, let it be known.

Last bit of advice:  check what’s on the nursing station desk next to your medical record before you get in bed.

Bariatric Surgery Can Be Safer Than Living With Obesity

January 31, 2010

For those of us in the law, who have litigated dozens of bariatric surgery cases, the following article from Medical News Today (Bariatric Surgery Can Be Safer Than Living With Obesity) must be read with the following paragraph from the article kept in the forefront when patients are decided WHERE to go to have this surgery performed:

To help alleviate a patient’s fears before surgery, the bariatric team ensures that patients and their families are thoroughly informed and comfortable with the procedure. Prior to surgery, patients undergo medical, psychological and nutritional evaluations, plus they attend two patient support groups and three educational classes.

Wondering what this surgery is all about?  It’s the medical term for what may commonly be called ‘weight loss’ surgery.  To get a basic understanding of the procedure as well as the ‘before and after’ care issues that are key to a successful procedure, here’s a video from YouTube.

Keep in mind that there are a lot of surgeons doing bariatric surgery; however, in most instances, the way you avoid a visit to your lawyer’s office is to chose the right surgeon and facility.

The American Society for Metabolic and Bariatric Surgery has a useful website on which there’s a patient primer about this procedure.  You can learn about the Centers for Excellence Program of the Society and get a listing of the members of the organization, who perform this surgery in your area.  It’s definitely worth checking out before you sign-up with a surgeon to have this potentially life-saving but nonetheless risky procedure performed.

Patients – Know Thy Physician!

Medical News: Sorting Out the Mammography Mess – in Hematology/Oncology, Breast Cancer from MedPage Today

January 30, 2010

Confused about when you should start undergoing screening mammography?  A recent article in medpage today –Medical News: Sorting Out the Mammography Mess – in Hematology/Oncology, Breast Cancer from MedPage Today – attempts to educate women about this seemingly ever-changing set of guidelines.

The article contains an audio interview with Dr. Len Lichtenfeld, Deputy Chief Medical Officer of the American Cancer Society, which is worth a ‘listen.’

This whole new discussion as to when women should get screening mammograms arose when the US Preventive Services Task Force issues its recent recommendations.

Perhaps the best advice – Women be knowledgeable about the recommendations and discuss them and their application to you and your risk factors for breast cancer with your gynecologist.  If you are a young woman or are unfamiliar with what a mammogram is all about, you may want to consider watching a video of what this test is all about and how it is performed.

RISKY BUSINESS: NEJM — Outcomes after Internal versus External Tocodynamometry for Monitoring Labor

January 30, 2010

In December 2003, ACOG, the American College of Obstetricians  and Gynecologists, issued a Practice Bulletin (#49) for its members, in which it recommended the use of intrauterine monitoring of contractions during augmentation or induction of labor in select patients, such as those suffering from obesity.  There were some obstetrical organizations who were recommending the routine use of internal contraction monitoring to assess contractions more accurately.

Of course, the intent behind such recommendations was ostensibly to provide the attending obstetrician with better/more accurate information with which to make clinical decisions regarding the need for an operative birth (i.e. C-section or instrument assisted birth), dosing effectively with oxytocin nad avoidance of complications in such labor situations – the common end-result being to improve fetal and maternal outcomes in such deliveries.

On the other side of the risk/benefit equation, it is only common sense that the use of an internal monitor would increase certain risks – the medical literature speaks of the most common of these as being placental and/or fetal vessel damage, infection and anaphylactic reaction.

A new study by the Academic Medical Center in Amsterdam, led by Jannet J. H. Bakker, MSc, and reported by The New England Journal of Medicine on January 28, 2010 – NEJM — Outcomes after Internal versus External Tocodynamometry for Monitoring Labor raises serious questions about the use of such monitoring when one applies a science-based risk/benefit analysis.

The study reports in pertinent part:

In summary, the results of our trial do not support the routine use of internal tocodynamometry for monitoring contractions in women with induced or augmented labor.

In this multicenter, randomized trial we found no significant difference in rates of operative delivery with internal tocodynamometry as compared with external monitoring of uterine contractions among women in whom oxytocin was used for induction or augmentation of labor. On the basis of the lower boundary of the confidence interval around the observed relative risk of the primary outcome, our data are plausibly consistent with no more than a 9% reduction and up to a 20% increase in the risk of operative delivery associated with internal tocodynamometry. For cesarean section alone, plausible results range from a 17% reduction in risk to a 30% increase in risk with internal tocodynamometry. These results are in concordance with those of three previous small trials that compared internal and external uterine monitoring (each including between 127 and 250 patients), all of which showed a nonsignificant increase in the frequency of cesarean sections in the internal-tocodynamometry group.

Our trial also showed no significant difference between the two types of monitoring in the rates of adverse neonatal outcomes, rates of use of analgesia or antibiotics, or time to delivery. Similarly, none of the earlier studies showed significant benefits in terms of other maternal or neonatal outcomes with the use of an intrauterine pressure catheter.

For a full review of the patient population, the limitations of the study, please refer to the NEJM article.

Physician Warning – Opioids – ‘Know Thy Patient’ – Reuters Health – News Page

January 19, 2010

For those lawyers, such as those in our firm, it is well known that there is a true risk to a patient/client on prescribed pain killers/opioids that such people may well become addicted and ‘at risk’ for greater harm – namely a lifetime of addiction or even worse – death.

There is an important posting in today’s Reuters Health – News Page,which speaks to this issue quite well.

A well-placed quote from a physician with the Centers for Disease Control summarizes the problem:

As a society, we have underestimated the possible risks from the dramatic increase in use of opioids,” said Dr. Leonard Paulozzi of the U.S. Centers for Disease Control and Prevention, who was not involved in the new study.

The study, conducted by a team headed by Michael Von Korff, ScD, a  senior investigator at Group Health Research Institute, was  published in the Annals of Internal Medicine and is summarized well in a posting found at ScientificBlogging.com.

From our standpoint as lawyers, in terms of good medical practice and standards of quality care, the key elements of interest were outlined by the author:

The team said that this research and the data reviewed cannot determine whether higher doses are a cause of overdose, but he noted that physicians should carefully evaluate and closely monitor patients using opioids long-term. (emphasis added)

Previous research had not tracked nonfatal overdoses. “Fatal overdose may be only the tip of the iceberg,” said Dr. Von Korff. “For every fatal overdose in our study, 7 nonfatal overdoses occurred, and most of the nonfatal overdoses were medically serious.”

The keys – ‘evaluate’ and ‘monitor.’  How many times over my 35 year career have I heard stories of patients ‘doctor shopping’ and dealing with the receptionist or office nurse in the seemingly never-ending quest to just get more drugs.  Their motives are rarely for financial gain – they are simply out of control and in need of good, quality of care oversight and monitoring.


Few Breast Cancer Surgeons Follow Quality Of Care Standards

January 6, 2010

Today’s online issue of Medical News Today offers good insight for women, who have been diagnosed with breast cancer.  A recent study by the University of Michigan Comprehensive Cancer Center notes that the standards of care in the treatment of such patients calls for, among other things, “consulting with other specialists and providing resources and education to help patients make treatment decisions.”

“Despite the mantra for multidisciplinary decision-making and care intake for patients, surgeons in the community are reporting relatively little of that in their practices,” says lead study author Steven J. Katz, M.D., M.P.H., professor of internal medicine at the U-M Medical School and professor of health management and policy at the U-M School of Public Health.

As further noted by one of the co-directors of the program at U-M Comprehensive Cancer Center:

“Either doctors are not convinced these elements matter or there are logistical constraints in terms of building these standards into their practices. What the implications are for patients is unknown. These results suggest patients might find a more integrated practice among surgeons with higher volume. But we don’t know whether that matters with regards to patient decision making, quality of life and satisfaction,” says Katz, who is also co-director of the socio-behavioral program at the U-M Comprehensive Cancer Center.

The authors of the article (for a full review, see Few Breast Cancer Surgeons Follow Quality Of Care Standards), in Medical News Today cite the following statistics with respect to breast cancer – “Breast cancer statistics: 194,280 Americans will be diagnosed with breast cancer this year and 40,610 will die from the disease, according to the American Cancer Society.”

It would seem that the moral of the story in this report for women dealing with this disease is – make sure you discuss your options with your doctor and specifically discuss the concept of a multi-disciplinary approach in the formation of your treatment choices.

There is also an encouraging report on the U-M Comprehensive Cancer Center’s site that speaks to their scientists having “uncovered an important link between inflammation and breast cancer stem cells that suggests a new way to target cells that are resistant to current treatments.”