Quadriplegic Suffers Traumatic Brain Injury When Ventilator Dislodges


Posted on 29th November 2010 by gjohnson in Uncategorized

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Here’s a textbook lesson in how nurses should not care for a patient.

You have quadriplegic patient who is on a ventilator. His ventilator accidentally becomes disconnected, setting off a warning light at a nurses’ station. You don’t notice the flashing light, and for 24 minutes the man’s brain is deprived of oxygen. The patient suffers traumatic brain injury and develops a seizure disorder. You get sued.


That’s the case in hand.

The family of Robert Knowles has filed suit in Suffolk County Supreme Court against the Medford Multicare Center on Long Island, N.Y., over the March 21, 2009 incident, according to the New York Post. The state Attorney General’s office is also investigating the incident. 

Knowles, an ex-truck driver, broke his neck when he fell from a ladder on Dec. 30, 2007. But he did not let his paralysis daunt him. He got around using a wheelchair that he controlled using a strawlike device that he would blow into. But then Knowles was admited to the Medford facility, and his life took another sad turn. 

When Knowles’ ventilator got detached, it set off a blinking green light on a computer screen. But for 24 minutes, none of the medical staff noticed that the warning light was on. According to the Post, there is a video from a surveillance camera that shows medical staff  “fiddling around” as the light flashes.  

Not surprisingly, Medford officials didn’t return the Post’s phone calls seeking a comment.

Study Finds That Patient Safety Remains An Issue At Hospitals


Posted on 26th November 2010 by gjohnson in Uncategorized

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Call me a cynic, but this headline doesn’t surprise me: “Study Finds No Progress in Safety at Hospitals.”


In a Page One story this week The New York Times reported that a new study — which tracked 10 North Carolina hospitals from 2002 to 2007 — determined that patients were fairly commonly harmed, and those incidents were not declining. 

Complications from procedures and drugs, as well as hospital-acquired infections, were the culprit in most cases, according to The Times.

Ironically the study, led by Dr. Christopher Landrigan of the Harvard Medical School, was conducted in North Carolina because hospitals there have instituted a lot of programs to improve patient safety. Instead, the research determined that roughly 18 percent of the patients were harmed by their medical care, and 63.1 percent of their injuries were considered preventable, according to The Times. Some 2.4 percent of the problems caused or contributed to a patient’s death.

The preventable problems included: bad bleeding during an operation; breathing problems caused by a procedure that was not done correctly and a hip dislocation caused by a fall.

The North Carolina hospitals that were part of the study were not named. That was lucky for them, since the research found 588 cases where a patient was harmed by medical care, or 25.1 injuries per 100 admissions, according to The Times. 



The study was published this week in The New England Journal of Medicine.     


Widow Gets $6 Million For Husband’s Deadly Fall At A Rehab Facility


Posted on 26th November 2010 by gjohnson in Uncategorized

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The widow of a man who died after falling out of a wheelchair and hitting his head at a New Jersey rehabilitation facility was awarded $6 millon by a jury last Friday, according to the Times of Trenton.


The panel in Mercer County, N.J., rendered the verdict on behalf of Elizabeth Shufflebotham, the wife of deceased George Shufflebotham, 62, of Lambertville, N.J., against the St. Lawrence Rehabilitation Center. The retired accountant-turned-real estate agent was rendered brain-dead following his fall there on Oct. 12, 2003.

Shufflebotham suffered a stroke at his home on Oct. 7, 2003, and was sent to the St. Lawrence facility for therapy on his left side. A few days later, Oct. 12, he fell out of his wheelchair and bumped his head. But the rehab facility did not make him undergo a CT scan, it instead just sent him back to bed, according to the Times.

But just hours later, a nurse noticed that Shufflebotham’s pupils were slowly reacting to light, which is an indicator of brain hemorrhaging. But the rehab facility still didn’t take him to the hospital.

It was only the next day, after Shufflebotham was vomiting and in a sweat, that St. Lawrence finally rushed him to the hospital. He was basically brain-dead at that point, and was put on life support. Then his brain totally stopped functioning and his family took him off life support. ‘

The lawsuit against St. Lawrence charged the facility with negligence, arguing that Shufflebotham could have been saved if a CT had been conducted right after his fall.  


Nurses Could Be Part Of The Cure For Heath Care Woes


Posted on 20th November 2010 by gjohnson in Uncategorized


How often have you heard the role of nurses discussed in all the debate over health care reform?

I’d venture to guess that you haven’t. That’s why a New York Times column this week on what part nurses can play in addressing America’s health care crisis, written by a doctor, Pauline Chen, was an enlightening read. 


She writes about a report released last month, “The Future of Nursing: Leading Change, Advancing Health,” that has several sensible recommendations. One of the prime notions was “a debunking of the notion that physicians are the only ones who should lead (and be reimbursed) for any changes in the current health care system,” Chen wrote.

As an example, Chen cites the Transitional Care Model program at the University of Pennsylvania. Nurses are matched with hospitalized high-risk elderly patients. For a three-month period after the patient is released from the hospital, that nurse visits him or her at home, goes with them to their doctor’s offices, and works with their primary-care doctor and family.

That program so far cut hospital readmissions and costs by as high as $5,000 a patient.

The report also recommmended that the whole issue of a nurse’s training be revisited, with a standard set for exactly what education constitutes a registered nurse. There is also the suggestion that residency programs perhaps be part of the curriculum.  

Not surprisingly the report, done over a two-year period by a panel assembled by the Institute of Medicine and the Robert Wood Johnson Foundation, has been skewered by the American Medical Association, according to Chen. The AMA in a statement said that “with a shortage of both nurses and physicians, increasing the responsibilityof nurses is not the answer to the physician shortage.”

Neither is clinging to old ways of thinking.     


Painkillers Darvon, Darvocet Withdrawn From Market Due To Heart Issues


Posted on 19th November 2010 by gjohnson in Uncategorized

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The painkillers Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, are being pulled from the U.S. market because they’ve been blamed for causing lethal heart rhythms, federal regulators said Friday.

Xanodyne Pharmaceuticals Inc., which manufactures the drug, agreed to withdraw the medication at the request of the U.S. Food and Drug Administration, the federal agency said in a press release.


Propoxyphene is an opioid used to treat mild to moderate pain. Xanodyne is based in Newport, Ky.

The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well.

The federal agency sought to ban  propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities, the press release said . As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.

“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” Dr.  John Jenkins, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER), said in a prepared statement. “These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”

The FDA is also advising doctors to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.

First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is under way.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death.

The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.

“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” Dr. Gerald Dal Pan, CDER director, said in a prepared statement.  “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

Still at least one group, the Public Citizen, Friday blasted the FDA for taking so long to ban propoxyphene.


“Since the time of the UK announcement in January 2005 of a phased, two-year withdrawal of this drug (which was followed by an immediate steep decline in use), approximately 120 million retail prescriptions have been filled in the U.S. for propoxyphene-containing drugs,” the Public Citizen said in a statement. 

“Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since time the UK ban was announced,” the statement continued. “The best forensic data, the kind relied upon in those countries for the UK and European bans, come from Florida where, because of routine drug testing required by the state medical examiner as part of many autopsies, deaths are categorized as being ’caused’ by certain drugs if the levels found are to be above a certain level. From 2005 through 2009, in Florida alone, 395 deaths were “caused” by propoxyphene. If data from 2007 are representative, in that year, 78 percent of the Florida deaths caused by propoxyphene were ruled accidental.” 

The Public Citizen said it will call for a congressional investigation “into whom in the FDA, specifically in the Center for Drug Evaluation and Research, was responsible for the loss of so many lives in this country. It is clear that long before today, many drug safety experts in the Office of Surveillance and Epidemiology had decided the drug should be removed from the market.”


MRIs Prove A Good Guard For Women At High Risk For Breast Cancer


Posted on 19th November 2010 by gjohnson in Uncategorized

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Yearly MRIs, in concert with breast exams and mammograms, apparently can mean the difference between life and death for women with a high risk of breast cancer, according to a new study.   


 The New York Times reported this week on the findings, which could spare women with a high risk of breast cancer from taking the drastic step of having a mastectomy to circumvent the deadly disease. 

For years doctors have suggested that women at a high risk for breast cancer get both a yearly mammogram and an  MRI, which is better at detecting tumors than the mammogram, according to The Times. But there had been no scientific evidence that the combination of both tests could actually save lives.

The new study is the first to track the survival of high-risk women who get MRIs. The research determined that following six years of follow-up, 93 percent of mutation carriers were still living, versus 73 percent still alive at five years in other studies, The Times reported.

And all the women at a high risk due to their family history were alive after six years, according to the latest study.

That research was published online in The Journal of Clinical Oncology, and was led by Dr. Jan G.M. Klijn, an emeritus professor at Erasmus University in Rotterdam. The study tracked 2,157 high-risk participants in the Netherlands.    


The Pros And Cons Of Investors, Like Hedge Funds, Bankrolling Lawsuits


Posted on 15th November 2010 by gjohnson in Uncategorized

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Hedge funds and banks are anteing up “hundreds of millions of dollars” to fund other people’s lawsuits in order to get a share of their awards, according to The New York Times.


In its lengthy Page One story Monday The Times outlined the pros and cons of investors paying for the costly experts and research necessary to litigate medical malpractice and other types of lawsuits. The story, by the way, was funded by the Center for Public Integrity. 

The benefit for plaintiffs is that the investment from outside parties is allowing people who may not have had the resources to sue, despite the merits of their cases, their day in court. Less litigation leads to less justice, as one person told The Times.

But there are a lot of  downsides in this kind of money-lending. By lending money, investors can control or even initiate a suit, or get access to confidential information. Lawyers are not even bound to tell their clients that they have borrowed money to proceed with the litigation. The interest rates on these types of loans are also high, more than 15 percent, according to The Times.

As an example of how lending works, the newspaper cited a case in which New York lender Ardec Funding forked oover $45,000 this summer to a Manhattan attorney who was representing parents with a baby who sustained brain damage at birth.

The attorney retained two doctors, a physical therapist and an economist to appear at the trial. A jury directed the delivering doctor and hospital to pay a $510,000 award, The Times reported.

“Ardec is collecting interest at an annual rate of 24 percent, or $900 a month, until the award is paid,” The Times said. 

The detailed story, headlined “Putting Money on Lawsuits, Investors Share in the Payouts,” raises interesting arguments on both sides of the issue.