This is a test

here is a link to our website to see if this works when I hit publish.  http://nashandassociates.com

Child Health: Labels Urged for Food That Can Choke

Earlier this year, we posted a blog on our website in regard to the American Academy of Pediatrics (AAP) policy statement in regard to the prevention of choking among children.  Earlier this week, the New York Times featured an in-depth story on an issue that is very much a part of this policy statement:  food choking hazards among small children.  The article discusses the advocacy efforts to place warning labels on foods, which pose a choking hazard to small children, as well as the proposition that small children should not be allowed to eat certain foods at all.  The article starts with an all too familiar setting that ended in tragedy:

On a July afternoon in 2006, Patrick Hale microwaved a bag of popcorn for his two young children and sat down with them to watch television. When he got up to change the channel, he heard a strange noise behind him, and turned to see his 23-month-old daughter, Allison, turning purple and unable to breathe.

As a Marine, he was certified in CPR, but he could not dislodge the popcorn with blows to her back and finger swipes down her throat. He called 911, but it was too late: by the time Allison arrived at the hospital, her heart had stopped beating. An autopsy found that she had inhaled pieces of popcorn into her vocal cords, her bronchial tubes and a lung.

Does this story make you think twice before giving your little ones popcorn?  On a personal note, I called my wife immediately after reading this story, and we discussed the fact that we should no longer allow our son, who is now two and a half, to have any popcorn. Ironically, she was on her way to take him to a movie that was going to be serving….you guessed it, popcorn.

Now, some of you may say “Well, little kids can choke on anything.”  Well, that is true.  However, there are some foods that pose an increased risk of choking.  Consider the dynamics of how a small child eats, as well as the size of their airway:

Children under 4 are at the highest risk, not only because their airways are small (the back of a toddler’s throat narrows to the diameter of a straw) but also because of the way their eating abilities develop. Front teeth usually come in at 6 or 7 months — so babies can bite off a piece of food — but the first molars, which grind food down, do not arrive until about 15 months, and second molars around 26 months.

“Between the ages of 3 and 4, they’re developing their ability to chew adequately and prepare for swallowing,” said Dr. Nisha Kapadia, a pediatric resident at Johns Hopkins Children’s Center.

When young children chew foods like peanuts, raw carrots and popcorn, some is ground down and some is not, and they tend to swallow unchewed bits of food that can block the airway or be inhaled into the bronchial tubes and lungs.

This concern and the tragic deaths associated with this concern have prompted several organizations to propose various options to attempt to prevent these injuries and deaths.  One such organization is the Center for Science in the Public Interest:

Some advocates say the government should put hazardous foods off limits to young children.

“The F.D.A. needs to set a uniform standard for cautionary information on food that should not be consumed by children under 5,” said Bruce Silverglade, legal director of the Center for Science in the Public Interest, an advocacy group that lobbied unsuccessfully in 2003 for a bill to require the Food and Drug Administration to develop food labeling regulations.

Where this debate will end up, we don’t know.  However, to think that in 2001 there were 17,500 children 14 years old and younger treated in emergency rooms for choking, with 60% of those events caused by food, there must be a way to create a safer environment for our children when they are eating.  Any suggestions?

Cardiac Health: Implantable Cardiac Devices – number of procedures on the rise, but is the technology really there to handle this boom?

It is reported that an estimated 650,000 people in the United States currently have implanted cardiac devices (ICD’s) designed for defibrillation (cardiac electro-shock therapy) or combination defibrillation and heart pacing.  For you  Baby Boomers rounding (or having passed) the 60’s bend, these numbers are expected to grow exponentially.  Cardiovascular Business posted an article on April 20 advising that hospital admissions for implantation of ICD’s increased ten-fold from 1990 to 2005.

This same article was quite alarming in its lack of scientific data on factors that determine the best results.  While it may be comforting to know that several large patient-studies have recently shown that centers performing the greatest numbers of procedures have the lowest rates of procedural complications, it is important to also note that authorities in this area of medicine warn that more data and study are needed on individual operator volume, specialty identification, training, performance and outcomes.

Cardiovascular Business News released a feature on April 20, 2010, citing an article published in 2009 by the Journal of the American Medical Association.  The data suggest that your odds of having procedural complications were greater if the device was implanted by a non-electrophysiologist. In short, does this mean you have better odds with an electrophysiology cardiologist? What about a general cardiologist? Or a thoracic surgeon? The study data apparently did not adjust for underlying health conditions or patients who are more ill. Why not? Are we to assume the latter groups of patients may have merely been more prone to complications? Or do the non-electrophysiologists just have less experience and training in implanting ICD devices? As of this time, Boomers, the medical profession has not published answers to these questions.

Perhaps we should be encouraged that Medicare is requiring implant and performance outcome data. As of June 2009, the agency had collected information on more then 380,000 implants.  Yet almost a year later, with many more procedures entered into that same database, the medical specialty communities are still unable to let us know which are the safest specialists and hospitals performing ICD implant procedures.  Physicians say longer term outcomes are needed.

In the meantime, are Medicare and other payors paying for all procedures regardless of the quality of practitioner or hospital performance?

More alarming, on May 17, 2010, Dr. Westby G. Fisher, a cardiologist at North Shore University Hospital Health System wrote in medcitynews.com that the medical system currently can no longer sustain the volume to maintain the implanted devices safely. He complains that physicians are unable to re-program ICD devices remotely.  Is this true? Due to the growing volume of implanted devices now occurring, technicians with no medical degree are programing patient devices from remote locations with sometimes no documentation or notification to the patient’s physician. Physicians are supposed to be overseeing the process according to Dr. Foster. However, he is of the opinion that due to the high maintenance these devices require, along with the growing number of patients, managing the technology will be of great concern to the boomer population and their physicians.  Once again, how are the pressing issues of quality, safety, and cost going to be timely addressed in this burgeoning aspect of our healthcare?

Finally, perhaps we can be comforted by the recent news release from the Heart Rhythm Society. Apparently, the medical profession had never previously determined parameters on how and when to stop these devices at the end of one’s life.  The study cited a dying patient whose defibrillator went-off  greater than 12 times, causing the patient needless suffering. Several groups of medical societies have now have published a consensus statement outlining ethical and legal issues, a decision-making algorithm for withdrawing/deactivating the device(s), and rights/responsibilities for those physicians who have ethical conflicts. The Heart Rhythm Society is encouraging and educating physicians and patients on what needs to happen in this algorithm for ending ICD-sustained life.

One can only hope that a physician is not placed into a remote call-waiting voicetree for dying boomers when the time comes to deactivate. It’s bad enough that we don’t yet know how to choose the best physician and/or hospital to have these devices implanted. Now there is growing concern that simple but critical issues of maintenance, remote re-programming and the like will get out-of-hand due to the ever increasing volume of these devices being implanted.

Contributor: Sharon M. Stabile

Why would anyone write a White Paper on how to get an #autopsy report?

On Saturday, April 22, 2010, I posted a new White Paper on our website, which deals with a number of issues of concern to many of our past clients – “They did an autopsy after my loved one died, but I can’t get them to give me the results. What can I do?”

In one week alone with had three calls from people saying the same thing in different plaintive words.

Last year, we successfully tried a lawsuit in Salisbury, Maryland relating to the death of a 19 day old infant. The parents knew that an autopsy had been performed as a result of their child tragically dying in his father’s arms. Patient for months, he called his now-deceased son’s pediatrician’s office several times and was basically told to not worry about it, they would let him know when they got word. Many months later, totally frustrated by the lack of caring and information and only wanting to know what had caused their baby to die so horribly, they sought out an attorney. The autopsy report finally surfaced – I wonder why.

I take  these wonderful people at their word. They had no intention of filing a lawsuit. As the months of frustration passed, they started to ask themselves – “Are they trying to hide something?” None of us will never know why such utter disregard and insensitivity to these grieving parents led to a failure by the doctor to provide the report and discuss it with the family. What it did was buy him a lawsuit and a multi-million dollar verdict.

So let’s examine why we just did a White Paper entitled “Having Trouble Getting a Hospital or Physician to Release an Autopsy Report?” Picture yourself in such a horrible situation. You just lost your spouse or child totally unexpectedly. An autopsy is done or requested. You don’t know which way to turn. All you want to do is try to understand what happened. You are put-off, ignored or  even berated for your persistence in simply wanting to know. This White Paper is offered to those in that horrible situation. Get some guidance on how to get  the information you so want.

While we hope you never need this information. If you do, it’s there for  the taking.

Non-Cardiac Surgery Too Soon After Cardiac Stenting Increases Risk of Complications

According to a recent study published in Circulation: Cardiovascular Interventions (an American Heart Association journal), patients should attempt to postpone having surgeries for at least six weeks after a coronary angioplasty procedure with stenting.  Researchers found that patients who wait at least six weeks before having another surgery are less likely to develop reduced blood flow to the heart (a.k.a. heart ischemia) and heart attacks.

The study data revealed that 42 % of patients who had other surgeries within the six-week period developed these complications. Only 13 % of patients who had surgeries beyond the six-week period developed the same complications. The study focused 1,953 patients with an average age of 64 who had cardiac angioplasty with stenting between 2003 and 2007.

According to the American Heart Association:

• Over 70 percent of coronary angioplasty procedures in the United States also include stenting.
• In 2006, approximately 65 percent of PCI procedures were performed on men, and approximately 50 percent were performed on people age 65 or older.
• In 2006, an estimated 1,313,000 PCI procedures were performed in the United States.
• In 2006, approximately 76% of stents implanted during PCI were drug-eluting, compared with 24 percent bare-metal stents.
• In 2006, there were 652,000 PCI procedures with stents — 425,000 in men, 227,000 in women.

If you recently had cardiac stenting and require another surgery, make sure to ask your doctor about waiting to have the next surgery. This is particularly true if your next surgery is an elective one. If your doctor or surgeon is not a cardiologist, you may want to consider asking your doctor for a referral to a cardiologist.  You may also want to make sure that your physician or surgeon obtains cardiac clearance before proceeding with another surgery.   Don’t assume that your doctor will do these things for you. Be proactive; ask questions.

For related blogs, please see:

• Drug- Eluting Stents Found Effective at Preventing Major Amputations
• Angina: The Efficacy of Percutaneous Coronary Intervention v. the Efficacy of Non-Surgical Treatment.
• The Efficacy of Drug-Eluting Stents and Bare Metal Stents in Heart Transplant Recipients with Coronary Artery Disease
• Study Finds Stents as Effective as Surgery to Prevent Strokes; European Study Finds Otherwise
• St. Joseph Medical Center Stent Patients Now Face Another Risk: The FDA Requires a Black-Box Warning on Anti-Clotting Drug Plavix
• St. Joseph Tells 169 More Patients They May Have Had Unneeded Surgery; Total Notified Now at 538
• Bill Clinton’s Stent Procedure – What It’s All About

Contributing author: Jon Stefanuca

Teenager loses 65% of her skin after prescription error. Jury award of $2.1M decimated by cap

Breanna Ellis was just 13 years old when she presented to Dr. Lois Jeansonne, III, now deceased,  for treatment of a sinus infection.  Dr. Jeansonne decided Omnicef would be prescribed for treatment because it was approved for treating pediatric sinus infections. However, she actually prescribed Septra DS.

The Septra DS treatment resulted in dermatological problems and forced Breanna to be transferred from Our Lady of the Lake Regional Medical Cente to Shriner’s Hospital of Texas. Breanna Ellis lost 65% her of skin and required skin grafting to correct the horrific injuries Septra DS caused her to suffer.

A Louisiana jury awarded Ms. Ellis and Debra McKee, Ms. Ellis’ mother, $2,100,000 million. However, Louisiana’s 1975 Medical Malpractice cap will only reduce the  total reward of $500,000. For the full story, see 2theadvocate.com | News | Jury awards $2.1M in case against late doctor — Baton Rouge, LA.

Drug-Eluting Stents Found Effective at Preventing Major Amputations

It is generally accepted in the medical community that drug-eluting stents (DES) are helpful in restoring normal blood flow to the heart. In recent years, however, DES treatment has been applied with proven success in other contexts.

For example, consider a patient with peripheral vascular disease (PVD); an unfortunately common medical condition characterized by the occlusion of the arteries of the legs and arms. This disease is usually caused or exacerbated by other medical conditions such as diabetes, high cholesterol, high blood pressure, and kidney disease. People who smoke are at a much higher risk for developing PVD as well. It has been reported that as many as five million adults in the U.S. have PVD.

Patients with PVD tend to experience a gradual decrease in blood flow to their extremities. Over time, this can result in a complete interruption of blood and the development of necrotic tissue. In the past, once necrotic tissue was present, amputation was often the only available medical treatment.

Recent research suggests that DES treatment may be used effectively to prevent or reverse arterial occlusions in patients with PVD. According to an article published by Modern Medicine, researchers studied 106 patients who were treated with DES to restore blood flow in the lower extremities.

There were no procedural deaths, and 96 percent of the patients were discharged within 24 hours. The researchers found that the three-year cumulative incidence of amputation was 6 percent ± 2 percent, survival was 71 percent ± 5 percent, and amputation-free-survival was 68 percent ± 5 percent. Also, only 12 percent of patients who died had a previous major amputation. The target limb revascularization rate was 15 percent.

This study suggests that DES treatment can be effective at preventing major amputations. If you are facing the possibility of amputation as a result of PVD or another ischemic process, ask your doctor about angioplasty and DES treatment.

Contributing author: Jon Stefanuca

Stroke Warnings:Most People Who Experience Minor Strokes Do Not Recognize Its Symptoms

According to an article published by WebMD, a recent study suggests that most people who experience minor strokes or transient ischemic attacks (TIA’s) do not recognize their symptoms and/or do not seek timely medical attention.A stroke is generally defined as an interruption of blood flow to the brain.

Strokes can be divided into two categories: hemorrhagic strokes and ischemic strokes. TIA is a condition that manifests itself with stroke-like symptoms for less than 24 hours. TIA does not by itself result in lasting neurological damage. However, people who experience TIA episodes often develop strokes. According to the article, one in 20 patients with TIA will develop a major stroke.

After interviewing about 1000 patients, researchers concluded that about 70% of the patients did not recognize TIA or minor stroke symptoms and that less than half of the patients with these conditions sought medical attention within three hours from the onset of symptoms.    

If you are at an increased risk for developing a stroke, ask your doctor for information on TIA and stroke symptoms. Early medical intervention is key in treating stokes. Please take some time to familiarize yourself with some of the TIA/stroke symptoms.

According to the article, people who experience minor strokes may develop one or more of the following:

• sudden numbness or weakness in the face, arms or legs, especially on one side of the body
• sudden trouble speaking or understanding
• confusion
• sudden vision problems in one or both eyes
• dizziness, loss of balance, or sudden trouble walking
• severe headache with no obvious cause

Remember – time is of the essence in getting treatment. Certain therapies (e.g. tPA) simply can not be administered to you if too many hours pass.

Contributing author: Jon Stefanuca

Cerebral Palsy: Cord Blood Stem Cell Research and Treatment in Clinical Trials – Update

For those of  you who follow our blogs, you know well that this is a topic of interest for us.  It bears repeating – our job as lawyers is to properly investigate potential claims of malpractice in areas such as cerebral palsy and seek redress for our clients when the evidence demonstrates a connection between birth injuries and medical care, but the much more important topic for our clients and victims of cerebral palsy is in the field of medical research. It is through research efforts – including clinical trials – that this dreaded condition will be ameliorated and hopefully eradicated. Trust me, after practicing law for over 35 years, I’m not worried about job security – the frailties of the human condition will more than suffice to fill our file cabinets with people to help due to the negligence of others.

We have reported previously on various topics involving cord blood and stem cell research as they relate to a number of conditions, including cerebral palsy.  It seems that months have passed since there has been any significant news about two programs underway: one at the Medical College of Georgia and the other at Duke.  Earlier this month, an update came across the social media network via a post by Singularity Hub – Cord Blood Stem Cell Treatment for Cerebral Palsy in Clinical Trial | Singularity Hub.

Here’s our encapsulated version regarding the studies and Singularity Hub’s report.

Photo provided by MSNBC

Duke University

According to the website ClincalTrials.gov, Duke began a clinical therapeutic trial – identifier: NCT00593242 – in January 2008 (estimated completion date of January 2011) whose primary purpose is listed as treatment of newborns with hypoxic ischemic encephalopathy (HIE) – inadequate oxygenation in the perinatal period for purposes of this study – through the controlled “collection, preparation and infusion of a baby’s own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.” For information concerning the inclusion and exclusion criteria for participation in this clinical trial, see the online posting. Essentially, the babies are then to be “followed for neurodevelopmental outcome at 4 – 6 and 9 – 12 months at Duke’s Special Infant Care Clinic. MRI’s will be obtained between postnatal weeks 1 and 4, and, for study purposes at 4 – 6 postnatal months.”

While other aspects of processing and administration are no doubt part of the key components of this project, it is readily apparent that the end-point goal is discovery of an effective treatment of cerebral palsy for the identified neonates in the study and then development of a second stage clinical trial to take such treatment modality to a greater number of potential beneficiaries.

Medical College of Georgia

For detailed information on this study, which began in February of this year, similar information is available through ClinicalTrials.gov under identifier NCT01072370.  This clinical trial investigation has a patient population consisting of children from ages of 2 to 12, “whose parents have saved their infant’s cord blood, who have non-progressive motor disability, and whose parents intend to have a cord blood infusion.”  Again – for full details regarding inclusion and exclusion criteria, see the full online posting.

For those parents who may be interested in determining if their child would qualify to participate, the study is still recruiting participants.  The contact information is also available at this link: Contact: James E Carroll, M.D.     706-721-3371     jcarroll@mcg.edu

Today’s report from Singularity Hub provides some encouraging – albeit anecdotal – news of potential progress.

The anecdotal evidence in support of treating cerebral palsy with cord blood stem cells is astounding. Much of it has actually been been performed at Duke University by one of the investigators in the pilot study: Joanne Kurtzberg. Among those that have been successfully treated at Duke include Ryan Schneider, Maia Friedlander, Chloe Levine, and Dallas Hextell. All had CP or CP-like symptoms and all made remarkable recoveries after cord blood stem cell treatments. Dallas Hextell, who showed improvements just 5 days after his therapy was featured on the Today show (the original report contains video compliments of MSNBC).

In addition to the early good news coming out of these projects, one other lesson is learned – for the time being, the storage of cord blood is an important component for those hoping to participate in such studies – particularly that being conducted at the Medical College of Georgia.  We have earlier reported on this topic as well.  You may want to refer to our early posting for some basic information if you are interested.

Obviously, the implications – if these projects prove to be successful – are far-reaching. The enthusiasm of the participants in these research projects is not limited to them alone. The words of the author, Aaron Saenz, from Singularity Hub somewhat tells it all:

So we have some exciting news for cerebral palsy, and some exciting news for those thinking about cord blood. What about the rest of us? Well the MCG and Duke work has some far reaching implications. Neurological damage, whether it’s caused by oxygen deprivation or some other injury, is one of the most difficult things to heal in the body. Work in animals (like that done by Carroll on rats) show that stem cells can not only help damaged brain cells recover, but they can also replace cells that have died. We may find that stem cells therapies have a wide range of applications for many different forms of brain damage. Kurtzberg is researching many different ways cord blood could be used (autologous or through donors) to treat a variety of conditions. In other words, today stem cells conquer cerebral palsy…tomorrow, the world.

Let’s all hope that Mr. Saenz is a prophet.

Have you ever wondered how people get in clinical trials? Well, you should check this out.

Are you aware of clinical trials that may be in your neighborhood? I just happened to come across this link to clinical trials.  Perhaps you are a lot more savvy than I (which would not surprise me one bit), but you can get ongoing information on these clinical trials by going to a website called Clinical Connection.

For example, there’s one in Baltimore for overweight folks being conducted at Harbor Hospital involving a new investigational medication.

In fact, if you go to this link, you will see that there are over 15 clinical trials for all types of conditions in the Baltimore area alone. If you are willing to travel 50 miles or less, there are even more in which you can enroll.

Do you have moderate or severe pain from osteoarthritis of the hip or knee?  Well Annapolis just might the place for you to visit and try out a new drug.  You have to be  over 18 years of age and according to the website, “study participants may be compensated for time and travel. All study-related care is provided at no cost and health insurance is not required to participate.”  I don’t know what “may be compensated” means – but if you are interested, check it out.

On the national level, the home page of Clinical Connection says there are 105,555 clinical trials underway – and there’s probably at least one in your neighborhood.

Do you suffer from chronic low back pain of greater than 3 months duration? That’s right – there’s a trial for you taking place at 7 locations, including California, Arizona, Florida, Washington and Nevada.

You name the condition – there just may be some free study out there waiting for you to volunteer.

These programs undoubtedly have very extensive packets of information about the study guidelines and the risks and benefits of the drug or therapy under study.  These trials are called clinical trials since the manufacturer has presumablyjumped over the hurdles of early non-clinical research in order to take the next step – how does our product work with real people?

Make sure you understand what you are signing up for before doing so.  Who knows, it may turn out that you get some real benefit from participating – hopefully you will not be a statistic in terms of adverse outcome. Just take time to understand what you are getting yourself into and what rights you are waiving.  If you’re good to go, we wish you well!