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Archive for October, 2008

Brenda

Cornell Study Defines Broad Spectrum of Patients at Risk for Development of Gadolinium-Induced Complications

Published by Brenda Fulmer in Defective Design, Mass Torts, Product Liability

A September of 2008 study published in the journal Radiology, sought to further identify those patients most at risk for the development of nephrogenic systemic fibrosis (NSF) as a result of exposure to gadolinium-based contrast agents.  Nephrogenic systemic fibrosis is an incurable, devastating disease that manifests itself as significant skin thickening, widespread fibrosis, and joint contractures.  This particular disease has only one cause – contrast agents commonly used in magnetic resonance imaging (MRIs) and angiograms.

In this study, the researchers reviewed medical records for nearly 75,000 patients treated at two hospitals over a ten-year period. The study noted that standard lab measurements of renal function were helpful in identifying patients most at risk for development of NSF.  Patients with a glomerular filtration rate (eGFR) of less than 15 were at highest risk, although NSF cases were also noted in patients with eGFR scores as high as 30.  This study is consistent with others that have confirmed that a wide range of patients are at risk for development of NSF, not just those patients with advanced renal failure.  The study noted that a shocking 8.8% of patients with an eGFR of less than 15 (and not undergoing dialysis) developed NSF. The study also concluded that patients receiving the highest doses of gadolinium faced the highest risks of developing NSF .

Be Careful What You Write In An E-mail Because It Will Exist Forever Once It Is Sent.

Published by Jeff Reynolds in Uncategorized

A very dear friend once told me to be careful what you write in a letter, because it could come back to haunt you in the future.  That advice was given to me in the early 1980’s by the CEO of a company in my hometown of Reading, Pennsylvania.  We did not even have e-mail at that time, but his words certainly apply to e-mail in the year 2008.
 
Unlike ink on paper, which can fade over time, e-mail can last indefinitely.  It is also important to remember that e-mails are almost too easy to write.  A person may feel very passionately about an issue one day, and decide to write and send a fiery e-mail.  However, upon further reflection, that person may regret what he or she has stated in the e-mail.  However, once e-mail has been sent, it is very hard if not impossible to un-send or to take back those words.
 
So, I would urge whoever reads these words be quick to hear, slow to speak, and even slower to write e-mail.
 
 
 
 

Hopkins

More Pain From a Pump

Published by John Hopkins in Corporate Fraud, Defective Design, Mass Torts, Professional Liability

Patients who undergo shoulder, knee and ankle surgery often experience significant pain; particularly immediately post surgery. To try and manage that pain, physicians have often employed the use of pain pumps. These pumps inject pain killer into the body in a regulated fashion to minimize pain, while controlling the tendency toward addiction.

The pain pump is attached to a catheter, which was routinely inserted into the soft tissue near the affected joint. This use of the pump worked fine until the manufacturers of these devices started recommending that physicians could insert the catheter directly into the affected joint space and provide a much higher degree of pain relief. This was, of course, welcome news for physicians who always want to attempt to relieve or minimize the suffering of their patients. So all was good, then?

What pain pump manufacturers failed to tell physicians is that the Food & Drug Administration had never reviewed, let alone approved, the use of the pumps directly into the joint space. What the manufacturers should have known is that at least one of the manufacturer’s, McKinley Medical, asked the FDA to permit insertion of the devices into the joint space and the FDA asked for proof of efficacy. As far as we know, no data or evidence was presented to the FDA. Soon after this, Stryker Corporation purchased the exclusive rights to the pain pump from McKinley. (more…)

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