Scalpel Weekly News

Week of: September 26, 2016

IN THE NEWS


FDA Approval of First Drug for Duchenne Muscular Dystrophy

On September 19, 2016, the FDA approved the first drug approved to treat patients with Duchenne muscular dystrophy (DMD), Exondys 51 (eteplirsen) injection. Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD. Exondys 51 is made by Sarepta Therapeutics of Cambridge, MA. Click title to continue reading...


 
MEDICAL ALERTS


Balloon Device for Persistent Ear Tube Dysfunction

The FDA, on September 16, 2016, permitted marketing of a device that uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear. The Aera Eustachian Tube Balloon Dilation System is manufactured by Acclarent, Inc. of Irvine, CA. Click title to continue reading...



Hyoscyamine Sulfate Recalled Due to Superpotent and Subpotent Test Results

On September 15, 2016 Virtus Pharmaceuticals Opco II, LLC of Tampa, FL, is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form. This recall is being initiated due to both superpotent and subpotent test results. All of these batches were manufactured by Pharmatech LLC for distribution by Virtus throughout the United States and Puerto Rico. Click title to continue reading...



Quarter of Older Adults Do Not Engage in Regular Physical Activity; Risk of Disease

Despite the many benefits of moderate physical activity, 31 million Americans (28 percent) age 50 years and older are inactive – that is, they are not physically active beyond the basic movements needed for daily life activities. This puts them at risk for heart disease, diabetes and cancer. This finding comes from a new study from the CDC published in the September 15, 2016 Morbidity and Mortality Weekly Report. Click title to continue reading...


  CASE ALERTS


Medical Center Default Judgment; Service Questioned; Patient Death

A woman was admitted to a medical center for gastrointestinal bleeding. Seven weeks later she underwent subtotal gastrectomy surgery, the surgical removal of all or part of the stomach. Following surgery, the woman contracted sepsis and passed away two weeks after the surgery while still in the medical center’s care. Click title to continue reading...



Neurological Deficits and Chronic Pain Due to Cervical Epidural Steroid Injection

A 43-year-old woman began experiencing pain and stiffness in her neck and tingling in her fingers. Her family physician first prescribed physical therapy, which failed to produce any lasting relief. The woman’s family physician referred her to a surgical center for pain management. Following a brief effort to treat her condition with medication, a physician at the surgical center gave the woman a cervical epidural steroid injection (CESI), which provided her with six to seven months of relief. Click title to continue reading...



Negligent Treatment of Rectal Prolapse Led to Bowel Incontinence and Blockages

A woman developed an intermittent rectal prolapse, a condition in which the rectum (the last part of the large intestine before it exits the anus) loses its normal attachments inside the body, allowing it to telescope out through the anus, thereby turning it inside out. The rectal prolapse would come out when the woman was on her feet for a lengthy amount of time. It was extremely painful and she would have to go to the restroom to reinsert it. Click title to continue reading...


FEATURE


Plaintiff's Expert Designation: Malpractice Involving Breast Resurgery After Reconstruction

As a special feature for our Premium subscribers we have included this feature containing an illustrative Plaintiff’s Expert Designation in a malpractice and lack of informed consent action involving breast resurgery after reconstruction on the wrong breast. The expert witness designation contains information on what the expert will testify to concerning the standard of care, causation, and damages, and that the expert’s opinions will be expressed to a reasonable degree of medical probability. Click title to continue reading...