Scalpel Weekly News

Week of: April 09, 2018

IN THE NEWS


Fully Interoperable Continuous Glucose Monitoring System

On March 27, 2018, the FDA permitted Dexcom, Inc., to market the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes. This is the first type of continuous glucose monitoring system permitted by the FDA to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters, or other electronic devices used for diabetes management. Click title to continue reading...


 
MEDICAL ALERTS


New Leukemia Treatment for Patients with Relapse Risk Factor

On March 29, 2018, the FDA granted Amgen Inc. accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen under a microscope. In patients who have achieved remission after initial treatment for this type of ALL, the presence of MRD means they have an increased risk of relapse. Click title to continue reading...



Nationwide Recall of Contaminated Topical Drug Products

On March 30, 2018, MarcasUSA, LLC and Industria Farmacéutica Andromaco, S.A. de C.V. recalled four lots of Pasta De Lassar Andromaco Skin Protectant, 25 percent zinc oxide. FDA analysis confirmed that Pasta De Lassar Andromaco was contaminated with high levels of yeast, mold, and bacteria. Click title to continue reading...



Increasing Diabetic Ketoacidosis Hospitalization Rates

On March 30, 2018, the CDC published a report that found that, between 2009 and 2014, hospitalization rates for diabetic ketoacidosis increased, most notably in people under the age of 45. Diabetes is a common chronic condition and as of 2015, approximately 30 million persons in the United States had diabetes (23 million with diagnosed and 7 million with undiagnosed). Click title to continue reading...


  CASE ALERTS


Failure to Establish Clinical Study Participation Caused Injuries

The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) was created to analyze the effects of differing oxygen saturation levels on premature infants. At the time of the study, the standard of care was to keep the oxygen saturation levels of low-birth-weight infants at between 85 percent and 95 percent. Click title to continue reading...



Standard of Care Expert Not Required to Testify To Methodology

A 67-year-old man underwent a coronary artery bypass. During the procedure, the heart surgeon placed a chest tube into the man’s anterior mediastinum, the area of the central compartment of the thoracic cavity in front of the heart, to monitor any postoperative internal bleeding and to drain blood and serum from under the breastbone. Through a separate incision, the coronary artery bypass was performed. Click title to continue reading...



Duplicate Payment from Auto and Health Insurance Policies

A couple was injured in a motor vehicle accident. The couple had health insurance coverage. The couple also had an automobile insurance policy that included medical payments coverage of $25,000 per person. The automobile insurance policy stated that it covered payment of reasonable expenses incurred for necessary medical services related to bodily injury caused by an accident and sustained by an insured. Click title to continue reading...


FEATURE


Complaint: Retained Surgical Item Injury

As a special feature for our Premium subscribers, we have included this feature containing an illustrative complaint involving a retained surgical item injury. In this illustrative situation, a man underwent surgery, suffered post-surgical pain and infection, and underwent an additional surgery to remove a piece of gauze used during the original surgery. The man sued the surgeon and the hospital for medical malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...