Scalpel Weekly News

Week of: December 18, 2017

IN THE NEWS


New Follow-On Short-Acting Insulin to Treat Diabetes

On December 11, 2017, the FDA approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged three years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway). Click title to continue reading...


 
MEDICAL ALERTS


Osteoarthritis Supplement Linked to Life-Threatening Problems

On December 5, 2017, the FDA alerted the public that it was investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis. Click title to continue reading...



Alcohol Prep Pads Recall; Lack of Sterility Assurance; Quality Issues

On December 5, 2017, Simple Diagnostics recalled three lots of Pharmacist Choice Alcohol Prep Pads due to the lack of sterility assurance and other quality issues. The recalled lots were manufactured by Foshan Flying Medical Products Co. Ltd., located in China. Click title to continue reading...



Cardiac Death at Birth; Screening for Congenital Heart Disease

On December 5, 2017, the CDC announced a report finding that infant deaths from critical congenital heart disease (CCHD) decreased more than 33 percent in eight states that mandated screening for CCHD. In addition, deaths from other or unspecified cardiac causes decreased by 21 percent in the states that mandated CCHD screening. Click title to continue reading...


  CASE ALERTS


Patient Profile Attributing Issues to Hospital Care Triggered Statute of Limitations

A 55-year-old woman presented to the emergency room (ER) complaining of dizziness, vomiting, and an inability to stand. Blood tests revealed that the woman’s blood sodium level was a critically low 97 mEq/L. Intravenous fluids were administered to correct the woman’s sodium levels. The woman was admitted to the intensive care unit (ICU). Click title to continue reading...



Blood Clot Filter Imbedded in Vein; No Standard of Care Evidence

A man was injured when the man fell from a roof, fracturing both heels and a vertebra. The man’s injuries required several surgeries, a 17-day stay in the hospital, and a subsequent period of immobilization. Prior to surgery, the hospital’s orthopedic surgeon ordered that a retrievable blood clot filter be placed in the man’s inferior vena cava (IVC), a large vein leading to the heart. Click title to continue reading...



Workers’ Compensation Shoulder Injury; Independent Medical Exam

A man was working when the man fell out of a truck. The man was diagnosed with a shoulder sprain, an open wound of the forehead, a head injury, and a wrist sprain. An x-ray revealed a small lesion in the proximal humerus with no evidence of fracture or dislocation. Click title to continue reading...


FEATURE


Complaint: Experimental Treatment Malpractice

As a special feature for our Premium subscribers we have included this feature containing an illustrative complaint for malpractice in the administration of an experimental treatment. In this illustrative situation, a woman participated in a physician’s experimental treatment study and was injured as a result of the experimental treatment involving chemicals and medications. Click title to continue reading...