Scalpel Weekly News

Week of: May 21, 2018

IN THE NEWS


Marketing Unapproved Stem Cell Products Enjoined

On May 9, 2018, the FDA sought permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. Click title to continue reading...


 
MEDICAL ALERTS


Neurovascular Stents to Treat Unruptured Brain Aneurysms

On May 8, 2018, the FDA issued a letter to health care providers making a number of recommendations regarding the use of neurovascular stent devices in the treatment of unruptured brain aneurysms. To promote safe and effective use of neurovascular stents used for stent-assisted coiling (SAC) of brain aneurysms, the FDA provided recommendations regarding patient selection and device use. Click title to continue reading...



Cleansing Foam Causing Multistate Outbreak of B. Cepacia

On May 10, 2018, the FDA advised health professionals and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing Foam. The CDC reported 10 confirmed cases of infection caused by bacteria within the Burkholderia cepacia complex, also commonly called B. cepacia, in three states: California, Pennsylvania, and New Jersey. These patients were already hospitalized for acute conditions and acquired the infections while hospitalized. Click title to continue reading...



Increase in Deaths from Falls Among Older Adults

On May 11, 2018, the CDC published a report that found the overall rate of older adult deaths from falls increased 31 percent from 2007 to 2016 (three percent per year). Deaths from unintentional injuries are the seventh leading cause of death among older adults, and falls account for the largest percentage of those deaths. Click title to continue reading...


  CASE ALERTS


Memory Care Facility Failed to Prevent Femur Fracture

A 90-year-old woman, who used a wheelchair and suffered from dementia, behavioral disturbances, and depression, was admitted to a memory care facility for long-term care. One evening the woman was admitted to the hospital after facility staff noticed the woman’s left knee was swollen and the woman was crying in pain. Doctors at the hospital diagnosed the woman with a left femur fracture. Because of the woman’s age, rather than performing surgery, the doctors recommended immobilizing the leg. The fracture led to an open wound, which became infected, resulting in the woman’s death. Click title to continue reading...



Cosmetic Surgeon Not Qualified As Expert; Plastic Surgery

A woman was admitted to a medical center as an outpatient to undergo various plastic surgery procedures. Specifically, the plastic surgeon was to perform liposuction on both thighs, fill indentations on the woman’s hips using the excess fat removed by the liposuction, surgically narrow the woman’s nostrils, and fill in the creases on either side of the woman’s nose. Click title to continue reading...



Balance Billing Prohibition Preempted for Air Ambulance

A child injured in an automobile accident was transported to a hospital by a helicopter, also known as an air ambulance. The personal injury protection (PIP) coverage of the automobile owner’s insurance policy covered the air ambulance transportation. Seeking reimbursement for the transportation, the air ambulance provider submitted a bill for medical services to the automobile owner’s insurer. The automobile owner’s insurance policy limited reimbursement of air ambulance services to an amount determined by a fee schedule set forth in a state statute. Click title to continue reading...


FEATURE


Interrogatories: Nursing Home Resident’s Injury

As a special feature for our Premium subscribers we have included this feature containing illustrative interrogatories to be served on the defendant nursing home in a case alleging nursing home negligence resulting in injury to a resident. Click title to continue reading...