Medical Risk Law Weekly News

Week of: April 22, 2019

IN THE NEWS


FDA Warning; Unapproved Concussion Assessment Apps

On April 10, 2019, the FDA warned the public not to use medical devices marketed to consumers that claim to help assess, diagnose, or manage head injury, including concussion, traumatic brain injury (TBI), or mild TBI. The FDA warned that such tools — such as smartphone apps marketed to coaches or parents for use during sporting events — have not been reviewed by the FDA for safety and efficacy and could result in an incorrect diagnosis, potentially leading to a person with a serious head injury returning to normal activities instead of getting medical care. Click title to continue reading...


 
MEDICAL ALERTS


New Osteoporosis Drug for High Fracture Risk Women

On April 9, 2019, the FDA granted Amgen approval to market Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies. Click title to continue reading...



Prevalence and Characteristics of Autism Spectrum Disorder

On April 12, 2019, the CDC published a report that found that, the overall autism spectrum disorder (ASD) prevalence was 13.4 per 1,000 children aged four years in 2010, 15.3 in 2012, and 17.0 in 2014. Click title to continue reading...


  CASE ALERTS


$13.5 Million for Transvaginal Mesh Product Liability

A patient experienced back pain caused by uterine fibroids and stress urinary incontinence (SUI). SUI is a chronic condition that causes urine to leak involuntarily during everyday activities such as laughing, coughing, sneezing, and exercise. Click title to continue reading...



Paralysis after Epidural Steroid Injection

A patient was injured in a car accident. When the patient’s neck, shoulder, and back pain did not subside after several weeks, the patient obtained an MRI, which revealed disc herniations in the lower cervical spine. Click title to continue reading...



Limited Health Insurance Coverage for Prosthetics

An insured was involved in a catastrophic farming accident which left the insured severely injured. The injuries required the insured to undergo a bilateral knee amputation. The left leg was amputated above the knee. The right leg was amputated below the knee. Click title to continue reading...


FEATURE


Damages Checklist: Malpractice for Failure to Diagnose and Treat Lupus

As a special feature for our Premium subscribers, we have included this damages checklist as guidance for counsel in a medical malpractice action involving the failure to diagnose lupus. This checklist can also be used by health care facility risk managers to assess potential liability and damages associated with diagnosing and treating lupus and to create policies to prevent liability and mitigate damages. Click title to continue reading...