Medical Risk Law Weekly News

Week of: April 01, 2019

IN THE NEWS


First Drug for Postpartum Depression

On March 19, 2019, the FDA granted Sage Therapeutics, Inc., approval to market Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD. Click title to continue reading...


 
MEDICAL ALERTS


Breast Implant Manufacturers Warned

On March 19, 2019, the FDA issued warning letters to two breast implant manufacturers for failure to comply with requirements to conduct post-approval studies to assess the long-term safety and risks of the manufacturers’ silicone gel-filled breast implants. Specifically, the FDA issued warning letters to Mentor Worldwide LLC (Mentor) of Irvine, California, and Sientra, Inc. (Sientra) of Santa Barbara, California. Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate the safety and effectiveness of the silicone gel-filled breast implants and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer. Click title to continue reading...



Cardiac Needle Recalled; Risk of Detached Plastic Fragments

On March 18, 2019, the FDA identified Cook Medical’s recall of its transseptal needle as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death. Click title to continue reading...



Emergency Visits for Childhood Sports-Related Traumatic Brain Injuries

On March 15, 2019, the CDC published a report that found that an estimated 283,000 children seek care in U.S. emergency departments each year for a sports- or recreation-related traumatic brain injury. Traumatic brain injuries sustained in contact sports account for approximately 45 percent of these visits. Football, bicycling, basketball, playground activities, and soccer account for the highest number of emergency department visits. Click title to continue reading...


  CASE ALERTS


“Natural Forces of Labor” Evidence Admissible; Plexus Birth Injury

A midwife delivered an infant. The midwife’s notes from the procedure showed that the midwife performed an assisted shoulder delivery and that the infant’s right arm was weak after delivery. The infant had suffered a brachial plexus injury that is most likely permanent. All five of the infant’s brachial nerve roots were either torn away from the spinal cord or ripped apart. Click title to continue reading...



No Liability for Asthma Steroid Treatment Side Effects

Beginning at the age of five and for nine years, a patient received medical care and treatment for allergies and asthma at an allergy clinic. The patient was diagnosed with allergies and asthma. The patient’s treatment involved the administration of corticosteroids. Treatment with corticosteroids ultimately resulted in the patient developing side effects including Cushing’s syndrome. Cushing’s syndrome, also called hypocortisolism, is a condition that occurs from exposure to high cortisol levels for a long time. Click title to continue reading...



No Vested Healthcare Benefits for Early Retirees

Employees who retired before age 65 during the term of a collective bargaining agreement (CBA) alleged that their former employer’s plan to terminate early retiree healthcare benefits breached the CBA and violated the Employee Retirement Income Security Act (ERISA). Click title to continue reading...


FEATURE


Complaint: Malpractice for Failure to Diagnose and Treat Lupus

As a special feature for our Premium subscribers, we have included this illustrative complaint as guidance for plaintiff’s counsel in a medical malpractice action involving the failure to diagnose and treat lupus. In this illustrative situation, a woman with a history of lupus fell at home and presented to a hospital emergency room, complaining of a fever, dizziness, facial swelling, chest tightness, troubled breathing, and one instance of fainting. The physician ordered a chest x-ray and prescribed antihistamines and pain medication. Over the woman’s objections, the physician, who suspected the woman was a drug seeker, discharged the woman. Hours later, the woman was found dead. The woman’s husband sued the physician and the hospital for wrongful death, based on a failure to diagnose and treat the woman’s lupus flare-up. Party identifying information has been redacted to protect privacy. Click title to continue reading...