Medical Risk Law Weekly News

Week of: January 14, 2019

IN THE NEWS


Essure Birth Control Safety After End of US Sales

On December 20, 2018, the FDA issued a statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure permanent birth control device following discontinuation of its U.S. sales on December 31, 2018. Dr. Gottlieb announced additional steps the FDA was taking to evaluate the product’s long-term safety profile past its scheduled discontinuation from the U.S. market following a series of earlier regulatory actions. Click title to continue reading...


 
MEDICAL ALERTS


New Treatment for Life-Threatening PNH Blood Disease

On December 21, 2018, the FDA granted Alexion Pharmaceuticals approval to market Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. Click title to continue reading...



Diagnostic Test Measures Breast Milk Nutrients

On December 21, 2018, the FDA granted Miris AB approval to market the Miris Human Milk Analyzer, a new diagnostic test to aid health care professionals in measuring nutrients in breast milk, including the concentration of fat, carbohydrate, protein, total solids, and energy. The test provides health care professionals with a new tool to aid in the nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions. Click title to continue reading...



Deadly Bypass Surgery Infections from Heater-Cooler Use

On January 4, 2019, the CDC published a report that described a series of infections related to the use of heater-cooler units during cardiopulmonary bypass surgery. The incubation period after exposure to Mycobacterium chimaera is long, with a median of 17 months and range between three and 72 months. Signs and symptoms of M. chimaera infection are generally nonspecific and include fatigue, fever, and weight loss. There is no established therapy and the fatality rate is about 50 percent. Click title to continue reading...


  CASE ALERTS


Wrong Drug, Incomplete History Requires Expert; Blood Clot

A patient presented to the emergency room (ER) complaining of a sudden onset of heart palpitations with associated shortness of breath and mild chest tightness. The ER physician diagnosed the patient with wide complex tachycardia, a very rapid heartbeat. Click title to continue reading...



Expert Opinion Based on Differential Diagnosis Admissible; Colon Rupture

About a month after a patient was admitted to a nursing home, the patient went 10 days without having a bowel movement. The nursing home did not treat the patient’s constipation until the ninth day, when the patient was given milk of magnesia. The following day, the patient was given a Dulcolax suppository because the patient still had not had a bowel movement. Click title to continue reading...



Insurer Not Required to Defend Hospital for Radiologists’ Error; Sponge

A patient underwent surgery at a hospital. The surgeon who performed the procedure had staff privileges at the hospital. The surgeon was associated with a surgical practice group. Over the next eight years, the patient complained of continuing pain and swelling at the surgical site. The patient underwent a series of investigatory procedures, including imaging studies at the hospital performed by two different radiologists. The radiologists were associated with a radiology practice group with which the hospital contracted for physician services. Click title to continue reading...


FEATURE


Interrogatories: Weight Loss Surgery Malpractice

As a special feature for our Premium subscribers, we have included illustrative interrogatories as guidance for defendant’s counsel in a medical malpractice action involving weight loss surgery. In this illustrative situation, an obese man underwent a tumescent liposuction procedure. As a result of the procedure, the man developed fulminating streptococcal necrotizing fasciitis. The man sued the surgeon for malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...