Medical Risk Law Weekly News

Week of: May 13, 2019

IN THE NEWS


No Ban on Breast Implants Linked to Cancer

On May 2, 2019, the FDA’s Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, announced that the FDA does not believe that textured breast implants meet the banning standard set forth in the Federal Food, Drug, and Cosmetic Act. Click title to continue reading...


 
MEDICAL ALERTS


First Dengue Disease Vaccine

On May 1, 2019, the FDA authorized Sanofi Pasteur to market Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages nine through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands. Click title to continue reading...



Serious Injuries Sleepwalking on Prescription Insomnia Drugs

On April 30, 2019, the FDA required a new boxed warning – the FDA’s most prominent warning – on certain prescription insomnia drugs to better ensure patients and healthcare professionals have the information they need when considering use of insomnia drugs. The boxed warning follows several reports of rare, but serious injuries and deaths resulting from various complex sleep behaviors after taking insomnia drugs. These complex sleep behaviors may include sleepwalking, sleep driving, and engaging in other activities while not fully awake, such as unsafely using a stove. The new warnings will be required for eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist). Click title to continue reading...



Severe Joint Pain and Physical Inactivity Among Adults with Arthritis

On May 3, 2019, the CDC published a report that found marked state-specific variations in the percentage of the population that is affected by arthritis, severe joint pain, and physical inactivity. The report also found that physical inactivity was more prevalent among persons with severe joint pain than among those with less pain. An estimated 54.4 million (approximately one in four) U.S. adults have doctor-diagnosed arthritis. Severe joint pain and physical inactivity are common among adults with arthritis and are linked to adverse mental and physical health effects and limitations. Click title to continue reading...


  CASE ALERTS


Nephrologist Liable for Dialysis Port Infection

A patient was diagnosed with kidney failure. The patient underwent surgery to create an arteriovenous (AV) fistula for vascular access on the right arm. An AV fistula is traditionally made by surgically joining an artery and a vein under the skin in the arm. After maturing for about six weeks, the vein can then receive the two needles used for each hemodialysis session. Click title to continue reading...



Administering QT-Prolonging Drugs; Failure to Administer Potassium

A patient presented to the emergency room (ER) complaining of fever, nausea, vomiting, urinary tract infection (UTI), kidney infection, gallstones, pneumonia, and critically low potassium. Critically low potassium, also known as hypokalemia, can cause an abnormal heart rhythm, known as a prolonged QT interval, and lead to cardiac arrest. Click title to continue reading...



SSA Failure to Explain Rejection of Medical Opinions; PTSD

An applicant sought disability insurance benefits and supplemental security income based on alleged physical and mental impairments. The applicant reportedly went to the dog park and ran errands with family members. Click title to continue reading...


FEATURE


Checklist: Defense Information-Malpractice for Sepsis

As a special feature for our Premium subscribers, we have included this checklist to guide defendant’s counsel in gathering necessary information from the client in a medical malpractice action involving sepsis. In this illustrative situation, a man presented at a hospital for an outpatient colonoscopy. Click title to continue reading...