Medical Risk Law Weekly News

Week of: November 12, 2018

IN THE NEWS


New Controversial Opioid

On November 2, 2018, the FDA granted AcelRx Pharmaceuticals, Inc., authorization to market Dsuvia (sufentanil), a 30-mcg sublingual tablet for management of moderate-to-severe acute pain in a medically supervised setting. Dsuvia is delivered through a disposable, pre-filled, single-dose applicator. The use of Dsuvia is restricted to certified medically-supervised health care settings ? such as hospitals, surgical centers, and emergency departments ? for administration by a health care professional. Click title to continue reading...


 
MEDICAL ALERTS


First Direct-To-Consumer Genetic Test for Medication Metabolism

On October 31, 2018, the FDA authorized 23andMe to market the 23andMe Personal Genome Service Pharmacogenetic Reports, a direct-to-consumer test for providing information about genetic variants that may be associated with a patient’s ability to metabolize some medications to help inform discussions with a health care provider. The FDA authorized the test to detect 33 variants for multiple genes. Click title to continue reading...



FDA Disagrees with NIH on Safe Levels of Cell Phone Energy

On November 1, 2018, Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, announced that the FDA disagreed with the conclusions of the National Toxicology Program’s final report, which found “clear evidence” of carcinogenic activity in rodents exposed to radiofrequency energy. The FDA reviewed the recently finalized research conducted by the National Toxicology Program (NTP), part of the National Institute of Environmental Health Sciences within the National Institutes of Health, on radiofrequency energy exposure. Click title to continue reading...



Hepatitis A Outbreaks from Drug Use, Homelessness

On November 2, 2018, the CDC published a report that found that, during 2017, the CDC received 1,521 reports of acute hepatitis A virus (HAV) infections from California, Kentucky, Michigan, and Utah. As of October 12, 2018, more than 7,000 cases associated with this outbreak have been reported from 12 states. Click title to continue reading...


  CASE ALERTS


Compartment Syndrome from Prolonged Surgery

A patient underwent a surgical procedure known as a robotic-assisted laparoscopic prostatectomy (RALP). The RALP procedure required the patient to be positioned in the lithotomy in a steep Trendelenburg (LST) position, with the arms tucked to the side. In the lithotomy position, a patient is placed on the back with the legs up in the air and spread away from the body and with the hips flexed. In a steep Trendelenburg position, the patient’s head is positioned below the pelvis at an angle greater than 30 degrees. A patient in a lithotomy in a steep Trendelenburg position is first placed in the lithotomy position and the body is then tilted, head first, 30 degrees or more down against the floor. Click title to continue reading...



Unauthorized Medical Information Disclosure by Employees

Two employees of a health care clinic disclosed a patient’s confidential medical information to another patient without the first patient’s authorization. Click title to continue reading...



Insufficient Evidence of Back, Knee, Thumb, Bladder Disability

Seven months after being laid off, the claimant applied for Social Security disability insurance benefits and supplemental security income. The claim alleged problems with the claimant’s back, right knee, and right thumb. The alleged onset date was the date that the claimant was laid off. Click title to continue reading...


FEATURE


Defendant’s Discovery Checklist: Misdiagnosis of Aneurysm as Migraine

As a special feature for our Premium subscribers, we have included this feature containing a checklist for counsel to use in preparing to defend a medical care provider in a medical malpractice action alleging the misdiagnosis of a migraine. In this illustrative situation, a woman suffering severe headaches, nausea, stiffness of the neck, and numbness of the right arm informed a physician that something “exploded” in the woman’s head the night before the woman’s first appointment with the physician. The physician diagnosed the woman with a migraine headache and prescribed painkillers. After repeated visits to the physician, the woman was eventually hospitalized for a lumbar puncture and angiogram that revealed an aneurysm. The woman underwent surgery for the aneurysm, but, as a result of the delayed diagnosis, suffered permanent brain damage. The woman sued the physician for malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...