Scalpel Weekly News

Week of: July 16, 2018

IN THE NEWS


Balancing Opioid Risks With Access to Chronic Pain Treatment

On July 9, 2018, the FDA held a Patient-Focused Drug Development meeting to gather additional viewpoints directly from adult and pediatric patients living with chronic pain. This meeting was part of the FDA’s effort to balance the need to ensure appropriate and rational prescribing of opioids with the needs of patients living with serious chronic pain or coping with pain at the end of life. Click title to continue reading...


 
MEDICAL ALERTS


Revised Guidance on Testing Donated Blood for Zika Virus

On July 6, 2018, the FDA announced the availability of a revised final guidance: “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components.” This revised guidance replaced the FDA’s August 2016 guidance, which recommended universal nucleic acid testing for Zika virus of individual units of blood donated in the U.S. states and territories. The revised guidance explains that, in order to comply with applicable testing regulations, blood establishments must continue to test all donated whole blood and blood components for Zika virus using a nucleic acid test, but may use pooled testing instead of testing individual units. Click title to continue reading...



More Informative Prescription Drug and Biological Product Labeling

On July 6, 2018, the FDA issued a draft guidance for drafting the Indications and Usage section of human drug and biological product labeling. The FDA regulations require the Indications and Usage section of drug labeling to state that the drug is indicated for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition; or for the relief of the disease or condition’s symptoms. Click title to continue reading...



Occupational Exposure Limits for Heat Stress in Outdoor Workers

On July 6, 2018, the CDC published a report that found, among 25 outdoor occupational heat-related illnesses studied, occupational exposure limits were exceeded for all 14 fatalities and for over 72 percent of nonfatal illnesses. Six of the studied fatalities occurred when the Heat Index was less than 91°F. Click title to continue reading...


  CASE ALERTS


Surgeon’s Dismissal Does Not Preclude Claim against Hospital

Three patients underwent bariatric surgery performed by the same surgeon. All three experienced post-operative complications. The patients sued the surgeon and the hospital where the surgery was performed for medical malpractice. The cases were consolidated for discovery. The complaints alleged that the surgeon was negligent in surgical care. The complaints alleged the hospital was vicariously liable for the surgeon’s negligence and independently negligent in the administration of its bariatric surgery program, including its hiring, selection, and credentialing. Click title to continue reading...



Brain Cancer Misdiagnosis Leads to Removal of Healthy Lobe

A patient underwent an operation to remove a potentially malignant tumor from the base of the patient’s skull. The patient received radiation treatments and was monitored through periodic MRIs. About four and a half years after the operation, an MRI indicated some changes in the patient’s left temporal lobe. A neurosurgeon performed a biopsy of the patient’s brain. A neuropathologist found one specimen was a malignant glioma, a type of tumor that starts in the glial cells, gluey supportive cells that surround nerve cells and help them function, of the brain or the spine. Click title to continue reading...



Medicaid Act Prohibited State Lien on Future Medicals

A Medicaid recipient suffered extreme injuries in an all-terrain vehicle accident. Florida’s Medicaid program, administered by the Agency for Healthcare Administration (AHCA) paid $322,222.27 for the Medicaid recipient’s medical care. The Medicaid recipient later settled with one of multiple alleged tortfeasors for $1 million. Click title to continue reading...


FEATURE


Interrogatories to Hospital: Recovery Room Injury

As a special feature for our Premium subscribers, we have included these illustrative interrogatories to the defendant hospital in connection with a case alleging negligent post-surgical recovery room care. In this illustrative situation, a woman was transferred to the recovery room after triple bypass surgery. While in the recovery room, the surgeon ordered the removal of an intra-aortic balloon pump inserted during the triple bypass due to a malfunction. After a radiological technician removed the balloon pump and left the recovery room, the woman’s blood pressure dropped 60 points. The recovery room nurse caring for the woman took no affirmative steps to assist the woman following the dramatic drop in the woman’s blood pressure as the nurse was extremely busy and the recovery room was short-staffed that day. As a result, the woman died. The woman’s husband sued the hospital, the surgeon, the radiological technician, and the recovery room nurse. Party identifying information has been redacted to protect privacy. Click title to continue reading...