Scalpel Weekly News

Week of: August 27, 2018

IN THE NEWS


Generic EpiPen; Emergency Treatment for Allergic Reactions

On August 16, 2018, the FDA permitted Teva Pharmaceuticals USA to market the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injectors in 0.3 mg and 0.15 mg strengths for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Click title to continue reading...


 
MEDICAL ALERTS


Temporary Total Artificial Heart Companion; Stroke, Death Risk

On August 17, 2018, the FDA recommended health care providers carefully consider newly discovered risks of stroke and death before making treatment decisions regarding SynCardia Systems’ Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). The recommendation was based on the FDA’s review of the final results from the post-approval study conducted by SynCardia for its TAH-t C2 Driver System. These final results indicated a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console. Click title to continue reading...



Transcranial Magnetic Stimulation for OCD Treatment

On August 17, 2018, the FDA permitted Brainway Ltd. to market the Brainsway Deep Transcranial Magnetic Stimulation System for the treatment of obsessive compulsive disorder (OCD). Click title to continue reading...



One in Four U.S. Adults Disabled

On August 16, 2018, the CDC published a report that found that one in four U.S. adults – 61 million Americans – have a disability that impacts major life activities. This is an increase from 2013, when one in five U.S. adults reported a disability. Click title to continue reading...


  CASE ALERTS


Heart Patient Died Before Surgery; Lack of Informed Consent

A cardiologist referred a patient to an interventional cardiologist for a cardiac catheterization. The patient was admitted to the hospital to undergo the cardiac catheterization. The interventional cardiologist discovered that three of the patient’s coronary arteries were blocked, including 95 percent of the right coronary artery. The interventional cardiologist diagnosed the patient with multivessel coronary artery disease and determined that the patient needed to undergo coronary artery bypass graft (CABG) surgery. The interventional cardiologist then advised the patient of at least some of the various risks and benefits associated with discharge, as well as the alternatives to leaving the hospital. The interventional cardiologist then referred the patient to a cardiac surgeon and discharged the patient from the hospital. Following the patient’s release, the interventional cardiologist was no longer involved in the patient’s care or treatment. Click title to continue reading...



Plaintiff May Amend Defective Expert Certification if Expert Review Timely

A patient underwent a laparoscopic hysterectomy. The procedure was performed by a physician who practiced in the area of obstetrics and gynecology, an OB/GYN. The patient sustained an injury to the right ureter. Click title to continue reading...



Non-Emergency Air Ambulance Not Covered Without Pre-Certification

An employer enrolled an employee’s family in its employee benefit plan. The coverage began on the employee’s hire date, but required about 15 business days to process enrollment paperwork. The plan provided that claims made during those 15 business days may be denied, but would be adjusted when the insurer processed the employee’s benefit selections data. Click title to continue reading...


FEATURE


Physician Deposition - Urological Malpractice

As a special feature for our Premium subscribers, we have included this feature containing illustrative questions to ask when deposing the treating physician in an action for negligent treatment of a urological disorder or urinary dysfunction. In this illustrative situation, a man sought treatment from a urologist due to the presence of blood in the man’s urine. The urologist performed diagnostic ureteroscopy. During the procedure, the urologist punctured the man’s right ureter. Following the procedure, the man developed persistent pain in the abdomen and a high fever. Follow-up testing revealed that the ureter had been punctured. The man sued the urologist for malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...