Scalpel Weekly News

Week of: November 19, 2018

IN THE NEWS


New OTC Primatene Mist for Mild Asthma Approved

On November 7, 2018, the FDA granted Amphastar Pharmaceuticals authorization to market Primatene Mist, a metered-dose epinephrine inhalation bronchodilator suspension. Metered-dose inhalers deliver an aerosolized dose of medication to the lungs. This over-the-counter (OTC) inhaler is intended to provide temporary relief for symptoms of mild, intermittent asthma including wheezing, tightness of the chest, and shortness of breath. Click title to continue reading...


 
MEDICAL ALERTS


First Ebola Fingerstick Test with Portable Reader

On November 9, 2018, the FDA issued an emergency use authorization (EUA) to Chembio Diagnostic Systems, Inc., to market the DPP Ebola Antigen System, a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus) used with blood specimens, including capillary “fingerstick” whole blood, from individuals with signs and symptoms of Ebola virus disease (EVD) in addition to other risk factors, such as living in an area with large numbers of EVD cases and/or having contact with other individuals exhibiting signs and symptoms of EVD. This is the second Ebola rapid antigen fingerstick test available under an EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated. Click title to continue reading...



New Inspection Protocol for Sterile Injectable Drugs

On November 9, 2018, the FDA announced new steps to modernize its pharmaceutical manufacturing inspections program with a new way of assessing, recording, and reporting the data from surveillance and pre-approval inspections for sterile drug products. Click title to continue reading...



Arthritis Activity Barrier and Diabetes Risk

On November 9, 2018, the CDC published a report that found that an estimated 54.4 million U.S. adults have doctor-diagnosed arthritis (arthritis). This number is projected to rise to 78.4 million by 2040. Physical inactivity and obesity are two factors associated with an increased risk for developing type 2 diabetes, and arthritis has been determined to be a barrier to physical activity among adults with obesity. Approximately half of adults with both prediabetes and arthritis are either physically inactive or have obesity, further increasing their risk for type 2 diabetes. Click title to continue reading...


  CASE ALERTS


Physician to Physician Communication Not Defamatory; Opioid Abuse

A patient was under the care of a physician at a clinic. The patient suffered from chronic back pain for which the physician prescribed opioid pain medications. The patient was required to comply with the clinic’s pain management policy. Under the terms of the policy, if the patient used any illegal substances, the physician was permitted to stop prescribing pain medications. The patient was required to submit to monthly drug screenings, performed by an outside lab, which tested for illegal or non-prescribed drugs. The patient signed the policy. Click title to continue reading...



Lost Chance to Save Arm, Toes from Amputation; Necrotizing Fasciitis

A patient fell and injured the patient’s right arm. Seven days later, the patient’s condition had not improved. The patient presented to an urgent care clinic. The patient was seen by a physician’s assistant (PA). The PA ordered an x-ray of the patient’s arm. The x-ray showed no broken bones. The PA noted swelling, bruising, tenderness, and limited range of motion in the patient’s right arm. The patient’s temperature was 99.7. The patient felt at risk of fainting. The PA gave the patient a shot for pain and a prescription for pain medication. The patient was advised to follow up with the patient’s regular physician in two days if the condition did not improve. Click title to continue reading...



ALJ Impermissibly Discounted Treating Neurosurgeon’s Opinion

A claimant applied for disability insurance benefits based on a degenerative back condition that required two surgeries. The administrative law judge (ALJ) concluded the claimant was not disabled. The ALJ determined that (1) the claimant had not engaged in substantial gainful employment since the alleged onset date; (2) the claimant’s degenerative disc disease of the lumbar spine with history of remote surgeries and obesity were severe impairments; (3) these conditions did not equal a listed impairment; (4) the claimant had the residual functional capacity to perform light work, except that the claimant could not climb ladders, ropes, or scaffolds and could occasionally climb ramps or stairs, balance, stoop, kneel, crouch, and crawl; and (5) the claimant could work as a wire assembler, assembly press operator, circuit board screener, or finish assembler. Click title to continue reading...


FEATURE


Checklist: Damages for Misdiagnosis of Aneurysm as Migraine

As a special feature for our Premium subscribers, we have included this checklist for counsel to use in connection with a medical malpractice action alleging the misdiagnosis of an aneurysm as 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 taken to the emergency room and was 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 and the emergency room physician for malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...