Scalpel Weekly News

Week of: October 22, 2018

IN THE NEWS


Nationwide Recall of Stem Cell Products; Adverse Reactions

On October 10, 2018, Liveyon, LLC (“Liveyon”), a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA, recalled all ReGen Series stem cell products due to reported possible adverse reactions. Liveyon marketed its ReGen Series as umbilical cord stem cells and growth factors used to improve quality of life for those suffering from debilitating diseases/disorders, such as arthritis and orthopedic indications. Click title to continue reading...


 
MEDICAL ALERTS


Vaccination Coverage in Kindergartners Continues Decline

On October 12, 2018, the CDC published a report that found that, during the 2017 to 2018 school year, median kindergarten vaccination coverage was close to 95 percent for the measles, mumps, and rubella vaccine (MMR); the diphtheria and tetanus toxoids, and acellular pertussis vaccine (DTaP); and the varicella vaccines. The overall percentage of children with a vaccination exemption increased for the third consecutive school year. The percentage of children reaching two years of age without having received any vaccinations has increased. Click title to continue reading...



Cybersecurity Updates for Implantable Cardiac Devices

On October 11, 2018, the FDA issued a safety communication to alert health care providers that Medtronic issued a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the internet connection used to download software from the Medtronic Software Distribution Network to the Medtronic CareLink and CareLink Encore Programmers, models 2090 and 29901. For the purposes of this safety communication, cybersecurity was defined as protecting patients’ medical devices and associated computers, networks, programs, and data from unintended or unauthorized threats. Click title to continue reading...



New DNA Test for Donor Blood Compatibility

On October 11, 2018, the FDA granted Progenika Biopharma S.A. approval to market ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types. ID CORE XT is the second molecular assay approved for use in transfusion medicine and the first to report genotypes as final results. Click title to continue reading...


  CASE ALERTS


Post-Operative Pneumonia; Expert Testimony

A patient underwent a left knee arthroscopy, a surgical procedure used to diagnose and treat a wide range of knee problems by allowing doctors to view the knee joint without making a large incision through the skin and other soft tissues. Shortly after surgery, the patient experienced shortness of breath. A doctor ordered a chest x-ray and placed the patient on oxygen. Two days later, the doctor discharged the patient from the hospital. Click title to continue reading...



Non-Cancerous Lung Tissue Removed; Res Ipsa Loquitur

A patient, who did not smoke, but lived with two smokers, and worked in coal mines for 30 years, presented with dyspnea, shortness of breath, and wheezing. Imaging revealed a mass in the patient’s lung. Click title to continue reading...



SSI Disability Claimant’s Right to Question Medical Consultants

A claimant filed a claim for disability benefits. At an administrative hearing, the claimant took issue with a residual functional capacity (RFC) form signed by a medical consultant, a doctor who worked for a state agency, who did not examine the claimant. The RFC form said the medical consultant reviewed the claimant’s medical records and determined that the claimant could stand for six hours in an eight-hour workday; sit for six hours in an eight-hour workday; occasionally lift 20 pounds; frequently lift 10; and frequently stoop, kneel, crouch, and crawl. Another state medical consultant reviewed the form and agreed with its conclusions. Click title to continue reading...


FEATURE


Medical Record Checklist: Meningitis Malpractice

As a special feature for our Premium subscribers, we have included this feature containing a checklist to be used by counsel for the review of medical records in preparation for the filing of a medical malpractice action involving meningitis and a related injury. In this illustrative situation, a man presented at the emergency room with a high fever, dizziness, neck stiffness, and a severe headache. Suspecting meningitis, the emergency room physician ordered a lumbar puncture and test of the man’s cerebrospinal fluid. The emergency room physician did not first order a CT scan or begin intravenous antibiotics. When the cerebrospinal fluid was extracted, pressure decreased and the man’s brain stem herniated, causing central nervous system damage. The man sued the emergency room physician for malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...