Medical Risk Law Weekly News

Week of: April 15, 2019

IN THE NEWS


Marketing Unapproved Stem Cell Products

On April 3, 2019, the FDA issued a warning letter to Cord for Life, Inc., located in Altamonte Springs, Florida, for manufacturing unapproved umbilical cord blood products in violation of current good manufacturing practice (CGMP) requirements, including failing to validate processes to prevent bacterial contamination, raising potential significant safety concerns that put patients at risk. In addition, the FDA issued 20 letters on April 3, 2019, to separate manufacturers and healthcare providers across the country who may be offering unapproved stem cell products. Click title to continue reading...


 
MEDICAL ALERTS


Seizures Following E-cigarette Use

On April 3, 2019, the FDA notified the public of reports indicating that some people who use e-cigarettes, especially youth and young adults, experienced seizures following their use. Seizures or convulsions are known potential side effects of nicotine poisoning and have been reported in scientific literature in relation to intentional or accidental swallowing of nicotine-containing e-liquids. However, a recent uptick in voluntary reports of adverse experiences with tobacco products that mentioned seizures occurring with e-cigarette use (e.g., vaping) signaled a potential emerging safety issue. An FDA review of voluntary adverse event reports for e-cigarettes submitted to the FDA and to poison control centers identified a total of 35 reported cases of seizures following use of e-cigarettes between 2010 and early 2019. Click title to continue reading...



Illegal Genetic Test to Predict Responses to Specific Drugs

On April 4, 2019, the FDA issued a warning letter to Inova Genomics Laboratory (Inova) of Falls Church, Virginia, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness. The tests claim to predict patients’ responses to specific medications based on genetic variants (pharmacogenetic tests). Selecting or changing drug treatment in response to the test results could lead to potentially serious health consequences for patients. The FDA is unaware of any data establishing that Inova’s tests can help patients or health care providers make appropriate treatment decisions for the listed drugs. Click title to continue reading...



Industry and Occupation-Specific COPD Prevalence Among Nonsmokers

On April 5, 2019, the CDC published a report that found that between 2013 and 2017, an estimated 2.4 million (2.2%) U.S. working adults eighteen and older who never smoked had COPD. The highest COPD prevalences among persons who never smoked were in the information (3.3%) and mining (3.1%) industries and office and administrative support occupation workers (3.3%). Women had higher COPD prevalences than did men. Click title to continue reading...


  CASE ALERTS


Failure to Diagnose Lung Tumor; Physician Practice Group Liability

A patient presented to the emergency room (ER) complaining of breathing difficulties. The patient was discharged later that day with an antibiotic prescription and instructions to schedule an appointment with a thoracic surgeon. The patient’s breathing difficulties worsened. The following day, the patient returned to the ER. The patient was examined and treated by two ER physicians. Despite the physician’s efforts, the patient’s condition quickly worsened and, by the following morning, the patient was pronounced dead. Click title to continue reading...



Failure to Diagnose and Treat Displaced Fractured Ribs; Jury Instructions

A patient presented to the hospital after falling at home. The patient was initially treated by the hospital’s emergency department personnel. The patient was later admitted to the hospital, where the patient was treated by hospitalists employed by one practice group. Click title to continue reading...



No Long-Term Disability Benefits for Attorney with Migraines

An attorney stopped working due to intractable migraines. The attorney applied for disability benefits through the law firm’s insurer. Click title to continue reading...


FEATURE


Interrogatories to Plaintiff: Rheumatoid Arthritis Malpractice

As a special feature for our Premium subscribers, we have included illustrative interrogatories as guidance for defense counsel in a medical malpractice action involving a patient’s misdiagnosed rheumatoid arthritis. In this illustrative situation, a young man presented to his primary care physician on multiple occasions, complaining of fatigue, as well as pain, swelling, and stiffness in various joints. Click title to continue reading...