Medical Risk Law Weekly News

Week of: January 07, 2019

IN THE NEWS


Dangerous Unapproved Stem Cell Products Put Patients at Risk

On December 20, 2018, the FDA issued a warning letter to Genetech, Inc., of San Diego, California, and its president, Edwin N. Pinos, for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing serious blood infections in patients. Genetech processed umbilical cord blood into unapproved human cellular products, which were distributed by Liveyon, LLC. Click title to continue reading...


 
MEDICAL ALERTS


Regulation of Products Containing Cannabis, Cannabis Compounds

On December 20, 2018, the FDA announced that the FDA would continue enforcing the law to protect patients and the public while providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds. The Agriculture Improvement Act of 2018 changed certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes included removing hemp from the Controlled Substances Act, which means that hemp will no longer be an illegal substance under federal law. Click title to continue reading...



First Treatment for Rare Bone Marrow and Blood Disease

On December 21, 2018, the FDA granted Stemline Therapeutics approval to market Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older. Click title to continue reading...



Big Increase, Geographic Spread of Synthetic Opioid-Related Deaths

On December 21, 2018, the CDC published a report that found that U.S. overdose death rates linked to synthetic opioids, likely from illicitly manufactured fentanyl (IMF), increased more than 45 percent from 2016 to 2017, while death rates from heroin and prescription opioids – still far too high – remained stable. More than 702,000 Americans have died from drug overdoses from 1999 to 2017 – about 10 percent of them in 2017 alone. Click title to continue reading...


  CASE ALERTS


Proof Required of Willful and Wanton Negligence for Emergency Obstetrical Claim

A patient elected to have labor induced at 39 weeks of pregnancy. The patient checked into the hospital’s obstetrical unit the evening before the scheduled procedure. The infant had difficulty moving through the birth canal. The obstetrician used forceps to deliver the infant’s head, but the infant’s shoulder became stuck in the pelvis, a complication called shoulder dystocia. After other maneuvers failed, the obstetrician reached into the birth canal and physically pulled the infant’s arm across the infant’s chest, dislodging the shoulder. The infant was soon delivered, but the infant suffered injuries to the network of nerves that runs through the shoulder. Click title to continue reading...



Anesthesiologist Failure to Relay Abnormal Test Results to Surgeons

A large mass developed in the back of a patient’s head. The patient’s primary care physician diagnosed the mass as a tumor and referred the patient to a neurosurgeon. The neurosurgeon believed the tumor to be an osteosarcoma, a malignant type of bone cancer that begins in the cells that form bones. The neurosurgeon did not order a biopsy of the tumor. Imaging studies of the tumor showed it had invaded the patient’s skull and could soon begin to press upon the brain. Click title to continue reading...



Insurer Not Liable for Alleged Benefit Payment Delay

An insured obtained a supplemental cancer insurance policy from an insurer. The supplemental cancer insurance policy limited coverage to any loss resulting from definitive cancer treatment with the requirement that pathologic proof of cancer must be submitted. Benefits were payable for expenses incurred by an insured from 10 days preceding the date of a positive diagnosis of cancer or from the first day of the period of hospital confinement during which the positive diagnosis was made, whichever was more favorable to the insured. The policy stated that the insurer would send forms for filing proof of loss following notice of a claim. The insurer would then pay benefits due under the policy after receiving proof of the loss established through a written statement of the nature and extent of the loss. Click title to continue reading...


FEATURE


Complaint: Weight Loss Surgery Malpractice

As a special feature for our Premium subscribers, we have included this illustrative complaint as guidance for plaintiff’s counsel in a medical malpractice action involving weight loss surgery. In this illustrative situation, an obese woman underwent gastric bypass surgery. As a result of the procedure, the woman suffered a stomach leak. The stomach leak led to bacterial peritonitis. The woman intends to sue the surgeon for malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...