Scalpel Weekly News

Week of: December 03, 2018

IN THE NEWS


E. Coli Outbreak-Avoid California Romaine Lettuce

On November 20, 2018, the FDA recommended that consumers not eat romaine lettuce and discard any product containing romaine lettuce and retailers, restaurants, and other food service operators should not serve romaine lettuce. The FDA, CDC, and state and local partners, were investigating a multistate outbreak of E. coli O157:H7 likely linked to romaine lettuce. As a direct response to the outbreak, the FDA will begin a special effort to sample and test for contamination romaine lettuce throughout the market. Click title to continue reading...


 
MEDICAL ALERTS


New Treatment for Acute Myeloid Leukemia

On November 21, 2018, the FDA granted Pfizer approval to market Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy. Click title to continue reading...



Severe Worsening of MS After Stopping Treatment

On November 20, 2018, the FDA warned that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare, but can result in permanent disability. As a result, the FDA has added a new warning about this risk to the prescribing information of the Gilenya drug label and patient Medication Guide. Click title to continue reading...



Acute Flaccid Myelitis Task Force Established

On November 19, 2018, CDC Director Robert R. Redfield, M.D., announced the establishment of an Acute Flaccid Myelitis (AFM) Task Force to aid in the ongoing investigation to define the cause of, and improve treatment and outcomes for, patients with AFM. Click title to continue reading...


  CASE ALERTS


Emergency Response Immunity Inapplicable to Days Prior to Emergency

A patient sustained a serious leg injury. The patient was treated for the injury and released from the hospital. Subsequently, the patient developed a staph infection. Treatment of the staff infection required self-administration of vancomycin twice a day via a peripherally inserted central catheter (PICC) line. Vancomycin is a potent drug, which can cause serious adverse health effects when improperly administered. An incorrectly inserted PICC line creates risk the drug will infuse into the wrong portion of the body. Click title to continue reading...



Failure to Include HIPAA Authorization with Pre-suit Notice

A Tennessee statute required that a health care liability plaintiff’s pre-suit notice include a Health Insurance Portability and Accountability Act (HIPAA) compliant medical authorization permitting the health care provider receiving the notice to obtain complete medical records from every other provider that was also being sent a notice. A HIPAA compliant authorization must contain the name or other specific identification of the person or class of persons to whom the covered entity may make the requested use or disclosure. Click title to continue reading...



Failure of Insurer to Reimburse Specialty Pharmacy

A pharmacy entered into a contract with an insurer to provide covered services to patients in return for claim reimbursement by the insurer. The covered services included the distribution of a blood clotting treatment to 24 patients with hemophilia, a blood clotting disorder. Those patients were clients of a disease management company and pharmaceutical wholesaler. Click title to continue reading...


FEATURE


Complaint: Surgical Burn Malpractice

As a special feature for our Premium subscribers, we have included this illustrative complaint to be used in a medical malpractice action alleging a surgical burn. In this illustrative situation, a man underwent high-current radiofrequency ablation to treat a tumor in the man’s liver. During the procedure, the man suffered third degree burns at the site of the grounding pad. The man sued the surgeon and the hospital for malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...