Scalpel Weekly News

Week of: December 22, 2014

IN THE NEWS


FDA Standards for Drug Labeling: Pregnant and Breastfeeding Women

The FDA published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding. Click title to continue reading...


 
MEDICAL ALERTS


Urgent Recall of Clot Monitoring System-Possible Inaccurate Results

The manufacturer of the Alere INRatio and INRatio2 PT/INR Monitor system warns this system should not be used to test certain medical conditions. In certain cases an INRatio and INRatio2 PT/INR Monitor system may provide an international normalized ratio (INR) result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions or can occur if the instructions for performing the test are not followed. Click title to continue reading...



Potentially Fatal Skin Reactions to Antipsychotic Drug

The FDA warned that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body. A new warning has been added to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Click title to continue reading...



Bacteria in Water Birth Pose Hazard; Legionnaires’ Disease

In 2014, a fatal infection with Legionella pneumophila serogroup 1 occurred in a neonate after water birth. The death highlighted the need for infection control education, client awareness, and standardization of cleaning procedures in midwife facilities. Click title to continue reading...


  CASE ALERTS


Hospital Vicarious Liability for Physician and Care Team; Compartment Syndrome

A man underwent a complex, six-hour, cardiac surgery. The doctor who performed the procedure went on vacation four days later. In his absence, other doctors assumed the role of the man’s primary physician. Click title to continue reading...



Damages Cannot Be Setoff by Settlements of Codefendants Without Fault

A man presented at a hospital emergency room with a severe nosebleed where he was treated and discharged. He returned the next month with the same symptom. A doctor examined him and recommended surgery. In an operation performed the same day, the doctor ran a catheter through an artery in the man’s leg up into his nose. Tiny particles were injected through the catheter to irreversibly block certain blood vessels. When the man awoke after surgery, he was permanently blind in one eye. Click title to continue reading...



Treble Interest, Attorney's Fees Award for Insurer’s Computer Review, Delayed Payment

A woman was in a car accident in which she was injured. She required medical treatment. The car in which she was a passenger was covered by a standard Massachusetts automobile insurance policy (auto policy) issued by an insurer. The insurer received a personal injury protection (PIP) benefits application approximately 90 days after the accident. About 90 additional days thereafter the insurer received treatment records and bills from a doctor for five different dates of treatment. Click title to continue reading...