Scalpel Weekly News

Week of: January 02, 2017

IN THE NEWS


New Warnings for General Anesthetic and Sedation Drugs for Children, Pregnant Women

On December 14, 2016, the FDA issued a warning regarding the repeated or lengthy use of general anesthetic and sedation drugs to put children younger than three years old or pregnant women in their third trimester into a deep sleep to prevent pain during surgery or procedures. The warning, which covers drugs injected into a vein or breathed in through a mask, indicated that such use of general anesthetic and sedation drugs may affect the development of children’s brains.  Click title to continue reading...


 
MEDICAL ALERTS


FDA Accelerated Approval for Ovarian Cancer Treatment

On December 19, 2016, the FDA granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca was approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA), as identified by an FDA-approved companion diagnostic test. Click title to continue reading...



Mental Health Side Effects Label Warning Removed for Anti-Smoking Drugs

On December 16, 2016, the FDA removed from the Chantix (varenicline) drug label and the Zyban (bupropion) drug label the Boxed Warning, the FDA’s most prominent warning, for serious mental health side effects. The existing warning section on both labels that described the side effects on mood, behavior, or thinking, was also updated to include the results from the clinical trial. Chantix and Zyban are prescription medicines that are FDA-approved to help adults quit smoking. Click title to continue reading...



Estimates of Birth Defects Following Zika Virus Infection

On December 15, 2016, the CDC published a report regarding birth defects potentially related to Zika virus infection during pregnancy.  Based on a review of preliminary data from the US Zika Pregnancy Registry (USZPR), CDC scientists estimate that six percent of completed pregnancies following Zika virus infection were affected by one or more birth defects potentially related to Zika virus infection during pregnancy. Click title to continue reading...


  CASE ALERTS


Arbitration Agreement Against Public Policy; Excluded Statutory Provisions; Stillbirth

Thirty-nine weeks into a woman’s pregnancy, the woman began experiencing contractions. The woman was turned away from her obstetrician’s appointment because the woman arrived a few minutes late for a scheduled appointment. The obstetrician’s practice group rescheduled the woman’s appointment for four days later. Three days later, the woman delivered a stillborn son. Click title to continue reading...



Informed Consent for Failure to Disclose Rare, but Serious, Complication of Epidural

A man suffered from back pain. He sought treatment from an orthopedic surgeon. Following an MRI, the orthopedic surgeon informed the man that he had a large herniated disc. The orthopedic surgeon referred the man to a back pain practice group for epidural injections. Click title to continue reading...



Accidental Death Insurance Covered DVT after Achilles Tendon Injury

A 31-year-old man was employed by a company that had obtained accidental death and dismemberment insurance coverage for its employees. The policy limited coverage to bodily injuries that result directly from an accident and independently of all other causes. Click title to continue reading...


FEATURE


Discovery Motion-Infant Glaucoma

As a special feature for our Premium subscribers we have included this feature containing an illustrative Affirmation in Support of Discovery Motion in a medical malpractice action involving an infant’s congenital glaucoma. In this illustration, the Chair of an eye institute’s ophthalmology department conducted an “investigation” and compiled a file regarding this investigation. Click title to continue reading...