Scalpel Weekly News

Week of: July 30, 2018

IN THE NEWS


U.S. Essure Birth Control Device Sales Stopped; FDA Scrutiny

On July 20, 2018, the FDA was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018. The company stated its decision to halt sales and distribution of the device was due to commercial reasons. Bayer’s decision to discontinue sales of Essure followed three years of FDA scrutiny. Click title to continue reading...


 
MEDICAL ALERTS


Expanded Use of Breast Cancer Drug; New Oncology Drug Review

On July 18, 2018, the FDA expanded the approval granted Novartis Pharmaceuticals Corporation to market Kisqali (ribociclib) in combination with an aromatase inhibitor for the initial endocrine-based treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Aromatase inhibitors (AIs) are a class of drugs used in the treatment of breast cancer in postmenopausal women. The FDA also approved Kisqali in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy. Click title to continue reading...



Targeted Treatment; Acute Myeloid Leukemia with Genetic Mutation

On July 20, 2018, the FDA granted Agios Pharmaceuticals, Inc., approval to market Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The FDA simultaneously granted Abbott Laboratories approval to market the RealTime IDH1 Assay, a companion diagnostic test used to detect specific mutations in the IDH1 gene in patients with AML. Tibsovo is approved for use with the RealTime IDH1 Assay. Click title to continue reading...



Residential Care Community Residents with Advance Directives

On July 20, 2018, the CDC published a statistical analysis that showed, in 2016, 77.9 percent of residents in residential care communities had an advance directive documented in their files. An advance directive is a written statement of a person’s wishes regarding medical treatment made to ensure those wishes are carried out should the person be unable to communicate them to a health care provider. Click title to continue reading...


  CASE ALERTS


Failure to Diagnose Cancer; Podiatrist

A patient saw a podiatrist for evaluation of a soft-tissue mass on the bottom of the patient’s foot. The podiatrist aspirated bloody fluid from the mass. The podiatrist did not send the fluid to a cytology lab, which would have evaluated the specimen for the detection of cancer, precancerous changes, and other benign conditions. Click title to continue reading...



Expert Testimony Excluded; Patient Did Not Take Drug As Directed; DVT

A patient’s primary care physician diagnosed the patient with hypogonadism, reduction or absence of hormone secretion or other physiological activity of the testes. The physician prescribed a topical gel containing one percent testosterone. The patient refilled the prescription only three times over the course of two years, so the patient did not have enough of the drug to take a full daily dose during the time period. When the patient did use the drug, the patient did so incorrectly. Click title to continue reading...



Disability Insurance Benefits for Chronic Back Pain

A man with a history of lower back pain underwent disc fusion surgery on the lumbar spine. Four years later, the man underwent surgery to repair the rod that fused the lumbar spine. The man continued to experience nearly constant back pain. Click title to continue reading...


FEATURE


Discovery Checklist: Recovery Room Injury

As a special feature for our Premium subscribers, we have included this checklist for plaintiff’s counsel to formulate discovery requests in a case alleging negligent post-surgical recovery room care. In this illustrative situation, a woman was transferred to the recovery room after triple bypass surgery. While in the recovery room, the woman became hypotensive. The recovery room staff caring for the woman failed to recognize that the woman was in distress. The recovery room staff were extremely busy and the recovery room was short-staffed that day. As a result, the woman went into shock and died. The woman’s children sued the hospital, the surgeon, the anesthesiologist, and the recovery room nurse. Party identifying information has been redacted to protect privacy. Click title to continue reading...