Scalpel Weekly News

Week of: November 07, 2016

IN THE NEWS


Device for Prevention of Recurring Strokes Approved

The FDA on October 28, 2016, approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to have been caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale (PFO), and then traveled to the brain. Click title to continue reading...


 
MEDICAL ALERTS


Risks Added to Testosterone, Anabolic Androgenic Steroids Labels

The FDA on October 25, 2016, approved class-wide labeling changes for all prescription testosterone products, adding a new warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS). Click title to continue reading...



Higher Mortality Rate Using Driver Systems for Artificial Hearts

On October 26, 2016, the FDA provided an update and additional information regarding SynCardia Systems, Inc.'s Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System), as well as information of recent events with an additional SynCardia pneumatic driver system, the Freedom Driver System. The TAH-t functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure. There has continued to be a higher mortality rate for the subgroup of patients requiring pre-implant circulatory rescue interventions when using the C2 Driver System compared to those using the CSS Console. Click title to continue reading...



Prevalence of Inflammatory Bowel Disease Far Exceeds Estimates

Approximately three million U.S. adults are estimated to have ever received a diagnosis of inflammatory bowel disease, according to a CDC report published October 28, 2016. This is almost three times the number of adults previously estimated to have inflammatory bowel disease based on less comprehensive data sources. Click title to continue reading...


  CASE ALERTS


False Claims Act Suit Did Not Toll Medical Malpractice Statute; Prostate Surgery

A man underwent a prostatectomy, a surgical operation to remove all or part of the prostate gland. The man did not experience the recovery he hoped for following surgery. He spent nearly a year consulting with doctors regarding side effects of the surgery. Eleven months after the procedure was the man’s final appointment with a doctor from the hospital and practice group that undertook the prostatectomy. Click title to continue reading...



Choice-of-Law Analysis for Defendants in Different States; Tay-Sachs Disease Testing

Prior to their marriage, a couple sought genetic testing to determine whether they were Tay-Sachs carriers. The husband was told he was not a Tay-Sachs carrier. The couple was married and had a daughter. When the daughter was seven months old, the girl was diagnosed with Tay-Sachs disease, a genetically inherited, incurable neurological disorder. At the age of three, the girl died of Tay-Sachs disease. Click title to continue reading...



Nursing Facility Reimbursements for Legal Claims/Insurance as “Allowable Cost”

A private, for-profit corporation operated nursing homes and assisted living facilities throughout the United States, including seven locations in West Virginia. The nursing home operator was a voluntary provider of medical services through West Virginia’s Medicaid program. It received reimbursement from the Medicaid program for certain expenses related to the medical care it rendered to qualified indigent individuals and their families. Click title to continue reading...


FEATURE


Noise-Induced Hearing Loss Worksheet

As a special feature for our Premium subscribers we have included this feature containing a plaintiff’s Hearing Loss Worksheet to be used to calculate an employee’s noise-induced hearing loss. Click title to continue reading...