Scalpel Weekly News

Week of: April 11, 2016

IN THE NEWS


Urogynecologic Mesh May Contain Counterfeit Raw Material

On April 1, 2016, the FDA announced that it was made aware of allegations that Boston Scientific's urogynecologic surgical mesh may contain counterfeit raw material. The agency is examining these allegations to determine any necessary and appropriate next steps. The FDA is currently not aware that the alleged counterfeit raw material contributes to adverse events associated with these products. Click title to continue reading...


 
MEDICAL ALERTS


FDA Proposes Limit for Inorganic Arsenic in Infant Rice Cereal

On April 1, 2016, the FDA announced that it is taking steps to reduce inorganic arsenic in infant rice cereal, a leading source of arsenic exposure in infants. Relative to body weight, rice intake for infants, primarily through infant rice cereal, is about three times greater than for adults. Moreover, national intake data show that people consume the most rice (relative to their weight) at approximately eight months of age. Click title to continue reading...



Dextrose Injection Recall Due to Container Leaks and Microbes

On March 28, 2016, B. Braun Medical Inc. of Irvine, CA recalled one lot of 5% Dextrose Injection USP 100/150mL in PAB container (Lot #J5J706, catalog #S5104-5264, NDC 0264-1510-32) to the consumer level. B. Braun recently identified an adverse quality trend in customer complaints reporting that some containers in lot J5J706 exhibited leakage and, in a few instances, visible particulate matter identified to be microbial growth. Click title to continue reading...



Estimated Autism Spectrum Disorder Prevalence Unchanged

According to a CDC report published April 1, 2016, an estimated 1 in 68 (14.6 per 1,000) school-aged children have been identified with autism spectrum disorder (ASD). This report shows essentially no change in ASD prevalence, the proportion of school aged-children with ASD, from the previous report released in 2014. However, it is too soon to know whether ASD prevalence in the United States might be starting to stabilize. The CDC will continue tracking ASD prevalence to better understand changes over time. Click title to continue reading...


  CASE ALERTS


Claim Against State Waived Medical Negligence Claim Against State Employee

A man injured his right leg. As part of his treatment, he was scheduled to undergo a surgery that involved the taking of a bone graft from the iliac crest of his hip. Because he had recently undergone another surgery to repair a right lower quadrant ventral hernia, he and his parents made it repeatedly known to his treating doctors, including a surgical resident, that he did not want the bone graft to be taken from his right hip in the surgery. Notwithstanding these instructions, an incision was made into the man’s right hip during surgery in an attempt to take the bone graft. Click title to continue reading...



Over $11M for Products Liability in Pelvic Organ Prolapse Transvaginal Mesh Repair

A woman suffered from pelvic organ prolapse (POP), which occurs when pelvic floor muscles become weak or dysfunctional and cease supporting the organs in the pelvic area, causing connective tissue attachments to stretch or break and organs to become displaced. If noninvasive treatments are not effective, there are various surgical options for POP. One option is to use polypropylene mesh to support the vagina. Click title to continue reading...



PIP Policy Gave Notice of Medicare Fee Schedule Use to Limit Reimbursement

An insurer issued separate automobile insurance policies, with Personal Injury Protection (PIP) insurance benefits, to a man and a woman. An endorsement in each policy added the following provision. Click title to continue reading...


FEATURE


Petition-Failure to Diagnose Malaria

As a special feature to our Premium subscribers we have included this feature containing an illustrative Petition for the failure to diagnose and treat malaria. The petition claims include the medical negligence of a physician and hospital, gross negligence, and vicarious liability. Click title to continue reading...