Scalpel Weekly News

Week of: March 14, 2016

IN THE NEWS


FDA Takes Action on Risks of Implantable Birth Control Coil

On February 29, 2016, the FDA announced actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. Essure is a permanent form of birth control that involves the insertion of flexible coils through the cervix and vagina into the fallopian tubes. Over a period of about three months after the insertion of Essure, scar tissue forms around the inserts and creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Click title to continue reading...


 
MEDICAL ALERTS


Nationwide Recall of Contaminated IV Antifungal Drug

On March 1, 2016, Sagent Pharmaceuticals, Inc., announced the voluntary nationwide recall of one lot of its antifungal medicine, Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg per 100mL flexible container bag (NDC 25021-113-82) Lot 40608 manufactured by ACS Dobfar INFO S.A. and distributed by Sagent. Click title to continue reading...



Risk of Zika From Human Cell and Tissue Products

As an additional safety measure against the emerging Zika virus outbreak, on March 1, 2016, the FDA issued new guidance for immediate implementation providing recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance addresses donation of HCT/Ps from both living and deceased donors, including donors of umbilical cord blood, placenta, or other gestational tissues. Click title to continue reading...



Fighting Antibiotic-Resistant Bacteria in Healthcare Settings

America is doing a better job of preventing healthcare-associated infections (HAIs), but more work is needed – especially in fighting antibiotic-resistant bacteria. The CDC’s latest report urges healthcare workers to use a combination of infection control recommendations to better protect patients from these infections. Click title to continue reading...


  CASE ALERTS


Failure to Provide Wound Care and Infection Prevention; Leg Amputation

A motorcycle rider was struck by a car. The accident left him with a broken leg and a degloved heel totally devoid of any skin. The broken leg was set and secured in a halo-type fixation device to hold the bones in place as the fracture healed. The man was placed on intravenous (IV) antibiotics. After being stabilized, he was discharged into the care of a general practitioner who referred him to a rehabilitative specialist. At the time of his transfer, the man was prescribed IV antibiotics for a 10-day period, he was listed in fair condition, his injured leg showed evidence of blood flow, and there was no obvious necrosis beneath the heel tissue. Click title to continue reading...



Trial Court Erred in Dismissing for Experts’ Failure to Address Standard of Care

A man underwent lower back surgery and later was discharged from the hospital. Due to pain and complications, the man was readmitted seven days after he was discharged. A physician’s order was issued directing nurses to ask that the doctor who performed the surgery be contacted to see the man regarding his symptoms. The nurses never contacted the doctor as ordered. Click title to continue reading...



ERISA Preempts Vermont All-Payer Claims Database Statute and Regulations

A Vermont statute requires health insurers, health care providers, health care facilities, and governmental agencies to report any “information relating to health care costs, prices, quality, utilization, or resources required” by the state agency, including data relating to health insurance claims and enrollment. Vt. Stat. Ann., Tit. 18, § 9410(a)(1) (2015 Cum. Supp.) (V.S.A.). The purpose of the statute is to allow Vermont to create an all-payer claims database (APCD), a large-scale database that systematically collects health care claims data from a variety of payer sources that include claims from most health care providers. Click title to continue reading...


FEATURE


Complaint: Narcolepsy Discrimination

As a special feature to our Premium subscribers we have included this feature containing an illustrative Complaint for unlawful employment termination, narcolepsy disability discrimination, emotional distress, and negligent hiring, supervision, and retention. The complaint claims, in part, violations of the Family and Medical Leave Act, the Age Discrimination in Employment Act, and ERISA. Click title to continue reading...