Scalpel Weekly News

Week of: July 01, 2013

IN THE NEWS


FDA Approves Plan B One-Step Emergency Contraceptive Without Prescription

The FDA approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013, order of the United States District Court in New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions. Click title to continue reading...


 
MEDICAL ALERTS


Device to Dilate Blood Vessels Recalled Due to Risk of Breaking During Procedures

The AFX Introducer System was recalled due to reports of the dilator breaking during procedures. Use of this recalled product may cause serious adverse health consequences, including death. Click title to continue reading...



FDA Approves Vibativ for Hospitalized Patients with Bacterial Pneumonia

The FDA expanded the approved use of the antibiotic Vibativ (telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Vibativ should be used for the treatment of HABP/VABP only when alternative treatments are not suitable. Click title to continue reading...



New Study Shows HPV Vaccine Helping Lower HPV Infection Rates in Teen Girls

A new study looking at the prevalence of human papillomavirus (HPV) infections in girls and women before and after the introduction of the HPV vaccine shows a significant reduction in vaccine-type HPV in U.S. teens. The study, published in The Journal of Infectious Diseases reveals that since the vaccine was introduced in 2006, vaccine-type HPV prevalence decreased 56 percent among female teenagers 14-19 years of age. Click title to continue reading...


  CASE ALERTS


Ambulance Driver Immune from Suit for Traffic Accident Causing Injury to Third Party

A motorist turned left at an intersection in front of three lanes of traffic. The vehicles in the first two lanes stopped to allow the motorist to proceed. An ambulance in the third lane did not see the motorist and collided with her. The motorist suffered a brain injury and was hospitalized. Click title to continue reading...



Indiana Holds Terminal Discovery Sanction for Medical Expert Witness Reversible

A podiatrist performed two surgeries on a woman's left and right feet, respectively. The woman filed a malpractice claim with the Indiana Department of Insurance and sued the podiatrist for damages. The woman alleged that the surgeries injured her and that the second surgery was performed without full consent. Click title to continue reading... 



DOJ Sues Louisiana Company for Distributing Unapproved and Misbranded Drugs

The Department of Justice, on behalf of the FDA, has filed suit in the U.S. District Court for the Western District of Louisiana against Sage Pharmaceuticals, Inc., its president, and its Director of Corporate Quality. According to the Complaint, the defendants violated the Federal Food, Drug, and Cosmetic Act by manufacturing and distributing unapproved and misbranded drug products. Click title to continue reading...