Scalpel Weekly News

Week of: March 18, 2013

IN THE NEWS


FDA Issues Draft Guidance for Manufacturers to Accurately Label Medical Products That Are Not Made with Natural Rubber Latex

The FDA issued draft recommendations to medical product manufacturers for providing consumers with accurate information about products that are not made with natural rubber latex (NRL). Click title to continue reading...


 
MEDICAL ALERTS


CDC Calls for Immediate Action to Halt Spread of Deadly CRE Bacteria

A family of bacteria has become increasingly resistant to last-resort antibiotics during the past decade, and more hospitalized patients are getting lethal infections that, in some cases, are impossible to cure. Click title to continue reading...



Multiple Brands of Tuna Recalled Due to Loose Seals that Could Lead to Contamination by Food-Borne Pathogens

Two major distributers of canned tuna products, Bumble Bee Foods and Tri-Union Seafoods, have recalled specific tuna and white albacore products. The recall has been issued because the seals on the cans are not sufficiently tight. Click title to continue reading...



Macro Micro Subdural Electrodes Recalled Due to Defective Microelectrodes that May Injure Brain

Macro Micro Subdural Electrodes are the subject of a Class I recall. There is a concern the microelectrodes are not flush with the silastic surface. Click title to continue reading...


  CASE ALERTS


Metallurgist’s Expert Testimony Based on Extensive Testing of Failed Prosthetic Bone Admissible in Opposition to Summary Judgment in California

A man was treated for cancer in his femur. His orthopedic surgeon ordered a prosthetic device to replace the middle portion of his femur. Click title to continue reading...



Patient Injury Arising from Fall from Hospital Bed Due to Faulty Bed Rail Amounts to Ordinary, Not Professional, Negligence in California

A hospital patient fell out of bed when her bed rail collapsed. She injured her knee and elbow. Just under two years later, the woman sued the hospital for general negligence and premises liability. Click title to continue reading...



Par Pharmaceuticals Pleads Guilty and Agrees to Pay $45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing

New Jersey-based Par Pharmaceutical Companies Inc. pleaded guilty in federal court and agreed to pay $45 million to resolve its criminal and civil liability in the company’s promotion of its prescription drug Megace ES for uses not approved as safe and effective by the Food and Drug Administration (FDA) and not covered by federal health care programs. Click title to continue reading...