Scalpel Weekly News

Week of: December 01, 2014

IN THE NEWS


MS Drug Linked to Death from Serious Brain Infection

The FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died. The patient who died was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML. As a result, information describing this case of PML is being added to the Tecfidera drug label. Click title to continue reading...


 
MEDICAL ALERTS


Electrodes Incompatible with Automated External Defibrillators; Global Recall

Conmed Corporation of Utica, New York, issued a Voluntary Urgent Device Correction for certain adult and pediatric PadPro and R2 Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units. Click title to continue reading...



Surgical Convenience Kits Recalled-Lack of Sterility; Potential Infections

Customed, Inc., of Puerto Rico recalled 233 sterile surgical convenience kits. The Convenience kits have a potential package integrity defect that may compromise the sterility of the product, as well as serious deficiencies in manufacture and storage of the products that may significantly affect the risk of contamination and resultant infection. Customed recalled these products after becoming aware of potential defects through its Quality System. Click title to continue reading...



One Million Doctor Visits for Contact Lens Eye Infections Annually; Blindness Potential

Each year, Americans make nearly a million doctor visits for eye infections, resulting in $175 million in direct health care costs, the CDC has estimated in the first study of its kind. Keratitis, an infection of the cornea, causes pain and inflammation and can lead to blindness in severe cases. Wearing contact lenses is the largest single risk factor for developing the infection. Improper contact lens habits pose major risk for serious infections. Click title to continue reading...


  CASE ALERTS


Transvaginal Mesh Verdict $3.31Million; FDA Postsurgery Regulatory Action Admitted

Pelvic organ prolapse occurs when a woman has weak vaginal walls that allow adjoining organs, the uterus, the bladder, and/or the rectum, to drop into the vaginal canal. If noninvasive treatments are not effective, there are various surgical options for pelvic organ prolapse. One option is to use polypropylene mesh to support the vagina. One way to implant this mesh is through an abdominal incision. Beginning around 2003, surgeons began using kits to implant the mesh transvaginally, i.e., through the vagina. Click title to continue reading...



Psychiatrist Has Duty to Those Endangered by Patient's Depression; Clinic Vicarious Liability for Deaths

A man saw a psychiatrist on an outpatient basis for treatment of his depression and bipolar disorder. He was put on medication. He expressed homicidal and suicidal thoughts to his psychiatrist and his family. His mother wrote a letter to his psychiatrist describing his homicidal thoughts. He stopped seeing the psychiatrist and having his medication managed. He struck his girlfriend’s son. They broke up. Click title to continue reading...



Expired Claims-Made Insurer Dismissed from Third-Party Medical Malpractice Case

The son of a deceased patient filed a medical malpractice suit against the hospital where she died. The complaint alleged that the hospital failed to provide adequate medical care and treatment to his mother. The hospital filed a third-party complaint against the woman’s treating physician and his insurer. The third-party complaint alleged that the physician's negligent acts and/or omissions and alleged departures from medical standards caused the patient's death. Click title to continue reading...