Scalpel Weekly News

Week of: April 25, 2016

IN THE NEWS


Catheter For Removal of Blood Clots from Coronary Arteries May Break; Global Recall

On April 8, 2016, Boston Scientific of Marlborough, MA, recalled all models of its Fetch 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries, due to complaints of shaft breakage. Click title to continue reading...


 
MEDICAL ALERTS


Herpes Tests Cross-Contaminate Samples; Invalid Testing

On February 10, 2016, Focus Diagnostics recalled Simplexa Herpes Simplex Virus 1 & 2 Direct and Simplexa Group A Strep Direct kits containing the Direct Amplification Discs due to poor lamination between the sample reaction wells. This poor lamination may lead to leakage into adjacent wells causing cross-contamination between samples, which could yield false positive, false negative, or invalid test results. Click title to continue reading...



Unsterile Pharmacy with Quality Problems Refuses to Cease Production; FDA Warning

On April 15, 2016, the FDA alerted health care professionals not to use any drug products that are intended to be sterile and are produced and distributed nationwide by Pharmakon Pharmaceuticals Inc., in Noblesville, Indiana, due to a lack of sterility assurance and other quality issues. Click title to continue reading...



Foodborne Illness Tests Make it Harder to Find Outbreaks, Check Antibiotic Resistance

Changes in the tests that diagnose foodborne illness are helping identify infections faster but could soon pose challenges to finding outbreaks and monitoring progress toward preventing foodborne disease, according to a recent CDC report. Click title to continue reading...


  CASE ALERTS


Verdict Upheld Against OB/GYN Who Stitched Ureter During Uterine Repair

A woman underwent a Caesarean section (C-section) to deliver her child. During the procedure, the woman's uterus was lacerated and required surgical repair. During the repair, the OB/GYN sutured the woman's left ureter. Click title to continue reading...



Adult with Physical, Cognitive Disabilities under Guardianship Lacked Standing to Sue

An adult woman who had physical and cognitive disabilities and whose parents had been appointed co-guardians underwent gallbladder surgery. The surgeon allegedly made an error that injured the woman. Click title to continue reading...



No Penalty for ERISA Plan Failure to Comply with Claims Procedure

A college student insured under the college’s health plan underwent eye surgery with doctors within the health plan network. Dissatisfied with the results of her treatment, she returned to her parents’ home, where she eventually underwent further surgery with doctors who were not in the plan’s network. The treatment was covered only if the condition treated constituted an emergency or urgent condition or if the insurer approved the treatment in advance. The insurer rejected the student’s claims for coverage. In at least one notification, the only explanation the insurer provided to the student was “Service Not Authorized.” Click title to continue reading...


FEATURE


Vector-Borne Disease Expert Checklist

As a special feature to our Premium subscribers we have included this feature containing a Checklist for an illustrative direct examination of a vector-borne infectious disease expert witness for the plaintiff-patient. Click title to continue reading...