Scalpel Weekly News

Week of: January 15, 2018

IN THE NEWS


FDA Warning on Unapproved Stem Cell Product

On January 4, 2018, the FDA posted a warning letter issued to American CryoStem Corporation of Monmouth Junction, New Jersey, and its Chairman/Chief Executive Officer for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that raise potential significant safety concerns, putting patients at risk. Click title to continue reading...


 
MEDICAL ALERTS


Nationwide Recall of Compounded Drugs; Lack of Sterility Assurance

On January 2, 2018, PharMEDium Services recalled certain lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. Click title to continue reading...



Injection Ampicillin and Sulbactam Recall; Glass Particles in Vial

On January 4, 2018, AuroMedics Pharma recalled one lot of Ampicillin and Sulbactam for Injection USP, 1.5 g in a Single-Dose vial (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt), to the hospital level. Lot AFO l 17001-A, Expiry date Dec 2018, has been found to contain glass particles. Click title to continue reading...



Superbug Outbreak at Kentucky Rural Community Hospital

On January 5, 2018, the CDC published a report about an investigation of a superbug outbreak at a rural community hospital. The superbug was Klebsiella pneumoniae carbapenemase (KPC)– producing carbapenem-resistant Enterobacteriaceae (CP-CRE). Click title to continue reading...


  CASE ALERTS


Whether Brain Surgery Left Boy Incompetent; Tolling Limitations

A 15-year-old boy began experiencing peripheral vision difficulties. The boy was diagnosed as having a large pituitary adenoma, a noncancerous tumor in the pituitary gland that typically does not spread beyond the skull. Click title to continue reading...



Plaintiff Could Rely on MRIs Submitted by Defendants to Show Injuries

A woman was in an accident. The woman sued the people responsible for the accident. The complaint alleged that the woman suffered injuries to both shoulders, cervical spine, and lumbar spine. Click title to continue reading...



Agency Reversal of Insurer’s Coverage Denial Did Not Support Suit against Insurer

A man was diagnosed with chondrosarcoma, a type of bone cancer that affects cartilage, in the thoracic (mid-back) region of the man’s spine. The man underwent several surgeries to remove the cancer. During the course of the man’s treatment, specialists recommended proton beam radiation treatment (PBRT), which is a form of radiation treatment that can be directed and localized to minimize side effects. Click title to continue reading...


FEATURE


Checklist: Consent to Use of Experimental Drug

As a special feature for our Premium subscribers we have included this feature containing an illustrative checklist for obtaining from a patient informed consent for the use of an experimental drug. The checklist can be used both to guide the drafting of consent forms as well as to guide evaluation of any consent form signed by a plaintiff in a medical malpractice action. Party identifying information has been redacted to protect privacy. Click title to continue reading...