Scalpel Weekly News

Week of: October 13, 2014

IN THE NEWS


Permanent Injunction To Stop Pharm Company Medical Device Sales

The FDA is seeking a permanent injunction to stop Pharmaceutical Innovations, Inc., and its principal officer from manufacturing, marketing, selling, and distributing medical products until they come into compliance with all applicable FDA requirements. The defendants are charged with distributing adulterated and misbranded medical devices. Click title to continue reading...


 
MEDICAL ALERTS


Nationwide Recall of Mislabeled NSAID for Post-Operative Pain Relief

Three lots of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials manufactured by Cadila Healthcare Limited and distributed by Sagent Pharmaceuticals, Inc., are the subject of a nationwide recall. Sagent initiated the recall to the user level due to labeling the product with the incorrect expiration date. The labeled expiration date exceeds the known stability of the product. Click title to continue reading...



FDA Recommendations for Management of Medical Device Cybersecurity Risks

To strengthen the safety of medical devices, the FDA finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. Click title to continue reading...



Opioid Pain Pill Abusers Switch to Heroin; Heroin Overdose Deaths Double

Nationally, death rates from prescription opioid pain reliever (OPR) overdoses quadrupled during 1999 to 2010, whereas rates from heroin overdoses increased by less than 50%. Individual states and cities have reported substantial increases in deaths from heroin overdose since 2010. The CDC analyzed recent mortality data from 28 states to determine the scope of the heroin overdose death increase and to determine whether increases were associated with changes in OPR overdose death rates since 2010. Click title to continue reading...


  CASE ALERTS


Insurer Not Liable for Failure to Warn of Medication Risks; Off-Label Use

An insured entered into a contract with an insurer to provide health insurance. The contract provided benefits for eligible prescription medications and excluded benefits for dental services, except in limited circumstances. Click title to continue reading...



Nursing Home’s Arbitration Agreement Did Not Apply to Wrongful Death Claims

A woman was admitted to a long-term care facility. Her agent signed the admission documents, which included an arbitration agreement. The arbitration agreement provided that any claim, controversy, dispute, or disagreement arising out of or in connection with the care rendered to the woman would be determined by submission to neutral, binding arbitration. It purported to bind not only the woman, but any future legal representatives, heirs, successors, etc., who might assert a claim against the long-term care facility. Click title to continue reading...



"Error in Physician Judgment" Jury Instructions Appropriate

A woman underwent an emergency cesarean section. The doctor who performed the procedure ordered and administered a single prophylactic antibiotic. This doctor also provided to the woman pre-and postoperative care. The woman experienced drainage from the surgical incision. A second doctor discharged the woman from the hospital. The woman called the second doctor several hours following the discharge and reported drainage from the surgical incision. The doctor who performed the cesarean section saw the woman at a follow-up visit and ordered no tests or treatment for the woman. Both doctors were employed by the same practice group. Click title to continue reading...