Scalpel Weekly News

Week of: January 21, 2013

IN THE NEWS


FDA Requires Lower Recommended Dose for Sleep Drugs Containing Zolpidem Due to Possibly Fatal Impairment Morning After Use, Especially While Driving

The FDA announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Click title to continue reading... 


 
MEDICAL ALERTS


Invacare Signs Consent Decree to Correct Wheelchair Manufacturing Problems

The FDA announced that medical device maker and distributor, Invacare Corp., and two of its top executives have signed a consent decree of permanent injunction requiring the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components. Click title to continue reading... 



Vaccine and Pediatric Tamiflu Shortages Aggravate Early Flu Season

The United States is having an early flu season with most of the country now experiencing high levels of influenza-like-illness (ILI) (reported to you in the Dec. 31 Scalpel Weekly News). There are localized shortages of the influenza vaccine. Click title to continue reading... 



Mitosol Kit for Ophthalmic Use for Glaucoma Surgery Recalled Because May Not Be Sterile; Use May Cause Blindness

Two lots of Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use, manufactured by Mobius Therapeutics, LLC, St. Louis, Missouri, have been recalled because they may not be sterile. Click title to continue reading... 


  CASE ALERTS


Where Community Standard of Nursing Care Equals National Standard, Jury Instruction Directing Application of Community Standard Not Reversible Error

A woman presented to the obstetrical department of a hospital approximately 35 weeks pregnant in severe pain. A labor and delivery nurse took a history and hooked her up to a fetal heart monitor. Click title to continue reading... 



Brand-Name Drug Company May be Liable for Labeling Fraud/Misrepresentation in Action by Consumer Claiming Injury Caused by Generic Drug Manufacturer

A man allegedly suffered injuries as a result of his long-term use of the prescription drug product metoclopramide, which is the generic form of the brand-name drug Reglan. Click title to continue reading... 



Medical Device Amendments to FDCA Regarding Post-Approval Adverse Event Reporting to FDA Did Not Preempt Arizona Negligence Claim

In 1988 the FDA granted pre-market approval to Medtronic’s SynchroMed Pump and Infusion System. Eleven years later Medtronic obtained supplemental pre-market approval for its SynchroMed EL Pump and Catheter. Click title to continue reading...