Scalpel Weekly News

Week of: April 22, 2013

IN THE NEWS


Another Compounding Pharmacy Recalls All Sterile Products Due to Concerns About Quality Control and Infection Risk

Every sterile drug product compounded, repackaged, and distributed nationwide by Green Valley Drugs is being recalled due to lack of sterility assurance and concerns associated with the quality control processes. The recall of sterile products is conducted based on observations of clean room personnel and certain aseptic techniques. Click title to continue reading...


 
MEDICAL ALERTS


Inadequate Sterilization Method for Ventilator Air Flow Sensors Causing Contamination by Bacteria Risking Lethal Infections in Newborns

Bacillus bacteria are found so commonly in the environment that sometimes finding them in medical specimens is considered routine and of no concern. However, certain types of these bacteria can cause serious, sometimes fatal, disease in newborns, especially those born prematurely. Click title to continue reading...



FDA Releases New BeSafeRx Interactive Online Pharmacy Map to Protect Consumers from Fake Online Pharmacies

As part of its ongoing BeSafeRx: Know Your Online Pharmacy effort to protect consumers from the risks of fake online pharmacies, the FDA has developed a new, easy-to-use interactive map tool that lets consumers locate a state-licensed online pharmacy, providing a quick way to ensure the site you order from is safe and legal. Click title to continue reading...



Total Knee Replacements Using Shapematch Cutting Guides Subject to Class I Recall Because They May Not Function Properly

On April 10, 2013, the FDA classified the recall of Stryker Corporation’s ShapeMatch Cutting Guides as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death. Click title to continue reading...


  CASE ALERTS


Justice Department Settlement Bars Chiropractor Association from Conspiring to Raise Fees Through Joint Contracting on Behalf of South Dakota Members

The U.S. Department of Justice reached a settlement with Chiropractic Associates Ltd. of South Dakota (CASD), an association comprising approximately 80 percent of all practicing chiropractors in South Dakota. The settlement prohibits CASD from jointly determining prices and negotiating contracts with insurers on behalf of competing chiropractors in South Dakota, North Dakota, Minnesota and Iowa.  Click title to continue reading...



Patients Lack Standing to Bring Federal and California Claims On Off-Label LASIK Surgery to Correct Farsightedness Prior to FDA Approval

Between February 1996 and October 2006, patients sought and received Laser in Situ Keratomileusis (“LASIK”) eye surgery with a Nidek EC–5000 Excimer Laser System (“the Laser”) to correct farsightedness, also known as hyperopic surgery. At the time of the patients’ surgeries, the FDA had not approved the Laser for this use. Click title to continue reading...



False Claims Act’s Public Disclosure Bar Does Not Apply to Claims Against Prescription Monitoring Service Provider Not Disclosed in Prior Suit

A company developed a urine drug-testing program for physicians to monitor the medications of chronic pain patients and to assess patients' compliance with prescribed medication regimes. The testing method begins as point-of-care testing in a doctor's office and uses various chemically-treated test strips (“units”) inserted into a single cup filled with the patient's urine (“specimen”) (collectively, the “test kit”). Click title to continue reading...