Scalpel Weekly News

Week of: June 24, 2013

IN THE NEWS


Cybersecurity Guidelines for Medical Devices to Prevent Cyberattack Failures

The FDA recommends that medical device manufacturers and health care facilities take steps to evaluate their network security and to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks. Click title to continue reading...


 
MEDICAL ALERTS


See’s Candies Milk and Dark Raisins Recalled Due to Unlisted Allergens

See’s Company of San Francisco is recalling all Milk and Dark Raisins because it may contain tree nuts and eggs that are not included on the ingredient list. People who have an allergy or severe sensitivity to tree nuts (e.g.: almonds, walnuts, pecans, cashews) and/or eggs run the risk of serious or life-threatening allergic reaction if they consume these products. Click title to continue reading...



Warfarin Tablets Recalled Due to Oversized Tablets Possibly Resulting in Bleeding

Zydus Pharmaceuticals USA Inc. recalled one lot of Warfarin 2 mg Tablets, Lot #MM5767, expiration date June 2014 to the retail level. Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint. Click title to continue reading...



Older Americans and Pregnant Women Face Highest Risk From Listeria Food Poisoning

Listeria can cause serious infection in certain vulnerable groups, resulting in higher rates of hospitalization and death than most other bacteria commonly spread by contaminated food. A new report by the CDC outlines the key groups particularly hard hit by listeria food poisoning. Click title to continue reading... 


  CASE ALERTS


Court Holds Natural DNA Not Patentable, But Synthetically Created DNA Patentable

Myriad Genetics, Inc. (Myriad), obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes. Mutations of these genes dramatically increase the risk of breast and ovarian cancer. This knowledge allowed Myriad to determine the genes' typical nucleotide sequence, which allowed it to develop medical tests useful for detecting mutations in these genes in a particular patient to assess the patient's cancer risk. Click title to continue reading... 



Reverse Payment Settlement For Drug Patent Holder and Generic Manufacturer

Solvay Pharmaceuticals obtained a patent for its approved brand-name drug AndroGel. Subsequently, Actavis and Paddock filed applications for generic drugs modeled after AndroGel and certified under paragraph IV that Solvay's patent was invalid and that their drugs did not infringe it. Solvay sued Actavis and Paddock, claiming patent infringement. Click title to continue reading... 



Florida WellCare Executives Found Guilty of Health Care Fraud

A federal jury in Tampa found four former executives of WellCare Health Plans Inc., a health maintenance organization (HMO) operator, guilty of various charges, including health care fraud, making false statements relating to health care matters and making false statements to a law enforcement officer. Click title to continue reading...