Scalpel Weekly News

Week of: May 12, 2014

IN THE NEWS


Kroger Ice Cream in 31 States Recalled for Undisclosed Allergen

 The Kroger Company recalled Private Selection Chocolate Hazelnut Mascarpone Ice Cream and Private Selection Caramel Hazelnut Fudge Truffle Ice Cream sold at the Kroger family of stores in 31 states because the products may contain egg not listed on the label. Click title to continue reading...


 
MEDICAL ALERTS


Ventricular Assist Locking Mechanism May Fail; Pump Stoppage in Heart Failure Patients

 HeartWare Ventricular Assist Devices have been recalled. The manufacturer, HeartWare, received reports where the driveline connector locking mechanism has failed to engage as a result of a faulty manufacturing assembly process. This failure could result in the pump stopping and potentially lead to serious adverse health consequences, including death. Click title to continue reading...



Infusion Pump Defect May Delay Medication, Blood Products

Baxter Healthcare Corporation has recalled its Sigma Spectrum Infusion Pumps with Master Drug Library. Baxter received over 3500 reports of System Error 322 “Link Switch Error (low)” incidents in which the device has malfunctioned, including nine severe adverse events and no deaths. The System Error 322 occurs when the pump improperly detects that the door is open when it is physically closed. A System Error 322 may lead to an interruption or delay in therapy. Click title to continue reading...



100,000 US Deaths from 5 Leading Causes Are Preventable

 Each year, nearly 900,000 Americans die prematurely from the five leading causes of death. Yet 20 percent to 40 percent of the deaths from each cause could be prevented, according to a study from the CDC. Click title to continue reading...


  CASE ALERTS


Strict Liability Claims Against Generic Drug Manufacturers Preempted

The FDA approved Merck's New Drug Application (“NDA”) for Fosamax in September 1995. Teva Pharmaceuticals USA, Inc., one of the generic manufacturers, then developed alendronate sodium—a generic form of the branded drug—and obtained FDA approval on its Abbreviated New Drug Application (“ANDA”) in February 2008. The other generic manufacturers subsequently obtained approval for alendronate sodium formulations as well. Click title to continue reading...



Injury from Fall While Under Anesthesia May Be Medical Malpractice

 A woman underwent surgery at a medical center. She was injured when she fell from the operating table either while or after being extubated. Three years after the injury, she sued the anesthesiologist and assistant surgeon. Click title to continue reading...



No Insurer Liability for Providers’ Delay in Ordering MRI; No Plan Bad Faith

A sixteen-year-old girl, enrolled in a health care plan administered by Kaiser Foundation Health Plan, began experiencing mild back pain. Over the next several months, the pain became more severe. She visited her primary care physician (PCP). The girl’s mother informed the PCP that the girl's chiropractor believed an MRI was necessary. The PCP told the mother and daughter that although she agreed an MRI was necessary, she lacked the authority to authorize the procedure. Click title to continue reading...