Scalpel Weekly News

Week of: April 15, 2013

IN THE NEWS


Diabetes Insulin Infusion Pump Recalled; Risk of Unintended Insulin Delivery and Possible Serious Health Consequences

Animas has identified a component issue affecting all lots of Animas 2020 Infusion Insulin

Pumps manufactured from March 1, 2012 to November 30, 2012. The Animas 2020 Insulin Pumps are used to deliver insulin directly into the blood for the treatment of diabetes. Click title to continue reading...


 
MEDICAL ALERTS


Urgent Recall of Immune Globulin Intravenous Product Due to Visible Contaminants

During a routine annual reserve inspection, visible particles were observed in Lot # 120016 of 100 mL sterile vials of BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid. The expiration date on the 100 mL sterile vials is March 31, 2014. BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid, is indicated for the treatment of primary humoral immunodeficiency. Click title to continue reading...



DNA Sequencing System Buffer Chambers Recalled Due To Possible Hazard to Operator

Siemens Healthcare Diagnostics is recalling certain MicroCel 500 and MicroCel 300 buffer chambers used in its OpenGene DNA Sequencing System. Some of these buffer chambers may have the potential to leak buffer when in use. If the buffer chamber leaks, it could cause premature failure with heat damage to the buffer chamber and Long-Read Tower and pose a hazard to the operator. Click title to continue reading...



Poor and African American Children Disproportionately Exposed to Lead, Increasing Risk of Neurological and Other Deficits

The adverse health effects of lead exposure in children are well described and include intellectual and behavioral deficits, making lead exposure an important public health problem. Lead toxicity can affect every organ system. Click title to continue reading...


  CASE ALERTS


Order Denying Hospital's Motion to Amend to Assert Release Defense Reviewable on Appeal from Final Judgment in Failure to Diagnose Aneurysm

A man suffered a sudden, severe headache accompanied by vomiting and sensitivity to light. The headache persisted for three weeks. The man consulted several doctors including his primary care physician and a neurologist. The man underwent a CT scan at a hospital. Click title to continue reading...



Third-Party Payors’ RICO and State Unfair Competition Claims Against Pfizer Survive Summary Judgment in Off-Label Marketing of Neurontin Case

The First Circuit U.S. Court of Appeals issued decisions in three cases that arose from multidistrict litigation (“MDL”) concerning the off-label marketing of Neurontin, including this case, In re Neurontin Marketing and Sales Practices Litigation, 2013 WL 1320408 (C.A.1 (Mass.), April 3, 2013) (not designated for publication) (referred to by the First Circuit as Kaiser Foundation Health Plan, Inc. v. Pfizer, Inc.). Click title to continue reading...



U.S. Obtains Permanent Injunction Against New York Dietary Supplement Firm’s Operations Due to History of Violations and Warnings

U.S. District Court Judge Joseph F. Bianco entered a consent decree of permanent injunction between the United States, Kabco Pharmaceuticals Inc. and its CEO and President. The consent decree entered by the court enjoins the defendants from violating the Federal Food, Drug and Cosmetic Act (FDCA) in connection with their manufacturing, packing and distributing of dietary supplements. Click title to continue reading...