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FDA MEDWATCH ALERTS

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

Summary:

FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

October 25, 2014

FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

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FDA MedWatch Intravia Containers by Baxter Recall

October 20, 2014

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

Summary:

FDA Medwatch Alert 10-20-14

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11th Circuit Court of Appeals Rules Individual Mandate Unconstitutional

Friday, August 12, 2011

The 11th Federal Circuit Court of Appeals panel released a 2-1 decision in the State of Florida, et. al. vs. the Secretary of the United States Department of Health and Human Services, et. al.  This decision declared the controversial individual mandate (also referred to as “minimum coverage provision”) section in the Patient, Protection and Affordable Care Act (PPACA)  to be unconstitutional. The individual mandate requires that nearly all Americans maintain health care insurance or pay an income-based fine for lacking coverage.    

The majority opinion noted: “The federal government’s assertion of power, under the Commerce Clause, to issue an economic mandate for Americans to purchase insurance from a private company for the entire duration of their lives is unprecedented, lacks cognizable limits and imperils our federalist structure.” 

A little over a month ago, the 6th Federal Circuit Court of Appeals ruled the individual mandate was constitutional. A decision is still pending in the 4th Federal Circuit Court of Appeals. These conflicting rulings significantly increase the likelihood that the United States Supreme Court will hear the case.     

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