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Illinois Pharmaceutical Manufacturer Sued for Injuries to Kentucky Resident
Date:5/14/2008

verse reactions from other lots of their Heparin Sodium Injection Products, Baxter recalled their remaining multi-dose and single-dose vials, as well as HEP-LOCK Heparin Flush Products.

In January of 2008, Mr. Banks received a box of 25 vials of Baxter Heparin from Fresenius Medical Care for use during home dialysis treatments. Banks used the product as prescribed but began experiencing numerous physical symptoms, such as wheezing, shortness of breath, coughing, dizziness, increased perspiration and sudden weakness. Today, Mr. Banks continues to suffer as a result of his Heparin use.

The suit falls on the heels of a recent finding by the Food and Drug Administration (FDA) identifying an unknown contaminant found in the Baxter Heparin. In early April of 2008, researchers confirmed the FDA's suspicion that the contaminant found in the Heparin is Oversulfated Chondroitin Sulfate (OSCS), a derivative of a popular supplement used to relieve arthritis, and a chemical which does not occur naturally during Heparin production.

Raw Heparin is derived from pig intestines and is often processed by small, unregistered "mom-and-pop" workshops in China. The key to establishing causation in this case, despite all of the issues with unsanitary conditions, etc., will be Baxter's failure to perform a chemical test on the Heparin which would have been sensitive enough to identify the difference between Heparin and OSCS. The abhorrent conditions in China from where Heparin was being imported (and the fact that the FDA was not doing significant inspections) required the need for more sensitive testing.

According to the FDA inspection, the Changzhou SPL Facility was unable to provide FDA with any assurance "that processing steps used to manufacture heparin sodium, USP are capable of effectively removing impurities." FDA also found that the facility failed "to have adequate systems for evaluating the suppliers of crude heparin materials, or the crude materials t
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SOURCE Nolan Law Group
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