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

Injuries Believed to be Caused by Contaminated Blood Thinner

CHICAGO, May 14 /PRNewswire/ -- The blood thinner Heparin continues to make headlines as more people are found to have suffered serious injuries and/or death after using the contaminated drug -- a group of which appears to include many Kentucky residents. On Friday, May 2, 2008, another lawsuit was filed against Chicago-area pharmaceutical giant, Baxter International Inc. on behalf of Louisville, Kentucky resident, Artemus Banks. The complaint was filed by Nolan Law Group in Federal Court located in Chicago, Illinois. Nolan Law Group has already been responsible for filing several lawsuits on behalf of victims and the families of victims who have suffered a personal injury and/or death caused by the use of this contaminated drug. Due to the enormity and severity of the contamination, Nolan Law Group expects to file many more similar cases.

This most recent lawsuit names Scientific Protein Laboratories L.L.C. (the company which manufactures the active pharmaceutical ingredient API in Heparin) as well as certain corporate officers of Baxter. The lawsuit asserts that Baxter International and its wholly-owned subsidiary, Baxter Healthcare Corporation, manufactured the drug with a contaminated API and that Baxter failed to recall the defective drug in a timely fashion. The suit cites four causes of action against Baxter and Scientific Protein Labs including Products Liability, Negligence, Breach of Warranties and Willful and Wanton Misconduct.

Baxter's Heparin has been implicated in more than 400 life-threatening incidents and may be responsible for as many as 81 deaths. In February 2008, Baxter initiated a voluntary recall of nine lots of Heparin Sodium Injection Multi-Dose Vials. According to Baxter International, they recalled the lots due to a spike in adverse reports associated with the use of Baxter Heparin Sodium Injections. After receiving additional reports of similar adverse 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 themselves, to ensure that these materials are acceptable for use." Moreover, the methods employed to test Heparin Sodium United States Pharmacopoeia (USP) had not been verified to ensure suitability under actual conditions of use and the equipment used to manufacture the product was "unsuitable" for its intended use.

China's Ministry of Commerce is now requiring local Heparin makers to increase testing of raw materials, improve post-sale tracking and ensure that their raw material comes from registered suppliers. This requirement follows U.S. Congressional inquiries into the FDA's overseas inspection process.

The House Oversight and Investigations Subcommittee held a hearing on April 15th of this year regarding the distribution of contaminated Heparin. A follow-up hearing took place on April 22nd at which time the committee asked FDA Commissioner Andrew von Eschenbach how the agency will address concerns regarding its efforts to inspect foreign drug facilities.

Mr. Banks is seeking judgment against all defendants for compensatory and punitive damages arising from the personal injuries that he suffered from the use of a pharmaceutical drug commonly known as Heparin.

Nolan Law Group is a Chicago-based personal injury law firm concentrating in aviation accidents, construction accidents, brain injury litigation, medical malpractice, premises liability, product liability, and trucking accidents.


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SOURCE Nolan Law Group
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