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Richard J. Serpe, P.C. Blog

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Medical Malpractice

4/30/2008
Alexandrea Sumuel
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FDA Says Heparin Tainting was Deliberate
You’ve probably heard about the problems that Baxter has been having with tainted heparin, and the 81 deaths that have been blamed on this contaminated product.  The latest news is that horrifying – the contamination may have been deliberate.
 
A Chinese subsidiary of Scientific Protein Laboratories has been identified as the source of the contaminated heparin.  Scientific Protein Laboratories claims that it tried to get to the bottom of the contamination, but was stopped by Chinese authorities.  Since being identified as the source of contamination, the Chinese plant Changzhou SPL, has been barred by the FDA from exporting product to the US due to problems found during FDA inspection.
 
Apparently the contaminant, oversulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin.  It is tragic and shocking that 81 people had to lose their lives because somebody saw an opportunity to make money off of a lifesaving medication.  However, Baxter and the FDA are not innocent bystanders in this case.
 
Baxter bought heparin from this source from 2004 to 2008, yet did not inspected the plant themselves until September 2007.  The FDA fared no better – the plant was never inspected by the FDA until the heparin controversy broke this year, and the first inspection was performed on the wrong plant due to confusion over the name.
 
With so mistakes by individuals, companies, and federal agencies the American people have every reason to worry about the safety of the US drug supply.  We can only hope that this tragic case underscores the need for change in the way drugs are manufactured, inspected, and approved.
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