Throughout what Congress called the “heparin catastrophe” millions of dosages of heparin weren’t diluted by 10%, but as much as 20%, not by harmless diluters, but by dangerous ingredients such as OSCS. See also the U.S. News story at http://health.usnews.com/articles/health/healthday/2009/10/01/us-health-officials-announce-new-heparin-formula.html
According to the U.S. News story:
The correct dosing of heparin has always been highly individualized and requires intense monitoring, which is a protocol that will remain in effect, officials said.
“The use of heparin is closely tied into monitoring and doses adjusted based on that,” said Dr. Dwaine Rieves, director of CDER’s Division of Medical Imaging and Hematology Products. “That procedure will not change.”
Now the FDA tells us that the correct dosing of heparin has always been highly individualized and requires intense monitoring? How could doctors have monitored heparin dosages when no one was monitoring how much active ingredient was in the product?
The litigation around heparin has swirled around a specific contaminant OSCS. Yet, there have been thousands of additional adverse reactions outside the recall time period, continuing up to this day.
Now it begins to become clear. If the manufacturer had no way to establish how pure the product was, how could “intense monitoring” have occurred? I believe the ultimate death toll from this drug will not just include OSCS poisoning, but complications because thousands more individuals didn’t and couldn’t get the right “intense monitoring” by their doctors.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
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