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drug_recall heparinHeparin deaths linked to Chinese raw ingredients now number more than 80, according to the U.S. Food and Drug Administration (FDA). Injuries and adverse events associated with contaminated heparin (sold by Baxter International) number in the hundreds.
Two heparin deaths were described at an April 2008 subcommittee hearing at the U.S. House of Representatives. Mr. Leroy Hubley of Ohio told U.S. lawmakers that both his wife Bonnie and their son Randy were undergoing kidney dialysis at a clinic where they were given heparin, an anticoagulant commonly given to dialysis patients. The heparin that they received was from a batch that was later recalled by Baxter in February 2008. Both patients had adverse reactions to the heparin and died within one month of each other.
Both houses of Congress have been criticizing the FDA for what has been labeled inadequate oversight of drugs and drug ingredients that are imported from foreign countries. The heparin deaths now at issue are linked to ingredients from China, which has repeatedly been the target of recalls in the U.S.
The recalled Baxter heparin was made with pig intestinal tissue harvested in Changzou, China. Chinese authorities now acknowledge that the heparin they supplied did indeed include a contaminant, an altered form of chondroitin sulfate called oversulfated chondroitin sulfate (OSCS) that mimics raw heparin.
The cost of making OSCS is one hundredth of what it is to manufacture pure heparin, Representative David Nelson said. The FDA recently stated that the contamination of the heparin from China may have been intentional, though the agency also said further investigation into the matter was necessary.
If you have been harmed by heparin, or if a heparin-related death has occurred in your family, contact a plaintiff’s attorney in your area to learn about your legal options.
After months of investigation, the U.S. Food and Drug Administration has definitively tied three patient deaths to contaminated heparin.
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