A Missouri family is seeking justice for a man who passed away after an adverse reaction to tainted Chinese Heparin. They say Tyco Healthcare waited too long to recall the drug, and the death toll continues to rise. As of August 2018, 81 other deaths linked to tainted Heparin have been reported. While Tyco Healthcare has not yet publicly explained why Freddie James Williams Sr. passed away, the FDA is investigating 81 additional deaths.
Heparin contaminated with OSCS
In a nationwide heparin recall, the OSCS component in tainted Heparin caused allergic and sometimes fatal reactions in hundreds of patients. The FDA is now investigating the possible cause of the problem, but the FDA has not yet approved a substitute for the chemical, which is substantially cheaper than heparin. In response to the contaminated heparin, Baxter Healthcare recalled 9 lots of heparin vials and filed a class action lawsuit on behalf of affected patients.
In 2009, the FDA found traces of OSCS in heparin that triggered severe reactions, including anaphylactic shock. This is because the OSCS mimics the effect of heparin. The FDA suspects that the drug manufacturer intentionally introduced OSCS to dilute heparin. This is a common misconception and is one of the main arguments in the Heparin contaminated with OSCS recall lawsuit.
Baxter’s failure to monitor for contaminants
In a recent Heparin Recall lawsuit, a group of doctors alleges that Baxter failed to properly monitor for contamination of its heparin. The heparin, manufactured in China, was contaminated with an unknown substance. The FDA has ordered the company to inspect the Changzhou SPL plant, which provided Baxter with heparin. However, the FDA never inspected the plant, and Baxter reportedly did not conduct a follow-up inspection. This has led to claims that multiple companies were involved in the tainted heparin contamination.
The recall came about after the FDA revealed the presence of Over-Sulfated Chondroitin Sulfate, a synthetic compound with anticoagulant properties. Baxter acquired contaminated API from a Chinese supplier and incorporated it into heparin products. This recall led to over eighty deaths and prompted a global recall of Baxter heparin products.
Unapproved preservatives in heparin
A series of recent recalls have linked unapproved preservatives to adverse reactions to Heparin. In February, the FDA announced that heparin products manufactured by Baxter International Inc. were linked to a spike in adverse events, causing the company to stop producing the drug. The company recalled the remaining supply in the US market, and FDA officials encouraged hospitals to switch to non-Baxter heparin.
One drug that contains unapproved preservatives is Benzyl Alcohol. Benzyl alcohol has been associated with serious adverse effects in neonates, and can even cause birth defects. While the background risk of major birth defects during pregnancy is unknown, all pregnancies carry a risk of adverse effects, including birth defects. However, estimates of the background risk of miscarriage in the U.S. general population are approximately 2-4% and between 15-%.
Allegations of serious allergic reactions from contaminated heparin
The FDA is investigating dozens of cases of serious allergic reactions to tainted heparin, which were caused by a contaminant found in Chinese factories. The FDA’s investigation found inadequate oversight and supply chain management, as well as a complicated production process prone to abuse. So far, no one has been charged with committing fraud or other mismanagement. Allegations of contaminated heparin have also affected patients in other countries.
The FDA announced this study after learning that a synthetic compound called OSCS was intentionally contaminated with heparin. This contaminant, also known as over-sulfated chondroitin sulfate (OSCS), was acquired by the drug manufacturer, Baxter, from a Chinese supplier. Baxter then incorporated this contaminant into certain heparin products.
Legal implications of contaminated heparin
If contaminated heparin is a causal factor in the onset of thrombosis, then the legal implications are numerous. While it is difficult to draw a direct correlation between contaminated heparin and thrombosis, studies suggest that a contaminant in heparin can cause certain illnesses and injuries. These studies also show that contaminated heparin is harmful in subcutaneous administration.
The FDA identifies the contaminant in contaminated heparin as Oversulfated Chondroitin Sulfate, a chemical that does not naturally occur in heparin production. The FDA issues a warning letter to Changzhou SPL Facility and holds live hearings on the contaminated heparin disaster. Pharmaceutical executive Robert Parkinson admits liability and testifies before the Subcommittee on Oversight and Investigations.