Heparin Deaths

Traceability, the ability of a manufacturer to track where it secured raw materials and where it shipped product, is a key issue in lawsuits regarding heparin, the tainted blood thinner that was recalled and is being blamed for causing countless U.S. deaths in 2007 and 2008. http://heparin-law.com

InTech Home, from the International Society of Automation, has a detailed analysis of the issue of traceability and suggests requirements for traceability systems. http://www.isa.org/InTechTemplate.cfm?Section=General_Information2&template;=/ContentManagement/ContentDisplay.cfm&ContentID;=81071

The article cites a number of pharmaceutical and food product recalls where traceability has been an issue, including heparin that came from China and had a deadly contaminant in it, allegedly killing people. The story also mentions two salmonella outbreaks: One caused by jalapeno peppers from Mexico, which sickened 1,442 people, in 2008; and the eight deaths, and sickening of more than 600 people, from foods containing tainted peanuts that same year.

“While the current U.S. Bioterrorism Act requires traceability known as ‘one up and one down,’ recent food scares such as contaminated peanuts and peppers have demonstrated true recalls and safety announcements multiple supplier cooperation,” the story says.

The article says traceability has to do with determining what lots went into a product, and that such “lot assignments are the norm in drug manufacturing.” Lawyers have a lot of questions for heparin makers about traceability and lots during litigation stemming from the deaths two years ago.

As for traceability standards, the story makes six suggestions for food products.

The story’s first recommendation for the food industry is to first create a system that identifies “all source component ingredients” of a product within seconds. The second is to enable tracing of any ingredient “to identify all associated products within seconds,” Third is to quickly implement the recommended practices. Fourth is to address public concerns about tracing products. Fifth is to create a low-cost, low-burden traceability system. Sixth is to support other industry safety initiatives.

Finally, the article calls for standard lot identification of food products, suggesting “a new universal 16-character code as a consistent method of identification.”

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Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

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