Heparin: Yet Another Dangerous Chinese Product Shipped to the United States

By Rheingold Giuffra Ruffo & Plotkin LLP

A simple definition of heparin is a blood-thinning drug made with raw pig intestines from China used to decrease the clotting ability of a patient’s blood. In 2007 and 2008, nearly 150 people in the U.S died, and hundreds suffered from serious injuries, as a result of being treated with Heparin. The American pharmaceutical firm, Scientific Protein Laboratories processed the raw materials for the recalled Heparin batches from pig intestines. According to the New York Times, “Problems with heparin reported to the agency include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that in some cases led to life-threatening shock.”

After receiving reports that a number of patients were experiencing severe reactions to Heparin, Baxter International, a major supplier to the U.S. market, recalled nearly all of its Heparin injections in the U.S and suspended the making of multi-dose vials of Heparin. Since then, the Food and Drug Administration (FDA) initiated 13 recalls of numerous contaminated medical products which all contained Heparin from several companies.

By March of 2008, the FDA confirmed that over sulfated chondroitin sulfate (OSCS) contaminant was discovered in samples of the active ingredient used in Baxter Heparin. This was a cheaper and adulterated version of the active ingredient in heparin. Since Heparin is made with raw pig intestines, when there was a lack of raw material, the company added OSCS (which impersonates the action of Heparin), to meet the rise in demand for the drug.

These events led to several congressional hearings, and the FDA was criticized for a lack of oversight on foreign drug manufacturers. Recently, the FDA has identified another 14 Chinese companies that also supplied contaminated materials to many drug-makers. According to The Wall Street Journal, the number of Chinese suppliers on the import alert list has increased to 22 suppliers whose products are intended to be out of the supply chain and can have their products stopped at U.S. borders. Last summer, a House committee communicated with several pharmaceutical companies about any knowledge of the incident. The FDA continues to face ongoing House investigations over the heparin crisis.

Our firm was part of the federal consolidation against Baxter. As many defendants do, they will broadly acknowledge that a problem occurred, but they attack individual claims saying they were not related to the product’s defects. Our firm has a full time nurse, and available medical consultants, who can address any case-specific medical issues which may arise in cases like this.

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