The AP has advised that the contaminant found in heparin has been identified. Specifically, Dr. Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, advised that the contaminant is called oversulfated condroitin sulfate. Apperantly, this is an artificial chemical unlike the condroitin sulfate which is a natural compound. Oversulfated versions have not been widely studied and Dr. Woodcock said: “We cannot rule in or out whether this was accidentally or deliberately introduced into the product.” She said further, “We are investigating how it got in.”

Alarmingly, there could be corporate monetary gain at the end of this invesigation as oversulfated condroitin sulfate is a less expensive ingredient in the process of making heparin. We are investigating this angle.

These lots of contaminated and adulterated heparin were marketed by Baxter International and produced in China.

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Why was Baxter International, Inc.’s Heparin recalled and APP Pharmaceuticals Heparin unaffected by the recent outbreak of allergic reactions and deaths? The answer is simple yet complex. Clearly, Baxter secured its product through a chain of distribution which, along the way from the slaughtered pig to the extraction and packaging of the raw agent, became adulterated. What may be ultimately discovered, however, is that the distribution chains utilized by Baxter and APP were both complex and susceptible to error but that Baxter failed to perform any testing and quality control on its product as it was entering the United States. The FDA has reported that Baxter’s representations as to its distribution chain in the aftermath of the outbreak and recall were not accurate. So, not only was there a failure at the point of entry into the U.S., but Baxter’s own understanding and grasp of its vendor supply chain was murky to say the least.

The FDA did apparently visit some of APP’s distributors in China but failed to inspect countless Baxter sites. However, it is not the FDA’s role or obligation to protect consumers. Rather, once it approves a product (based on the manufacturer applicant’s own representations), the drug maker is wholly responsible for pre-sale inspection and testing and post-marketing surveillance.

Baxter’s failings here are too many to count and, fortunately for consumers who have been harmed, it will not be able to hide behind the recently expanded and bastardized legal tenant of “preemption”.

The number of reports of serious adverse reactions and events to Baxter International, Inc.’s Heparin has now reached approximately 700 with perhaps as many as 21 deaths. The symptoms to look for include tongue and eyelid swelling, rapid increase in heartbeat and blood pressure drop.

Now, the main focus has turned to a contaminant that mimicked the drug’s key ingredient and questions of whether the China based distributors were using a counterfeit alternative. Given that the symptoms in patients and victims were reportedly similar to toxic reactions to chemicals, it stands to reason that the CDC and FDA are analyzing the product which was on hospital shelves but which was not yet utilized. A toxicology screen should lead to the culprit agent and then, hopefully, we will know more about Baxter’s apparently negligence and, potentially, criminal behavior.

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Scientific Protein Laboratories of Waunakee, Wisconsin has just received word that three of its larger purchasers of the active ingredient in Heparin have cancelled orders and will stop doing business with the company. The companies, based out of Japan, manufacturer Heparin and compete with Deerfield, Illinois based Baxter International Inc. in the production of Heparin Sodium for use during surgery.

Scientific Protein issued a statement Monday saying: “The three Japanese companies made clear that the recall was simply a precaution, as there has not been a pattern of adverse reactions to heparin reported in Japan similar to what has been observed in the U.S. and Germany.”

Allergic reactions have been linked to China-sourced heparin ingredients in Germany where dozens of adverse reactions have also been reported. In the U.S., however, FDA officials said a foreign “heparin-like” substance was founded in recalled batches of heparin sold by Baxter.

The very complex supply chain, which begins with pigs at farms in rural China winds through unregulated and uninspected family workshops to small village depots to factories like those run by Scientific Protein in its Changzhou factory.

The FDA is currently investigating the exact nature of the defect and cause of adulteration of the Heparin supplied by Baxter.

If you or a loved one has suffered from the use of Heparin, please contact us for more information.