The director of China's "FDA" told a press conference that Baxter had failed to cooperate with Chinese experts sent to the U.S. to investigate the Heparin Disaster. The director, Jin Shauhong, also claimed that there was no "confirmed" link between the Over Sulfated Chondroitin Sulfate ("OSCS") and the deaths of patients in the United States.

Chinese representatives claimed that Baxter and the FDA failed to provide them with medical records, medical histories, and information on Baxter's manufacturing practices. The Chinese also complained that they had not been given samples of the contaminated product. Baxter now says it will give the Chinese samples of the product to test.

The FDA tried to inspect the Changzhou Techpool Pharmaceutical Co. ("CZTP") in Changzhou, China on February 27, 28 and 29, 2008. This company supplied SPL Changzhou with raw heparin and may have been a source for the contaminant.

During those inspections the FDA was accompanied by a representative of the U.S. Embassy from Beijing. This facility was NOT regulated by the Chinese because it did not sell any product within China. Instead its products were all made for export; therefore neither the Chinese nor the FDA inspected this plant.

Changzhou SPL, a defendant in the cases we have filed, owns 45% of CZTP. During the FDA inspection CZTP refused to provide the FDA with records for review.

Now the Chinese are complaining that U.S. companies are not cooperating with them in their investigation. What a surprise.

This illustrates a number of critical shortcomings in our drug system. First, as admitted by the FDA last week, the FDA is woefully underfunded and unable to inspect foreign manufacturers. Second, the manufacturers themselves cannot be relied upon to self-regulate their suppliers. Third, China and the United States have been unable to cooperate with each other to insure that good manufacturing practices are followed throughout the chain.

The only regulation that is truly reliable is that obtained by our common law. Companies that fail to insure the safety of ingredients in their products must be held strictly accountable for all injuries and deaths they cause. They must be held strictly accountable.

SPL used to be called Oscar Mayer. It used the small intestines of American grown hogs to make the raw heparin. There was no adulteration by counterfeit heparin because Oscar Mayer was an American company with a reputation to protect and a business to run. It would be unthinkable.

Yet somewhere along the way, through free trade agreements, the drive for ever higher shareholder return, corporate profits, deregulation, and business - friendly agencies we have lost our way. As we go through the documents and take the depositions of these corporate officers we are going to learn a lot more. And it isn't going to be a pretty picture.

By the way, if the Chinese are really worried about the relationship between the counterfeit heparin and the injuries and deaths, I suggest they read the recent article in the New England Journal of Medicine. We have a link to it on our web site. Maybe we should translate it into Mandarin.

Labels: Baxter, Changzhou, China, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, OSCS, over sulfated chondroitin sulfate