Heparin Deaths

One of the surprising things to me when I consider the scope and controversy about the Baxter Heparin debacle, is that all of the focus is on OSCS (the identified anaphylactoid agent) not the total lack of sterility in a IV drug. Defense tactics in major cases are all about misdirection and even though it seems somewhat self-defeating to do so, Baxter has succeeded in limiting the inquiry into the Heparin deaths to the issue of whether there was OSCS in a given dose.

That is wrong. This is a drug intended for intravenous administration to extremely sick people. To assume that the only problem with Baxter’s manufacture of an IV drug outside the U.S. is this one identified contaminant, is naive. What we know from the Congressional testimony of those who inspected the Chanzghou SPL plant is that no proper procedures were being followed, no one on site had any meaningful expertise in the manufacture of heparin and that they were using unsanitary equipment that was being used to product that had to be sterile and pure.

On April 29, 2008, the House Subcommittee on Oversight and Investigations held hearings entitled, The Heparin Disaster: Chinese Counterfeits and American Failures
For more on those hearings, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

The link provides written transcripts of the prepared remarks of the witnesses at such hearing, which included four panels, detailed below. However, the transcript of such hearings has never been added to that page, and I have been unable to find a copy of it online. Further, I requested such transcript the day of the hearing but have never received it.

All of that testimony is significant and I have quoted some of that before. But on the issue of the non-sterility of this IV drug, I believe the Testimony of Regina T. Brown, Consumer Safety Officer might be the most important. I will begin my discussion of her testimony in today’s blog and continue it in later blogs this week.

In such testimony, Brown identified a series of problems with the way in which SPL (Baxter’s supplier of heparin API) was producing heparin at the Changzhou SPL in China. She identified specifically these things about the way Heparin was being manufactured at Changzhou SPL:

1. That inadequate procedures were being followed to determine what was in the Heparin API,
   
2. That the tanks in which Heparin was being made were unsanitary,
   
3. Three that the centrifuges which were being used to separate out the Heparin from other raw materials were not calibrated; and
   
4. That no one on site had any real expertise in the manufacture of Heparin.

All of these issues point to the inference that this bad Heparin could have contained contaminants far more diverse than OSCS. Almost anything that goes through the small intestines of a pig could have been in that Heparin API. The NEJM of study in June of 2008,
“Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System” identified that the contaminated lots not only contained OSCS, but also another troubling compound: Dermatan Sulfate. But what of germs, other impurities or organic compounds that could cause a completely different but deadly disease process than OSCS?

In our next blogs, we will work thru the different issues identified by Regina Brown in her inspection of the Chanzghou SPL plant.

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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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