A Small Echo of the Case of the Adulterated Heparin

A small news item published by Bloomberg is a reminder of a serious case that was never resolved:

Baxter International Inc., which recalled its blood thinner heparin amid reports of allergic reactions and deaths in 2008, faces at least 30 lawsuits in Chicago by injured people or their estates.

As many as 300 product-liability complaints may be filed in the Illinois state court, plaintiffs’ attorney Allen Schwartz of Kralovec, Jambois & Schwartz said today in a phone interview. His law firm and two others are working to comply with a judge’s order last year to convert an aggregate lawsuit to individual claims against the Deerfield, Illinois-based company.

I have appended a summary of the case at the bottom of the post, with relevant Health Care Renewal links.   What is most striking about this case is that it involved the deaths of many patients, and serious complications of many others.  While the nature of the contamination of the heparin, and the biology of its adverse effects were elucidated, how the contaminant was introduced into the drug marketed in the US was never clear.  Finally, to date, no individual has been held accountable, and no individual has suffered any negative consequences from a case that was as deadly as a terrorist attack. 

The best that the leadership of Baxter International could do was described by Bloomberg thus:

'We deeply regret any impact the 2008 heparin contamination situation may have had on patients and family members,' [Baxter International spokesperson Erin] Gardiner said in an e-mailed statement. 'If these lawsuits are similar to those that have already been filed, a large number of claims don’t involve contaminated heparin or in some cases, even Baxter heparin,' she said.

Again, the "impact" apparently included death. The deaths and morbidity were due to an adulterated drug sold in the US as pure. Combatting drug adulteration was the reason the US Food and Drug Administration was founded.

What amazes even me is that a case with such severe outcomes has received so little attention. To my knowledge, there has never been a formal investigation by any branch of government, or by academia, for that matter, of how the contamination occurred, or who was responsible. Aside from some minor attempts to increase general supervision by the FDA of the manufacture of drugs and drug ingredients in other countries, I am aware of no specific changes in policy or regulation meant to prevent another case of deadly drug adulteration. This is a profound and disturbing example of the anechoic effect, i.e., that stories that the often rich and powerful insiders who now may lead health care might find offensive produce few echoes.

If there is no outrage about drug adulteration leading to patient deaths, how do we ever expect to improve our dysfunctional health care system?

Case Summary


- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.
- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.
- Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.
- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."
- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.)
- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible.  (See post here.)