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Contaminated Heparin Can do more than Kill It seemed so obvious, but a brain damage expert I know felt the need to say it twice: That which can kill can do a lot of damage to those who survive. The body is a closed vessel, that is designed to very closely monitor that which comes in and out, especially the things that get into the blood stream. All organs are extremely susceptible to a disruption in what is supposed to be in the blood supply. That susceptibility applies not only to a poison that shouldn’t be there, but also if there isn't enough of what should be there: i.e. fuel to make the body work (glucose) and oxygen to make the fuel burn. Further, if the blood isn't circulating properly, the waste products from this biological fire will not be carried away. In a very similar way to how people will succumb to carbon monoxide poisoning, the body's cells and organs will be injured or killed by failure to properly ventilate (via the veins) the waste products created by keeping the body running. When you put contaminated heparin intravenously into a human body, you bypass all of the body’s filters. The blood stream directly circulates that contaminant to every cell and organ. So what happens when a toxin runs amuck in our bodies? Almost anything that can go wrong, could go wrong. Let us discuss the articulated theory from the CDC and the FDA of "acute allergic-type reaction has been defined as an episode of anaphylactic or anaphylactoid reaction". See: What can happen with anaphylactic shock? The body goes into shock. And more specifically with respect to shock: Some highlights from Wikipedia: "Shock is a serious, life-threatening medical condition where insufficient blood flow reaches the body tissues. As the blood carries oxygen and nutrients around the body, reduced flow hinders the delivery of these components to the tissues, and can stop the tissues from functioning properly." And guess what can happen when the tissue stops functioning properly - brain damage and other organ damage, from a condition called hypoxia. We know that reduced blood flow is one of the common symptoms of the Heparin contamination cases, because of the hypotension (low blood pressure) reported in most of these cases. Some highlights from Wikipedia.org about the risk of brain damage from hypoxia: "Cerebral hypoxia refers to deprivation of oxygen supply to brain tissue. ... Extended periods of cerebral hypoxia can lead to brain death or permanent brain damage. ... The effects of certain kinds of severe generalized hypoxias may take time to develop. For example, the long term effects of serious carbon monoxide poisoning usually may take several weeks to appear. Recent research suggests this may be due to an autoimmune response caused by CO induced changes in the myelin sheath surrounding neurons." Symptoms of hypoxia? Cognitive problems similar to what might be expected with a concussion. Amnesia, confusion, difficulty doing complex tasks, responding to unexpected processing demands. While there is some controversy about how much hypoxia can occur without long term damage, we believe this is the most important issue to evaluate in any Heparin contamination case. So far no one at the CDC or FDA has announced any inquiry into whether hypoxic damage to the brain or other organs has occurred. While the brain is the most susceptible to permanent damage in a healthy person, since the recipients of this contaminant were those with compromised organs (hemodialysis patients for example), other organ damage may have occurred before the evidence of cerebral hypoxia showed up. Further, as vital organs like the kidneys and liver started to malfunction, other toxins could have been circulated into the blood stream. It is time to insist the inquiry in this matter is no longer ruled by the presumption that those who survived the allergic reaction will have no long term damage. It is unimaginable that something toxic enough to have killed 62 people while affecting as many as 5,000 others, didn't leave some permanent damage behind. The unraveling of the Heparin conspiracy got a little clearer yesterday when the FDA announced that it is suspecting business fraud as the primary culprit behind the contamination of Baxter's Heparin. The FDA's theory is that somewhere in the China supply chain for the Heparin, some person or entity thought they could make a higher profit margin if they substituted counterfeit Heparin raw material, for the real thing. Woops if the substitute just happens to be toxic. Assume the FDA is right. Should American drug companies be able to shift blame by finger-pointing at Chinese suppliers? Not in our book. A drug such as Heparin and its raw materials are ultra-hazardous substances, especially because they are to ultimately put right into the bloodstream of humans. And not just any humans, in the case of Heparin, very ill and vulnerable individuals. Who needs a toxin or hypotension (with resulting hypoxia) less than a kidney patient? See blog for a discussion of hypoxia. Questions that must be answered:
The Why China issue. Later as we learn more, I will probe into why dialysis patients reactions were noticed first. But click here for an amazing story of the one doctor who uncovered the whole conspiracy. We don't yet know the specifics of the either the bean counting that made the choice to go Chinese versus American on the pork. We may never know how that calculated profit was enhanced by a sophisticated counterfeiting process. What we can clearly presume, however, is that if Baxter had wanted to make sure that Heparin was pure, it could have used American pigs to produce it. The United States is the largest single exporter of pork in the world, trailing only the combined the combined European union for pork exports. While the Chinese produce more pork total than the U.S., actually their billion plus population consumes a much higher percentage than in other countries and they are actually fifth in exports. So we know that since we are exporting pork in the U.S., Baxter could have bought it here. If they went overseas to get it, that says that to them, pork bi-products had a lower value than all those other American companies who makes things from pork, such as pizza, bacon and countless bi-products. Well, the safety and purity of things I put in my mouth is important to me. But a lot less so than the safety of what I put in my bloodstream. My mouth and stomach are made to filter out the contaminants, before the contaminants get into my blood stream. How could they value the purity of their product less than those who make frozen pizzas? At some point we will learn than Chinese pork, by some sort of bizarre bean counter logic, added up to 1 cent or maybe 5 cents a dose. But Baxter sold a lot of Heparin and that must have been millions and millions. Greed. For that incremental saving, we lost how what will likely add up to hundreds of lives and still not even remotely assessed, permanently damaged human organs? There exists a remedy in American jurisprudence for bean counting gone haywire: it is called punitive damages. Usually it is reserved for the calculation to not fix an known defect, because of the cost of retooling or of making it safer. Clearly, that application will likely apply here. But in this case we have more: we have homicide. The Heparin deaths, if the FDA is right, counterfeiting Heparin is murder by poison. Clear and simple. Only punishment, and severe punishment can once again tell the corporate world that crime doesn't pay. Next: Heparin Lawsuit: Areas of Inquiry For information on the recall, click here: To contact us, call 800-992-9447. Gordon Johnson is the Owner of the Johnson Law Office. He is affiliated with the Nolan Law Group and is co-counsel on all of the firm's Heparin cases. ©Gordon S. Johnson, Jr. 2008 |
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