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Heparin Lawsuit: Areas of Inquiry
As the lawsuits explode on the scene of the heparin cases, here are some issues that need to be addressed:
1. How do we know that this catastrophe began with September of 2007 produced product, and not much earlier? Doctors, medical examiners and pathologists had no basis to suspect heparin in any deaths prior to January of 2008. Unfortunately, as most of those receiving heparin were already very sick, a suspicious death or reaction might just have been attributed to the already compromised health of the person receiving heparin. Will the FDA, Baxter, the CDC go back and do additional surveillance of all deaths in dialysis patients in the period prior to the fall of 2007, to see if there is a pattern that was previously missed?
2. What is the precise method of death and morbidity caused by this contaminant in the heparin? Is it strictly a anaphylactic or anaphylactoid reaction, or is there something more complex going on?
3. If it is anaphylactic or anaphylactoid reaction, has the patient been sensitized to the contaminant because of earlier treatments (such as with a prior bee sting) and then has the anaphylactic reaction upon the later treatment (the second bee sting)?
4. What health risks/disabilities have those with adverse reactions who survived faced? Are they at greater risk of anaphylactic or anaphylactoid reaction in the future? Do they need to carry precautionary warnings, medications with them?
5. What about the thousands of those exposed to this toxin, who did not have an adverse reaction? If the issue is anaphylactic or anaphylactoid reaction, are they at greater risk of anaphylactic or anaphylactoid reaction in the future because they have now had the equivalent to the first bee sting?
6. In the survivors, is there any risk of organ damage or brain damage as a result of the cardiac or hypotensive events that occurred?
7. If the pathology is broader than an anaphylactic or anaphylactoid reaction what other damage did it do to the bodies of those who survived?
8. What diagnostic tests should be being performed on the survivors? MRI of the brain, EKG’s. Clearly, it would seem imperative to do kidney function tests, on the hemodialysis survivors.
9. What about all of those exposed to the toxins, without a clinically significant acute reaction? This exposure presumably went on for weeks and even months. Could they have chronic damage with a more subtle manifestation?
 The lawsuits provide the best mechanism to get to the bottom of these issues, but we hope that Baxter, its joint venture participants, the CDC, the FDA and other government agencies will be pondering these issues and looking for the truth, not just pointing fingers.
Next: FDA Press Releases
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