The Heparin Debacle Part Four – Baxter International Getting Away with Murder?

Getting away with murder? That’s a pretty harsh question to ask when talking about a drug company. But, I question the policy of drug maker, Baxter International to leave a product on the market for as long as possible before issuing a recall. I’ve heard their arguments, that because the side effects are so rare that more patients are being helped that being harmed. That’s an argument that almost makes sense until you talk to the families of the 785 patients that suffered from severe adverse reactions and 81 patients that have died since January 2007.

To help put those numbers in perspective, according to the FDA report, Information on Adverse Reports and Heparin, of those 81 heparin related deaths, 66 deaths occurred between October 2007 and February 2008. In contrast, there were only 3 heparin related deaths for the entire year of 2006.

In October 2007 there were 4 heparin related deaths reported to the FDA. That’s more than the entire year of 2006. In November 2007 there were10 heparin related deaths. In December 2007, 13 deaths, that’s over 4 times as many deaths as the entire year of 2006. In January 2008, 21 deaths and February 2008 there were 18 heparin related deaths. There were no deaths reported in March 2008.Yet it took the FDA and Baxter over four months to issue a recall. If the recall had been issued in November 2007, 52 deaths might have been prevented.

The FDA does state in its report:

• That the heparin related deaths in the report “concern heparin produced by any manufacturer.”

• The fact that someone reports an adverse event does not necessarily mean that a specific drug caused the medical event or death.

•       • Reports have to be analyzed to see if there is a plausible causal association between the drug and the medical event.
•        •It is often not possible to tell in an individual case if there is a causal relationship between the drug and the medical event or death. 
•         • Many patients have other serious conditions that could have caused the reported problem.

Is Baxter guilty of murder? According to Wikipedia murder is legally defined as:

…a common law murder is defined as the unlawful killing of a human person with malice aforethought if the defendant acts with any of the following states of mind:

(i) Intent to kill; (ii) Intent to inflict serious bodily harm; (iii) Reckless indifference to an unjustifiably high risk to human life (abandoned and malignant heart); or (iv) Intent to commit a felony (felony-murder doctrine).

Under element (iii) abandoned and malignant heart, the killing must result from defendant’s conduct involving a reckless indifference to human life and a conscious disregard of an unreasonable risk of death or serious bodily injury.

Reckless indifference to human life…allowing an additional 52 people die sounds like reckless indifference to me.