Personal Injury Law

FDA Review of Recalled Heparin Deaths Conservative, Insults Victims of the Baxter-Chinese Blood Thinner

I?ve been covering the tainted, dangerous Baxter-Chinese heparin recall, in our Tennessee Law Blog since the story broke in February. While dangerous heparin remains, its circulation is finally diminishing. From 1 January to 31 March, 93 heparin-related deaths were reported to the FDA, and yesterday FDA officials stated that they?ve completed their review. And reporting on these heparin-injuries and deaths, the FDA played it conservative.

Three heparin related deaths were undoubtedly caused by tainted heparin; what the FDA reported on the remaining 90 is an unsettling reminder of how our Food and Drug Administration is not a proactive testing regulatory agency with our nation?s health at its foremost but a political regulatory agency that drags its feet whenever they must be moved.

This is the first time since the Baxter recall that the FDA has allowed themselves to state conclusively that any deaths were caused by the tainted heparin. These three persons each had an infusion of the blood thinner which led to an adverse allergic reaction and the loss of life.

The three deaths were among ten patients who had an allergic reaction to heparin, specifically its contaminant (oversulfated chondroitin sulfate) that tainted the recalled Chinese heparin, but FDA officials were unable to say whether or not the other seven deaths were from the heparin lots that were known to be tainted. They only know that reaction to the contaminant caused the deaths--so these were not counted as caused by Baxter's contaminated Chinese heparin. This is similar to detectives stating that they know the homicide victim died of massive blood loss from a bullet wound, but because no bullet was found in the body, they cannot state with certainty the man with the smoking gun was responsible.

Of the remaining 83 tainted heparin deaths reported in those three months, FDA officials dismissed 25, leaving 58 losses of life attributed to heparin but not from allergic reaction. Because heparin may have contributed to factors leading to a loss of life but heparin did not alone cause the death, FDA officials didn't count them conclusive.

So when the FDA reports three deaths due to tainted heparin, what is meant is that these three deaths cannot possibly be from another cause that could cast doubt. It does not mean Baxter?s questionable business practice of buying heparin from unregulated Chinese villages led only to three deaths.

If you were one of the over 1,000 people on dialysis, undergoing heart surgery, or other medical procedure and injured by tainted heparin, I?d like to know about it. Give our Nashville law offices a call at (615) 353-0930 or fill out our quick heparin injury attorney question form.

Full post as published by Tennessee Law Blog on July 31, 2008 (boomark / email).