FDA Finds "Clear Link" Between 81 Deaths and Contaminated Heparin

As reported in the New York Times, federal officials have now identified a “clear link” between contaminated heparin from China and 81 US deaths from severe reactions to the drug. Up until this point, Chinese heparin manufacturers (including Baxter) have openly doubted that a link could be proven connecting these deaths to the contaminant. Baxter even issued a public statement claiming that they did not expect any “material litigation” as a result of the dangerous drug.

Similarly, Chinese officials have now joined the drug manufacturers in disputing the validity of this FDA report showing a “clear link” between reported illness and contaminated heparin. They openly dispute the possibility that the fake chemical additive found in Heparin was responsible for the 81 deaths and countless severe reactions reported in the US. Chinese officials are also suggesting that because reactions to heparin have only occurred in the United States, the problem must stem from the American processing plants that also handled the drug.

Unfortunately, international reports have proven otherwise. German officials have recently come forward reporting strange reactions in dialysis patients after heparin use. The contaminant itself (which has been linked directly to the Chinese manufacturers) has also been found in heparin supplies in 11 other countries to date. And, although Chinese manufacturers and officials dispute a link between the contaminant and the resulting illnesses, FDA director Dr. Janet Woodcock makes an excellent point: “Heparin should not be contaminated, regardless of whether or not that contamination caused acute adverse events.” She also adds that, “we [the FDA] are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions.”

And while China attempts to pass the buck onto American processing plants, China”s recent track record is a major factor contributing to the public”s distrust. Contaminated Heparin is just another addition to the other toxic imports from China, including contaminated toothpaste, dog food, lead paint toys and tainted fish products. After the discovery of these products, China was equally defensive and unwilling to accept responsibility until July of 2007 when the government executed its top food and drug regulator for taking bribes and promised product safety reforms.

Obviously, those reforms were not carried out. Furthermore, Chinese officials have made clear that plant inspections and better testing methods will only be implemented if the United States agrees to reciprocity. This means that the inspection of Chinese plants will only be allowed if the Chinese can set up shop in the US and inspect our facilities as well (something they know that the US is less than willing to concede). Budget issues are another factor stopping better regulation of dangerous foreign imports. The Government Accountability Office has found that the FDA will need an additional $56 Million next year alone to conduct more thorough drug inspections abroad. Additionally, the Bush Administration has failed to provide funding for additional FDA personnel in it”s current budget proposal. Without the necessary personnel in place, it is clear better inspections will be difficult, if not impossible to follow through with.

The whole situation is very disturbing and has left a bad taste in the mouths” of American consumers. Locally, people have no way of knowing if heparin has been distributed in New Jersey or Pennsylvania hospitals. They want to know if there is any link between contaminated heparin and the illnesses they have experienced. Even more disturbing is that these people aren”t sure where to go for answers. Most reports about contaminated heparin have been vague at best, and there is really no way of knowing at this point where and when contaminated vials of heparin were administered. The most concrete information released by the FDA is that the contaminant was found in vials manufactured as early as 2006, with the majority of reactions and deaths occurring between November and February of this year.

It”s clear that these reports have been considered unacceptable by injured patients and the lawsuit process has begun for many consumers of the drug. This is true even in the local New Jersey and Pennsylvania area. While it is sad that it has to come to this point, sometimes the litigation process and the monetary judgments against such companies are the only language that these manufacturers seem to understand. Their number one concern seems to be profit, and as long as that remains untouched, they will continue to produce unsafe products for the unsuspecting American public. Until then, people want answers-and if they FDA or heparin manufacturers will not give it to them, they will take matters into their own hands and file suit.

Alternatively, if you suspect that you or a loved one has experienced a bad reaction after taking contaminated heparin, our licensed RN is available to help you and your family determine if there may be a link between your illness and the drug. It”s OK to ask questions and we encourage you to do so–even if you are not sure if Heparin is to blame for your injuries. Our firm has received numerous inquiries from people that just want answers and quite frankly, that”s what we are here for.

Should you have a Heparin related question, we encourage you to call (856) 333-0600 in NJ or (215) 567-2380 in PA or follow the link below to fill out an online case evaluation form:

Medical Malpractice