Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The FDA has stated it does not have the resources to inspect imports of Heparin and other drugs

In March 2008, major recalls of heparin were announced by the FDA due to contamination of the raw heparin stock imported from China. The FDA admitted that it had violated its own policies by failing to inspect the American pharmaceutical firm Scientific Protein’s plant in China before approving the drug for sale.

This news seems to be only the most recent in a string of reports of defective or downright dangerous products from China, with the finger of blame pointed at lax regulations and reviews of products coming into the U.S. from that country.

Pharmaceutical grade heparin is derived from mucosal tissues of slaughtered meat animals, such as pig intestine or cow lung.

In the case of heparin, an examination of the manufacturing process for the medication provides even more reason for concern. A recent Wall Street Journal investigation into the process reveals crude facilities – little more than shacks – where pig intestines are handled by workers not even wearing gloves, on old wood plank tables. Pulp is wrung out of pig intestines, which are then tossed into concrete vats for heating and processing.

The WSJ reported a case in which officials closed sausage-casing companies that were producing heparin on the side, and documented dirty water on the floor of one factory that contained ten-centimeter-long worms.

The image doesn’t exactly coincide with the American ideal of a sterile medical environment.

Today, more than half the world’s heparin comes from China.

While heparin goes through extensive processing from the raw stage before it is cleared for medical use, if there’s a problem with the final medication, it can be nearly impossible to trace the raw heparin back to the source.

And, it seems to be a case of “buyer beware,” as the FDA has stated it does not have the funds nor bear the responsibility to regularly inspect overseas manufacturers of active pharmaceutical ingredients such as heparin.

Do you have a heparin claim?

If you or your loved one has suffered a serious injury or death as a result of contaminated heparin, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our heparin lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.