Heparin, a prescription injectable blood coagulant often used in hemodialysis (the filtering of blood) and cardiac invasive procedures, has been a source of controversy since several companies recalled the drug. Although heparin is widely used, most of us don’t really know much about the drug.

Attorney Douglass Kreis

Attorney Douglass Kreis, whose firm protects the rights of consumers who are seriously injured due to defective drugs such as heparin, has been following the controversy and explained what’s it about in a recent interview. According to Kreis, there are two different types of heparin cases involved in the current litigation. He explained:

Sierra pre-filled heparin syringe cases

The first relates to the Sierra pre-filled heparin syringe cases, which involves the distribution of heparin-filled I-V medical syringes contaminated with bacteria. According to a heath alert issued on December 21, 2007, many people have become ill with what is called serratia marcescens (a bacteria, pronounced mar-shush-ens) after using the contaminated syringes as part of home i-v therapy. The syringes were manufactured in North Carolina and are labeled "Sierra Pre-Filled," lot number 070926h. Symptoms include fever, muscle aches, and chills. However, cases of a rare bloodstream infection have appeared in states including Texas, Colorado, Pennsylvania, Illinois, and Florida.

Class 1 recall. Since the initial January 18, 2008 press releases by both AM2 PAT, Inc. and B. Braun, a Class 1 recall (the most serious class of recalls) was initiated by the FDA on January 30, 2008 in which AM2 PAT, Inc. notified healthcare professionals a nationwide recall of all lots of both Heparin and Normal Saline pre-filled flushes. These products are distributed under brand names, Sierra Pre-Filled Inc and B. Braun and are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline.

Baxter’s heparin

The second is the Baxter heparin case. This is one in which the heparin sodium solution is provided to a patient when they are undergoing an invasive procedure. Typically, it is given during a bypass or something in which they need the blood-thinning agent to help regulate the blood and make sure it doesn’t coagulate. There were 1,000 units and nine lots of what they call multi-dose vials which were urgently recalled (also a class 1 recall) on a national basis by Baxter, who also sent out some dear doctor letters.

Where the product originates

Kreis told us that heparin is a product which comes naturally from pig intestines that are being wrung and cleansed in tiny villages throughout China. However, inspection processes are virtually non-existent. He explained, “There is very little regulation and really no documented list of the suppliers of the raw product in China. The Chinese government has said openly that they do not inspect all of the plants from which the heparin comes from. There was a pig flu or disease that had gone around and killed a lot of the livestock in China within the last year, although there is very little information about it.”

Other companies may be involved

Kreis suspects that there are other companies, in addition to Scientific Protein Laboratories, that are suppliers of this product. “It’s almost a black market, really. The pharmaceutical industry is hell bent on getting products to consumers that costs are cut on the front end and it ends up creating a regulatory nightmare.”

If you’ve been injured due to heparin use, contact an attorney to discuss your situation. The consultation is free and without obligation. To contact a qualified attorney whose practice focuses in this area of law, please click here.