Chinese Heparin Recall Continues

Follow-up to Tennessee Law Blog’s 02-05-08 Heparin Recall Article.

Concerned that not all health care providers have recalled their medical products containing unsafe Chinese heparin, FDA officials again notify health care professionals about the FDA heparin recall. FDA has sent notices to various clinics and doctors about the recall of injectable heparin medicines. The cause for the FDA recall was dangerous contamination of heparin by oversulfated chondroitin sulfate.

Ordered earlier in February of this year after at least 81 people died from what are suspected to be defective heparin-related deaths, the FDA believes that quantities of this unsafe blood thinner used in heart surgeries and dialysis. FDA regulators suspect there is still contaminated, recalled heparin in storage areas, emergency kits, and dialysis units.

Despite this recall of China-produced heparin, FDA officials prefer to keep their orders private, having signed confidentiality agreements with the drug companies. These agreements make it illegal for the FDA, the highest U.S. authority in regulating drugs and charged with providing protection from dangerous drugs, to reveal the names of companies who purchased potentially tainted supplies of Chinese heparin and who are not adhering to the heparin recall.

Meanwhile, the price of heparin goes up. USA Today reports that the price of the blood thinner has doubled since last month, according to dialysis centers throughout the U.S. This is due not only to recalls in the U.S. but throughout the world where the dangerous Chinese heparin was sold.

APP Pharmaceuticals became the U.S.’s only supplier of heparin for surgeries and dialysis after the FDA heparin recall. While APP Pharmaceuticals also purchases heparin from China, its heparin appears to not contain the potentially fatal contamination found in the heparin cut by Chinese suppliers with a cheap counterfeit ingredient.

While demand for the limited heparin supply is part of driving heparin costs up 100%, the Chinese suppliers also raise their prices to meet and ensure basic safety standards, according to the USA Today article. In other words, or in my words, the cheap heparin upon which Baxter made its profits at the cost of providing its American customers an unsafe product is only now coming to cost its real market value for cheap labor and lack of oversight.

If you believe you might have a heparin injury lawsuit resulting from dangerous, FDA recalled heparin, contact me, Nashville attorney Jim Higgins, at (615) 353-0930 or fill our drug injury legal consultation forms for our legal services spanning Tennessee.