A federal mass-tort lawsuit alleging deaths and injuries from imported Chinese heparin is moving forward, and The Wall Street Journal is reporting that defendants Baxter International Inc. and Scientific Protein Laboratories LLC (SPL) have hit a roadblock in a bid to block disclosure of documents relating to the 2008 tainted heparin debacle. The companies claim they will be harmed by disclosing information which is proprietary.
A company that isn’t party to that lawsuit – Amphastar Pharmaceuticals Inc. – says some of the information Baxter and SPL want to keep confidential is important to public health and drug safety, and could reveal information about the sources of toxic heparin, the Journal said.
In January 2008, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme – and in some cases fatal – allergic reactions, after being administered the products. The US Food & Drug Administration (FDA) ultimately initiated 13 recalls of multiple contaminated medical products containing heparin from several companies. Eighty-one US deaths were ultimately tied to the contaminated heparin.
In March 2008, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based SPL. The FDA investigation has never identified the culprits in the contamination, with the agency maintaining that there were too many sources to trace.
As we’ve reported in the past, Changzhou used two consolidators to supply it with a raw ingredient made from pig intestines, as is chondroitin sulfate. Those consolidators obtained the ingredient from unregulated workshops. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.
According to The Wall Street Journal, some of the documents Baxter and SPL want kept confidential include portions of depositions related to Momenta Pharmaceuticals Inc., which helped the U.S. government investigate the tainted heparin. On Aug. 3, federal Judge James Carr in Toledo, Ohio, ruled in favor of the confidentiality motion by Baxter and SPL.
But last week, Amphastar argued that public health could benefit if the depositions shed light on circumstances in China. According t0 the Journal, the company also said the nformation is important to a congressional investigation into the FDA handling of the heparin crisis.
The Wall Street Journal also noted that Amphastar and Momenta are competing for approval to make a newer and more expensive form of heparin, called enoxaparin. Last month, the FDA approved Momenta’s application for its product, but Amphastar’s remains on hold. Amphastar said in its court filing that the “serious safety concerns” involving heparin are relevant to enoxaparin because heparin – most of which is sourced from China – is the starting material of enoxaparin’s active ingredient.