Twists and turns in Baxter's heparin lawsuit

Baxter is fighting to prevent the disclosure of documents relating to the 2008 contamination of heparin products which led to 81 deaths in the USA.

Baxter and its heparin supplier Scientific Protein Laboratories are cited in a class action lawsuit which claims the two companies were negligent because they did not do enough to check the quality of the contaminated active pharmaceutical ingredient that ended up in heparin products distributed to patients.

Baxter and SPL are trying to block an attempt by Amphastar Pharmaceuticals to force disclosure of documents relating to the case which they claim contain proprietary and commercially-sensitive information, according to a report in the Wall Street Journal.

Meanwhile Amphastar maintains that the documents could reveal important information about the origins of the tainted API.

Among the documents under dispute is the deposition of another company, Momenta Pharmaceuticals, which assisted the US Food and Drug Administration in its investigation of the scandal.

Amphastar and Momenta are both vying to get generic versions of a low-molecular weight heparin product called enoxaparin onto the US market. The FDA approved Momenta's application in July, making it the first generic manufacturer to offer a copycat version of Sanofi-Aventis'  blockbuster medicine Lovenox in the USA.

Amphastar's application remains under review despite being filed two years before Momenta's and last year the firm accused former FDA director Janet Woodcock of deliberately blocking its application because of links to Momenta forged during the heparin investigation. That allegation was rejected by the US Department of Health and Human Services Inspector General.

The heparin incident centres on so-called economically-motivated adulteration, a hot topic among medicine regulatory authorities, in which ingredients are deliberately adulterated to fool lab testing and increase their value.

In this case, the FDA believes that the heparin was laced with a cheaper, toxic contaminant - oversulphated chondroitin sulphate - which was indistinguishable from heparin using the standard identity testing recommended at the time.


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