Friday, August 20, 2010

Baxter's Heparin Saga Continues

The Wall Street Journal writes about the preliminary legal wrangling by Baxter regarding their class action lawsuit over the 2008 contamination of heparin products which led to 81 deaths in the United States.

In the class action lawsuit, Baxter and its heparin supplier Scientific Protein Laboratories are cited as being 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.

According to the story in the Wall Street Journal, “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.”

Amphastar claims 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.

This story, like several other high profile issues regarding the quality and efficacy of pharmaceuticals, is a cautionary tale to all within the pharmaceutical supply chain to protect their products.

With an entire criminal industry that focuses on counterfeiting and what many call economically-motivated adulteration, in which ingredients are deliberately adulterated to fool lab testing and increase their value, the pharmaceutical industry, the value of their individual brand and the health and well being of the average consumer is in the cross hairs. Manufacturers, distributors and dispensers need to deploy and integrate technologies to verify and authenticate their raw materials, products, inventories and dispensed medications.

As it relates to Baxter, the FDA believes that the heparin was purposely laced with cheaper, toxic contaminants - oversulphated chondroitin sulphate – which ultimately lead to the deaths of 81 people.

No comments: