As FDA continues investigation, jury decides for patient in Heparin case
The first Heparin verdict came down today on the side of an Illinois patient who died after being given the contaminated blood thinner in 2007. In the first of nearly 300 pending suits against drugmaker Baxter for its negligent role in the manufacture of Heparin, an Illinois state court jury found Baxter responsible for the death of the 63-year old patient and awarded $625,000 to the man’s estate. (Read the Chicago Tribune story here.)
After a rash of unexplained adverse reactions to Heparin in 2007 and 2008, Baxter recalled the drug and an FDA test discovered a contaminant, over-sulfated chondroitin sulfate, or OSCS. This compound was later linked to hundreds of allergic reactions, including approximately 140 that proved fatal.
Baxter and its ingredient supplier, Scientific Protein Laboratories (SPL), announced in 2008 that the OSCS contaminant was introduced intentionally by their suppliers in China. Financial motives are presumed, because Heparin costs 100 times more to make than OSCS. In addition, Heparin which is harvested and purified from the intestines of pigs, was even harder to obtain in 2007-08 because a global pig disease epidemic had created an unexpected shortage in China and elsewhere.
The timing was right, and seems the chemistry was, too. The OSCS contaminant was not initially discovered because it mimics some chemical properties of Heparin, suggesting that it was introduced by suppliers in China who possessed the biochemical savvy to fool the standard chemical purity tests then in use by Baxter and the FDA. (The assay test has since been improved by the US Pharmacopeia.)
Congressmen Joe Barton and Michael Burgess, both from Texas, have criticized the FDA and the Chinese government for their poor investigation into the source of the intentional contamination, or adulteration, of Heparin. The FDA has said that their continuing investigation into the source of this dangerous contaminant has been “severely hampered” by China’s unwillingness to cooperate. (See WSJ article here).
Today’s verdict and the pending cases are tragic and critical reminders of the need for greater FDA resources and authority to regulate today’s global drug supply chain. China imports nearly $1.5 billion in medical products to the U.S. each year, and the FDA itself has acknowledged that another Heparin-like crisis is ‘inevitable’ unless the agency is given new authorities to inspect internationally, and to require manufacturers to follow good manufacturing practices.
Ultimately, today’s verdict is a good result for the victims of contaminated Heparin, and a wake-up call to drug manufacturers. Consumers of all medicines—prescription and over-the-counter alike—deserve protection from harm, and manufacturers should be held responsible to make sure their products are made safely. Increasing FDA’s authority to ensure the safe manufacturing is in everyone’s best interest.
–Wells Wilkinson, Staff Attorney, Community Catalyst