BELLEVILLE, Ill. (CN) - Baxter Healthcare diluted its blood thinning drug Heparin with a similar chemical that was not approved by the U.S. Food and Drug Administration, a class action claims in St. Clair County Circuit Court. Baxter diluted the Heparin to make more money, says the plaintiff.
Named plaintiff Joyce Osteen says that around March 5, 2008, Baxter found a Heparin-like molecule called over-sulfated chondroitin sulfate (OSCS), which mimics Heparin. OSCS is not approved in the United States and is not allowed in Heparin, the complaint states. It claims patients who received Baxter's OSCS-tainted Heparin suffered side effects such as oral swelling, abdominal pain, burning sensation, chest pain, diarrhea, dizziness, loss of consciousness, vomiting, palpitations and kidney damage.
The FDA has reported more than 103 cases of death in Heparin patients since Jan. 1, 2007, with 91 of those cases coming after Jan. 1, 2008, the complaint states.
Due to the clusters of adverse Heparin reports, the FDA began investigating Baxter's manufacturing plant in Cherry Hill, N.J. in January 2008 and found the OSCS contamination, according to the complaint. The FDA conclusively linked deaths of patients infused with Heparin to specific OSCS-tainted lots manufactured by Baxter, the suit states.
Osteen claims Baxter intentionally mixed in the OSCS because it is significantly cheaper - $9 for OSCS for a similar amount of Heparin that would cost $900.
Baxter holds at least 50 percent market share for Heparin in the United States. It sells an estimated 35 million units of Heparin each year and reported $11.3 billion in total sales in 2007, according to the complaint.The class consists of all Illinois residents who bought Heparin, not including any individuals with an action for personal injury or wrongful death from Heparin use. The class is represented by John Driscoll of St. Louis.
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