Baxter Denies Recent Heparin Problems Linked to Product Quality

Following two patient deaths and serious complications experienced by a third at Beebe Medical Center in Delaware, Baxter International indicates that their investigation has found no evidence of problems with the quality of their heparin premix product that was used with all three patients.

Baxter and the FDA were contacted by Beebe Medical Center on May 8, 2009, after the three patients all experienced similar heparin problems involving intracranial bleeding after receiving the blood thinner through an IV from pre-mixed bags.

According to a statement released by Baxter on May 15, 2009, the pharmaceutical company conducted an array of tests to verify the product’s integrity and to confirm that there were no contaminants present that may account for the complications.

“Following extensive product testing and further medical evaluation, we are confident that the events at Beebe Medical Center are unfortunate, isolated, institution-specific issues, unrelated to the quality of Baxter’s heparin premix product,” said Camille Farhat, general manager of Baxter Pharmaceuticals & Technologies, part of Baxter’s Medication Delivery business.

News of the problems involving the Baxter blood thinner sparked immediate concerns about a potential repeat of widespread contamination that led to a Baxter heparin recall early last year after hundreds of people suffered severe allergic-type reactions, including at least 80 deaths.

Following that recall, investigations by federal health officials discovered the presence of a counterfeit chemical, oversulfated chondroitin, which was received from raw heparin ingredients manufactured in China.

Baxter currently faces a number of heparin lawsuits over the contaminated blood thinner, which allege that the company failed to take sufficient steps to ensure the purity of their product and did not have sufficient quality control measures in place to protect people who relied on their critical care drug.

All federal lawsuits over Baxter heparin have been consolidated in an MDL, or multidistrict litigation, which is centralized in the United States District Court for the Northern District of Ohio for pretrial proceedings.