The complaints accuse Baxter and its supplier, Scientific Protein Laboratories LLC, of negligence, alleging Baxter’s heparin was unsafe for the intended use. The lawsuits seek money damages.

The nightmare began in late 2007, as reports of serious allergic reactions and deaths following use of Baxter’s heparin began mounting. By March 2008, the Food and Drug Administration (FDA) issued a major recall of heparin. At the time, Baxter supplied about 50 percent of heparin to the U.S. As Baxter began pulling its heparin, investigations into the source of the contaminant focused on Baxter International’s China plant. The culprit was identified as over-sulfated chondroitin sulfate, or OSCS, a man-made chemical that mimics heparin.

While Baxter was at fault for distributing the tainted heparin, critical eyes fell on the FDA for not properly inspecting foreign drug manufacturing plants. The agency admitted it was simply too understaffed to properly inspect most of the foreign food and drug manufacturing plants. The FDA soon after received funding to open overseas field offices, the first three of which were opened in China.

The stricter inspections hardly console the victims and families of victims who suffered or died from the contaminated blood thinner. The FDA reports that as many as 395 deaths and 785 reports of serious injury were associated with the contaminated heparin.

Source: Bloomberg

SOURCE: Heparin Recall › Baxter faces numerous lawsuits over tainted heparin scandal