Baxter pays $625K in first heparin contamination suit
Patients affected by Baxter Healthcare's tainted heparin caught a win after a Cook County judge awarded $625,000 to the estate of 63-year-old Chicagoan Steven Johansen, who died due to adverse events linked with the contamination. The case was the first of hundreds of lawsuits alleging that Baxter distributed contaminated heparin drug vials.
In May 2008, the FDA found that Baxter International knew that the Changzhou SPL plant in China had never been inspected by the agency. This oversight led to the manufacturing of hundreds of contaminated batches of heparin. In fact, the tainted heparin batches were linked to 81 deaths and 785 severe allergic reactions.
After investigation, it was found that these affected lots were “man-made fake herparin” that were contaminated with oversulfated chondroitin sulfate, a compound consisting of animal cartilage usually distributed as a dietary supplement. Baxter referred to this heparin as “the cheap stuff” in company documents, according to a press release by the Nolan Law Group. After inspection of the Chinese plant, the FDA found multiple violations that resulted in an import ban.
During the current court case, the judge ruled in favor of Johansen saying that the blood thinner he was administered was “defective as a matter of law.” The judge said that the compensation was for the pain and suffering Johansen endured over a five-day period after he was administered a bolus dose of the drug contaminated during dialysis.
This specific case triggered a congressional investigation that aimed to expose shortcomings in the drug oversight process, particularly when drugs are imported from China and other developing companies.
Last year, U.S. Reps Joe Barton (R-Texas) and Michael Burgess (R-Texas) accused the FDA of mishandling the investigation of Chongqing Imperial, a Chinese pharmaceutical company that had knowledge of the contaminated heparin. The representatives said that the agency neglected to follow-up on “specific and credible information” that linked Chinese heparin manufacturers to the tainted drug.
The remaining lawsuits are pending in the Circuit Court of Cook Country in Chicago before Judge Jennifer Duncan-Brice and the U.S. Northern District Court in Toledo, Ohio, before Judge James G. Carr.
In May 2008, the FDA found that Baxter International knew that the Changzhou SPL plant in China had never been inspected by the agency. This oversight led to the manufacturing of hundreds of contaminated batches of heparin. In fact, the tainted heparin batches were linked to 81 deaths and 785 severe allergic reactions.
After investigation, it was found that these affected lots were “man-made fake herparin” that were contaminated with oversulfated chondroitin sulfate, a compound consisting of animal cartilage usually distributed as a dietary supplement. Baxter referred to this heparin as “the cheap stuff” in company documents, according to a press release by the Nolan Law Group. After inspection of the Chinese plant, the FDA found multiple violations that resulted in an import ban.
During the current court case, the judge ruled in favor of Johansen saying that the blood thinner he was administered was “defective as a matter of law.” The judge said that the compensation was for the pain and suffering Johansen endured over a five-day period after he was administered a bolus dose of the drug contaminated during dialysis.
This specific case triggered a congressional investigation that aimed to expose shortcomings in the drug oversight process, particularly when drugs are imported from China and other developing companies.
Last year, U.S. Reps Joe Barton (R-Texas) and Michael Burgess (R-Texas) accused the FDA of mishandling the investigation of Chongqing Imperial, a Chinese pharmaceutical company that had knowledge of the contaminated heparin. The representatives said that the agency neglected to follow-up on “specific and credible information” that linked Chinese heparin manufacturers to the tainted drug.
The remaining lawsuits are pending in the Circuit Court of Cook Country in Chicago before Judge Jennifer Duncan-Brice and the U.S. Northern District Court in Toledo, Ohio, before Judge James G. Carr.