Verdict Comes in Baxter Heparin Lawsuit

On 10 June 2011, came jury verdict on one of the many lawsuits filed against Baxter heparin. In 2008, contaminated vials of heparin were found. Same year FDA came to know that Baxter International was fully aware that its plant in China was never inspected by the agency. This plant was responsible for chu
ing out contaminated heparin vials. This lot of the drug caused many deaths and around 800 cases of severe allergy. Later, it came into light that affected lots were fake heparin. These fake drugs were man made and were contaminated by over-sulfated chondroitin sulfate. Import ban was levied on this plant after finding out these drugs.

Several people suffered from severe allergic reaction such as nausea, vomiting and difficulty in breathing. After finding out contamination in Heparin, many lawsuits were filed against Baxter International. Recently one of the first lawsuits, which went for trial got jury verdict. The lawsuit was associated with Steve Johansen, a 63-year-old patient, who died due to use of heparin. He was given low doses of contaminated heparin during dialysis. Later he was also administered with a bolus dose of heparin in Palos Community Hospital. This was a case of late 2007.

The judge ruled in favor of Steve Johansen on the grounds of the drug, which Johansen was administered being “defective as a matter of law.” The judge favored the suite and said compensation for the pain and suffering Johansen bore has to be paid. Johansen suffered for over a five-day period after having a bolus dose of the contaminated heparin. The Baxter and the Chinese supplier, Scientific Protein Laboratories LLC was found liable to pay the compensation.

The Cook County judge awarded $625,000 as compensation in this case. The Estate of 63-year-old Chicagoan Steven Johansen will receive this amount.

This case lead to a congressional investigation regarding heparin contamination. It exposed the shortcomings in the drug oversight process. It gave stress especially on import process of drugs from China and other developing countries.

This case brought into light the poor pharmaceutical supply chain, poorly supervised manufacturing in China and the failure of FDA to exercise proper oversight. Later the Chinese supplier was banned for import.

After the verdict Baxter took responsibility for legitimate cases of harm related to the contamination. Its spokesperson said, “It will vigorously defend claims that are not consistent with the definition established by public health authorities” in a statement given to the Tribune.

Baxter said in the above said statement, “Both the Centers for Disease Control and Prevention and FDA identified a well-defined and discrete set of symptoms potentially associated with heparin contamination.” Baxter will follow the rules and take responsibility for genuine cases.