Baxter Healthcare Found Liable in Death of American from Contaminated Imported Chinese Heparin

FOR IMMEDIATE RELEASE
Bloomfield Hills, Michigan, United States of America (Free-Press-Release.com) August 25, 2011 -- A 63 year-old Chicago area, retired meat plant worker died after he received contaminated heparin during dialysis treatment and in hospital during 2007.

Dr. Cliff Siporin of Greystone Pharmaceutical Consulting and a Regulatory Affairs Associates Good Manufacturing Advisor was the expert witness for the plaintiff. The 12-member jury reached a unanimous decision in favor of the plaintiff. Baxter must now pay significant financial penalties to the family that would have been avoided if Baxter audited their suppliers as required by Good Manufacturing Practices.

The contaminated heparin was manufactured in China, shipped to Scientific Protein Laboratories in Waunakee, Wisconsin, and then sold to Baxter Healthcare Corp. in Deerfield, Illinois who manufactured the finished Heparin Injection product. Baxter Healthcare recalled its heparin vial products in early 2008 following an alarming and unexpected high rate of adverse reactions and deaths. Now hundreds, perhaps thousands of lawsuits have been filed from injuries to American patients.

Neither USFDA nor the Chinese regulatory officials ever inspected the Chinese plant in Changzhou. FDA finally inspected the Chinese plant after the heparin recall, issuing multiple violations and an import ban.

Regulatory Affairs Associates performs worldwide supplier audits and GMP reviews for drug and device companies who cannot perform these vital activities.

Contact:
S. Goldner
sgoldner@regaffairs.net
[01] 248 747 8008

Heparin Lawsuit     Pharmaceutical Company