When FDA approved the Trasylol drug in the year 1993, hardly did it know that Bayer Pharmaceuticals Company had not informed the FDA about its adverse effects like kidney failure, heart stroke or even deaths. As a result many lawsuits were filed against Trasylol, alleging that Bayer was well aware of the adverse effects and kept them under wraps for its own benefit. The filed litigations also pointed out that Bayer studied a pool of more than 78,000 patients in the duration January 2003- March 2006, and concluded that the risk of death was 64% higher amongst Trasylol users than amongst the users of similar medicine.

Late Samuel Nakis, of St. Louis, age 81 years, was one such patient. He underwent a heart surgery in December 2005, followed by a renal failure. Though he was put on dialysis, but that did no good and he died within one month of the surgery. His family then filed a lawsuit on his behalf in the month of March in the federal court in St. Louis.

Another case was that of Joe Randone. Two weeks post New Year eve, in the year 2005, he was admitted to Long Island Hospital for a heart valve replacement surgery. As per the doctors, the surgery was a low risk operation and Joe would be discharged in a week’s time. He was administered Trasylol, which was injected in Joe’s IV and kept flowing for four hours. After the surgery was completed, Joe’s family was told that there were certain complications. Within no time, Joe suffered from two heart attacks and kidney failures. As per doctors, it was “Aprotinin- induced graft thrombosis” which implies blood clotting i.e. thrombosis due to Trasylol which is aprotinin. Joe Randone is succeeded by his wife Josephine Randone and Marrisa Randone, who have sued Bayer for Joe’s death.

The CBS 60 minute program aired on February 17, 2008, revealed the all the truths that the manufacturer wanted to hide the study and its conclusions that clearly stated the dangerous side effects of Trasylol. To make the matters even worse, FDA also did not take the required actions on time, thereby increasing the extent of damage. FDA dismissed Dr. Dennis Mangano’s research studies due to lack of comparable study, which though was available with Bayer, however the manufacturer withheld the same and did not share it with FDA. It is estimated that if FDA had taken appropriate actions timely, at least 431,000 patients would not have used the drug and at least another 22,000 lives would have been saved.

Month before Trasylol was pulled off the market in May 2008; about 78 lawsuits were already filed in the U.S. only. In early May, the U.S. judicial panel on Multidistrict Litigation (MDL) did consolidate about 18 lawsuits across 14 federal courts. It then, transferred them all to Miami based court, as requested by the plaintiff’s attorneys. However Bayer wanted the proceedings to happen either at District of Connecticut, or the Northern District of Georgia.