Both complaints were filed in the St. Clair County Circuit Court.

Gary Harms received a Trasylol injection in 2005 while he was undergoing heart surgery at Des Peres Hospital in St. Louis, Missouri. He has since suffered from acute renal failure and requires regular dialysis to perform the functions of his failed kidneys.

Researchers first discovered a link between Trasylol and kidney failure in the early 1980s when lab animals that received the drug developed severe kidney failure. Subsequent tests confirmed Trasylol’s danger to humans, yet Bayer consistently denied the existence of a link between their drug and acute renal failure and death. The company also failed to fund and perform adequate clinical tests that would have conclusively demonstrated the drug’s risks.

Harms’ suit claims that he has suffered from emotional distress and anxiety, physical personal injury, medical expense, loss of consortium, services, love and affection, permanent loss of an important bodily function, permanent impairment of the ability to enjoy life and financial expenses. He seeks $550,000 in addition to attorney’s fees and other costs.

Richard Kopsie also received Trasylol during his coronary artery bypass graft surgery at Christian Hospital in St. Louis, Missouri in 1996. He experienced kidney failure shortly after surgery and required dialysis for years. Kopsie passed away in March 2003 at the age of 53, but his final years were marked by pain and suffering from Trasylol-induced injuries, medical costs, disability, and a diminished ability to enjoy life, according to the complaint filed by his wife Linda.

Linda Kopsie seeks a $1.1 million on 22 counts plus attorney’s feels and other costs against Bayer.

Both suits claim that Bayer acted negligently for continuing to market Trasylol when the drug’s dangers were known, for failing to alert the FDA to dangers of the drug, and failing to attach appropriate warnings and safety information to the drug. For years, Bayer also avoided performing large scale tests that would have effectively underscored the drug’s dangers.

SOURCE: Trasylol Recall › Two suits filed against Bayer in Illinois

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.

SOURCE: Trasylol Recall › physicians favor drug safety litigation