Two Illinois citizens have filed suit against Bayer, seeking more than $2 million and claiming a drug the company produced caused acute renal failure and led to the death of one of the complainant's spouses.
Both Gary Harms and Richard Kopsie were given the drug Trasylol during a coronary artery bypass graft surgery, according to the complaints filed Sept. 25 in St. Clair County Circuit Court.
The drug was approved by the Food and Drug Administration in 1993 for use in patients undergoing the same surgeries as Harms and Kopsie and those who are at an increased risk for blood loss, the suit states.
Harms underwent the surgery in which he was given the drug in 2005 at Des Peres Hospital in St. Louis, while Kopsie had his in August 1996 at Christian Hospital in St. Louis, the suit states.
The drug caused damage to both Harms's and Kopsie's kidneys, resulting in acute renal failure, Harms and Linda Kopsie claim.
Seth Sharrock Webb of Brown & Crouppen in St. Louis is representing the plaintiffs.
Dialysis is a mandatory treatment when patients suffer from acute renal failure, according to the complaint.
"It is a life support treatment," the suit states. "When healthy, the kidneys remove waste products from the blood and also remove excess fluid in the form of urine. Dialysis treatments have to duplicate both of these functions as dialysis and ultrafiltration."
Bayer issued no warnings until Dec. 15, 2006, on the increased risk of kidney failure because of the drug, despite the fact that by 2006 about 10,000 patients were on dialysis because of their exposure to Trasylol, the suit claims.
It also continued to market the drug until December 2006, even after the company knew the risks associated with it, according to the complaint.
By Nov. 5, 2007, Bayer announced a worldwide suspension of the marketing of Trasylol, and it remains off the market today, the suit states.
Richard Kopsie died on March 23, 2003, at the age of 53 as a result of Bayer's negligence, Linda Kopsie claims.
Before his death, Richard sustained injury, incurred medical costs, suffered from disability and a diminished ability to enjoy life and experienced pain and suffering, according to the complaint.
Linda claims she and Richard's three adult children sustained a loss of companionship, society and consortium because of his death.
She also claims she was responsible for funeral and burial costs.
Harms has suffered 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 since he was given the drug, the suit states.
He also claims he has sustained emotional and mental distress and anxiety.
Bayer was negligent because it continued to market the product, failed to warn the FDA of safety facts regarding the drug and failed to supply appropriate warnings for the drug, even though it should have known Trasylol's dangerous side effects, according to the complaint.
It also failed to perform adequate testing that would have revealed the drug's dangerous side effects, Linda and Harms claim.
In her 22–count suit, Linda Kopsie is seeking a judgment in excess of $1.1 million, plus costs and attorney's fees.
In his 11–count suit, Harms is seeking a judgment in excess of $550,000, plus costs and attorney's fees.