A man and woman have filed a suit against Bayer, alleging they were not warned of possible side effects in a drug used to control bleeding in coronary artery bypass grafting.
Don Juan Brown and Jean N. Snyder claim their use of Trasylol led to renal damage, renal insufficiency and multi-system organ failure.
Trasylol, which was approved by the FDA in 1993, is usually supplied as a colorless, sterile isotomic solution that is administered through an IV during coronary artery bypass grafting, according to the complaint filed Aug. 20 in St. Clair County Circuit Court.
"Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of CABG procedures," the suit states. "The effects of Trasylol use in cardiopulmonary bypass surgery involve a reduction in inflammatory response, which translates into a decreased need for allogenic blood transfusions and reduced bleeding."
When Trasylol first appeared on the market, it included a warning about possible anaphylactic reactions, which are increased when patients have been exposed to aprotinin prior to their Trasylol use, the complaint says.
However, it provided no warnings about its link to renal toxicity, which was first revealed in an online "Transfusion" article dated Jan. 20, 2006, according to the complaint.
Another study was published in the "New England Journal of Medicine" on Jan. 26, 2006, reporting Trasylol's association with serious renal toxicity and ischemic events, the suit states.
The FDA began to evaluate the studies, and during its assessment, issued a warning to physicians to monitor patients for toxicity.
After a 19-member advisory panel studied the matter, it recommended to the FDA that Bayer's warnings on Trasylol did not need to be strengthened, the complaint says.
But just days after the panel's recommendation, a professor at Harvard's School of Public Health contacted the FDA about a 67,000 patient study he helped to perform at Bayer's request. The study confirmed that Trasylol increased the risk of renal failure, heart attack and stroke, Brown and Snyder claim. In addition, it suggests that patients who receive Trasylol are at an increased risk of death, kidney failure and congestive heart failure.
Bayer knew of the study and its results, but failed to disclose the data to the FDA, according to the complaint.
Finally, on Dec. 15, 2006, the FDA approved revised labeling for Trasylol that specifies the drug should be given only to patients who are at an increased risk for blood loss and blood transfusion. The label also includes a warning that Trasylol increases the risk for kidney damage, according to the complaint.
Since Trasylol's approval, 4.3 million patients have been subjected to the potentially lethal drug, Brown and Snyder claim. In 2005 alone, Trasylol generated about $293 million in sales, the complaint says.
Because of their exposure to Trasylol, Brown and Snyder say they have suffered anxiety, distress, fear, pain, suffering and depression. In addition, their ability to enjoy life has greatly decreased, they sustained a loss of earnings and have incurred medical expenses, the suit states.
In the 12-count suit, Brown and Snyder allege defective design, strict product liability, intentional infliction of emotional distress, common law fraud, negligence and negligent misrepresentation.
They are seeking a judgment of more than $1.2 million, plus costs and other relief the court deems just.
They will be represented by John J. Driscoll of Driscoll and Cueto in St. Louis and by Christopher Cueto of Driscoll and Cueto in Belleville and by Robert L. Salim of Natchitoches, La.
St. Clair County Circuit Court case number: 09-L-439.