HUNTINGTON -- A federal lawsuit has been filed against Bayer in which the Ohio plaintiff alleges he was not warned of possible side effects in a drug used to control bleeding in heart surgeries that caused the plaintiff to experience acute renal failure.
The lawsuit was filed Oct. 20 in U.S. District Court for the Southern District of West Virginia and alleges James Foster Mathis experienced renal failure after he was administered Trasylol on June 28, 2004, before an aortic valve replacement and coronary artery bypass graft at St. Mary's Hospital.
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.
"Trasylol was indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass surgery," 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 complaints say.
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, Mathis claims. 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 included a warning that Trasylol increases the risk for kidney damage, according to the complaint.
And on Nov. 5, 2007, Bayer suspended worldwide marketing of Trasylol when the FDA stated, "It is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks."
On May 14, following a study finding an association between Trasylol and increased mortality, Bayer notified the FDA of its intent to remove all remaining supplies of the drug from hospital pharmacies and warehouses, the suit states.
Since Trasylol's approval, 4.3 million patients have been subjected to the potentially lethal drug, Mathis claims. In 2005 alone, Trasylol generated about $293 million in sales, the complaint says.
Because of his exposure to Trasylol, Mathis says he suffered acute renal failure and permanent injuries.
His wife and co-plaintiff in the suit, Clo Ann Mathis, says she has become liable for medical costs and has suffered the loss of her husband's support, companionship, services, society, love and affection.
This is not the first lawsuit of its type to be filed. In Illinois, multiple complaints were brought against Bayer for Trasylol use.
In the 12-count suit, the Mathises are seeking an unspecified judgment, plus punitive damages, costs, interest and other relief to which they may be entitled.
They will be represented by P. Gregory Haddad, Kerrie Wagoner Boyle and Jonathan D. Boggs of Bailey and Glasser in Charleston.
U.S. District Court case number: 3:09-CV-1147