Bayer sued over drug used in bypass surgery

By Kelly Holleran | Dec 2, 2008

An Illinois woman has filed a wrongful death suit against Bayer, alleging her 79-year-old husband died after being injected with Trasylol, a drug used in coronary artery bypass graft surgeries.

Sneathia James claims her husband, Sam Lee Erby, suffered acute renal failure after undergoing the surgery at St. Vincent's Hospital in Birgingham, Ala., in October 2006.

Trasylol was typically used in patients who are at an increased risk for blood loss, so it was administered to Erby before his surgery, according to the complaint filed Nov. 24 in St. Clair County Circuit Court.

But because of the acute renal failure the drug caused, Erby died on Dec. 7, 2006, the suit states.

Acute renal failure is characterized by retention of waste products normally excreted by the kidney. It can be accompanied by the decrease or cessation of urine production, according to the complaint.

James claims neither she nor her husband knew about the risks involved in taking the drug.

There were no warnings about Trasylol until January 2006, when an article published in the New England Journal of Medicine revealed the drug doubles the risk of renal failure, according to the complaint.

The U.S. Food and Drug Administration issued a Public Health Advisory on Feb. 8, 2006, regarding the findings, according to the complaint.

And even though Bayer knew of Trasylol's risk, it did not warn consumers of the risk of renal dysfunction, kidney failure, dialysis and other kidney problems until December 2006, the suit states.

Finally, on Nov. 5, 2007, the FDA and Bayer suspended the marketing of Trasylol, which still remains off the market today, James claims.

After being injected with Trasylol and until his death, Erby suffered injury, incurred medical expenses, suffered from disability and a diminished ability to enjoy life and experienced pain and suffering, according to the complaint.

Because of Erby's death, James incurred funeral and burial expenses and sustained a loss of Erby's companionship, society and consortium, according to the complaint.

Bayer was negligent in putting the drug on the market in 1993 without performing adequate tests, according to the complaint.

"Adequate testing would have shown that Trasylol possessed serious potential side effects with respect to which full and proper warnings accurately and fully reflecting symptoms, scope and severity should have been made with respect to the use of Trasylol," the suit states.

The company also failed to take the drug off the market, despite the fact it knew Trasylol caused "unreasonable, dangerous side effects which many users would be unable to remedy by any means," the suit states.

Bayer failed to provide adequate warnings about Trasylol, James claims.

The company also practiced misconduct when it "intentionally" concealed information about the drugs potential serious adverse effects from Erby, according to the complaint.

"Defendant knew that the Plaintiff would suffer mental distress and anxiety upon learning that Trasylol possessed a likelihood of serious adverse effects as described herein, thereby potentially causing acute renal failure," the suit states.

In the 22-count suit, James is seeking a judgment in excess of $1.1 million, plus costs, attorneys' fees and other relief the Court deems just.

Seth Sharrock Webb of Brown and Crouppen in St. Louis will be representing James.

St. Clair County Circuit Court case number: 08-L-603.

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