Heart surgery patients were more likely to die if given the anti-bleeding drug Trasylol, two more U.S. studies have found, renewing the claims that the drug is dangerous. Bayer AG stopped selling the drug last fall, after a Canadian study was halted because of deaths among patients taking Trasylol. But the new research reignited controversy over Trasylol, which was on the market for 14 years and used by doctors to treat hundreds of thousands of heart bypass patients each year.

Bayer funded one of the two new studies, and had the preliminary results before a September 2006 federal hearing on the drug's safety - but did not present them. The company issued a statement this week saying both the new studies are flawed. But the spokesman for a consumer advocacy group said the studies are convincing confirmation of the drug's dangers. "I just don't know how much further evidence you need," said Dr. Sidney Wolfe of Public Citizen's Health Research Group. The new studies are being published this week in the New England Journal of Medicine.

Trasylol, known generically as aprotinin, was used in heart bypass surgeries to control bleeding. The U.S. Food and Drug Administration approved it in 1993 after studies showed its clotting powers clearly reduced the need for blood transfusions, and it became a top choice for surgeons. The first new study looked at more than 10,000 patients who had bypass surgeries at Duke University Medical Center from 1996 through 2005. It found that 6.4 percent of patients who were given Trasylol died within 30 days of the surgery, a rate nearly 2 1/2 times higher than patients who got another drug or who received no treatment for excessive bleeding. At one year after surgery, almost 16 percent of Trasylol patients had died - again, roughly 2 1/2 times higher than the other two patient groups. The second study - the one funded by Bayer - looked at more than 78,000 patients nationwide in a period from Jan. 1, 2003, to March 31, 2006. After adjusting for other factors, the researchers found that the risk of death after surgery was 64 percent higher in the Trasylol group than in those taking a comparison drug.

Learn more about Trasylol dangers and your legal rights.

A Fremont man has filed a class-action lawsuit against Medtronic Inc., a Minnesota-based medical technology company whose defibrillator wires for heart patients were recalled in October. In a complaint filed in a San Francisco federal court late last month, plaintiff Rashid Hunter alleged that four types of wires, or leads, sold under the Sprint Fidelis label were prone to bending or kinking.

Implantable cardiac defibrillators can slow down or speed up a patient's heart rate, with the aid of electrodes built into wires that sense the heart's rhythm. Defective wires could lead to unnecessary shocks or failure to shock when needed, causing injury or death, the suit states. Hunter is seeking compensation for himself and all Californians affected by the Sprint Fidelis wires -- a number that could reach into the thousands, according to the suit."I live in constant fear, wondering if my lead will malfunction and kill or cause me severe pain as it has done to others," Hunter said in a statement.

The plaintiff is seeking a court order to have Medtronic pay for a monitoring program and future medical expenses incurred by affected California patients as a result of the faulty leads. Patients who are considered party to the suit are those with the following implanted Sprint Fidelis models: the 6949 LFJ extendable/retractable screw fixation; the 6948 LFH tuned fixation; the 6931 LFT S fixation; and the 6930 LFK T fixation. Lieff Cabraser Heimann & Bernstein LLP, a law firm with offices in San Francisco, New York and Nashville, is representing the plaintiff.

For more information, visit http://www.medtronicheartleadrecall.com or http://www.medtronic.com/fidelis/index.html.