Bayer Pharmaceutical facing 78 Trasylol lawsuits in U.S.

COLOGNE, Germany - Bayer’s CEO stated that Bayer AG is facing 78 Trasylol lawsuits in the United States as a result of its heart surgery drug. “We are not aware of any lawsuit outside the United States,” Werner Wenning told a shareholders’ meeting.

Each year approximately one million patients undergo surgery following a heart attack. Prior to Trasylol being withdrawn from the marketplace, the majority of patients who were at increased risk of bleeding during surgery had the option of one of three antifibrinolytic drugs to limit blood loss: Trasylol (Aprotinin), Amicar (aminocaproic acid), or Cyklokapron (tranexamic acid). These drugs work by inactivating an enzyme called plasmin so it stops from breaking down blood clots which helps prevent bleeding.

Bayer’s Trasylol heart surgery side effects have recently been linked to an increased rate of kidney failure, heart attack, and death in the five years following a patient undergoing heart surgery.

In November 2007, Bayer withdrew Trasylol from the marketplace following a Canadian study that associated Trasylol with an increased risk of death and kidney failure. Bayer plans on defending Trasylol claims vigorously, however time will tell how they deal with potentially thousands of claims from individuals and families throughout the country as litigation continues.

Trasylol Lawsuits Filed | Renal Failure Wrongful Death

Bayer is potentially facing thousands of Trasylol lawsuits brought on behalf of individuals and families of heart surgery patients throughout the United States. Trasylol also referred to as “Aprotinin” is a bovine pancreatic trypsin inhibitor (BPTI). Trasylol is used during heart surgery to help prevent excessive bleeding.

In November 2007, the Food and Drug Administration requested that Bayer stop marketing Trasylol until further review of a Canadian study that revealed the heart surgery drug increased the risk of death. From the FDA website:

The FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study’s researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

An important study published in the New England Journal of Medicine in January 2006 linked Trasylol with kidney damage compared to less expensive generic medications aminocaproic acid and tranexamic acid. It is estimated that if Trasylol had been taken off the market in early 2006 following the study, 22,000 patient lives could have been saved.

For more information regarding a Trasylol lawsuit please call Fields Law Firm or e-mail us for a free confidential consultation. We are presently representing patients and families throughout the United States.

Trasylol Recall Follows Kidney Failure Problems

On November 5, 2007, the U.S. Food and Drug Administration (FDA) announced that Bayer Pharmaceuticals Corporation agreed to a “marketing suspension” of its Trasylol drug. Trasylol is a drug that was designed to control bleeding during heart surgery. Two weeks before the FDA’s announcement, researchers from the Ottawa Health Institute notified the FDA that they had stopped a study on Trasylol because it appeared to increase the risk of death for patients, compared to two other drugs used in the study.

Prior to the Trasylol recall, Dr. Dennis Mangano, a medical researcher, published a study in the New England Journal of Medicine in January 2006 that patients who had been given Trasylol had twice the rate of kidney failure and an increased risk of strokes, heart attacks and encephalopathy (a type of brain disease).

After the Trasylol recall, two studies published on February 28, 2008 in the New England Journal of Medicine confirmed that patients who were given Trasylol had an increased risk of death. The release of these studies follows an interview of Dr. Dennis Mangano on the TV show 60 Minutes. Dr. Mangano contended that the FDA should have pulled Trasylol from the market after his study was released in January 2006. It is estimated that approximately 413,000 patients received Trasylol between the time of his study and the time of the recall. According to Dr. Mangano, 22,000 lives could have been saved if the drug had been taken off the market in January 2006.

For more Trasylol news please visit our Trasylol lawsuits news and information website.

60 Minutes Trasylol Video

60 Minutes Story on Trasylol Kidney Failures and Heart Attacks

On Sunday, February 17, 2008, the CBS news show 60 Minutes, featured a story concerning the serious side effects from Bayer’s heart surgery drug called Trasylol. According to the 2006 study by medical researcher Dr. Dennis Mangano, the most serious and common complications associated with Trasylol were increased incidents of renal and kidney failure and heart attacks. His observational study included over 5000 patients around the world. When asked about his Trasylol study, Dr. Mangano told 60 Minutes’ that, “It showed an important association between Trasylol use and kidney failure requiring dialysis and it showed a trend towards increased death in hospitals in these patients.”

The 60 minutes story also profiled the Trasylol patient Joe Randone. He went in for heart valve replacement surgery at the age of 52. Following surgery where Trasylol was put in Mr. Randone’s IV, he suffered two heart attacks and kidney failure. In August 2006 Mr. Randone died from complications. The family has filed a Trasylol lawsuit against Bayer. Dr. Mangano estimated that 1000 lives per month could have been saved if the drug had been taken off the market after his Trasylol study was published.

Trasylol Class Action Lawsuits

Trasylol lawsuits have been filed throughout the United States alleging that the heart surgery drug is a defective medication. They state that Trasylol (aprotinin) has caused kidney failure, heart attacks and strokes. These aprotinin lawsuits claim that Bayer, the drug’s manufacturer, marketed and sold Trasylol as a safe and effective medication to help prevent excessive bleeding during bypass surgery. They also claim that Bayer failed to adequately warn patients of its side effects. 

Bayer disputes the growing number of aprotinin studies that show increased risk of serious complications and death in Trasylol recipients. The causal link between Trasylol and these potentially fatal side effects has been known for several years and there is evidence that Bayer has known about the link between Trasylol and kidney failure as far back as the early 1980’s. The German scientist Dr. Juergen Fischer, director of the

Institute ofExperimental Medicine at theUniversity ofCologne, found severe incidents of kidney damage in animals that were given Trasylol more than 20 years ago. According to Dr. Fischer, he was surprised Bayer wasn’t interested in his findings.