Trasylol Lawsuits and Patient Safety

In light of the number of people suffering from Trasylol related kidney failure and other side effects Trasyol lawsuitsuch as strokes and heart attacks the number of Trasylol lawsuits being filed continues to rise. Later this year the Supreme Court will hear the case of Wyeth v. Levine which asks the vital question of whether a patient who has been harmed by a drug can sue under state law if the drug was approved by the FDA. The scope of this decision cannot be underestimated. People injured by defective drugs, including people who have filed a Trasylol lawsuit, will be affected by the Supreme Court’s decision in this case.

The top doctors at the New England Journal of Medicine (NEJM) have come out and strongly stated their opinion along with 47 state attorneys general and two former FDA commissioners, David Kestrel and Donald Kennedy. The journal editors asked the justices to carefully consider how overwhelmed the FDA is and to weigh that against patient safety stating:

"The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety," the doctors said in a brief filed Thursday. Without the discoveries dredged up by plaintiffs' lawyers through liability litigation, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."

The Wyeth case involves Diana Levine, a Vermont guitarist, who was injected with Phenergan, a medication for nausea, and subsequently developed gangrene which led to the amputation of her arm. She sued the drug’s manufacturer Wyeth, arguing that the manufacturer failed to adequately warn consumers about the risks of the injections. The NEJM editors and scores of others concerned with patient safety are worried that the rights of patients are eroded in the face of preemption arguments aimed to protect drug companies. Proponents of preemption stand by their position that the FDA weighs the risks and benefits of a drug’s safety and after approval the drug manufacturer should be protected from lawsuits by consumers who were injured by the approved drug.

For the latest legal information please visit our Trasylol lawsuit center.
 

Trasylol Kidney Failure | Trasylol Class Action Lawsuits

Patients and families across the United States have filed Trasylol lawsuits based on the devastating side effects of the drug. Currently no Trasylol class action suits have been filed and claims are being filed individually. The lawsuits claim that Bayer, the drug’s manufacturer, was negligent in multiple ways including:

• marketing and selling Trasylol as a safe and effective medication for heart surgery patients
• failing to adequately warn patients of unreasonable and dangerous side effects some of which were fatal
• failing to conduct adequate pre-clinical testing and post-marketing studies to determine the safety and side effects of Trasylol
• failing to use ordinary care in designing, testing and manufacturing Trasylol

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 1993, Trasylol (also referred to as “aprotinin”) received FDA approval for use in certain types of heart surgeries. Until recently, Trasylol was used to reduce the amount of blood a patient loses both during and after a surgery. However, a mounting controversy surrounded the continued use of Trasylol, and in February of 2006, the FDA issued a public health advisory warning physicians to limit use of Trasylol.

A recent study based on observations at 69 leading cardiac centers around the world was published regarding Bayer Pharmaceutical’s heart surgery drug Trasylol. Kidney failure, heart failure, and stroke are side effects associated with Trasylol heart surgery patients according to the study published by Mangano et al. in January 2006 in the New England Journal of Medicine (NEJM).

On September 21, 2006, the FDA met to investigate the dangers of Trasylol. Although Bayer appeared to cooperate with this FDA investigation, it was later learned that Bayer was withholding data from a study which revealed Trasylol causes serious and potentially deadly side-effects. The FDA learned that Bayer did not disclose this important data shortly after the FDA completed its investigation. However, the FDA learned about this data only because a scientist from Bayer’s study tipped off the FDA. Bayer failed to willingly disclose the data to the FDA even when Bayer representatives met with FDA officials to go over the dangers of Trasylol, and even though numerous FDA officials commented to Bayer that they needed more data. Following increasing studies showing the serious risks of Trasylol, Bayer finally removed Trasylol from the marketplace in November 2007.

Most heart surgery patients don't know if they were given Trasylol during their open heart surgery. Many patients suffering from Trasylol kidney damage side effects don't know if they were given Trasylol during their surgery because the surgeon made the decision whether to administer the drug to stop excessive bleeding during surgery.

For more information please visit our Trasylol lawsuit center.

78 Trasylol Lawsuits Filed Against Bayer in U.S.

Trasylol lawsuitCOLOGNE, 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.

Trasylol affects the way in which blood clots. Prior to the drug’s removal from the market it was given to open bypass surgery patients to prevent excessive bleeding. Trasylol was mainly used during repeat coronary artery bypass surgery to reduce the amount of bleeding both during and after surgery. One of the most serious complications for bypass surgery patients is excessive bleeding. Clotting medications such as Trasylol reduced the amount of blood transfusion needed during surgery. In 2006 The New England Journal of Medicine (NEJM) published a study that reported Trasylol problems with an increased risk of developing heart failure, kidney damage, myocardial infarction, and stroke in bypass heart surgery patients.

Bayer withdrew their heart surgery drug Trasylol from the marketplace late in 2007 following a Canadian study that linked Trasylol with an increased risk of death and kidney failure. Bayer plans on defending Trasylol claims vigorously, however they are facing the potential of thousands of lawsuits from individuals and families throughout the country as more people discover that Trasylol was used during their heart surgery

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. We have additional information available at our national Trasylol lawsuit website.

Trasylol Recall

On November 5, 2007, Bayer agreed to a Trasylol recall or as it was announced by the Food and Trasylol recallDrug Administration, a “marketing suspension” of its heart surgery drug which has been associated with serious risks such as kidney failure, heart problems and death. 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.

Dr. Dennis Mangano, a medical researcher had published a revealing study in the New England Journal of Medicine in January 2006 prior to the Trasylol recall. His study showed 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 bypass 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 stated that in his opinion 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.

Trasylol 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 of Experimental Medicine at the University of Cologne, 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.

For a free consultation and help finding out if you or a loved one was given Trasylol during their heart surgery please visit our Trasylol Lawsuit Center.

60 Minutes Trasylol Video

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."

60 Minutes lead story - Trasylol kidney failure and heart attacks

On Sunday, February 17, the lead story on 60 Minutes was Bayer's heart surgery drug Trasylol. Kidney failure and heart attacks are the two main side effects associated with Trasylol according to the 2006 study by medical researcher Dr. Dennis Mangano. His observational study included over 5000 patients in 17 countries. Dr. Mangano told 60 Minutes' correspondent Scott Pelley that "[I]t showed an important association between Trasylol use and kidney failure requiring dialysis and it showed a trend toward increased death in hospital in these patients."

The 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. Over an eight month period of time he had 19 operations. 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.

Pelley also interviewed Dr. William Hiatt, the chair of the FDA's advisory committee that was presented with the Mangano study in 2006. Dr. Hiatt stated that Bayer did not disclose their own study which confirmed Dr. Mangano's findings and Hiatt's FDA committee voted to keep Trasylol on the market. The following week the author of the Bayer study, Alexander Walker, blew the whistle on Bayer and presented the study to the FDA.

Services

The Fields Law Firm limits their practice to the areas of consumer rights, disability and personal injury. They focus their Trasylol lawsuit practice on helping people who have been seriously injured and the families of those who have died as a result of Trasylol kidney failure and Trasylol heart attacks.

Fields Law Firm is a law firm based in Minneapolis, Minnesota. It has attorneys licensed in the state of Minnesota. Fields Law Firm works in association and consults with pharmaceutical lawyers throughout the United States. Our team of Trasylol attorneys represents clients in all 50 states. Our Trasylol kidney failure lawyers are ready to help answer your questions regarding the Trasylol recall and have already filed Trasylol lawsuits for victims across the United States.

For more information please visit our Trasylol Class Action Lawsuit Center.

The Fields Law Firm team of attorneys handle Trasylol lawsuits, claims and settlements in Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, D.C., Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming.


Contact

If you or a loved one has suffered from any of the possible harmful Trasylol heart surgery side effects, such as kidney problems, heart attack or stroke, you may be entitled to file a Trasylol lawsuit against the drugs manufacturer. A Trasylol attorney can help evaluate your claim.

Many people are suffering from the dangerous side effects of Trasylol used during their heart surgery. Unfortunately, most people don’t know if they were given Trasylol during their surgery since their physician made the decision whether or not to use Trasylol.

We can help you find out if you were given Trasylol and help you understand your legal rights if you suffer from Trasylol kidney failure, heart attack or stroke.

For a free consultation from a Trasylol attorney regarding how we can help find out if you were given Trasylol and protect your legal rights you can call anytime. If you prefer you may contact us via e-mail.

Fields Law Firm
210 N. 2nd Street
Minneapolis, MN
55401
mailto:steve@injurygroup.com
www.trasylollawsuitcenter.com

612-370-1511
1-888-343-5375

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Protecting individuals and families affected by Trasylol and representing Trasylol heart surgery victims throughout the United States.