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 After Heart Surgery | Kidney Problems

Trasylol kidney failureAs the results of more studies are published, the evidence is continuing to show the problem of Trasylol kidney failure following heart surgery. Patients and families around the country are filing Trasylol lawsuits as the public becomes more aware of Bayer’s heart surgery drug side effects. Trasylol has recently been linked to a higher risk of kidney damage, heart attack, and death in the five years following a patient undergoing bypass heart 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. This study was followed by an increasing number of Trasylol studies that confirmed the findings of the 2006 NEJM study.

Trasylol studies increasingly show that the drug causes serious problems in bypass patients. In 1993 Trasylol, also referred to as “Aprotinin”, was approved by the Federal Drug Administration (FDA). Aprotinin is manufactured by Bayer under the brand name Trasylol. Over the past several years Trasylol sales continued to increase even though studies indicated serious Trasylol kidney damage side effects until late in 2007 when Bayer finally withdrew their heart surgery drug from the market.

Most bypass heart surgery patients are unsure if they were given Trasylol during their open surgery. Many patients suffering from Trasylol kidney failure or stroke side effects don't know if they were given Trasylol during their surgery because the surgeon made the decision whether to use the drug to help prevent excessive bleed loss during surgery.

Trasylol affects the way in which blood clots. It is given to open heart surgery patients to help prevent excessive bleeding. 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. Trasylol is primarily used during repeat coronary artery bypass surgery to reduce the amount of bleeding both during and after surgery. The drug had been in use for 13 years and a million patients had received it before Bayer withdrew it from the market after growing evidence of serious side effects.

For the latest information and litigation news please visit our Trasylol lawsuit website.

Trasylol Kidney Failure Stroke Attorney Lawyer | Drug Industry to Revise Marketing Code

Given the growing number of reported problems involving Trasylol kidney failure and strokes and Trasylol kidney failurethe increasing lawsuits filed by Trasylol victims throughout the United States it is interesting to look at the drug industry’s latest voluntary marketing guidelines that are expected to be announced this week.

The Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors is expected to announce a new marketing code this Thursday. This voluntary guideline written by the industry’s trade association (PhRMA) will ask the chief executives of large drug manufacturers to provide written certification that “they have policies and procedures in place to foster compliance with the code.”

The new marketing code will presumably ban pharmaceutical marketing campaigns that in the past have provided doctors with gifts such as mugs, pens and pads. The code requires drug companies to set annual limits on the amounts they pay doctors for educational lectures. However, the industry code fails to define any limits on money spent on speaking and consulting arrangement between the drug makers and doctors throughout the country. Furthermore, these new guidelines do not apply to biotechnology or medical device companies.

PhRMA Chairman and Chairman and CEO of Merck & Co., Inc., Richard Clark, stated “Informative, ethical and professional relationships between healthcare providers and America’s pharmaceutical research companies are instrumental to effective patient care”.

Among its changes, the revised Code:

- Prohibits distribution of non-educational items (such as pens, mugs and other "reminder" objects typically adorned with a company or product logo) to healthcare providers and their staff. The Code acknowledges that such items, even though of minimal value, "may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues."

- Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals' offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals.

- Includes new provisions that require companies to ensure that their representatives are sufficiently trained about applicable laws, regulations and industry codes of practice -- including this Code -- that govern interactions with healthcare professionals. Companies are also asked to assess their representatives periodically and to take appropriate action if they fail to comply with relevant standards of conduct.

- Provides that each company will state its intentions to abide by the Code and that company CEOs and Compliance Officers will certify each year that they have processes in place to comply, a process patterned after the concept of Sarbanes-Oxley compliance mechanisms. Companies also are encouraged to get external verification periodically that they have processes in place to foster compliance with the Code. PhRMA will post on its Web site a list of all companies that announce their pledge to follow the Code, contact information for company compliance officers, and information about the companies' annual certifications of compliance.

For more information on Trasylol lawsuits and Trasylol medical and legal news please visit Trasylollawsuitcenter.com.

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 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."

Aprotinin - Trasylol Class Action Suit

Many people are wondering if there is a Trasylol class action lawsuit against Bayer Pharmaceuticals. Currently Trasylol lawsuits are being filed by individuals and families throughout the United States. No class actions have been filed, however given the number of potential Trasylol victims, attorneys and courts will likely look to multidistrict litigation and class actions to more efficiently handle the growing number of cases. The potential number of patients suffering from side effects such as aprotinin kidney failure, stroke and heart attacks is staggering.

According to Dr. Dennis Mangano, around 431,000 patients received aprotinin between the time his Trasylol study was published and the time Bayer withdrew the drug from the market. He estimates that approximately 1,000 lives per month could have been saved if Trasylol had been pulled more quickly. This is during a relatively short period of time considering how long the drug has been on the market.

Trasylol lawsuit filed over kidney damage

On January 25, 2007, Cory Watson Crowder & DeGaris, P.C. filed one of the first Trasylol lawsuits against Bayer Corporation on behalf of Ada Williams. Trasylol is a drug sometimes given to patients during heart surgery to control bleeding. According to the complaint, Ada M. Williams was given Trasylol during her surgery and subsequently suffered kidney failure.

The lawsuit claims that Williams is now required to undergo kidney dialysis three times a week. She is seeking damages for her pain and suffering as well as her ongoing medical costs. The suit was filed in the United States District Court for the Middle District of Tennessee, Columbia Division (Case 1:07-cv-00004).