Trasylol Lawyer & Attorney : Fields Law Firm : Trasylol Injury, Kidney & Heart Failure

One of the biggest questions people have when they or a family member have suffered side effects such as kidney failure, stroke or a heart attack following open heart surgery is how to find out whether or not Trasylol was used during the surgery. Patients who underwent bypass surgery most often do not know what medications were used during the surgery because their surgeon made the decision of whether to use Trasylol based on the risk of excessive blood loss during the procedure.

Looking at the hospital records associated with the surgery is the best place to find out whether Trasylol was used. Alternatively, you can also look at the hospital billing statement to see if Trasylol (also referred to as “Aprotinin”) is listed under the charges. Under federal law called the “HIPAA Privacy Rule” you have the right to see and receive a copy of your medical records. Typically after requesting your medical records you should receive them within 30 days of the time of request.

Common Questions:

Q: Is there a charge for requesting my medical records?

A: The hospital or medical provider is able under the law to charge a fee for retrieving and copying the requested medical records. Because of this, it is important to initially request only a limited number of surgery records to help lessen the charges associated with the request. In some situations the records can number into several hundred or thousands of pages depending on the specific circumstances. This can translate into a retrieval and copying bill of several hundred to over a thousand dollars since many medical providers charge one or more dollars per page of medical records.

Q: Can I request the medical records on behalf of a family member or friend?

A: Generally, you are only able to request your own medical records. Another person is able to grant another person permission to request their medical records, however his must be done in writing or in certain circumstances a legal guardian must be appointed by the court.

Q: Am I able to request the medical records of a person who has died?

A: Typically, the person who is able to request the medical records of a person who is deceased is the personal representative of the deceased who has been designated by a will or a court has appointed the person. The key to requesting medical records of a person that has died is to include documentation along with request showing you are entitled to access the medical records.

It is a good idea to have the records reviewed by someone who can correctly interpret the records and if there is any doubt contact a medical professional or attorney who can help you in requesting and reviewing the appropriate records.

An attorney at Fields Law Firm is available to answer any questions you may have regarding how to find out if Trasylol was used during heart surgery. We will also request copies of your medical records or family member’s records at no cost to you in order to help find out if Trasylol was used.

For more information please visit our Trasylol lawsuits information website.
 

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As more Trasylol lawsuits are filed there is increasing pressure to revisit individuals right to hold companies accountable when they market a dangerous product. On the same day of a House Oversight hearing the New England Journal of Medicine (NEJM) published the results of a Canadian study that showed Trasylol (Aprotinin) increased the risk of death in patients by 50 percent. Previous studies had associated Trasylol with kidney failure, heart attacks and stroke.

On May 14, 2008 Gegory Curman, the executive editor of the NEJM testified regarding safety issues with drugs following their approval. Henry Waxman, D-CA, the House Government Reform and Oversight Committee Chair gave the opening statements. 

TESTIMONY
House Committee on Oversight and Investigations
Wednesday, May 14, 2008
Preemption – Drugs and Medical Devices
My name is Gregory Curfman, and I am the executive editor of the New England Journal of Medicine. I am here today along with my colleague, Dr. Stephen Morrissey, the managing editor, to provide testimony from our Journal. We will make the case that preemption of common-law tort actions against drug and medical device companies is ill advised and will result in less safe medical products for the American people.

The New England Journal of Medicine is nearly 200 years old. Our mission is to publish important advances in medical research, including research on new drugs and medical devices. During my 23 years at the New England Journal of Medicine, I and my colleagues have published many articles on new drugs. Some of these drugs have succeeded, but others have failed, in most cases owing to problems with safety.

We have learned over the years that approval of a new drug by the FDA by no means guarantees its safety. It is not uncommon for drugs to be approved by the FDA without long-term studies of their safety. Indeed, FDA approval of a drug is just one milestone along a path to the assessment of long-term safety. It is essential that a drug’s safety continue to be carefully monitored during the post-marketing period, because we know that serious safety issues may come to light only after a drug has entered the market. I will give three specific examples that I have encountered in my work at the New England Journal of Medicine.

The first is rofecoxib, or Vioxx, a COX-2 inhibitor used to treat arthritis pain, which was approved by the FDA in 1998. In 2000, we published in the New England Journal of Medicine a clinical trial called the VIGOR study, which showed that Vioxx effectively relieved pain while causing less gastrointestinal bleeding than traditional nonsteroidal painkillers.

However, something that the Journal editors learned later was disturbing. What was not adequately conveyed in that article was the fact that for each episode of serious gastrointestinal bleeding prevented by the use of Vioxx, one heart attack, stroke, or other serious cardiovascular problem was caused by Vioxx. There was a one-to-one trade-off, but the authors of the article, two of whom were employees of the manufacturer of Vioxx, left most of those data out, and therefore the Journal’s readers and the public were not fully informed about this serious problem.

The FDA was provided with the missing data after the article was submitted, but it was not until 2002 that the label for Vioxx was revised to reflect these cardiovascular risks; and it was not until 2004, six years after the drug was approved by the FDA and after millions of people had taken it, that it was finally removed from the market, in part owing to the mounting threat of product-liability litigation.

Example 2 is rosiglitazone, or Avandia, which was approved by the FDA in 1999 for the treatment of type 2 diabetes. It was approved solely on the basis of its ability to lower blood sugar. Whether it would make a difference to patients with diabetes by reducing the risk of cardiovascular disease, the major complication of type 2 diabetes, was unknown, because long-term clinical trials to study cardiovascular end points had not been done.

It came as a surprise when, in 2007, researchers from the Cleveland Clinic reported in the New England Journal of Medicine that, on the basis of a meta-analysis of data from multiple studies, Avandia appeared to be associated with an increased risk of cardiovascular events, not a decrease. This was a worrisome finding for fragile type 2 diabetics.

Even more surprising, was the revelation that the manufacturer of Avandia had commissioned a similar study in 2005 that showed the same result. To meet legal requirements arising from a lawsuit in New York, the company placed the results of that study on a section of its Web site, but those results were never publicized and never published in a medical journal. Today, nine years after FDA approval, Avandia remains on the market, but in November 2007 a warning about potential cardiovascular risks was added to its label, and its use has declined substantially. Last month the FDA sent a warning letter to the manufacturer for failure to submit reports on a large number of studies on Avandia to the FDA, as required by law.

The third example involves a drug called aprotinin--the brand name is Trasylol--which was approved by the FDA in 1993 and is used to control bleeding in patients undergoing cardiac surgery. In January 2006 a study in the New England Journal of Medicine suggested that the use of Trasylol was associated with an increase in heart attack, stroke, kidney failure, and death.

Later in 2006 the FDA held an advisory committee meeting to reexamine the safety of Trasylol. Shortly after the meeting, FDA officials were stunned to learn that the manufacturer had commissioned a similar study, which confirmed the findings in the New England Journal article, but had withheld the results from the advisory committee.

Tonight at 5:00 p.m., we will publish on the New England Journal of Medicine Web site a large clinical trial that shows definitively that Trasylol, as compared with other drugs used to control bleeding, results in higher mortality in patients undergoing high-risk heart surgery. The editorial accompanying the article states that, after 15 years, in all likelihood this is the end of the story for Trasylol.

What do we learn from these examples?

1. Together, these three drugs have placed millions of Americans and other people around the world at substantial risk. But patients who have been harmed by a drug have had the right to seek legal redress. Preemption would erase that right.
2. Serious adverse drug effects may not become apparent until after drugs are granted FDA approval, sometimes long after approval.
3. FDA approval by no means guarantees the safety of drugs.
4. The Congress’s FDA reform efforts in 2007 made it clear that approval is usually based on short-term efficacy studies, not long-term safety studies.
5. Manufacturers may not immediately make public information indicating safety problems with their drugs.
6. Despite the usually admirable work of the FDA, the agency is hampered by lack of resources in addressing drug safety concerns and may be slow in resolving them.

If drug and medical device companies are shielded against common-law tort actions by preemption, what will be the effect on the safety of our drugs and devices? The answer is intuitively obvious. We recently wrote in an editorial in the New England Journal of Medicine that the safety of drugs and devices in our country will almost certainly be diminished. If drug and device companies are immunized against product-liability suits, companies will surely focus less attention on the safety of their products. The possibility of litigation serves as a strong inducement for companies to be especially diligent in scrutinizing their products for safety problems. It is questionable that the purported benefit of making drugs and devices available more quickly should outweigh the possibility of redress when safety flaws are discovered later.

Patients injured by unsafe drugs and devices should not be stripped of their right to seek redress through due process of law. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices and will have a chilling effect on the doctor-patient relationship, which has traditionally been built on trust.

Mr. Chairman and members of the Committee, we urge you and your colleagues to pass legislation that will unambiguously eliminate the possibility of preemption of common-law tort actions for drugs and medical devices. Removing this patient right would not only be unjust, but will also result in less safe drugs and medical devices for the American people.

Thank you, Mr. Chairman.

For more information on help finding out if Trasylol was used during heart surgery or information regarding Trasylol claims please visit our Trasylol lawsuit center.

 

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As 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.

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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.

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.

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Trasylol, an expensive medication given to heart surgery bypass patients during their surgical procedure to help prevent excessive bleeding may have caused staggering numbers of heart failure, kidney failure and strokes. Patients undergoing cardiac surgery were unaware that Trasylol, a medication manufactured by Bayer, has been found in clinical studies to lead to greater risk of death, stroke, and acute kidney failure.

If a patient was found by their surgeon to be at risk of excessive bleeding during surgery the patient had no way of knowing Trasylol had been found to be not only dangerous but extremely expensive compared to the generic alternatives.


Trasylol Bypass Surgery Alternative Drugs Available


A New England Journal of Medicine study reported that two other generic medications were available that are safer and less expensive than Trasylol.
Heart surgery medications that help prevent excessive bleeding during surgery:

• Trasylol cost per dose is $1,300
• The generic aminocaproic acid cost per dose is $11
• The generic tranexamic acid cost per dose is $44

The generic heart surgery drugs were revealed to be far less costly with no increased risk of heart attack, stroke or kidney failure.


For more information, please visit our Trasylol class action lawsuit website.

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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.

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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."

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Following the Trasylol study Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) published in the May 14, 2008online issue of The New England Journal of Medicine study, Bayer decided to remove the remaining supplies of Trasylol from hospitals. This is the latest in a growing number of studies showing the dangers of Trasylol. In November 2007, Bayer agreed to suspend marketing their heart surgery drug Trasylol (aprotinin) after preliminary results from a Canadian study that revealed an increased risk of death for patients given Trasylol during bypass surgery.

Trasylol has been used by patients throughout the world during heart bypass surgery to reduce bleeding. Trasylol is an expensive drug costing $1200 to $1500 compared to cheaper and safer alternative drugs which cost around $150. The BART study was merely the latest study that have shown evidence of Trasylol increasing the risk of serious side effects like kidney failure, stroke and death. For more information please visit our Trasylol Lawsuit Center.

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Another study reveals an increased risk of significant Trasylol side effects leading to a higher mortality rate in aprotinin recipients. A recent study published in The New England Journal of Medicine on February 21, 2008 shows an increased risk of death for patients receiving aprotinin (Trasylol) during coronary-artery bypass grafting (CABG). The researchers analyzed hospital data from over 33,000 heart surgery patients who received Trasylol and around 45,000 patients who received aminocaproic acid.

The study looked at hospital records with operating-room charges that included charges for either Trasylol (33517 patients) or aminocaproic acid (44,682 patients). Patients In patients receiving Trasylol during their heart surgery there was a 64% increased risk of death. The researchers concluded that physicians should weigh the benefits of Trasylol with the increased risk of death considering aprotinin showed little or not benefit in reducing the number of blood transfusions compared to the alternative drug aminocaproic acid. The researchers have provided the study data to the FDA and the manufacturer (Bayer); however Bayer has disagreed with the methods and conclusions of the study.

Study: Aprotinin during Coronary-Artery Bypass Grafting and Risk of Death
N Engl J Med 2008;358:771-83

For more information regarding a free consultation please visit our Trasylol Lawsuit Center.

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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.

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On February 8, 2008, the American Journal of Nephrology published a study of aprotinin and kidney failure. Aprotinin is marketed as “Trasylol” by the drug company Bayer. This is the first aprotinin study to evaluate the effect of the drug on urinary NGAL (neutrophil gelatinase-associated lipocalin). Urinary NGAL increases dramatically following kidney damage.

In this observational study 369 patients undergoing heart surgery were either given aprotinin or aminocraproic acid during surgery. 205 patients received aprotinin and 164 received aminocaproic acid. The study found that the patients who were given aprotinin (Trasylol) during their surgery had a twofold higher risk of developing kidney failure compared to the patient group receiving aminocaproic acid. 25% of the patients receiving aprotinin (51 of the 205 patients) developed kidney failure. The results of this study confirm the results of Dr. Mangano’s earlier Trasylol study which revealed that patients who received the aprotinin had around a 50 percent increased risk of dying.

Study: Increased Incidence of Acute Kidney Injury with Aprotinin Use during Cardiac Surgery Detected with Urinary NGAL

Am J Nephrol 2008;28:576-582

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December 30, 1993 – Aprotinin (Trasylol) Receives FDA Approval
The Food and Drug Administration announces the approval of aprotinin, a drug used to control excess bleeding in bypass heart surgery patients.
The FDA stated that the use of Trasylol should be reserved for heart surgery patients with a high risk of excessive bleeding. During clinical trials kidney toxicity was reported as a problem in some patients.

January 20, 2006 – Trasylol Associated With Renal Toxicity
Karkouti, et al. publishes an article in the journal Transfusion suggesting a link between aprotinin and kidney problems among cardiopulmonary bypass patients.

January 26, 2006 – Risks Associated with Aprotinin in Cardiac Surgery
The New England Journal of Medicine publishes an article by Mangano et al. reporting an association of Trasylol (aprotinin injection) with serious kidney problems and heart attacks. The study found that patients who were given aprotinin were more than twice as likely to have kidney failure requiring dialysis, a 55% increase of heart failure and a 181% increase in stroke. The authors advised against further use of the drug, since safer, cheaper alternatives are available.

February 8, 2006 – FDA Public Health Advisory
Following two studies associating the use of Trasylol with increased risk of kidney failure, heart and central nervous problems after heart surgery, the FDA issued a public health advisory. The FDA recommended limiting Trasylol use to those situations where the clinical benefit of reduced blood loss outweighs the potential risks.

September 21, 2006 –Cardiovascular and Renal Drugs Advisory Committee
The FDA holds a public meeting to discuss the safety and overall risk-benefit profile for Trasylol. The committee supports acceptable safety and efficacy for Trasylol among coronary artery bypass graft (CABG) surgery patients.

September 27, 2006 – Additional Study Revealed by Bayer
Bayer Pharmaceuticals reveals to the FDA that it had conducted an additional Trasylol safety study. The study shows use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. The failure of Bayer to disclose the data from the additional study seriously undermined the advisory committee process and delayed the safety review.

September 29, 2006 – FDA Public Health Advisory
Federal Drug Administration announces that Bayer failed to disclose a Trasylol study prior to the September 21, 2006 public meeting held to discuss the safety of Trasylol (aprotinin). The FDA warns doctors who administer Trasylol to carefully monitor their patients for any adverse events, in particular, problems with the kidneys, brain or heart. Physicians treating Trasylol patients are also encouraged to report any Trasylol problems to the FDA or Bayer Pharmaceuticals.

October 13, 2006 – Bayer Suspends Employees Over Trasylol Study
Following the failure to reveal a Trasylol safety study, Bayer has suspended two employees in what seems like an attempt to justify why the study was not disclosed. The safety trial results focused on the potential Trasylol risks and side effects for patients using the drug during bypass heart surgery. The suspended Bayer employees are members of the Germany Drug Safety Group.
The Federal Drug Administration began reviewing Trasylol after two published studies associated the drug with serious side effects including kidney damage, heart attacks, and stroke.
The FDA panel had concluded that Trasylol was safe and effective but issued a warning on the product after reviewing the newly revealed data. Bayer stated that it had mistakenly failed to reveal the data because of its preliminary nature and did not attempt to knowingly withhold Trasylol study data from the panel.

December 15 2006 – FDA Revises Trasylol Labeling and Strengthens Safety Warnings
Following a review of safety information conduced by the Food and Drug Administration the Trasylol labeling was changed. The review, which started in January 2006, was prompted by Trasylol studies that showed an increased risk of kidney failure, heart attack and stroke in patients who were given Trasylol during heart surgery. The new labeling limits the drugs usage to specific situations where the patient has an increased risk for blood loss during surgery.

November 5 2007 – Bayer Withdraws Trasylol From the Marketplace
Bayer stopped selling the heart surgery drug Trasylol after studies linked the drug to a 50 percent higher risk of death than other drugs in the clinical trial. The FDA requested that Bayer withdraw Trasylol from the marketplace until further studies could be reviewed.

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On November 5, 2007 the Food and Drug Administration (FDA) announced that Bayer Pharmaceuticals Corp. has suspended the sale of Trasylol. Recall of this controversial drug at the request of the FDA was based on preliminary data from a Canadian study that compared heart surgery drugs used to prevent excessive bleeding.

The Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study was halted on October 19, 2007 due to the increased mortality in patients in the aprotinin (Trasylol) treatment group. The other anti-bleeding drugs in the study, aminocaproicacid and tranexamic acid, did not have the same increased risk of death compared to aprotinin. The study had planned to enroll around 3,000 adult Canadian patients who were going to have various types of cardiac surgery that put them in a high risk category for bleeding.

The FDA began taking a closer look at the safety of Trasylol in January 2006 after the publication of studies that linked the drug to dangerous side effects including heart attacks, kidney problems and strokes. In light of the initial BART study information, the FDA anticipates re-evaluating the risks and benefits of Trasylol. The FDA is working with Bayer to carefully phase Trasyol out of the marketplace in an attempt to prevent shortages of other drugs used prevent excessive bleeding during cardiac surgery.

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