Trasylol Heart Surgery Kidney Failure Lawsuit

Bayer’s widely used Trasylol heart surgery drug was subject to a recall in 2007 following a study that raised safety concerns. Prior to the recall, Trasylol (also referred to as Aprotinin) was used to help prevent excessive bleeding during open heart surgery. The study reported that Bayer’s heart surgery medication increased the risk of dying the five years following surgery by almost 50 percent.Alternative and cheaper medications used to prevent bleeding did not raise the risk of death significantly. Prior to Trasylol being withdrawn from the market late in 2007, the drug had been used for 13 years and a million patients had received it.

Trasylol heart surgery medication has come under increased scrutiny since the Trasylol recall in November 2007. It was reviewed in several studies that showed an increase risk of life threatening side effects such as kidney failure, heart attack, stroke and complications leading to death. The number of Trasylol lawsuits filed throughout the United States is increasing as the public becomes more aware of Trasylol problems such as renal failure and strokes.

Even though Trasylol sales and marketing was suspended in November 2007 patients were still given this dangerous medication. The FDA worked with Bayer to phase Trasylol out of the marketplace in an attempt to prevent shortages of other drugs used to prevent excessive bleeding during cardiac surgery. This phase-out however, led to the continued use of Trasylol during bypass surgeries until May 2008.

A Trasylol lawyer at Fields Law Firm is available to answer any questions you may have regarding how to find out if the drug 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. We are currently filing lawsuits for individuals and families affected by Trasylol in all 50 states.

Heart Surgery and Kidney Failure | Trasylol Class Action Suit

Following a Trasylol recall in 2007, Bayer’s heart surgery drug continued to be used during heart surgery even though cheaper and safer alternative drugs were available. Unfortunately, Trasylol was used until as recently as May 2008.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.

Trasylol is an antifibrinolytic drug which helps slow down the breakdown of blood clots and prevent excessive bleeding during open heart surgery. Trasylol came under increased scrutiny following a Canadian study that showed the drug increased the risk for death compared to the generic alternatives.

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

Dr. Mangano’s observational study concluded, “Our findings raise serious concerns regarding the safety of an approved drug intended to limit blood loss in at-risk patients undergoing surgery.” Mangano related his opinion regarding the ongoing use of Trasylol, stating “In good conscience, I could not administer (Trasylol) to this group of patients, especially given the availability of safer alternatives.” Trasylol problems continue to be studied and the drug is no longer being used during heart surgery.

If you or a loved one has had open heart surgery and then experienced Trasylol kidney failure, heart failure or stroke, you may be able entitled to compensation. A Trasylol lawsuit attorney can help evaluate your claim. For a free, confidential no-obligation consultation contact us via e-mail or by calling our toll free number 1-888-343-5375.

Trasylol Kidney Failure Following Heart Surgery

Bayer’s problems are growing as they face thousands of potential Trasylol lawsuits following increasing reports of their heart surgery drug’s side effects. Trasylol has recently been linked to a higher risk of kidney failure, heart attack, and death in the five years following a patient undergoing bypass heart surgery. In 1993 Trasylol (Aprotinin) was approved by the Federal Drug Administration. Aprotinin is manufactured by Bayer under the brand name Trasylol. Most heart surgery patients and families of patients who died following bypass surgery don’t know if they were given Trasylol during their open heart surgery. Many patients suffering from Trasylol side effects such as kidney failure or heart failure don’t know if they were given Trasylol during their surgery because the heart medication was given during the bypass procedure.

Trasylol affects the way in which blood clots. It is given to open heart surgery patients to help prevent excessive bleeding. Trasylol is mainly used during repeat coronary artery bypass (CABG) surgery to reduce the amount of bleeding both during and after surgery. Until being pulled from the market late in 2007, the drug had been in use for 13 years and a million patients had received it. One of the most serious complications for bypass surgery patients is excessive bleeding. Clotting medications such as Trasylol reduce the amount of blood transfusion needed during surgery. In 2006 The New England Journal of Medicine (NEJM) published a study that reported Trasylol side effects with an increased risk of developing heart failure, kidney failure, myocardial infarction, and stroke in bypass heart surgery patients.

On September 21, 2006 the FDA’s Cardiovascular and Renal Drug Advisory Committee met to discuss current data regarding Trasylol problems. On September 29, 2006, the FDA issued a public health advisory stating that it had new information that Bayer neglected to disclose an earlier study it had conducted involving 67,000 heart surgery patients. Preliminary review of this study suggested that Trasylol side effects included higher risks for stroke, congestive heart failure, kidney failure, and death. Bayer failed to disclose this study during the Advisory Committee on September 21, 2006.

Dr. Dennis Mangano, the lead author of the NEJM Trasylol side effects study, has noted that Trasylol problems occurred more frequently than those linked with the drug Vioxx. Dr. Mangano relates, “In fact our findings raise even more troubling concerns, for:
(1) aprotinin has been on the market for three times as long as Vioxx, yet few comprehensive safety studies have been conducted since approval;
(2) the life-threatening complications with aprotinin found here occurred far more frequently than those with Vioxx; and
(3) far less expensive generic alternatives to aprotinin which are equally effective in limiting bleeding have been available, but have been underused.”

The observational study concluded, “Our findings raise serious concerns regarding the safety of an approved drug intended to limit blood loss in at-risk patients undergoing surgery.” Mangano related his opinion regarding the ongoing use of Trasylol, stating “In good conscience, I could not administer (Trasylol) to this group of patients, especially given the availability of safer alternatives.” Trasylol problems continue to be studied and the number of patients affected by the drug continues to rise as the public becomes more aware of the drugs devastating side effects.

If you or a loved one has had open heart surgery and then experienced Trasylol kidney failure, heart failure or stroke, you may be able entitled to compensation. A Trasylol lawsuit attorney can help evaluate your claim.

How To Find Out If Trasylol Was Used During Heart Surgery

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. Someone trying to get copies of their medical records is able to grant another person permission to request their 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.

Trasylol Information News Video | Trasylol Heart Medication Class Action Lawsuit Attorney Lawyer

Bayer is reviewing the results of the Canadian study of their Trasylol heart medication drug. Trasylol problems including kidney failure, stroke and death have affected thousands of patients across the United States. The Canadian study (referred to as the “BART” study) was a randomized clinical trial involving patients who underwent one of the following procedures: repeat cardiac surgery, isolated mitral-valve replacement, combined valve and CABG surgery, multiple valve replacement or repair, and surgery of the ascending aorta or aortic arch procedures.

The BART study was stopped after a planned periodic data analysis indicated reduced bleeding but also an increase in all-cause mortality for patients in the aprotinin (Trasylol) treatment arm compared to patients who received either of the generic drugs aminocaproic acid or tranexamic acid. Bayer is waiting until more information becomes available following their final data analysis before they take further action regarding Trasylol.

If you or a loved one has had open heart surgery and then experienced Trasylol kidney failure, heart failure or stroke, you may be able entitled to money damages. A Trasylol lawsuit attorney can help evaluate your claim.

Trasylol Information News Video | Trasylol Kidney Problems Attorneys| Renal Failure Lawsuits

In November 2007, Bayer withdrew its heart surgery drug Trasylol from the marketplace. A study based on observations at sixty nine cardiac centers was published that showed Trasylol kidney failure along with other serious side effects such as heart failure and stroke. The observational study raised significant questions regarding the safety of Bayer’s drug.

The study revealed that patients receiving the drug had double the risk of Trasylol kidney problems along with other side effects. It is estimated that as many as 10,000 patients may be on kidney dialysis due to Trasylol. Many patients have suffered from renal failure which can often lead to death. After Trasylol enters the body during bypass surgery it is attracted to the kidneys where, as in many patients, it causes kidney problems including kidney failure. The following video describes the anatomy of the kidneys.

If you or a loved one has had open heart surgery and then experienced Trasylol kidney problems, heart failure or stroke, you may be able entitled to money damages. Trasylol lawsuit attorneys can help evaluate your claim.