The heart surgery drug Trasylol was taken off the market in the U.S. in 2008 after research revealed the medication increased the risk of kidney failure, congestive heart failure, stroke and death.
If you suffered side effects or lost a loved one because this drug was used during open-heart surgery, you may be able to file a Trasylol lawsuit to pursue compensation. O’Connor, Acciani & Levy’s defective drug lawyers can lead you through the legal process, investigating your situation, building a case and fighting for all of the compensation you are owed.
At our firm, we offer a free, no obligation legal consultation where we can determine if you have grounds for a lawsuit and how much compensation you may be able to recover. If we take your case, we will not charge for representing you unless you receive compensation.
RESEARCH ON TRASYLOL SIDE EFFECTS
Aprotinin, known by the brand name Trasylol, was approved by the U.S. Food and Drug Administration (FDA) on Dec. 28, 1993. This medication was approved to reduce bleeding and the need for blood transfusions during cardiopulmonary bypass surgery and other surgical procedures where there is a high risk of bleeding, according to an FDA briefing document about Trasylol and FDA actions concerning this medication.
When the drug was released, the prescribing information noted concerns about the risk of heart attack and renal dysfunction. At the time, the FDA and Bayer, the manufacturer, agreed it was necessary to conduct additional research to fully assess these risks.
In early 2006, these and other risks of Trasylol were assessed in two observational studies, published in the New England Journal of Medicine (NEJM) and the journal Transfusion.
In Jan. 2006, the NEJM published a report on the five-year mortality data on 4,374 patients who underwent cardiopulmonary bypass in the course of coronary artery bypass graft (CABG) surgery. The report said aprotinin use increased the incidence of the following:
- Cardiovascular events like heart attack and congestive heart failure
- Cerebrovascular events like stroke, coma or encephalopathy
- Renal events like kidney dysfunction and/or kidney failure requiring dialysis
The other study was released in March 2006, and it consisted of an analysis of adverse events among patients at high risk for needing a transfusion during cardiac surgery. Researchers compared patients who were treated with aprotinin to those treated with tranexamic acid. They found Trasylol could be associated with worsening kidney function in patients who already have kidney dysfunction.
If you suffered side effects after you were treated with Trasylol during CABG surgery, contact us about filing a Trasylol lawsuit to pursue compensation.
FDA PUBLIC HEALTH ADVISORIES ABOUT TRASYLOL
The first observational study from early 2006 led to the FDA issuing a public health advisory on Feb. 8, 2006. The advisory notified consumers and health care providers about the risks of using Trasylol during heart surgery.
Bayer sent letters to more than 110,000 physicians and health care providers and posted a notice online about the potential risks of the drug.
Bayer also provided the FDA with an extensive review of safety data on the use of Trasylol during CABG surgery. Bayer’s database included information on 2,249 patients treated with aprotinin and 2,164 treated with a placebo. The evaluation sent to the FDA also included a review of spontaneous reports received by the company.
ADVISORY COMMITTEE MEETING
On Sept. 21, 2006, the FDA’s Cardiovascular and Renal Drugs Advisory Committee met to analyze both observational studies and the information provided by Bayer. The meeting included presentations by the authors of the two observational studies and representatives of Bayer.
While the committee agreed the data showed an association between Trasylol use and kidney impairment, most members were not convinced of a definite increased risk of kidney failure requiring dialysis. Committee members agreed there was no association between Trasylol use and an increase in the risk of myocardial infarction (heart attack)
The committee voted 18-0, with one member abstaining, that the totality of clinical data showed Trasylol was safe and effective for use among certain patients undergoing CABG surgery or cardiopulmonary bypass (CPB) surgery.
SECOND PUBLIC HEALTH ADVISORY
Just eight days after the committee meeting, on Sept. 29, 2006, the FDA posted a public health advisory about Trasylol on its website.
The advisory cited data from a preliminary report on a study by i3 Drug Safety on the effects of aprotinin in patients undergoing CABG surgery. The FDA’s advisory said preliminary findings show that Trasylol may increase the chance of death, serious kidney damage, congestive heart failure and strokes. The FDA said it was evaluating data and implications of the data to determine appropriate use of the drug.
Our attorneys can review your situation in a free consultation if you suffered an injury because Trasylol was used during your heart surgery. We may be able to file a Trasylol lawsuit to attempt to recover compensation.
We have a successful record of recovering fair compensation for victims of defective drugs and other products.
BAYER TAKES TRASYLOL OFF THE MARKET
In Nov. 2007, Bayer suspended marketing of Trasylol in the U.S. after reviewing preliminary results of a controlled drug trial in Canada, titled Blood Conservation Using Antifibrinolytics: A Randomized Trial in a Cardiac Surgery Population (BART).
The trial began in 2001 and included 3,000 patients who would undergo heart surgery. However, initial results showed Trasylol increased the risk of death from all causes compared to patients taking aminocaproic acid or tranexamic acid. The results were consistent with findings from other studies.
The FDA released a statement after marketing of Trasylol was suspended saying it was working with Bayer to phase Trasylol out of the marketplace without causing shortages of other drugs used for the same purpose.
However, this decision did not come quickly enough for the author of the 2006 study published in NEJM, Dennis Mangano. In an interview broadcast on the CBS show 60 Minutes in 2008, Mangano said 22,000 lives could have been saved if regulators had been quicker to remove the drug from the market.
The final results of the BART trial were published online on May 15, 2008 in the NEJM. Investigators randomly assigned 2,331 high-risk cardiac-surgery patients to be treated with aprotinin, tranexamic acid or aminocaproic acid. The 30-day mortality rate was more than 50 percent higher in patients treated with aprotinin than other drugs.
A cause of death analysis for 2,328 patients found 3.2 percent of aprotinin-treated patients died from cardiac causes, compared to 1.3 percent of patients treated with tranexamic acid and 1.7 percent of patients treated with aminocaproic acid.
Researchers concluded treatment with Trasylol significantly increased the risk of death compared to the other two medications studied. This led Bayer to remove all remaining supplies of the drug from hospital pharmacies and warehouses. This effectively ended use of the drug in the U.S., but the company will still make the drug available as an investigational medication under a special treatment protocol.
If you suffered an injury because of Trasylol, our attorneys may be able to help you hold Bayer accountable. We may also be able to obtain compensation through a Trasylol lawsuit.
Nearly 1,800 lawsuits have been filed against Bayer over side effects from the use of Trasylol during heart surgery. This includes approximately 200 in the mass tort program in the Philadelphia Common Pleas Court in Pennsylvania and approximately 1,600 in a multidistrict litigation (MDL) in the Southern District of Florida.
An MDL is one legal action that contains numerous lawsuits with similar allegations and issues of fact. The U.S. Judicial Panel on Multidistrict Litigations consolidates similar cases this way to help speed up the legal process. After a few cases in an MDL go to trial, others may be thrown out or settled. This is often faster than if all of the cases were tried individually.
Victims of Trasylol began filing lawsuits even before marketing was suspended and the drug was pulled off the market in May 2008. However, there was a flood of lawsuits following these moves by Bayer.
In April 2010, one of Bayer’s lawyers told the judge presiding over the MDL that the company had settled 63 cases. In July, a spokeswoman for Bayer announced the company had settled with 120 plaintiffs and had not made an admission of liability.
In Aug. 2010, Bayer announced that it agreed to a $60 million settlement of approximately 150 Trasylol lawsuits. Victims who were part of the settlement received an average of $400,000 per person.
In 2013, the judge presiding over the MDL decided to dismiss some of the Trasylol lawsuits after finding that an expert witness had not properly considered information that the drug was responsible for kidney failure and death.
If you suffered an injury due to Trasylol, contact our firm today to review your situation. We might be able to file a Trasylol lawsuit to pursue compensation.
CONTACT US TODAY ABOUT FILING A TRASYLOL LAWSUIT
Drug manufacturers have a legal responsibility to make safe products and adequately warn the public and doctors about the potential risks. If drug makers fail in these obligations, they should be held accountable for any harm their drugs cause.
Our defective drug attorneys can review your situation in a free legal consultation to determine if you have grounds for a Trasylol lawsuit. We can manage every aspect of the legal process, defending your rights and pursuing the fair compensation you deserve.
We take cases on a contingency fee basis, so you will not be charged for our services unless you receive fair compensation.