Bayer’s Trasylol was approved for post surgical bleeding primarily after heart surgeries. However, it’s now being discovered that Trasylol had many serious side effects that could have been responsible for thousands of deaths.

Neil Overholtz

To get a legal expert’s analysis on the Trasylol controversy, we asked Neil Overholtz, a Florida attorney whose practice represents clients injured by drugs such as Trasylol. Overholtz provided the following history and explained how Bayer seized a marketing opportunity to create a niche market for the drug:

Trasylol’s history

Open-heart surgery is often accompanied with significant bleeding. Patients on Coumadin are usually taken off of it prior to surgery. However, they’re at least heparinized prior to surgery. Because of the risk of bleeding, they are given a drug of a class of drugs that is known to reduce post-surgical bleeding. This isn’t bleeding during surgery, but bleeding after surgery, which happens to a lot of patients.

These post-surgery bleeding drugs have been around for a while, but Bayer developed Trasylol Aprotinin in the mid 1980s and had gotten it approved around 1993. These post surgical bleeding drugs work in different ways, but the simple and the most straight forward approach is that these drugs work to make sure that blood viscosity is such that it doesn’t result in significant bleeds post surgically, ether into the body or even that would cause strokes or hemorrhagic type strokes.

Bayer seized an opportunity

Although there were already several drugs on the market available to doctors that worked fine, Overholtz says that Bayer seized an opportunity to create a niche market for Trasylol. He explained:

[The question] Bayer focused on was, ‘How do we get a niche into this market?’ What they focused on was studying the drug in heart bypass patients. They tried to show doctors that their drug can be effective at preventing transfusions, because reducing transfusions is good for patient health and no one disputes that.

They worked on showing that Trasylol was effective at reducing the number of transfusions after heart bypass surgery or what’s called CABG surgery, or coronary artery bypass grafting. That was the indication that they sought from the FDA, that this was a drug that could be used to prevent post-surgical bleeding in heart bypass patients. So, it had a limited indication for use to a heart surgeon.

And then ran with it

Overholtz says that he hasn’t seen any specific data that Trasylol had special properties that made it more beneficial in heart bypass surgery patients. He told us that, “By focusing on that niche, [Bayer] was able to market the drug to doctors as being the only drug approved specifically for the prevention of post-surgical bleeding in heart bypass patients – which is how Trasylol got its niche.”

“Now, over time it began to get used in more and more surgeries. By 2006, it was being used in nearly 1/3 of all open heart surgeries irrespective of whether it was bypass, valve surgery, heart reconstruction, basically any and all open heart surgeries that might be happening during that time. So, while they initially saw it as this very limited indication, by 2006 the drug was being used in all types of surgery despite the fact that the FDA never did give a broader indication of use approval for the drug.”

If you’ve been injured due to a drug such as Trasylol, contact an attorney whose practice focuses in this area of the law to discuss your situation. Consultations are free, without obligation and strictly confidential. To contact a qualified attorney, please click here. We may be able to help.