FDA Still Sitting on the Trasylol Issue
Yes I know 60 Minutes did a huge story on Trasylol a little over a month ago where, among other things, the leading researcher on this drug, Dr. Mangano, who has been fighting an up hill battle for over 2 years on this drug, indicated that the FDA could have saved 22,000 lives if it would have pulled this drug off the market when Mangano's first study on Trasylol was published in the New England Journal of Medicine (NEJM) back in January 2006. Since that report on 60 Minutes, many plaintiff's law firms have been searching far and wide for potential cases regarding this drug. However, like Dr. Mangano, I also have been fighting the good fight on this drug since his study first appeared in the NEJM.in late January 2006.
When I first read the study, I was convinced that this was a drug with significant problems and issues. I immediately addressed the issue with the partners in my old firm and convinced them we needed to help people who had been significantly injured by this drug. One of the biggest injuries caused by Trasylol, as addressed in Mangano's first study, was that the drug, given most often during heart bypass surgery to assist in reducing bleeding, had a significant potential to cause permanent kidney failure. Those patients unfortunate enough to have had this reaction are resigned to a life of 3 days of dialysis every day for the rest of their lives.
This was personal to me. My own father, after open heart surgery over 8 years ago, ended up in kidney failure and has been tied to a dialysis machine ever since. Here was a man, who worked hard his whole life so that he and my mother could spend their retirement years enjoying the fruits of their labors, but instead they have spent the past 8 years running to doctors, hospitals, and dialysis centers. My dad for the past 3 years has essentially become an invalid and my mother his round the clock caregiver. Thus, when I saw clear, medically and scientifically validated information indicating a drug, which people don't even know they are given and thus have the chance to refuse, can cause a person to spend the rest of their lives tied to a machine just to keep them alive, I knew I had to do something to help.
As a result, I was the first lawyer in the United States to file a case in court claiming that a patient was given this drug and as a result, their kidneys failed, requiring them to have dialysis the rest of their lives. I was interviewed by an independent reporter from Germany who was doing a "60 Minutes" type report on Trasylol which was shown in Germany almost 6 months before the 60 Minutes report appeared. For those who don't know, Trasylol is a drug manufactured by Bayer Corporation which has its international headquarters in Germany.
What has been learned over these past two years of fighting the good fight is more evidence of corporate greed and decisions made by Bayer to expand the use of Trasylol to other surgeries and hide all the bad evidence indicating the drug had a significant potential to cause kidney failure. This included a scandal where Bayer representatives appeared before a FDA committee investigating Trasylol where they steadfastly took the position that there was nothing wrong with the drug, when Bayer knew that it had paid for its own study on Trasylol which confirmed the findings of Dr. Mangano, and hid that information from the FDA. To follow that up, even after Bayer decided to TEMPORARILY stop selling Trasylol in the U.S., it hired doctors to trump up to other doctors, the benefits of Trasylol. There is even indication now that Bayer knew back many many years ago when Trasylol was first put out on the German market that a concern was raised about increased risk of kidney failure from use of Trasylol. It appears that concern was pushed aside, and instead Bayer continued to aggressively pursue the sale and use of Trasylol.
I am continuing the fight I started on this drug over two years ago when I read the first study by Dr. Mangano. If you had open heart surgery and after the surgery ended up on dialysis for the rest of your life, you may have been given Trasylol during your surgery which may have lead to your kidney problems. It is a terrible cost to have to pay. You may want a lawyer to evaluate whether you might have a case against Bayer. My only suggestion in choosing a lawyer to assist you in this process is to make sure you choose one who understands the problems with this drug and can properly evaluate whether Trasylol caused your kidneys to fail. I will continue to provide information about this drug as I learn more because it is important for the public to be aware of what can happen when the drive to make money overrides the concern for patient safety.
