TRASYLOL® LITIGATION UPDATE

Cory Watson has been on the forefront of the Trasylol litigation against Bayer for almost two years; representing individuals who were given the drug during surgery and are now resigned to a life of living on dialysis. The first two lawsuits filed in the US against Bayer regarding the problems with Trasylol were filed by our firm.

On September 12, 2007, the FDA Advisory Committee responsible for evaluating the drug Trasylol (Aprotinin) met again to address recent studies which have shown that use of Trasylol during open heart surgery requiring use of the heart/lung machine was associated with an increased risk of kidney dysfunction, kidney failure requiring dialysis and death. Trasylol is a drug given to patients intravenously during open heart surgery to reduce the potential for bleeding requiring blood transfusions.

The Advisory Committee ultimately agreed to recommend to the FDA that Trasylol remain on the market. However, many members of the committee indicated they were concerned with the lack of sufficient warnings given in the label for the drug regarding the potential for kidney dysfunction and kidney failure when the drug is used on patients.

Moreover, the Advisory Committee voted unanimously that additional safety studies should be made a prerequisite to the continued marketing of the drug by its manufacturer, Bayer. It was pointed out to the Committee at the hearing that the FDA does not have the authority to make a company conduct another clinical trial on a drug already approved for use. Some of the Committee’s members said the FDA should use any power it has to make sure Bayer does perform the additional clinical trials to determine whether and to what degree there is a risk of kidney failure and death due to the use of Trasylol. This included pulling the drug off the market if Bayer did not comply with the request to do more trials. It should be noted that during the meeting spokespeople for Bayer agreed that there is definitely an increased risk of renal dysfunction when the drug Trasylol is used during open heart surgery.

In many states, the 2 year statute of limitation will run on January 26, 2008 for those individuals who had open heart surgery before January 26, 2006. If you are reviewing claims and are considering getting involved in this litigation, we are very interested in assisting or advising in this litigation. We are only accepting cases where the patient underwent open heart surgery requiring the use of the heart/lung machine and after surgery developed kidney failure requiring dialysis. Please note, patients will not be aware they were given the drug since it is given during surgery. We will obtain the necessary records to determine if you were given the drug.

From our conversations with medical experts and from marketing done by referring attorneys,
these cases will be extremely limited in number and possibly difficult to find. 

For more information about our pharmaceutical drug and medical device litigation,
contact us at (800) 852-6299 or (205) 328-2200 or visit our Web site at www.cwcd.com.

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