Sunday, April 20, 2008

Trasylol MDL: West Palm Beach

Judge Donald Middlebrooks, judge for the United States District Court for the Southern District of Florida will oversee the Trasylol Multi District Litigation. He served as General counsel to the Governor of Florida from 1974 - 1977, and in in 1997 was appointed by President Bill Clinton to serve as a United States District Judge.

Judge Middlebrooks heard the Bush lawsuit back in 2000. From the NY Times:

"The federal judge selected at random to hear the Bush campaign's lawsuit seeking to block hand-counting of ballots in some counties in Florida is a lifelong Democrat who has long been active in liberal causes ... . The judge, Donald M. Middlebrooks, is also highly regarded by Democrats and Republicans, as well as prosecutors and criminal defense lawyers, who after working with him or appearing in his court widely agree that he is fair and thoughtful." Source here.

Trasylol or Aprotinin, is also referred to as a bovine pancreatic trypsin inhibitor, BPTI. Trasylol is used as medication administered by injection to reduce bleeding during complex surgery - typically heart or liver surgery.

What does it do? The goal is to slow down fibrinolysis, a process that leads to the breakdown of blood clots.

In late 2007, The FDA asked Bayer Pharmaceuticals to suspend marketing of the drug, pending a detailed review of preliminary results from a Canadian study that suggested an increased risk for death. From the FDA website:

The FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.

Source here.