BREAKING NEWS ON TRASYLOL

According to a report on 60 Minutes, the delay in taking Trasylol off the market after the publication of Dr. Dennis Mangano's groundbreaking study showing elevated risks of kidney damage (including dialysis), heart attack and stroke may have cost 22,000 lives. Dr. Mangano estimates that as many as 1,000 people per month died as a result of the use of Trayslol during Coronary Artery Bypass Graft surgery from the publication of his article in January, 2006 until the drug's withdrawal in November of 2007. You can view the entirety of the report by clicking the link.


On February 21, two studies were published in the New England Journal of Medicine. Both studies confirm that Trasylol causes an increased risk of death and kidney damage compared to alternative medicines or no medicine at all. Trasylol is an antifibrinolytic agent used during cardiac surgery to reduce the risk of blood transfusions. However, for patients that require the use of such a medication, two alternatives exists - aminocaproic acid and tranexamic acid - both of which are substantially less expensive than Trasylol. According to the two most recent articles and Dr. Mangano's study, aminocaproic acid and tranexamic acid are equally effective in reducing the risk of needing blood transfusions due to blood loss and present none of the health risks associated with Trasylol.


According to the February 2008 article by Dr. Andrew Shaw, et al., "survival was worse among patients treated with [Trasylol], with a main-effects hazard ratio for death of 1.32 (95% confidence interval, 1.12 to 1.55) for the comparison with patients receiving no antibrinolytic therapy (P=0.003) and 1.27 (95% CI, 1.10 to 1.46) for the comparison with patients receiving aminocarpoic acid (P=0.004).


In addition to the Shaw article, an article by Dr. Schneeweiss, et al., is also being published in the New England Journal of Medicine this month. This is the study that was actually funded by Bayer and withheld from the FDA until after a pivotal Advisory Committee meeting on Trasylol. This study concludes that the risk of death is 64% higher with Trasylol compared to aminocaproic acid (relative risk, 1.64; 95% confidence interval, 1.50 to 1.78).


Levin Papantonio is one of the leaders in the Trasylol litigation. We have filed multiple cases and are proceeding in both state and federal court. We are in the process of reviewing millions of pages of documents produced by Bayer in relation to this dangerous drug. Next month, the Judicial Panel on Multidistrict Litigation will hear argument on the formation of an MDL. Levin Papantonio is supporting an MDL in the Northern District of Georgia or the Middle District of Florida. Bayer is proposing an MDL in the District of Connecticut. Other alternatives proposed are the Southern District of Florida and the Northern District of California.


We know you will be interested in pursuing clients who were injured by Trasylol. We believe, given Dr. Mangano's estimates of the number of lives that could have been saved, that a lot of people injured by this drug are currently unrepresented. Please call Levin Papantonio immediately for any assistance you may need in the pursuit of clients and the prosecution of these important cases.