Trasylol Special on 60 Minutes
Recently, the TV show 60 Minutes ran a special on a case that the lawyers at Carey & Danis have chosen to pursue. The manufacturer is Bayer and the bad drug is Trasylol. Bayer’s drug Trasylol has been used during cardiac bypass surgery to help reduce blood loss.
The reason for the 60 minutes show was a January of 2006 study, conducted by a San Francisco doctor, Dennis Mangano, showed an association between Trasylol and kidney failure and death. Shortly afterward, the Mangano Study appeared in the New England Journal of Medicine and affirmed what Bayer had known for decades.
European studies done in the 1980s had shown increased kidney toxicity associated with Trasylol. Bayer failed to conduct any follow-up studies upon learning of these risks. This was perhaps because there are two other drugs on the market that are as effective as Trasylol without the risk of death and kidney failure.
Each of these drugs costs about $50 apiece while Trasylol costs over $1,000.
In the summer of 2006, Bayer appeared before an FDA Advisory Committee considering whether to increase the warning label following the publication of the Mangano Study. Unknown to the FDA, Bayer had initiated its own study headed up by Harvard doctor Alexander Walker.
Dr. Walker's study included review of 70,000 patient records and confirmed what Dr. Mangano had found with his study population. Bayer did not disclose the Walker study to the FDA during the Advisory Committee hearing, although the study was finished. After the FDA Advisory Committee met, Dr. Walker told the FDA that his study, commissioned by Bayer, should have been disclosed. Dr. Walker's study was released in September 2006 and showed an elevated risk of death and kidney failure.
Dr. William Hiatt, the Chairman of the FDA Advisory Committee, later released an article with regard to "transparency" in the FDA process that harshly criticized Bayer. Later, a Canadian study (the BART Study) was used by Bayer to stall the FDA process which was considering changing the warning labels and pulling Trasylol from the market. The Canadian study was abruptly stopped in November 2007 because of increased risk of death and kidney toxicity. Canada and Germany pulled Trasylol from the market.
The FDA has not required Trasylol to be taken off the market but has restricted sales of Trasylol by Bayer. In other words, hospitals can continue to use the Trasylol they have in stock but Bayer can't sell them any more. It is estimated that 4.5 million people received Trasylol and that 1.5 million are American. Dr. Mangano estimates that there have been approximately 1000 deaths per month since his study was released. His estimate only concerns deaths and the Carey & Danis attorneys know that there have been many cases of (a) long-term dialysis; (b) short-term dialysis; (c) amputation; and (d) renal injury as a result of the administration of Trasylol.
Below is a link to the 60 Minutes program mentioned above: