Injury Law Report

The risks associated with Trasylol --- kidney failure, serious heart problems and possibly death --- long ago could have been avoided if Bayer and the FDA would have heeded the warnings revealed in several studies. Why was Trasylol the drug of choice for controlling bleeding during surgery when cheaper alternatives were available? Recent studies state that the cost per dose of Trasylol is $1,300. The generic drug Amicar, which also limits bleeding in operations, is $11 per dose. The generic Cyklokapron, another option, is $44 per dose. According to the studies, neither of the generic drugs was linked to increased risk of kidney failure, heart attack or stroke. What is the reason for exposing the American public to increased risk at a high cost when cheaper and safer options are available?#

If you had open heart surgery prior to November 2007, you may have received Trasylol without even knowing it. Most likely you received a drug to control bleeding during the operation. Your doctors made the decision to use Trasylol or a similar drug, and it’s not the type of decision about which you would have been consulted. So how can you find out if you or a loved one received the drug? The first place to check would be the medical records. Obtaining a copy of the medical records of the surgery generally is not difficult, but sometimes the copying charges can be a bit expensive (for example, $1.00 per page).

Trasylol is a drug that long ago should have been pulled from the market. The failure of Bayer, manufacturer of the drug, and the FDA to suspend its use probably has led to the death and serious injury of thousands of patients who were given this drug during surgery to control bleeding. 60 Minutes recently did a great story on how this drug ended the life of a man who should not have died so young.

If you have not read the most recent blogs of the Injury Law Report on this subject, here’s a brief summary:

Trasylol is a drug used to control bleeding and limit the need for blood transfusions in patients undergoing Coronary Artery Bypass Grafting (CABG) surgery. Trasylol is administered intravenously after a patient is under anesthesia and not aware of receiving this drug. Several studies have linked Trasylol to a nearly doubling of the risk of kidney failure resulting in the need for dialysis. In September 2006, Dr. Dennis Mangano presented a study on the drug to the FDA concluding that Trasylol increased the risk of kidney failure, and the risk of death by about 50 percent for some patients. Bayer complained, and the FDA permitted the drug to remain on the market. While this was not the first study linking Trasylol to adverse consequences, it was one of the first that clearly gave the FDA significant data that Trasylol posed an unacceptable risk to patients.

Unfortunately, we cannot depend upon the Food & Drug Administration (FDA) or the drug industry to keep us safe from dangerous drugs. In the case of Trasylol, a drug formerly used during surgery to control bleeding, both the FDA and Bayer, the manufacturer of the drug, knew or should have know that the drug posed a serious health risk for patients.

Trasylol, also known as aprotinin, has been produced and sold by Bayer for about 14 years. It’s been a very popular drug that was used in more than a third of the heart bypass surgeries in America. Some doctors now believe that this drug may have caused the death of 22,000 patients since the FDA first became aware of its serious health risks. How could the government allow this drug to remain on the market given all of the studies linking it to serious injury and death?

Trasylol was a huge money maker for Bayer, the German based drug manufacturer best known for its popular aspirin used by many Americans. Bayer made millions each year off of Trasylol, a drug used to control bleeding during operations. It was the choice of many doctors who performed cardiac bypass surgery. Nearly 1/3 of all such heart operations relied upon Trasylol, also called aprotinin, to control bleeding during this long and complex procedure.

If you are a welder or former welder, you should be particularly concerned if you did most of your welding in your career indoors in tight and unventilated work spaces. Here are some of the symptoms that you should look for:

• tremors or shaking
• balance problems
• slowed movement (doctors call this “bradykinesia”)
• stiffness and difficulty moving
• problems in moving your face muscles (a “mask–like” face)
• memory loss and slurred speech.

Our last blog briefly reported the news of a welder who received a substantial jury verdict as a result of developing a disabling disease from breathing years of welding fumes.

What are the dangers of welding fumes?

A federal jury in Cleveland returned a verdict in favor of a sick welder for $20.5 million against Lincoln Electric, Hobart Brother Co. ESAB Group, TDY Industries and BOC Group. At the core of the case was the defendants' failure to warn former welder Jeff Tamraz of the toxicity of manganese in their products. The welding fumes have disabled Mr. Tamraz. The defendants are appealing the case.

What is this welding case all about? More about the dangers of welding fumes in the next blog.

Zelnorm (tegaserod maleate), a prescription medication approved for treatment of irritable bowel syndrome (constipation), has been pulled from the market. Swiss pharmaceutical maker Novartis AG will stop selling this drug at the FDA’s request. Zelnorm has been linked to higher chance of heart attack and stroke, U.S. government health officials said Friday.

Lead counsel for the Justice Department in its landmark lawsuit against Big Tobacco said yesterday that Bush administration political appointees repeatedly ordered her to take steps to weakened the government's racketeering case.

Merck & Co.'s Vioxx painkiller helped cause an Idaho mail carrier's heart attack, a New Jersey jury found earlier today, ordering the drugmaker to pay him and his wife $47.5 million in a retrial of a case the man originally lost.The loss is Merck's fifth dealing with the failed painkiller Vioxx.

Eli Lilly announced last week that it will settle about three-quarters of the present liability clams stemming from its Zyprexa schizophrenia drug.

Lilly will establish a fund not to exceed $690 million for plaintiffs who agree to settle their claims. The number of claimants covered by the settlement is estimated to be 8,000, comprising about 75% of the claims.

Merck was victorious on Tuesday, September 26, against consumer Robert Smith, a 56 year old Kentucky native who had a heart attack after taking Vioxx for about 4 months. Smith, a manager at a chemical plant, began taking Vioxx in 2002. He had a heart attack in February 2003.

Smith's case involved something that the other nine Vioxx trials did not: Smith took the drug after the medication's label was changed to warn of an increased risk of cardiovascular problems. The nine previous suits that were tried were brought by people who took the pill before the label change. The company has won five and lost four trials, with one victory overturned last month.

Merck pulled Vioxx from the market in September 2004 after a clinical study connected long-term use of the pain reliever with an increased risk of heart attack or stroke in certain patients.