When Trasylol, Bayer’s drug used to limit bleeding in heart surgery, was pulled off the market earlier in 2008, a flood of lawsuits were filed against the pharmaceutical manufacturer for not warning patients and doctors about the dangers of the drug – information that Bayer allegedly kept secret. Now that litigation has begun, we asked one attorney whose firm is handling Trasylol litigation, to explain which causes of action will likely apply.

Likely causes of action

Frank Woodson, an Alabama attorney whose firm is handling Trasylol litigation, told us that typically, he sees allegations of failure to warn in these cases. He explained, “Any drug is going to have the potential to cause a side effect. So drug companies are required to warn about side effects and if they don’t you see patients who are injured by a drug arguing failure of the product manufacturer to adequately warn them about the risk of whatever they’re concerned about.”

“In Vioxx, it was the risk of heart attack; in Baycol, it was the risk of the muscle problems of rhabdomyolysis and with Rezulin, it was liver damage. With Trasylol, it’s going to be kidney failure and/or sudden death. Obviously in these cases, when you’re undergoing open heart surgery, doctors or patients may be willing to use a drug with risks to keep from bleeding too much during surgery.”

Risk / benefit analysis needed

Patients needing open heart surgery must do a risk / benefit analysis; yet, according to Woodson, that’s difficult to do when they don’t have all the facts. He explained, “Basic product liability law contains the duty to inform the doctors and to warn the patients so they can take that into consideration in the risk benefit analysis that they have to do in determining whether they need to undergo open heart surgery. That’s number one. Number two, doctors need to know what drugs can be used to decrease bleeding after the surgery’s over. Without that information, they can’t do the proper risk benefit analysis.”

Preemption issues

Woodson told us that preemption may be an issue in Trasylol litigation depending on what happens in the Wyeth vs. Levine case that will be before the U.S. Supreme Court in November of this year. He explained:

What we understand the premise of that argument is going to be by the pharmaceutical company is that, if our drug is approved by the FDA, we have preemption, we have total immunity, you cannot sue us and the state law should not have any play or bearing on what goes on with the drug.

However, I was told by an attorney in San Francisco yesterday that he’s got a bunch of cases involving Plavix where the judge has just stayed the entire litigation waiting on this Wyeth vs. Levine decision that’s coming out later this year. So, it can have something to do with it here because even if it’s obvious that Bayer never adequately warned about the side effects that Trasylol can cause, then it won’t matter if the U.S. Supreme Court says that once the drug is FDA approved, they have immunity.

That’s a very scary thing that could happen. It’s what happened in Michigan where they have a state statute that basically gives drug companies immunity from lawsuits unless you can prove that the drug company acted fraudulently against the FDA. That’s the only exception. However, that’s about next to impossible to do, so it’s really not an exception at all.

If you or a loved one may have been injured or died due to the use of Trasylol, contact an attorney whose practice focuses in this area of law to discuss your situation. The consultation is free and without obligation. To contact a qualified attorney, please click here.