The American Association for Justice (AAJ) thinks that the U.S. Food and Drug Administration (FDA) is allowing drug companies to run the show by giving them immunity when they fail to warn the public about a drug’s potential dangers.

AAJ says the system is broken

In recent correspondence, the AAJ basically told the FDA that the system seems to be broken. Drug companies have long been required to warn the public when they discover new information that could make a drug’s usage unsafe. However, under the FDA Amendments Act of 2007, drug companies now only have to warn consumers about potential dangers when they feel that there is a “causal association” between the drug and the hazard. Defining when a causal association exists will be difficult to determine at best and drug companies don’t have the best track record in this area as of late…

Case in point

According to industry analysts, Bayer Pharmaceutical’s removal of its drug, Trasylol, which is used to limit bleeding in heart surgery, is a perfect example of drug companies already not doing everything they can to warn the public of potential dangers. It has been estimated that Trasylol was given to nearly one third of all heart bypass patients in the United States from 1993 to 2007.

Researchers say that it is clear that Bayer knew about the dangers associated with the drug – but did nothing. As a result, thousands of lives may have been taken too early according to a segment on CBS’s 60 Minutes. Bayer has made billions of dollars from Trasylol sales over the years, so pulling it off the market before they had to would mean a lesser bottom line – which many believe is just another example of mega pharmaceutical companies putting profits over patients.

One attorney’s views on profits over patients

Frank Woodson, an Alabama attorney whose firm represents Trasylol patients, told us that he’s seen this type of practice all too often. Woodson, whose practice focuses in the area of mass torts related to pharmaceuticals, explained, “The company knows far more than anyone else in the world about the drug, including the FDA. So, why didn’t they do something about it? Because they were making money off of it. If they put a warning in their label that the drug is associated with an increased risk of kidney failure or death, then there are other drugs available to do the same thing and they’re going to lose sales – which is just another example of companies placing profits over patient safety.”