Washington bureaucrats taking over American justice system - Article by Lieff Cabraser attorney Mark Chalos

ARTICLE

Washington bureaucrats taking over American justice system

Tennessean.com, December 26, 2007

A child's birth is one of life's happiest moments. In the bustle of the delivery room lies a helpless infant, completely reliant on others.

One couple recently welcomed healthy twins, Zoe and Thomas. Their joy turned quickly into a nightmare: the children were overdosed with a powerful medication. They were given a dose 1,000 times the recommend dose. Medical personnel apparently confused the vial containing the higher dose with the vial containing the proper dose. The vials were reportedly the same size, color and shape.

According to the twins' family, the drug's manufacturer knew that other infants had died because of confusion between the different dosage vials. Even with this knowledge, according to the family, the company failed to change the labeling and failed to properly notify the medical community of the danger. The confusing label was reviewed and approved by the federal Food and Drug Administration (FDA).

The media have widely reported the twins' story -- not because medical errors and poorly labeled medications are rare and newsworthy, but because the twins' father is the actor, Dennis Quaid.

The Quaids are not alone in their suffering. A recent study found almost 90,000 serious adverse drug events related to prescription drugs in 2005, a 2.6-fold increase from 1998. The study also found more than 15,000 fatalities from adverse drug events in 2005, a 2.7-fold increase from 1998. Another recent study done in collaboration with the FDA estimated the number of serious adverse drug reactions in the U.S. to be 2 million yearly, with 100,000 deaths yearly.

Many Americans believe that the FDA ensures that dangerous medical products are not sold in the United States. It doesn't. There have been numerous recent examples of dangerous products being approved by the FDA, only to be taken off the market after reports of deaths and serious injuries. In 2004, the anti-inflammatory drug Vioxx was withdrawn from the market after the manufacturer admitted that Vioxx caused a substantial increase in heart attack risk. In October 2007, medical device manufacturer Medtronic announced a recall of implantable cardiac defibrillators because of fractures in the devices' wires that led to what the FDA called a "reasonable probability that use of the product will cause serious injury or death."

The FDA's failures result from longstanding institutional problems. A recent report by an FDA advisory panel detailed a "plethora of inadequacies" in the agency. (Tennessean, Dec. 3) The report concluded that the FDA cannot ensure the safety of medical products because it is unable to keep up with scientific advances, lacks adequate personnel, and lacks current technology. The report also concluded that because of the FDA's inadequacies, "American lives are at risk." The FDA said it does not plan to make any immediate changes based on the report.

The FDA has also been plagued by allegations that its decisions are influenced by individuals with financial ties to drug companies -- the very companies it is supposed to be watching over. Moreover, the FDA receives hundreds of millions of dollars from drug companies each year in "user fees." These entanglements, coupled with FDA's documented inability to ensure the safety of medical products, put American families in danger.

When a child is injured by an unsafe product that made it past the compromised FDA, the families' only recourse is the jury system. Juries are great equalizers. Injured families, rich or poor, have the right to tell their story to a jury of their peers. The jury decides who, if anyone, is responsible for causing injuries and holds wrong-doers accountable, even if the wrong-doers are large, powerful corporations. Washington lobbyists, political contributions, and insider back-slapping are useless to wrong-doers in front of juries. Juries are ordinary folks given the extraordinary opportunity to use wisdom and life-experience to right wrongs done to our families. The American jury system is like no other in the world. It is an institution that makes America great.

Nevertheless, there is a well-financed assault on the jury system by those who want to avoid accountability for wrong-doing. For example, the U.S. Supreme Court recently heard arguments in a case against the medical device company, Medtronic. Medtronic argued the FDA has the sole power to decide whether a medical device is safe. Even if the product proves to be unsafe, any person injured by the product has no remedy. Washington bureaucrats, according to Medtronic, have the final word about what is best for American families.

If this argument succeeds, injured families like the Quaids will no longer have their "day in court." The door to the courthouse would be closed. While most bureaucrats are well-meaning and hard-working, there should be limits to what they are asked to do. There is a role for Washington bureaucrats in regulating medical products, but they should not be permitted to take power that for centuries has belonged to juries. To paraphrase Matthew 22: give unto the federal bureaucrats what is theirs and give unto the wise juries what is theirs -- the power to right the wrongs inflicted on our children.

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