FDA Sides with Drug Companies

For Immediate Release
Contact: Cecelia Prewett, Jennifer Fuson

202-965-3500 x369AAJ Press Room

Preemption Clause Would Grant Blanket Immunity

from Lawsuits Involving Drugs Used by Pregnant Women

Washington, DC – Drug and device manufacturers will have immunity from lawsuits even if they fail to update warning labels to include dangerous side effects for pregnant and breast-feeding women if a Food and Drug Administration (FDA) proposed rule is made final. The American Association for Justice (AAJ) today submitted comments on the new label requirements.

“The civil justice system and regulatory authority are meant to complement each other to protect consumers. Instead, we are seeing the same complete immunity preemption language over and over again that would allow manufacturers to escape accountability for hazardous drugs and take away the right of consumers to seek justice in the courts,” said American Association for Justice (AAJ) President Les Weisbrod.

AAJ is asking the final rule eliminate any reference to giving complete immunity to manufacturers. Seven federal agencies have issued over 59 rules with preemption language in the preamble of the rule. Congress has expressed intent to permit consumers to bring state law claims against drug manufacturers in the Food and Drug Administration Amendments of 2007 and in numerous floor statements.

“There is no guarantee the FDA’s new labeling requirements will compel manufacturers to disclose product hazards,” said Weisbrod. “This new policy will only hurt patients and relieve drug manufacturers of the obligation to compensate those that are harmed by their products before ever testing if the new labeling system works properly. The FDA needs shift their focus back to the safety of pregnant women and their children and not protecting the drug companies.”

For a copy of AAJ’s comments, see www.justice.org

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As the world's largest trial bar, the American Association for Justice (formerly known as the Association of Trial Lawyers of America) works to make sure people have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others--even when it means taking on the most powerful corporations.
Visit http://www.justice.org

Lawsuit not 'frivolous' to the one injured

By: Deric Beaudoin
Attorney at Law and GTLA Member

**The following is a response to a guest column printed in the AJC on 7-30.

A grueling mistrial? Perhaps. A frivolous lawsuit? Not a chance.

While I can certainly understand the frustration Mr. Pitfield has felt as a result of his juror experience, I don’t think it is fair to consider the time spent by everyone involved in this case as being anything near frivolous. I am thankful that this jury devoted so much of their time trying to reach a unanimous decision in this case and I am thankful that we have people in our community like Mr. Pitfield that are willing to share their opinions openly. The fact that twelve people that did not know either party to the case spent two days of their lives (after three days of hearing evidence and argument) trying to reach a decision that would have been fair to both parties is a testament that there are indeed plenty of good people left in our society.

At trial, I represented the plaintiff. My client, a married Korean born 20 + year Cobb County resident and stay-at-home mother of two, had incurred over $65,000 in medical bills as a result of the negligent driving of the defendant. There was no question that the defendant caused the accident because at the scene she received a citation from law enforcement which she pled guilty to and never challenged the ticket.

My client’s Ford Taurus wagon had damage to the unibody which is made of steel and takes the place of what has been traditionally referred to as the frame of a car. The accident caused spinal injuries requiring significant medical attention and for which there is essentially no cure. Hurt through no fault of her own, my client cannot be the person that she once was.

The life changing effect of this wreck and the amount of medical bills that Ms. Kim’s family has racked up as a result of this wreck are anything but “frivolous." The pain that Ms. Kim endures on a daily basis as a result of the defendant pulling out in front of her and stopping in the middle of the road is anything but "frivolous."

With the rising costs of gas, an unsteady economy, and everyday financial worries, the idea of being saddled with tens of thousands of dollars in medical expenses for injuries caused in an accident that was undeniably the fault of another is unbearable. Making a mistake that hurts somebody is one thing, but refusing to accept responsibility for hurting somebody the way Bonnie Kim was hurt is an insult.

Our jury system is designed to offer a fair and just decision for the parties involved in a case. Sometimes, they cannot reach agreement. However, that lack of consensus does not indicate a “frivolous” case. My client is a real person—a mother, a wife, a neighbor, a PTA member. Her family has incurred medical costs that would not have been necessary but for the negligence of the defendant. We did not go into that Courtroom and ask for a million dollars, all we asked for was that Ms. Kim’s medical bills be paid and that the jury award whatever they felt fair and reasonable for her other human losses in light of the evidence presented at trial.

Obviously we affected some of the jurors enough to keep them busy for two days trying to reach a unanimous verdict. It would be interesting to see what some of the “unreasonable” jurors would have to say about the experience. I appreciate Mr. Pitfield’s time on our jury and thank him for sharing his thoughts and opinions with us both after the trial and in his comments to the editor.

I regret however, that Mr. Pitfield did not comment on the civility of the trial and the incredible emotion felt by the parties, the attorneys and the jurors at various times of the trial. I personally have never had a better trial experience between opposing counsel and the defendant and perhaps I never will. Everything about our trial was professional and civil and our judge was exceptional.

If cases like this one are "frivolous," then we need to come up with a new word for lawsuits that have absolutely no merit, because this one, I can assure you, was not one of them.