Wednesday, August 27, 2008

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


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.

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