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 Post subject: Drug Makers Near Old Goal: A Legal Shield
PostPosted: Tue Apr 08, 2008 12:25 am 
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By GARDINER HARRIS and ALEX BERENSON
Published: April 6, 2008

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But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product ? even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases.


Link to article: http://www.nytimes.com/2008/04/06/washi ... vra&st=nyt


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