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Supreme Court Hears Diana Levine Case (Part One)

Posted by Jane Akre
Monday, November 03, 2008 1:14 PM EST
Category: Major Medical, Protecting Your Family
Tags: Federal Pre-emption, Diana Levine, Wyeth

Supreme Court Listens to Diana Levine case 

Simon Heller of the Alliance for Justice

Simon Heller, Legal Director of  Alliance For Justice 

Diana levine

Diana Levine, was in the courtroom

Diana Levine case before the Supreme Court

To learn more about this work and ways you can help, please visit www.afj.org/accessdenied

 

Simon Heller is Legal Director for Alliance For Justice, a Washington D.C.-based association of environmental, civil rights, consumer groups that work to ensure equal justice to all Americans.  

The case of Diana Levine was heard this morning. Diana and her daughter Jessamine were in the courtroom surrounded by almost 150 lawyers from drug and medical device companies, consumer groups, and the government.

Injuryboard’s news editor, Jane Akre talked to Heller right after the hearing, about an hour ago. One of Two Parts - Part Two continues 

Q: What were your impressions? 

Heller:  “ The argument almost quickly became technical in that the justices were interested in understanding when FDA approval or what types of lawsuits would be preempted by FDA approval of a drug, or what types of lawsuits would not be preempted.

“Both sides in the case seemed to agree, including the lawyer representing the government from the Solicitor General’s office, that some cases would be preempted and some wouldn’t be. But they didn’t agree what cases would fall on either side of that line. 

“They started talking more and more about whether Wyeth had some sort of new information or new analysis of the risks and benefits of this drug that it either didn’t inform the FDA about or if it did the FDA never rendered any type of judgment about it.

Q:   That’s one of the things the FDA insiders say, that the drug company is the first ones to get the adverse event reports, not the FDA.

A: “The drug company certainly has a legal responsibility to gather new information about the harm caused by the drug and to transmit that information to the FDA.  Both sides agreed if a manufacturer says to the FDA we want to change our label to reflect a new warning and the FDA says a no you can’t, we reject this. Then lawsuits should be preempted.

“But Diana Levine’s case doesn’t fall into that category.  The warning that the Vermont jury and supreme Court should have been given to physicians was something to the effect that the IV push method, which was the method of administration that caused Diana Levine to lose her arm, they wanted a warning that said that method should not be used or carried a grave risk of gangrene or amputation.

"That warning was never proposed to the FDA, and I think that is going to be the crux of the case. Wyeth never even proposed that to the FDA, even though Wyeth knew or should have known that there were numerous cases of amputations resulting from the IV push method.

"The lawyer for Wyeth, Seth Waxman, claimed that Wyeth had asked for stronger warnings on the IV push, but did not provide any specifics to the court for what those requests for stronger warnings were. So to some extent, it was a little unsatisfactory because those of us listening never got to heard what Wyeth proposed about strengthening the warning about the IV push method. so the audience was left not knowing how strong those proposals were, and we also didn't know if the FDA specifically rejected those warnings or ignored the proposal."

 - (Part Two continues)


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