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Diana Levine Case - Can We Rely On Drug Labels?

Posted by Jane Akre
Tuesday, November 04, 2008 12:03 PM EST
Category: Major Medical, Protecting Your Family
Tags: Federal Pre-emption, FDA and Prescription Drugs, Diana Levine, Tort Reform, Wyeth

Diana Levine case may be decided early next year.


IMAGE SOURCE: iStockphoto/ courtroom gavel


When Diana Levine turned 63 recently, her daughter made her a birthday card drawing her as Diana the Huntress of Greek mythology, except without a right arm. The character pulls back a bow string ready to fly at a target titled, “Wyeth monster.”

Yesterday, Levine, 63, sat in the high court surrounded by family members amid more than 100 lawyers, some for drug maker Wyeth, before the nine U.S. Supreme Court justices who will decide her case sometime next year.

The jurists have before them the question - whether Wyeth, the maker of the drug, Phenergan, should have included in the label an explicat warning against the method of delivery into Levine’s arm – an IV push, a more aggressive method of drug delivery that quickly sends the anti-nausea medication into the blood stream, but also potentially causes gangrene when it misses the artery.

Does Wyeth even have the authority to do so?  If not, who does, and how often should a label be updated?

When Levine, the Marshfield, Vermont musician went to an emergency room in 2000 with a migraine headache. She received Demerol for headache and injectable Phenergan made by Wyeth for the nausea. It was given once intramuscularly and the second time in an IV push. The gangrene that resulted caused her to lose her right arm below the elbow.

The drug label, approved by the Food and Drug Administration (FDA)  had warned that “inadvertent intra-arterial injection” can result in “gangrene requiring amputation.” But the label did not rule out administration of the drug by IV push.

Levine says no one discussed the risks of an IV push method of administration with her. She had been told that an IV administration would deliver, “more potent and expeditious antinausea relief,” according to Wyeth’s brief.

“All they had to do was change the label and say, ‘Don’t give it this way’” she said to the New York Times.

Injectable Phenergan has since been "discontinued" by Wyeth.


The Bush administration and lawyers for the government argued that the lower court ruling that awarded Levine $6.7 (reduced from $7.4 million by the judge) should be thrown out on the basis that federal law pre-empts or supercedes state court claims.

If the Court agrees, the implications are far-reaching and could potentially impact anyone who takes prescription medication, such as Levine, but also anyone who suffers an injury from any product – whether automobile, industrial chemicals, or drugs – and then seeks a remedy in court.

The transcripts from Monday’s proceedings indicate the jurists want to know more about how much the FDA knew about the drug’s dangers, and why Wyeth did not change the label when it reportedly knew about 20 cases of gangrene and amputation?

Justice Samuel Alito wanted to know how the FDA approved Phenergan as “safe and effective” when you have the risk of gangrene?

Justice Ruth Bader Ginsburg asks “No matter what benefit there was, how could the benefit outweigh that substantial risk?”

Justice Antonin Scalia pointed out that the Wyeth label for Phenergan warned it was “dangerous,” but in certain circumstances. 

The Wyeth label for Phenergan, shows a warning about gangrene if the drug is exposed to arterial blood. The label said intramuscular injection is the preferred method of delivery. 

Arguing for Wyeth, Seth Waxman explained of the technical language, “This is labeling that is directed at medical professionals.”

He says there is ample warnings about the risks and it wasn't a "floor,"  - a minimum standard - but took into account all of the risks and benefits and issued a label that reflected the optimal information to achieve safety, essentially - a "ceiling".  

David Frederick, arguing for Levine, called the warning weak. He said drug companies change their labels all the time as new information comes in and the manufacturer is responsible for the label and post-market information.  

As an example, Mr. Frederick compared Phenergan to a warning for an anti-nausea drug that Pfizer changed, making IV push an unacceptable method of delivery after two amputations were reported.

Wyeth has said its ability to change a drug label, even when adverse health events are coming in, is superseded by the federal government, specifically the Food and Drug Administration which oversees drugs and their labels.

But Justice David Souter questioned that by saying, “…as I understand it, the company, Wyeth, could have gone back to the FDA at any time and said, either based on experience or just our rethinking of the data that we have, we think the label out to be changed to say ‘Don’t use IV push’  Wyeth could have done that at any time, and it simply didn’t do it.”

Those arguing for pre-emption say when state law differs from the federal impositions of the FDA, that federal law should reign.  Historically, state law and federal law have co-existed until recent years under the Bush administration where increasingly, federal mandates are precluding state lawsuits in many areas of product liability from automobiles to drugs.  

Judge Souter acknowledges the historical co-existence when he asked, “Where is the conflict?”   

After collecting the communications between Wyeth and the FDA, looking at the label and the adverse reports that came into Wyeth – the jurists could ultimately find that clear negligence on the part of drug makers does open up the companies to lawsuits.

The decision may be determined by who writes the opinion.  One Wyeth attorney indicates Congress should consider establishing a fund to help drug injury victims, similar to vaccine-related injuries.  #

1 Comment

Anonymous User
Posted by Lana Russo
Saturday, November 08, 2008 12:47 PM EST

I was given an Iv injection of this medication 3 years ago, the nurse did a fast push while my Iv was in hand. It burned my soft tissue and veins and nerves, and I developed rsd, which is very painful and at times,I want them to cut my arm off,this is a very bad nerve damage that will be with me for the rest of my life, It's been hell.This is a very strong medication that should only be given by medical personal that are experts with this medication. This did not have to happen to myself or Diana.Please get this medication off the market.I've been a Barber for 20 years and it's all over because I was not warned of any problems this med could cause.I've had many surgery to help with the pain and here's the worst, there's no cure and it travels trough my body, 4 more years and I'll be done.

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