Today a vitally important case was argued before the Supreme Court: Levine v Wyeth

[cali]

MARSHFIELD, Vt. - When Diana Levine turned 63 recently, her daughter made her birthday card, drawing on Greek mythology with an illustration of Diana the Huntress, her bow string drawn taut, an arrow ready to fly.

But the arm pulling at the bowstring was amputated below the elbow — just like Diana Levine's — and the target was labeled the "Wyeth monster."

That's Wyeth as in Wyeth Pharmaceuticals, the company Levine blames for a botched injection of the Wyeth-made drug Phenergan that led doctors to amputate her right arm in 2000.

<snip>

Huge implications
Wyeth and the FDA say when a drug like Phenergan has a federally approved label, its manufacturer is immune from lawsuits in state court. Wyeth maintains its label clearly describes the risks of Phenergan, and that it was not only approved but mandated by the FDA. "Wyeth could not change Phenergan's labeling to comply with Vermont law without violating federal law," it said in court papers.

Consumer groups are mounting a vigorous campaign against that position, saying federal regulation should represent the floor, not the ceiling, of a drug company's responsibility.

"What a trial lawyer reasonably could fear in this case is that in one fell swoop, the U.S. Supreme Court would eliminate the right of an injured person to recover from a drug company in the case of a dangerous drug that caused their injury," said Fordham University law professor Benjamin Zipursky, a product liability expert.


The court could effectively "eliminate all pharmaceutical company liability in this one case," he said.

<snip>

http://www.msnbc.msn.com/id/27435447/

[sharesunited]

1. And you just KNOW how Scalia, Thomas, Roberts and Alito will rule.

For big business and against the injured individual.

[BrklynLiberal]

2. I hope and pray that President Obama can undo all the corporate passes that were

given out by BushCo..
The FDA, Osha, the EPA, FEMA, Justice Dept, VA, Dept of the Interior, and how many other govt agencies have been totally undermined by the appointees that prez shit-for-brains put in charge of them...and the laws that have been passed by the repuke Congress?

[cali]

4. I just hope and pray that the SCOTUS doesn't rule for Wyeth

There's a reason that 46 states are siding with Diana. As the prof in the article says, this could effectively cut off legal recourse to plaintiff in pharmaceutical liability cases.

[alfredo]

3. Thanks for the heads up

[cali]

5. On Newshour now

and here's more about Diana in the NYT

Drug Label, Maimed Patient and Crucial Test for Justices
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By ADAM LIPTAK
Published: September 18, 2008
MARSHFIELD, Vt. — When Diana Levine starts talking about her rock ’n’ roll days, she plays a little air guitar, mimicking the way she used to handle her electric bass in bands like the Re-Bops and Duke and the Detours. But Ms. Levine is missing much of her right arm, which was amputated below the elbow after a medical disaster.

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Nathaniel Brooks for The New York Times
Diana Levine lost part of an arm after being given a drug. A jury ordered Wyeth, a pharmaceutical company, to pay $6 million.
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Read All Comments (116) »She sits at her kitchen table, strumming an imaginary guitar with a phantom hand.

In November, the Supreme Court will hear arguments about whether Ms. Levine may keep more than $6 million that a Vermont jury ordered Wyeth, a pharmaceutical company, to pay her for failing to warn her adequately about the risks of one of its drugs. The case, the latest in a brisk parade of similar ones, will help define the contours of a signature project of the Roberts court.

In legal jargon, the cases concern “pre-emption,” a doctrine that can bar injured consumers like Ms. Levine from suing in state court when the products that hurt them had met federal standards. The issue is less boring and more consequential than it sounds, and Ms. Levine’s case is shaping up to be the most important business case of the term.

“Federal pre-emption is the fiercest battle in products liability law today,” said Catherine M. Sharkey, a law professor at New York University. “The court clearly recognizes this, as it has agreed to hear so many cases and seems eager to give clarity to what has been, to date, an undisputably muddled area of law
<snip>
http://www.nytimes.com/2008/09/19/us/19scotus.html?scp=2&sq=Diana%20Levine&st=cse

[bemildred]

6. If they know, they have to tell what they know.

That is the standard. All this other crap is just crap.

[cali]

7. well, they did tell, but the FDA approved the drug and the delivery

that was used on Diana. The VT Supreme Court found that was enough to remove liability on the part of Wyeth. Of course, the other question, and one that a couple of the justices brought up, is what the hell the FDA was doing approving this delivery system when the risk is so huge.

[elias7]

8. phenergan IV push is one of the most common drugs used in any ER

"The second injection accidentally punctured an artery, prompting gangrene to set in. After several weeks of deterioration, her arm was amputated."

She did settle with the clinic. IV injections are generally venous, not arterial. There was certainly error in the administration of the drug, but is the drug company liable?

Phenergan does come with the following warning:

Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection of promethazine hydrochloride, usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Intravenous injection was intended in all the cases reported but perivascular extravasation or arterial placement of the needle is now suspect. There is no proven successful management of this condition after it occurs.