I haven't read a whole lot about this case. I THINK part of the case is that the drug fact sheet, or instructions, did not warn against IV problems. I'll try to find something more accurate
But I THINK the main deal w/this case, is "preemption" whether federal law preempts state law.
A possible positive outcome out of a lawsuit like this, is a manufacturer may be motivated to have better, clearer instructions, warnings, or change labels (like they did after that heparin situation w/actor Dennis Quaid's infant twins) that result in better hospital safety procedures or better informed medical staff. Just a thought, I'm neither a medical or legal person, just a consumer, user of prescription meds, and sometimes patient.
[QUOTE=Joie]Lorster,
Well none of you are addressing my issue. What about when the companies hide negative studies, mislead the FDA, etc. We base our decisions on the facts we get from the FDA. Look at the list of meds that have had lawsuits behind them - vioxx etc.
I haven't read a whole lot about this case. I THINK part of the case is that the drug fact sheet, or instructions, did not warn against IV problems. I'll try to find something more accurate
But I THINK the main deal w/this case, is "preemption" whether federal law preempts state law.
A possible positive outcome out of a lawsuit like this, is a manufacturer may be motivated to have better, clearer instructions, warnings, or change labels (like they did after that heparin situation w/actor Dennis Quaid's infant twins) that result in better hospital safety procedures or better informed medical staff. Just a thought, I'm neither a medical or legal person, just a consumer, user of prescription meds, and sometimes patient.
[/QUOTE]
How much clearer do they have to be? They warned of the possibility of gangrene with IV push. Do they have to put a picture of a gangrenous arm on the vial? This kind of crap really makes me angry.
[/QUOTE]
I too get angry over people who exploit situations that have no merit and sue, especially, because it makes things difficult for those people who have been seriously injured by a company's faulty product or negligence and have a legitimate case for bringing a lawsuit.
In the Wyeth and Levine case, an excerpt from an article (see link below):
"Inadvertent arterial injection of Phenergan is known to be dangerous, and some hospitals have banned Phenergan. Levine has contended that Phenergan’s labeling failed to adequately warn about the dangers of using the I.V. push method. In 2000, the same year Levine sustained her injury, Wyeth changed the label of Phenergan to warn that the drug should not be given by intra-arterial injection because of the risk of gangrene."
But the question before the Supreme Court, is whether one can sue a drug manufacturer in a "state court" since the drug in question was approved by the FDA, a "federal agency."
In Wyeth vs. Levine, which will be heard by the Supreme Court this fall, the main question deals with federal pre-emption -- in which circumstances federal law and regulation, trump state law.
The following Associated Press article of 5/08 discusses federal pre-emption:
Bush administration's agency rules limit consumer lawsuits
By The Associated Press
05.16.08
WASHINGTON — Faced with an unfriendly Congress, the Bush administration has found another, quieter way to make it more difficult for consumers to sue businesses over faulty products. It's rewriting the bureaucratic rulebook.
Lawsuit limits have been included in 51 rules proposed or adopted since 2005 by agency bureaucrats governing just about everything Americans use: drugs, cars, railroads, medical devices and food.
Decried by consumer advocates and embraced by industry, the agencies' use of the government's rule-making authority represents the administration's final act in a long-standing drive to shield companies from lawsuits.
President Bush has campaigned for lawsuit reform since his days as Texas governor. As president, he has made little headway on the issue in Congress. He's been thwarted by Democrats every time he's tried to tackle the issue head-on.
Turns out there was another way, one little-noticed step at a time.
If the rulemaking at the various agencies had been a centralized effort in the White House or the Justice Department, "it would have failed because immediately everybody would have mobilized resistance," said Michael Greve of the American Enterprise Institute, a conservative Washington think tank.
Limits on lawsuits have been ordered or proposed for drug labeling and packaging — an issue that got a big airing May 14 because of a case involving actor Dennis Quaid's newborn twins — and for rules ranging from mattress-flammability standards to schoolbus-passenger seating to dietary sweeteners and roof-crush requirements in car rollovers.
Of the 51 regulations, 41 came from the Food and Drug Administration and the National Highway Traffic Safety Administration, or NHTSA.
Ten of 15 federal traffic safety regulations from last year have been finalized by NHTSA and are now in force or soon will be. That development has drawn little public attention.
Underlying this bureaucratic version of lawsuit reform is the concept of federal pre-emption — a legal idea that is hard to build widespread public interest in. Rooted in the "supremacy clause" of the Constitution, federal pre-emption refers to circumstances in which federal law and regulation trump state law, in this instance state laws that govern when one person may be held liable for another's injury.
Frequently filed in state courts, where juries often are more receptive to plaintiffs' claims against corporations, product-liability lawsuits are often moved at the request of business defendants to more restrictive federal courts. Regardless of where the suits end up, the issue is increasingly whether companies can use broad preemption language in regulatory preambles to get cases thrown out.
The preambles are the agencies' interpretation of whether the federal regulatory law permits preemption of lawsuits. An expansive interpretation of preemption leaves little room for consumers to sue, and that is what the national trial lawyers group, the American Association for Justice, says is taking place.
The First Amendment right to petition the government for redress of grievances includes a right to file suit in a court of law.
For rest of article see:
Does nobody else see what I'm seeing here? Our constitution is being used to hog tie us. What ever happened to the idea of a balance between states rights and federal powers?
Here's that link to the FDA and Daniel Troy going to work for GSK. OMG - he's been bought and sold like a 'ho.
And here it shows that it's hard to keep a bad man down -
Wake up people!
Pip
Edited because I used the same link 2 times! Duh!
Edited again because I had different fonts.
Pip!2008-07-29 09:12:11SHannon Brownlee in her book says drug companies influence which studies are published in medical journals and which aren't. She thinks they have far too much influence. So does Melody Peterson. I agree,
Jan
The revolving door: Congressman Tauzin, who sponsored and pushed through the 2003 Medicare Prescription Drug Act, a windfall for pharm companies, left Congress and shortly went to work for million a year for pharma's largest lobby. Daniel Troy, former General Counsel for the FDA, and architect of preemption, now works as a lobbyist for the drug company Glaxosmithkline, (a company facing numerous lawsuits for the antidepressant Paxil). Hmmm, when they were on the fed gov payroll (paid by us taxpayers) just whose interests were they looking after then?
The FDA'S General Counsel position was always filled by a civil servant until Bush's appointment of Troy, an agent for Bush's political agenda. Troy spent most of his career suing the FDA on behalf of drug and tobacco companies. Before going to the FDA, he had worked for a major law firm that represented pharm companies. Under Troy's leadership as General Counsel, in an unprecedented move, agency lawyers argued that because prescription drugs and medical devices had been approved by the FDA, such lawsuits were "preempted" by federal law and should be dismissed.
Troy's predecessor, Margaret Porter, a career official, wrote in 1997 that the FDA had a long-standing policy against preemption, because "even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems presented by the product.... Preemption of all such [tort liability] claims would result in the loss of a significant layer of consumer protection."
Sorry consumers, this Administration protects business interests over the public and consumer's interests.
[QUOTE=Pip!]
Does nobody else see what I'm seeing here? Our constitution is being used to hog tie us. What ever happened to the idea of a balance between states rights and federal powers?
[/QUOTE]
Hey Pip,
Careful what you wish for. The balance between state's rights and federal powers is indeed completely out of whack, but if the feds were suddenly limited to the powers specified in the constitution I think most people, especially on this board, would be verklempt.
Joe
[/QUOTE]
Pip,
I think you're probably thinking of the checks and "balances" that should exist between our three branches of government -- executive, legislative, and judicial. I can understand your mixup though, with the latest reign of Imperial President George W. Bush and his expansion of powers -- now, that is completely out of whack.
No, I'm specifically referring to a lot of our legal court cases. Many are argued under the guise of 'states rights' vs 'federal rights'. Goes all the way back to the Revolutionary war and who had to pay what taxes. There is supposed to be a balance between what the states want to legislate (in this case right to sue Pharma) and what the federal government wants (not able to sue Pharma). We have moved so far into the federal rights arena on so many things that the sovereignity of the states has been almost abolished.
Joy - its not just this - most of the loss of civil liberties we've given up since 9/11 are based on 'federal rights' trump card.
Joe - laughed out loud at verklemtp! But I probably didn't type it right - if our consitution is sacroscant - then over use of federal powers in such manners undermines everything America stands for.
You know what I keep thinking of - there was a series of books in the old days, can't remember the authors full name, Anthony??? Drury - about how America was destroyed from within. This was, of course, written about the 'dangerous liberals'. But I think its going on now with the Republicans. Advise and Consent! Thats it. Only instead of liberals and the media its the Republicans and the 'federal rights' and we're moving towards Imperial George or McBush.
Hugs,
Pip
PS - Or maybe it's a cross between Stephen King (Dead Zone) and Advise and Consent. OK, now I'm scaring myself. The only thing that scared me more was Perot.
Right Pip. A strict reading of the Constitution would limit the federal government to levying taxes, declaring war, and regulating interstate commerce. A strict reading would mean the federal government can not do things like education, social security, welfare, medicare, etc. The problem is that today the federal government seemingly gets involved with everything, yet can not seem to do the things it is supposed to do according to the Constitution, like protect our borders.
What worries me is the government moving to back a particular party. We've had the rise of 3rd parties before, but as this happens more and more, and with this polarization by the media (dem or rep only and not even reporting on the huge mass of people voting 3rd party) we are quickly moving to a government that is taking care of the ruling party only and ignoring the masses. Exactly what the founding fathers wanted to avoid.
Pip
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