Drug Maker Liability Suit Hits High Court

Justices To Decide If FDA Approval Preempts Companies From Lawsuits Over Botched Treatment

(CBS/AP)  The U.S. Supreme Court will hear the case Monday of a Vermont musician who is suing drug maker Wyeth because her arm had to be amputated following a high-volume injection of the anti-nausea drug Phenergan.

The injection accidentally punctured an artery, prompting gangrene to set in.

Sixty-three-year-old Diana Winn Levine of Marshfield, a guitarist and pianist, argues that the drug's maker, Wyeth Pharmaceuticals, knew the drug, improperly-injected, could have devastating consequences and had a duty to warn consumers.

A Vermont jury awarded Levine $6.7 million, agreeing that Wyeth should have been clearer in its warning label about the risks of improperly administering the drug.

Wyeth and the Bush administration, however, are asking the court to rule that drug makers may not make changes to labels without the approval of the federal Food and Drug Administration, and that people cannot sue under state law for harm caused by an FDA-approved drug.

Wyeth v. Levine is one of the most closely watched business cases of the Supreme Court's term.

At issue is whether the federal government can limit lawsuits by consumers like Diana Levine who have been harmed by prescription medications.

In recent years, the administration and business groups have aggressively pushed limits on lawsuits through the doctrine of pre-emption - asserting the primacy of federal regulation over rules that might differ from state to state.

In an amicus brief, the Bush administration argued that state laws cannot override federal oversight, noting that "liability under state law turns on whether a drug, as labeled, is 'unreasonably dangerous.' … Any such finding would directly conflict with FDA’s determination that the drug is safe and effective under the conditions prescribed, recommended, or suggested in the labeling."

The concept of preemption could carry to other industries as well, hence the support that Wyeth is receiving in their case from the Product Liability Advisory Council and the U.S. Chamber Of Commerce, which says that state liability law regarding warning labels conflicts with the FDA's goals of "overwarning" and patchwork regulation.

Supporting Levine are former FDA Commissioners under Presidents Jimmy Carter, George H.W. Bush and Bill Clinton; the National Conference of State Legislatures, the attorneys general of 46 states, several medical associations, AARP and other consumer groups.

The justices are hearing arguments in Levine's case Monday, shortly after the court announces whether it will accept other cases for argument sometime next year.

[McGuy420]

Just think about the new vaccines when you agrue whether or not the drug makers should be liable....no liablity really scares me on a vaccine they are selling world wide..

[connapa]

If a company knowingly uses faulty research data to gain FDA approval, that company should be held liable. Most injectable meds that I know of are clearly labeled as "for intramuscular and intravenous administration ONLY." You can''t get more specific than that. In this case, the worng parties were sued. Unfortunately, that is not what the court is considering.

[excoachken]

The FDA "belongs" to the Drug Corporations. After all that is what "Trickle Down" is meant to do. We are simply the Guinea Pigs for experimentation, not the consumers for the thoroughly tested product.

[juwboy]

Where is the evidence that the drug, Phenergan, caused the problem that led to the arm amputation?

It states clearly, at the beginning of the article that the problem was caused by the accidental puncturing of an artery, followed by infection with gangrene.

The presence of the drug is irrelevant.

The problem was caused by faulty injection technique and subsequent mismanagement of the wound.

[barbaram99]

I hope the woman wins and she will if she hangs in there and not give up. I know someone who did win a suit against a drug company. I can''t say who it is as I am told to not talk about it. I think they know the meds are not safe for everyone,,,the bottom line is greed and money they make..Sure they don''t care. I tell the doctors right out i only will take what I truly need and no I don''t trust the doctors.. Learnt that the hard way, a DOCTOR ALMOST STOLE WHAT LITTLE SIGHT i HAVE IN ONE EYE. i READ HIM THE ROIT ACT. Another doc in the nick of timed saved my eye. Hospitals/doc offices are disty places when yer think their clean when there not. Did they wash their paws and things. They kill as well. My aunt died that way. Dad told me the left a tool in side her and it caused her death,

[voidmaster-2009]

Here is how this ruling should (SHOULD) go. The Supreme court should rule that drug companies are not liable for such litigation when the FDA has approved the drug in question -- but that the FDA IS.

That at least should tighten up what the FDA allows onto the market.

[barbaraf4]

The pharmaceutical companies rush to market while suppressing or ignoring the dangers. They believe the profits will offset the judgements.

[kurlikew]

Amen, notfooled. My thoughts exactly. Wake up and smell the coffee, folks. The drug companies get away with this stuff all the time; people suffer and die, but nothing is ever done about it. The whole business is about nothing but greed and profits, and they don''t care who or how many they have to kill or mame to make them. :o

[mcapek]

"There should be a big price to pay for pushing synthetic products into the human body." next time you run to ER with your problems, we won''t have anything to offer you, so please just stay home and take care yourself.

[mcapek]

I cannot wait to see the new perfect and safe drugs (and perfect world coming to think of it) that the Obama/Biden duo will bring us (hopefully in my lifetime), hehehehe...

Hell no make them pay. They ignore all side effects of their synthetic poisons in lieu of profits. There should be a big price to pay for pushing synthetic products into the human body.

[notfooled]

Just because the FDA labels a drug as safe doesn''t in any way mean that it is.

The FDA is a board of bought and paid for drug company executives who''s only interest is making money for the drug companies and protecting the giant pharmacutical companies.

And having the support of their bought and paid for political leaders is meaningless.

Be very wary of anything the Bush/Cheney crime syndicate supports.

And just because the FDA rubber stamps their cronies drugs, doesn''t make the crony any less liable for making unsafe drugs.

[jjp735i]

"directly conflict with FDA%u2019s determination that the drug is safe and effective under the conditions prescribed, recommended, or suggested in the labeling"

It sure does not sound safe why has the FDA not taken another look? Bush and Big Business...Jan. 09 will just not come soon enough.

[hennighg]

This is Bush''s America. The rich don''t have to pay for anything. Wyeth will get out of any financial liability by virtue of being rich and powerful. OJ, Phil Spector, and Robert Blake walk our streets. The poor don''t have health care. For that matter, NO ONE has health care. Wyeth is one of the primary beneficiaries of this set up, so the heck with this lady''s arm. It wouldn''t kill them to pay, but it''s the principal of the thing: who do those poor people think they are? Bigger than the Constitution or something?
The point is that they are liable but that doesn''t matter. Even if they paid, their friends would all tell them how stupid they were to do the right thing. In the conservative''s America, money is ALWAYS the right thing to do.

[mcapek]

Sue, sue, sue them all to oblivion!!!!! Send all the evil profiteering corporations abroad. Pretty soon we won''t have anyone here to employ you idiots!

To my knowledge, ANY injection made into an artery
has the potential for a great deal of damage. I don''t
see how the liability of the drug company is greater
than that of the individual who improperly administered the medication, if at all. You can "flush
an arterial line with a saline solution to keep it
functional, but a needle injection of any solution
into a large artery like the brachial artery, could
be a very big problem. That artery is your blood
supply for your whole lower arm.

[drinuk]

The case for the Bush Wyeth cartel, indeed for all the incestuous ''Arrangements'' between OUR government and Big Pharma are totally outrageous, criminal and mirror Nazi Germany from 1933 to it''s inevitable downfall in 1945. Will these crooks never learn, or is it going to take another revolution to get the whole bunch of them off the gravy train and behind bars.

The majority of the electorate are suffering financially with no health insurance and a bleak future and still the politicians of either side continue their clandestine illegal activity at the expense of each and everyone of us. Bush ? no not just Bush, it''s all of ''em, Clinton, Gore, Obama McCain, pick any name, they are all has bad as each other.

The Time is fast approaching when the people will take this country back, sack the management and honour the constitution.

[docpeter1953]

From the above article, ''Wyeth and the Bush administration, however, are asking the court to rule that drug makers may not make changes to labels without the approval of the federal Food and Drug Administration, and that people cannot sue under state law for harm caused by an FDA-approved drug.''
______________

Here we go, O guess this is one regulation GWB & CO don''t want to change, since it protects Corp. America from the citizens, and places profit above all.

[toolmangler-2009]

Corporations uber alles....
Posted by Nancy_Naive at 10:55 AM : Nov 03, 2008



Heil "W"

[deepperppl]

Posted by pirmin3: "The court is stacked by Bushit so consumers have no chance. Big lobby money totally controls the US of A."

It''s been this way for decades, under Republican AND Democratic administrations. Bush is not the reason stuff like this has happened.