Supreme Court Gives Immunity to Generic Drug Makers

[pam4water]

[quote]"Last week the U.S. Supreme Court handed the drug industry a free pass to kill and cripple American consumers without any fear of being held accountable.
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So if generic drug kills you it's OK, because the generic maker of the drug did not design the drug, just manufactured it, knowing it would kill you.

[djean111]

1. Plus - I believe vaccine makers are also exempt from liability.

The United States is one big Koch paradise, or is getting there.

[pam4water]

2. Are they? I think the government assumed some of the liability in for vaccine. There used to be fund

that payed out to people injured by vaccines. I think the money cam form the American tax payer.

http://www.hrsa.gov/vaccinecompensation/index.html

For generic drugs looks like you are just screwed. Welcome to Miltonfriedmanville. Pay twice before you exit through the mausoleum. Trademark!

[Honeycombe8]

3. That's not exactly what the ruling says. What it means....

Lady sued generic drug mfr for failing to include a warning about the effects that she suffered (there must've been some reason that the drug mfr should have known about those effects, I guess...if the court even got that far).

The ruling is that the warnings the generic drug mfr used are identical to the brand name's warnings because the law requires them to use the SAME warning as the brand name mfr's warnings. So the generic drug mfr can't be held liable for not doing something they are forbidden by law to do.

It sucks, though, because she may not be able to sue the brand name mfr because that wasn't the specific drug she was taking.

It's a catch-22.

But the generic drug mfr could still be liable for things NOT involving the warning label.

What I'm not clear on, though, is why the generic drug mfr can't use the same warning label as the brand name, and add an add'l warning. That doesn't take any of the original warnings away. I wonder.

It sucks.

[pam4water]

4. So that only exempted them for liabilities they knew about when manufacturing the drug, not

liabilities they didn't know about?

I think M C Escher just tripped over Kafka while they chased each other around a mobius strip that was spontaneous created by the knotted inanity of that ruling.

So the generic manufactures might still be liable for errors they made while manufacturing the drug?

I'm sure the catch-22 was an intention insertion from by a too clever lobbyist.

[Honeycombe8]

5. I think you're spot on. A clever lobbyist wrote this law. Our country is being run by corporations.

I hate to think about it, it's so upsetting.

[MannyGoldstein]

7. All labeling - including warnings - need to be approved by the FDA

If labeling gets changed, I believe that the approval process becomes different than if a generic just uses the same labeling.

Best way to fix this is strong FDA monitoring for problems once the drug is approved (and not approving bad drugs, of course). Once a problem is found, FDA can order all makers to update labeling (or pull the drug).

[fasttense]

11. There was evidence that the Generic manufacturer knew about these side effects

And in 2005, the FDA had recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning.

So it was out there that this side effect was possible if the FDA was actually making some weak little noises about it.

Seems to me the FDA should have done a better job of labeling this drug.

But of course the Obama administration that went to bat for the drug manufacturers against this poor woman is in the pocket of big pharma. So, the likelihood of any new drug being labeled accurately are nil to none.

Seems this poor woman was screwed from the moment she was prescribed the drug. From shoulder pain to toxic epidermal necrolysis. Now we tax payers will provide minimal support for this once productive citizen. Seems to me big pharma should be shouldering the costs of the dangers of their drugs as well as the profits.

[Honeycombe8]

12. Yes. It's scary...big pharma is running a big chunk of the country, now. nt

[Chan790]

6. The problem to me is that Pap's reporting of the facts and the contents of the ruling...

are linked to the facts of the case by the thinnest of threads.

His credibility is nil when he misrepresents the facts of the case and the contents of the ruling. SCOTUS didn't rule that generic drug makers have a license to kill...they ruled they generic drug-makers can't be sued for what they are legally-barred from doing: changing, altering, removing or adding anything to the FDA-approved warning label issued by the original manufacturer.

It all comes down to the principle of "quod est necessarium est licitum". Because the contents of the label are dictated by law and it is legally-necessary that those contents be printed exactly, no legal action may result subsequent and directly from complying with the law. She can't sue them for following the law, legally their culpability is non-existent.

This isn't the result of a corporatist court, it's the result of a correct interpretation resulting in an undesirable outcome. Undesirable or not, it's the legally correct outcome.

[hungar14]

9. magritte

Unlike Magritte you have no moral sense.

[Chan790]

10. Morality.

Like David Hume, I believe that all morality is by-necessity subjective, emotive and dependent upon the perception of the receiver. In that, I'd say I have more sense on morality than most.

Examine it in all lights, and see if you can find that matter of fact, or real existence, which you call vice. In which-ever way you take it, you find only certain passions, motives, volitions and thoughts. There is no other matter of fact in the case. The vice entirely escapes you, as long as you consider the object. You never can find it, till you turn your reflection into your own breast, and find a sentiment of disapprobation, which arises in you, towards this action. Here is a matter of fact; but 'tis the object of feeling, not of reason. It lies in yourself, not in the object. So that when you pronounce any action or character to be vicious, you mean nothing, but that from the constitution of your nature you have a feeling or sentiment of blame from the contemplation of it. Vice and virtue, therefore, may be compar'd to sounds, colours, heat and cold, which, according to modern philosophy, are not qualities in objects, but perceptions in the mind: And this discovery in morals, like that other in physics, is to be regarded as a considerable advancement of the speculative sciences; tho', like that too, it has little or no influence on practice. Nothing can be more real, or concern us more, than our own sentiments of pleasure and uneasiness; and if these be favourable to virtue, and unfavourable to vice, no more can be requisite to the regulation of our conduct and behaviour.

--David Hume, A Treatise of Human Nature

[ErikJ]

8. KEY!!: 450 generic drugs on the market the originators said were too dangerous to sell.