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boutons_deux
06-23-2011, 03:21 PM
... states interfere with (BigPharma) UCA

SCOTUS Dumps On States Rights To Give Legal Immunity To Big Pharma


Earlier today, a 5-4 Supreme Court reached the somewhat bizarre conclusion that generic drug manufacturers are immune from state lawsuits claiming that they failed to warn their consumers of potential risks, but brand name drug makers are not. The five conservatives concluded that a federal law requiring generic drug makers to use the same FDA-approved warning label as their brand name counterparts preempts any state laws requiring stronger labels, while the four more progressive justices believed the drug makers must first ask the FDA to consider ordering a new label before they can invoke lawsuit immunity.

http://thinkprogress.org/justice/2011/06/23/252416/scotus-loves-pharma/

Wild Cobra
06-23-2011, 03:22 PM
Under the conditions said, what's wrong with the ruling?

Stringer_Bell
06-23-2011, 03:35 PM
The decision is stupid as hell, and the only conclusion I can reach is that this is being done to fuck with the generic drug companies. Oh well!

fyatuk
06-23-2011, 04:06 PM
Meh. Seems a weird case to begin with.

But since we're talking FDA warning labels here, state's rights are hard to apply anyway.

I'd have to actually look at the case to really get a foothold on what the heck they're talking about, but offhand I'd say it's crap because it protects companies from lawsuit's based on actions of other companies.

From what it sounds like, it effectively removes liability from generic drug manufactures, and leaves those harmed by inadequately labeled generic drugs (provided they use the same label as their non-generic counterparts) without remedy. If you can't sue the generic manufacturer based on this ruling and have no cause against the non-generic manufacturer, what the hell are you supposed to do?

My guess would be sue the FDA for not requiring an adequated label.

boutons_deux
06-23-2011, 04:32 PM
A backgrounder is that BigPharma has been and is still seeking a "shield law" that would say if their drug or device was FDA approved but maimed or killed somebody, the corp could not be sued since its device complied with FDA.

Of course, the FDA is totally corrupted/captured by BigPharma, so FDA's approval is no guarantee of safe status. In fact, in many/most cases, FDA approval is in practice "here's a beta version, let's see how many people it kills or maims before we black label it or pull it"

Wild Cobra
06-23-2011, 04:33 PM
Meh. Seems a weird case to begin with.

But since we're talking FDA warning labels here, state's rights are hard to apply anyway.

I'd have to actually look at the case to really get a foothold on what the heck they're talking about, but offhand I'd say it's crap because it protects companies from lawsuit's based on actions of other companies.

From what it sounds like, it effectively removes liability from generic drug manufactures, and leaves those harmed by inadequately labeled generic drugs (provided they use the same label as their non-generic counterparts) without remedy. If you can't sue the generic manufacturer based on this ruling and have no cause against the non-generic manufacturer, what the hell are you supposed to do?

My guess would be sue the FDA for not requiring an adequated label.

Unless I read it wrong, the labeling requirements didn't have to be stricter for generics than the name brand, and it was the original manufacturer held liable for their creation. Not the generics, who only copied it.

TeyshaBlue
06-23-2011, 07:45 PM
Lol @ thinkprogress.

fyatuk
06-24-2011, 07:58 AM
Unless I read it wrong, the labeling requirements didn't have to be stricter for generics than the name brand, and it was the original manufacturer held liable for their creation. Not the generics, who only copied it.

Which would make no sense. Since pharmaceuticals basically have 7 years to offer themselves before a generic can even exist (and can be extended unless that's changed that I'm not aware of), any problem should have come up and required a revised FDA label.

But even without that, you cannot hold one company liable for another's problems and retain any semblence of being a free and fair country.

I can understand generics having the right to use the same FDA label as the non-generic. Makes sense since ideally, everything is the same in them anyway. But you have to hold them liable for their own products.

boutons_deux
06-24-2011, 10:37 AM
It's unfair to the original drug patent holders if a generic drug maims or kills (happens by 1000s every year) by a generic for the generic mfr to escape liability.

The other pro-BigPharma/anti-patient ruling, using 1st Amendment bullshit to violate "reasonable expectations of privacy", violates the confidentiality of the doctor-patient relationship by allowing commerce of and data mining of the doctors' prescribing histories, enabling BigPharma sales bots to corrupt the medical profession more accurately and more deeply.

Wild Cobra
06-24-2011, 12:39 PM
It's unfair to the original drug patent holders if a generic drug maims or kills (happens by 1000s every year) by a generic for the generic mfr to escape liability.

My understanding is that this applies to when the formula is the same. Now if a batch is tainted, that's a different story.