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In reply to the discussion: Holy Shit! New Law: Drug Companies exempt from Lawsuits -Supreme Court Ruling [View all]elleng
(141,926 posts)40. Thanks. Discussed yesterday.
http://www.democraticunderground.com/?com=view_post&forum=1002&pid=3203879
For those who might want to understand:
My post, #6, 'The Courts ruling a week ago on behalf of generic drug makers is actually a continuation
of a ruling made by the same Court in 2011. At that time, the Justices ruled that the original inventors and manufacturers of pharmaceutical drugs, also known as name brand drugs, are the only ones that can be sued for mislabeling, fraud or adverse drug reactions and side effects. If the generic versions of the drugs are made from the exact same formula and labeled with the exact same warnings as their brand name counterparts, the generics and their manufacturers were not liable.
The Court ruled, Because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law, New Hampshire's warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce."'
And Sgent's #10:'The drug company in this case had no control over the labeling on the drug, the prescribing information, or anything else. The wording was dictated to them by the FDA -- and they do not have standing to challenge that wording and remain a generic drug.
This lawsuit was not based on the idea that the drug company failed to deliver what was on the label, but rather that the label was incorrect. The problem is that the only person with the ability to change the label is either the original drug manufacturer through application or the FDA on its own initiative. The generic manufacturer has no ability otherwise.'
For those who might want to understand:
My post, #6, 'The Courts ruling a week ago on behalf of generic drug makers is actually a continuation
of a ruling made by the same Court in 2011. At that time, the Justices ruled that the original inventors and manufacturers of pharmaceutical drugs, also known as name brand drugs, are the only ones that can be sued for mislabeling, fraud or adverse drug reactions and side effects. If the generic versions of the drugs are made from the exact same formula and labeled with the exact same warnings as their brand name counterparts, the generics and their manufacturers were not liable.
The Court ruled, Because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law, New Hampshire's warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce."'
And Sgent's #10:'The drug company in this case had no control over the labeling on the drug, the prescribing information, or anything else. The wording was dictated to them by the FDA -- and they do not have standing to challenge that wording and remain a generic drug.
This lawsuit was not based on the idea that the drug company failed to deliver what was on the label, but rather that the label was incorrect. The problem is that the only person with the ability to change the label is either the original drug manufacturer through application or the FDA on its own initiative. The generic manufacturer has no ability otherwise.'
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Holy Shit! New Law: Drug Companies exempt from Lawsuits -Supreme Court Ruling [View all]
Fantastic Anarchist
Jul 2013
OP
I don't understand why the labeling requirements would have to be the same ...
Fantastic Anarchist
Jul 2013
#29
"it helps the original manufacturer by imposing extra costs on the generic competition."
HiPointDem
Jul 2013
#65
Would it bother you to know that the line you cite at the top of your post does not appear anywhere
onenote
Jul 2013
#43
If anyone was napping, not realizing ours is a wholly-owned corporatist government, this ruling
indepat
Jul 2013
#9
personal bank acc'ts of justices need to be audited to see where the money's coming from!....
dmosh42
Jul 2013
#15
Big Pharma imports cheap drugs made in China, now with impunity! What a sick country we live in.
reformist2
Jul 2013
#35
Thanks for the clarification. At first glance I was like, WTF. That makes more sense. nt
Incitatus
Jul 2013
#44
Okay. As you request. Now, how do I deal with this pesky HIV thing I have?
Liberal Veteran
Jul 2013
#64
the ruling doesn't make any generalized principle such as you claim. it's specific to this
HiPointDem
Jul 2013
#67
Another great decision from Ralph Nader's US Supreme Court. Thanks Ralph! NT
graham4anything
Jul 2013
#77