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I'm sure this has already been diaried but couldn't find in search.  Just when I think our corporate-owned SCOTUS couldn't shock me, they did.

This ruling says that Big Pharma has legal immunity for 80% of their products because their products first pass through the corrupted FDA.  This just amazes me.

In a 5-4 vote, the US Supreme Court struck down a lower court’s ruling and award for the victim of a pharmaceutical drug’s adverse reaction. According to the victim and the state courts, the drug caused a flesh-eating side effect that left the patient permanently disfigured over most of her body. The adverse reaction was hidden by the drug maker and later forced to be included on all warning labels. But the highest court in the land ruled that the victim had no legal grounds to sue the corporation because its drugs are exempt from lawsuits.
The Court’s 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.
http://www.whiteoutpress.com/...

The corporatists are getting bolder and bolder.

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Comment Preferences

  •  Whatever happened to acting in good faith, and (11+ / 0-)

    the test of the reasonable person???

    Who cares if a company is exempt from lawsuit, if they intentionally hide something adverse??  That USED TO trump any disclaimers or legal protections.

    Just because you post a sign saying you are not liable, you USED TO have to practice according to a standard, in good faith, or you were subject to lawsuits.

    Ayn is the bane! Take the Antidote To Ayn Rand and call your doctor in the morning: You have health insurance now! @floydbluealdus1

    by Floyd Blue on Wed Jul 10, 2013 at 10:15:51 AM PDT

    •  U.S. corporations are evil. (14+ / 0-)

      And I used to be a pretty big fan of them.

      But, something changed over the past 20-30 years.

      I'd say the corporate raiders and slash-and-burn artists and amoral douchebags coming out of the business schools, but I'm just guessing.

       

      •  Not a bad guess. I got my MBA along with some of (3+ / 0-)

        those amoral douchebags, back in the 80s.  I ended up using the knowledge to write business-minded novels, that lampoon the entire corporate structure.

        It might also be a life cycle. I mean, we are in uncharted territory here with this Capitalism thang.

        Perhaps the rise of unions and govt regulations is all part of the market, all a part of the life cycle of capitalism; as a natural reaction to the robber baron stages of nacent capitalism (the frontier of capitalism that russia and china are now experiencing).

        From one of those novels:

        "...Above the raucous din, for the first time ever, I could hear and feel tremendous booming.  They were either blasting with dynamite, or driving a giant steel pile, and the thunderous shaking was suddenly overwhelming.  There was no shutting out the existence of the demolition, the tearing up of roads used by millions, the destruction all the way down Atlantic Avenue anymore.  In a way it was like the subway vibrations we all feel in our neighborhoods, as the train-cars rocket through the bedrock.  You get used to that.  But this was far louder and far more intense.  The ground was shaking with every boom, and all I could think of as I looked straight ahead at the informal Tea Party gathering in my shop, was of vermin:  rats.  Thousands of rats, of all sizes; from mouse-like, to dog-sized, running, running - in all directions - set free from their concrete caves, from the sewers, from the subway tunnels.  Set free by the vibrations under the street, from the booming artificial thunder; set free by the blasts of progress.  Rats set free to run wild, to venture everywhere their curiosity takes them, to explore new territories, new markets, to infest and overwhelm; just as the booming progress has set free the hoards of new Capitalists in places like China and Russia, to run boundless and careless in search of new opportunities.  They cut corners and find these new markets everywhere:  contaminating babies’ milk with carcinogens to boost the protein levels; infesting drywall with lethal formaldehyde; laying radioactive waste to towns and villages for forever-and-a-half-life, in setting up their factories; killing and maiming untold generations, while tallying their precious profits in the billions.  A loaf of bread loaded with plaster of paris; a severed finger in a can of beans:  Ahh, the rugged frontier of new Capitalism.  We’d already been there and done that in this country generations ago..."

        (And yet, these corporatist clowns want to take us backwards!!!)

        Ayn is the bane! Take the Antidote To Ayn Rand and call your doctor in the morning: You have health insurance now! @floydbluealdus1

        by Floyd Blue on Wed Jul 10, 2013 at 10:36:52 AM PDT

        [ Parent ]

        •  *nascent (1+ / 0-)
          Recommended by:
          bumbi

          Fuck!!  You just can't find good editors anymore for 2.35 an hour who work on tips and have their wages loaded onto debit cards.

          Ayn is the bane! Take the Antidote To Ayn Rand and call your doctor in the morning: You have health insurance now! @floydbluealdus1

          by Floyd Blue on Wed Jul 10, 2013 at 10:38:06 AM PDT

          [ Parent ]

  •  We've gone from , "needed to treat" ... (2+ / 0-)
    Recommended by:
    bumbi, CuriousBoston

    ... to "needed to kill"

    Dudehisattva...

    "Generosity, Ethics, Patience, Effort, Concentration, and Wisdom"

    by Dood Abides on Wed Jul 10, 2013 at 10:21:10 AM PDT

  •  It's possible (12+ / 0-)

    someone diaried on it, but this is one of those things that can't be discussed enough anyway. What a frightful joke this is. Horrible. Did you see the person who sued? One of the NYC papers had it yesterday. I'm not sure if they ran with an actual picture of this victim, or if it was simply an example of a person with this flesh-eating bacterial disease, but it was awful to see.

    SCOTUS justices who voted to support Big Pharma should have to look at this woman's disfigured face and body every single day. Fucking heartless, morally-bankrupt bastards...

  •  I personally don't think of (16+ / 0-)

    Generic drug makers as being Big Pharma. FWIW.

    This is an awful case. I feel terrible for the individuals involved. I really do.

    But as yesterday's LA Times Explained generic drug manufacturers were stuck.

    Brand name drugs are rushed to market. They get FDA labels with warnings based on risks known at the time. When generic manufacturers start to produce these drugs, they MUST use the same labels. If they discover additional risks or side effects, generic manufacturers must advise FDA.

    But they MUST continue to use the original brand name labels despite new information.

    The issue is that FDA as a federal agency enforcing federal law  pre-empts (is superior to) state laws, based on the _supremacy clause in the Constitution.

    That is a good clause that the federal government often invokes when states try to do really stupid things.

    So this case has a terrible personal outcome for the individuals involved, based on a solid constitutional principle.

    Now, back to the FDA:

    The Food and Drug Administration has been considering changes to its labeling rules aimed at giving generic drug users more protection. And last week, the Obama administration filed notice that the FDA's efforts are coming closer to bearing fruit.

    According to the notice, the FDA is working on a rule that would "revise and clarify procedures for changes to the labeling" of approved drugs, whether they be name brand names, generics or biologics. The change would either enable or require -- it's not clear from the limited information released by the FDA -- drug makers to make public possible changes to their warnings while the FDA was considering them. And it would make clear that both the brand-name and the generic versions of the drug would have to change their warning labels in the event that the FDA acted on a proposed change emanating from either camp.

    So it does appear that while the injured party in this case will not be compensated, a concern of the dissent -- protection of consumers -- is being addressed.

    But IANAl. And I'll defer to my bar-admitted peers for full legal analysis of the case.

    © grover


    So if you get hit by a bus tonight, would you be satisfied with how you spent today, your last day on earth? Live like tomorrow is never guaranteed, because it's not. -- Me.

    by grover on Wed Jul 10, 2013 at 10:40:16 AM PDT

  •  this was decided on the 24th, so any diaries (1+ / 0-)
    Recommended by:
    Catte Nappe

    about it will be around that date.

  •  This is a mighty be "If" (4+ / 0-)
    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.
    Because AFAIK, generics do NOT have to be exactly the same, just biosimilar, bioequivalent, or some such term  (in fact, the original patent holders can (at least sometimes) trademark the color, appearance, etc of their medicine to keep generic manufacturers from making an exact mimic of their product).
    •  'big" not 'be' (0+ / 0-)

      damn spell checker!

    •  Even if they use the the exact same ingredients, (2+ / 0-)
      Recommended by:
      Eyesbright, Roadbed Guy

      they may not be biosimuilar. Some MDs will not prescibe generic thyroid products. I am required to take generic, so blood needs to be tested on a regular basis.

      The sourcing of the generics, especially the sourcing of the ingredients, is a problem.

      It is not possible for the FDA to investigate overseas labs. If there are multiple deaths, traceable, THEN the FDA will send someone.

      My pharmacist states generics increasingly from East Asia. Indonesia, China.

      Looking at med holder: wishing for Harvard or equivalent lab to analyze meds.

      Help Senator Warren. Encourage people to co-sponsor her bills, & the bills she has cosponsored. Elect Ed Markey.

      by CuriousBoston on Wed Jul 10, 2013 at 12:27:32 PM PDT

      [ Parent ]

    •  Oh, I missed that. (1+ / 0-)
      Recommended by:
      Roadbed Guy

      That is a big "if".  Most often the excipients (that is, the inactive ingredients, coatings and so on) are actually very different.  IIRC from working in the industry (been a few years), something in the patenting laws prevents generic companies from making exact copies right down to the inactive ingredients (despite that they win their right to produce the generic version based on proving a patent expired or invalid).  Instead they choose their inactive ingredients out of whatever's in the pantry, so to speak, and fiddle around with proportions until they have something that meets the requirements for bio-equivalence, as mentioned above: correct assay value, acceptable levels of impurities, equivalent dissolution characteristics, and so on.  And that's what's sold.

      For most drugs this works pretty well, since the inactive ingredients are all pretty similar and well understood, and the drug is intended to just reach the stomach intact and then fall apart and dissolve within a few minutes.  For some, though, proving bio-equivalence can be an insurmountable bar for the generic company: I'm convinced this is one reason behind the recent explosion of extended-release, modified-release, delayed-release and other fancy formulations coming from the brand name manufacturers.  Getting a dissolution profile to come out the same as the brand for such products while working with none of the same ingredients is a bear, and often fails entirely.

      Sorry for diversion. :)

      Back on track, though, this is a nonscientific article whose writer may not know the jargon very well. I wonder whether "exact same formula" even applies to the inactive ingredients, or whether it's only meant to distinguish birth control A with 0.5 mg of X and 1.0 mg of Y from birth control B with 0.5 mg of X and 1.5 mg of Y.  That sort of thing.

  •  Wow. Even for them, this is shocking NT (0+ / 0-)
  •  Another case for Congress (7+ / 0-)

    Because federal laws created this double bind.

    Justice Clarence Thomas, writing for the majority, said it was impossible for generic drug makers to comply both with federal laws requiring them to have the same label as the brand-name drugs and state laws that require them to add additional warnings. So the federal law prevails.
    http://www.cbsnews.com/...

    “Texas is a so-called red state, but you’ve got 10 million Democrats here in Texas. And …, there are a whole lot of people here in Texas who need us, and who need us to fight for them.” President Obama

    by Catte Nappe on Wed Jul 10, 2013 at 10:50:37 AM PDT

  •  Uh, yeah (2+ / 0-)
    Recommended by:
    Valar Morghulis, JerryNA

    That smell?  It's the coffee.  Laws, like taxes, are strictly for the little people.  You didn't notice this when torturers were allowed to walk scot-free?  When citizens paid taxes to make sure banksters got their bonuses?  Well, the hits just keep on coming.  Get used to it.  Reaganite neoliberalism is truly hegemonic, embraced, promoted and defended by both major parties and all significant elements of the establishment.  That's what Hegemony means.  We're soaking in it.

    "Patriotism is the last refuge of a scoundrel" ~Dr. Samuel Johnson

    by ActivistGuy on Wed Jul 10, 2013 at 11:39:49 AM PDT

  •  Drugs that are potentially (0+ / 0-)

    dangerous or addictive require a doctor's prescription under federal law.

    Is sulindac addictive? No

    Therefore, one can assume it is potentially dangerous.

  •  Can the patient still sue the name-brand company? (1+ / 0-)
    Recommended by:
    sewaneepat

    The article doesn't make it entirely clear.  It actually makes sense to me that generic pharmaceutical companies (which are mostly not, by the way, what most people think of as "Big Pharma") should not be liable for side effects or for problems with the labels.  Independent side effect testing is not within the scope of what generic manufacturers do and probably should not be: in producing their off-patent versions of the original drugs they are obligated to rely on the data provided to them by the FDA and by FOIA requests to the original patenting company.  If that is false or misleading, there's not really much that a generic company can do about it.  And as a former employee of a generic pharmaceutical company, I can tell you with authority that labels must be reproduced almost unchanged from whatever the original patenting company chose to put there: there is no authority for them to produce or advise anything that varies from the original in any meaningful way.  That's their whole purpose and the scope of what they're allowed to do -- to copy.  They should IMO be liable if they have failed to do that properly, but not for inherent problems with the original drug substance itself.

    If by closing the door to suits against generic companies on these grounds, it has also meant that no such suit can be brought at all against anyone?  That's quite, quite different, and clearly meant to deny many if not most people who have been injured by bad drugs the right to do anything about it.  Do you know which is the case?

    •  If you take the name brand, you can sue that (0+ / 0-)

      manufacturer. But I don't see how you can sue a company for a product they don't produce, control, distribute, sell or otherwise have anything to do with.

      That's the catch 22.

      Add to it the fact that many patients have no choice but to buy generics. They literally have ZERO options. Even if the generic doesn't work as well as the name brand, their insurance won't pay for the more expensive name brand.

      As I noted above, the Obama Admin and FDA seem to be trying to fix this asap now.

      It seems that they're trying to round up and push all the horses back into the barn immediately.

      The good thing is that generic manufacturers seem to be realizing that there are problems with drugs -- like side effects, adverse reactions, drug interactions, etc -- and that what THEY find will force big pharmaceutical companies to change THEIR labels as well. We all know (or should know) that few drugs are perfectly safe. But we all are entitled to informed consent. It's about time that the large manufacturers don't have a monopoly on what is known about the drugs and their generics.

      We finally won't have static labels that were created and approved years or even decades ago.  The price paid by the injured party is very high. But if this works, we all owe her a huge debt.

      © grover


      So if you get hit by a bus tonight, would you be satisfied with how you spent today, your last day on earth? Live like tomorrow is never guaranteed, because it's not. -- Me.

      by grover on Wed Jul 10, 2013 at 01:06:04 PM PDT

      [ Parent ]

      •  Well, it's the original company that (1+ / 0-)
        Recommended by:
        sewaneepat

        developed, produced and marketed the drug substance that is the ultimate cause of the injury.  It would seem to me that there ought to be standing to sue the company that actually created the drug substance and carried out the safety studies (or failed to do so properly).  But I'm not a lawyer and wouldn't be surprised if there were none.

        Poor woman.

  •  I wonder if this is actually going to hurt (0+ / 0-)

    generic manufacturers/suppliers.

    Because if they can't be sued, but the original supplier can, one can envision that a certain number of people are going to go out of their way to request the original just to keep their lawsuit options open . . ..

  •  Sue the corporate board (0+ / 0-)

    As individuals, naming 10000 "John Does" they're not exempt

    "My case is alter'd, I must work for my living." Moll Cut-Purse, The Roaring Girl - 1612, England's First Actress

    by theRoaringGirl on Wed Jul 10, 2013 at 12:56:42 PM PDT

  •  Remember when? (0+ / 0-)

      Big Pharma, et al - raised a big stink about the time it took for the FDA to approve drugs?   Once upon a time, we had a slow moving FDA that did perform "due diligence" and Big Pharma et al whined.   Then came "fast track drugs".   Next was the high profile "off-label" use that physicians used, because the Pharma rep sold it for exactly that purpose....never bothering to inform the patient that it was an off-label use or of the risks.  

       For those who use medications - some pharmacists, not the pharmacy techs that work at most sites,  may be the only person to "trust" - unless they are really busy/ over worked / underpaid and leave the patient on their own.

       To the average consumer - you are on your own and need to be an "expert" at navigating the FDA adverse reaction site - because it takes an unknown number of adverse reactions to trigger any sort of investigation.  

       The Pharmacy has now a "buyer beware" location and if you suffer - tough!
    http://www2.bloomberglaw.com/...
       

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