Supreme Court rules Drug Companies exempt from Lawsuits

This is what we call a Corporate Fascism.

It's Official.

The U.S. of A. is officially owned and operated by the very companies that have made themselves exempt from the law.

These are the very companies running this country. It is not a democracy or a republic, it is a Corporately owned and operated country where money talks and the courts, senators, congressman, and even the President are all bought up by hush money. See "lobby groups."

It's a disease that is killing and rotting this country from the inside out.

A big fat sweaty middle finger goes out to Big Pharma. Karma's a beeatch!!!!

Matter of time before the People have their say. Won't be pretty. See Egypt and others.

Originally posted by Aloysius the Gaul
reply to post by liveandlearn

 

Interesting - so it doesn't protect "big pharma" at all then - the original "brand name" manufacturers CAN be sued, but the generic ones cannot because they are making a product that they have been told is OK to make.

That wasn't my take away

n short, the Court ruled that the FDA has ultimate authority over pharmaceuticals in the US. And if the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions.

However, probably need to take a closer look. This sounds like an opinion.

reply to post by liveandlearn


I think you are seeing the same thing - the FDA is saying to the "generic" companies "you are allowed to produce this product" - therefore the FDA is taking "responsibility" for it - AS LONG AS the generic product carries the same warnings and other information as the original "branded" product carries.

The generic companies are not doing any research into the safety of het product - the presumption is that the original manufacturer and/or FDA have done that - and that is how the generic product can be cheaper - it has no research and testing costs to pay back.

Personally I'd be going for het original branded manufacturer and seeing what their testing revealed and maybe what they concealed - even if the product being taken was generic - because it is the original research that is where the problem should have been identified.

And/or the FDA......but apparently the FDA is immune to being sued.

I am confused, because what I read there, and what seems to be summarized from it by others here, is not the same thing?

That articles says that the brand name pharmaceuticals can be sued, just not the generics.... this woman can sue the company that produces the brand name version of the drug she took.

It looks to me like that article was just slightly misleading in parts, no?

reply to post by Bluesma


How can you sue the brand name, for a drug another company made? They would likely just try and shirk the blame onto the generic company, that can't be held responsible for it. Say they didn't follow the proper protocol or screwed up their ratios or something.

I looked at the scotusblog link that was so kindly provided. Frankly, the opinion itself requires two or three readings, so after giving it a shot I turned to the Syllabus. Here are a couple of interesting comments from it.

Held: State-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA.

Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac's label or composition and its state-law duty to either strengthen the warnings on sulindac's label or change sulindac's design.

Here, however, redesign was not possible for two reasons. First, the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as its brand-name drug equivalent. Second, because of sulindac's simple composition, the drug is chemically incapable of being redesigned. Accordingly, because redesign was impossible, Mutual could only ameliorate sulindac's "risk-utility" profile by strengthening its warnings. Thus, New Hampshire's law ultimately required Mutual to change sulindac's labeling.

(3) But PLIVA makes clear that federal law prevents generic drug manufacturers from changing their labels. Accordingly, Mutual was prohibited from taking the remedial action required to avoid liability under New Hampshire law. (Case cites and page references removed)

I think the Court said Mutual has one set of requirements under state law and another under federal law. Since they couldn't do both, federal law is the one to be followed.

It's also mildly interesting that the risk of this particular outcome was mentioned in the package insert. Her doctor admitted he did not read the insert.

reply to post by Aloysius the Gaul


Okay this is from the Washington Post June 24 and seems to include only generic drugs. See bolded portion below.

Interesting how little this is reported.

“Today’s court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients,” Michael Carome, director of Public Citizen’s Health Research Group, said in an interview.

He pointed out that, in many cases, the potentially dangerous side effects of medicines have not come to light until decades after they were approved and often after there was no longer a branded version on the market.

With the threat of litigation removed, “groups that think this undermines patient safety could be onto something,” said David Maris, an industry analyst with BMO Capital MarketsTe. “The blanket protection that they are under now is that if the FDA says you are approved, as long as [generic-drug makers] don’t introduce new problems into the drug, then they’re fine.xt”

Originally posted by SpaDe_
Still think it's possible to change the system from within and without any violence? I laugh at the people who think there is a way.

edit on 7/9/2013 by SpaDe_ because: (no reason given)

Unfortunately, this is the human way. How did we fend of them British? We f'd them up. Anybody that is sufficiently empowered will abuse you relative to the amount of power they have. Not there yet but we're closing in on time to put pleasant words away. The hate has to grow a bit more.

I have a feeling something horrible will have to happen before
most of this country wakes up to the real issues, like some kind
of water contamination or food or even drug contamination that
is ignored for profit reasons and affects so many it simply cannot
be ignored.

Exempting a company from being held accountable is beyond
a bad idea, but hey so long as they have a good profit margin
then it will all be A OK........

More and more the truth is starting to shine through, protection
for John Smith is going out the window in favor of protecting
profit margins, all the while execs of these companies get
yearly bonuses that should be illegal they are so massive.....

It will eventually get so bad things wont be easy to hide anymore,
and honestly i hope its sooner rather than later so we can just
fix this stuff and get out of this darn purgatory they seem intent
on keeping this country in.

reply to post by halfmask
So basically what they are saying is that unless you buy the extremely over priced "name brand" versions of your medicine you have absolutely no protection from the law. Thanks Big Pharma! Your dedication to thinning out the 99% is astounding! Freakin' jerks!

reply to post by littled16

Dear littled16,

I think I see it a little differently from the way you do. May we talk about it for a minute?

It sees to me the Court is saying that Federal law requires a company that wants to make a generic version of a drug, to make it exactly the same as the original version which underwent all the research and government approval. The company can't change the flavor, make little modifications, change any of the warnings, etc. It's got to be the same thing so that people know that if they buy the generic, it's the same medicine as the original.

In this case, the Court found that the state was expecting the company to make changes to the product, which the company wasn't allowed to do under Federal law. The company was sued and lost in state court, but the Supremes said, "Nope, Federal law is what we're going to follow. You can't punish him for following our law."

Remember, that a generic is identical to the original which has gone through all of the necessary testing. Also, the original has been on the market for years before a generic can be made. The patent protection on a drug is 17 years, so it's not only been tested in the lab, it's been tested in the real world.

So basically what they are saying is that unless you buy the extremely over priced "name brand" versions of your medicine you have absolutely no protection from the law. Thanks Big Pharma! Your dedication to thinning out the 99% is astounding! Freakin' jerks!

I'm not sure that's what the Court is saying, but I'd love to talk with you about it, if you'd like.

With respect,
Charles1952

reply to post by charles1952


Wow, Charles. Something we actually agree on. I do believe this is a first! Maybe it calls for a little celebration?



I am just wondering if people who purchase the generic versions can indeed sue the original manufacturer of the drug (the "brand" name company), even if that company is not where they got the drug from. It seems like people should have some recourse, especially if there are no warnings posted.

reply to post by charles1952
Good morning Charles!

I do understand what you are saying concerning the identical ingredients in the generic medicines, and that I believe is a good thing. But there have been drugs considered safe by the FDA that have turned out to have some bad side effects in the long term or had unknown side effects in a certain percentage of users that had not been considered. No one, not the FDA nor the pharmaceutical companies, checks for every possibility- they just determine whether or not the product is safe for the majority of users, and sometimes there is information that is intentionally kept from the public regarding some medicines.

I find it unfair that if one suffers debilitating side effects from a generic version of a drug he/she is prohibited from seeking restitution from the pharmaceutical company but if one is using "name brand" drugs all options are on the table. The majority of people will choose generic when label is too expensive out of fiscal necessity. Is there to be no recourse for these people should something go wrong with their medicine? And besides that what happens if the medication is somehow tainted or contaminated? Does this ruling encompass that as well?

Much Respect, littled16

reply to post by kaylaluv and littled16

Dear Ladies,

And good morning to you, littled16.

I couldn't be happier that kaylaluv agrees! There is no way we could both reach a wrong conclusion. (See, kaylaluv, I told you we should get married.)

But I really like the question that you both raise. This poor woman is really suffering. How can she get some compensation? Well, the lawyer's first rule is sue everybody that even knows about the situation, someone's got to be guilty of something. But you ladies are more moral and thoughtful than that. So let's start with "Who did something wrong or careless?"

And besides that what happens if the medication is somehow tainted or contaminated? Does this ruling encompass that as well?

In that case, you can go after whoever was responsible for, or should have known of the contamination. Maybe it was in the production process. If so, the generic company is fair game. Sue their pants off. (Umm, 'scuse me ladies.) Sometimes, the product degrades over time or through improper storage. In that case, you've got good targets as well. Did the company keep it warehoused improperly? Did the shipping company do something wrong? Should the pharmacist have checked it?

But let's assume that what she swallowed is exactly what the original company designed and the FDA tested. Even in this case, there's one immediate possibility. the doctor. The story says that this particular problem was mentioned in the insert inside the drug box, and the doctor admitted he didn't read it. Certainly a jury might find that to be careless.

But there have been drugs considered safe by the FDA that have turned out to have some bad side effects in the long term or had unknown side effects in a certain percentage of users that had not been considered. No one, not the FDA nor the pharmaceutical companies, checks for every possibility. . .

If the original company lied about their tests, you've got a decent path to take. It's a little tougher if the government fouled up. Suing the government for money is a tricky proposition, but sometimes it's possible, and there's alays a chance for a settlement. But to be fair to the company, if they play the game according to the rules, and 20 years down the road a problem surfaces, how do we say it's their fault? Well, maybe a lawyer could, but I think it would be tough. BUT, if a problem surfaces, and the original company doesn't tell anybody about it, then you've got a great case and she'll be rolling (painfully, unfortunately) in money.

I hope that's a start to answering your questions. I'm really grateful you both posted. Thanks a lot. I'm at your service at any time.

With respect,
Charles1952

reply to post by charles1952
Thank you for sharing your thoughts Charles! I will admit that though I'm not someone who condones the many frivolous lawsuits that occur so regularly I have a dog in this hunt. My husband takes a generic version of a life saving medicine that he will be taking for the rest of his life. To buy the "label" product would eat up nearly half of our grocery budget for the month. While thus far there have been no averse side effects no one can tell what the long term effects might be many years down the road as the drug is on the "newer" end of that class of drugs even though it so far has been considered one of the safest and causing the least amount of side effects. If many years down the road if something bad were to occur due to the fault of the pharmaceutical company (doctored test results, intentionally hidden information, mishandling or procedural mistakes, etc.) I feel we should be entitled to the same options as those who buy the "label" brand of the same medicine. I don't feel that the name of the medicine should make any difference.

Kindest Regards, littled16

reply to post by littled16

Dear littled16,

My sincerest sympathy. You're both taking a risk with huge stakes, but it sounds like it's working so far. I pray that it continues.

I hope I don't sound heartless, and I realize this might be a cliche, but every day he gets is a big plus and is to be celebrated.

I assume that this is the best of the alternatives available to you, but I'm really sorry you're in this spot. It doesn't sound like there's much real choice for you.

With respect,
Charles1952

reply to post by liveandlearn

This just sucks big time for those dependent on drugs and gives pharmaceutical companies a lot of leeway to do just about anything they want. There is something seriously wrong here. Trust me, I am the FDA.

So a drug company can still be sued - but only if it invented the drug in the first place?

Surely if the FDA plays God in these matters - and God screws up - God is also liable to face litigation and pay compensation? Sue the FDA no?

reply to post by charles1952
Thank you Charles, but don't be sad. Every day we have is a blessing to our family. My husband has a strange form of epilepsy that runs in his family. The doctors can't agree on exactly which category to place it in as it exhibits the symptoms of multiple sorts, but the bottom line is that when these seizures occur he expels all of his breath and his heart completely stops. Three family members have died due to the same seizures, and if not for being fortunate enough that I've always been around when it has occurred and that I was trained as a medic he would have been gone many years ago. His doctor and neurologist finally found a medicine and proper dosage and he has not experienced a full seizure in close to three years. He has two other relatives with the same condition that are on the same medicine now who have also been doing extremely well on it.

On the bright side I have convinced everyone in his family who was not previously trained to learn CPR and they have learned to recognize the minute signs that give clues to the possibility of such a seizure coming on. It is interesting to note that with the exception of one relative none of them had any seizure disorders until they were well into adulthood. My husband's family is spread all over the country and didn't keep in touch often before I started making phone calls asking questions about family medical history and none of them had put two and two together. Now everyone keeps in touch on a regular basis and are closer than ever before, so something very good has come from what was bad- and that is a blessing in itself!

reply to post by christina-66

I'm not sure that you have it absolutely correctly.

A generic drug company can be sued if they do something wrong or negligent. The federal law requires the generic company to produce drugs which are exactly like the original; packaging, formula, everything. If they don't, they can be sued.

But if they follow all the federal laws, they can't be sued under a different set of state laws. That only makes sense, they might have to follow up to 50 different state laws as well as the federal, and that might shut down the generic market. And in this case, the state laws contradicted the federal laws, so it was ruled that the company should follow the federal laws.

I think part of the reasoning was that the FDA is set up to test and examine new drugs, and the original manufacturer has to run tests as well. So what would be the point in running a third set of tests?

Of course, if the FDA or the original manufacturer does something wrong there is a possibility of recovering, depending on the circumstances, but at some point somebody has to say "It's Ok, you can sell this." Who else should beside the people who want to put it on the market originally and the FDA?

Originally posted by Merlin Lawndart
Monsanto is exempt, big pharma is exempt, the Fed is exempt, none can be held accountable in court. You know what these people aren't exempt from? People taking to the streets, dragging them out of their homes and publicly lynching their asses.

That's the medicine I prescribe for these people, I doubt the FDA will approve it but who cares.