241
Post by: Ahtman
July 7, 2013. Washington. In case readers missed it with all the coverage of the Trayvon Martin murder trial and the Supreme Court’s rulings on gay marriage and the Voting Rights Act, the US Supreme Court also made a ruling on lawsuits against drug companies for fraud, mislabeling, side effects and accidental death. From now on, 80 percent of all drugs are exempt from legal liability.
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.
Karen Bartlett vs. Mutual Pharmaceutical Company
In 2004, Karen Bartlett was prescribed the generic anti-inflammatory drug Sulindac, manufactured by Mutual Pharmaceutical, for her sore shoulder. Three weeks after taking the drug, Bartlett began suffering from a disease called, ‘toxic epidermal necrolysis’. The condition is extremely painful and causes the victim’s skin to peel off, exposing raw flesh in the same manner as a third degree burn victim.
Karen Bartlett sued Mutual Pharma in New Hampshire state court, arguing that the drug company included no warning about the possible side effect. A court agreed and awarded her $21 million. The FDA went on to force both Mutual, as well as the original drug manufacturer Merck & Co., to include the side effect on the two drugs’ warning labels going forward.
Now, nine years after the tragedy began, the US Supreme Court overturned the state court’s verdict and award. Justices cited the fact that all generic drugs and their manufacturers, some 80% of all drugs consumed in the United States, are exempt from liability for side effects, mislabeling or virtually any other negative reactions caused by their drugs. In 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.
Court ruling
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.
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 that ruling flies in the face of both common sense and justice. And as Karen Bartlett can now attest, it leaves 240 million Americans unprotected from the deadly and torturous side effects of pharmaceutical drugs. As a reminder, the number one cause of preventable or accidental death in the US is pharmaceutical drugs.
Article 
91
Post by: Hordini
Oh goody.
57210
Post by: DemetriDominov
And the day has finally come, in the land of a pill for every ill, is the fastest and most legal way to kill.
18698
Post by: kronk
I'm not a fan of this ruling.
34390
Post by: whembly
Me too... seems very strange on the surface.
I need to dig deeper into the nuances of this case... probably tomorrow.
23223
Post by: Monster Rain
I need to research this further before really forming an opinion.
This can't be what it looks like.
91
Post by: Hordini
 Monster Rain wrote:I need to research this further before really forming an opinion.
This can't be what it looks like.
I hope you're right.
5470
Post by: sebster
I can see the point, to be honest.
I mean, it's kind of silly to insist every company that wants to manufacture a generic brand drug needs to undertake its own testing of what is, basically, an identical product. Instead it should be enough to just take the work already done by the original company and the FDA and copy that warning label.
23223
Post by: Monster Rain
It seems like someone can still sue the original manufacturer of the drug though, right?
50512
Post by: Jihadin
Yep. Not the generic brand makers
91
Post by: Hordini
So just to be clear, someone who takes a generic version of a drug can sue the maker of the brand name drug, even if they didn't take the brand name drug?
If that's the case, this doesn't really seem that bad.
23223
Post by: Monster Rain
Yeah, it just looks like this holds the original manufacturer of a drug liable for side effects, and not the people who just copy the formula and sell it for a discount.
Unless I'm seriously missing something.
34644
Post by: Mr Nobody
And this is why I only take Advil.
299
Post by: Kilkrazy
I don't see how you could sue the maker of the original drug if you suffered a reaction to a generic version. The original maker would simply say you had not taken their drug.
5534
Post by: dogma
I suppose it won't be too hard to sue Merck & Co..
Oh, wait, it is one of the largest pharmaceutical companies the the world.
61627
Post by: KalashnikovMarine
This screams "terrible idea"
23223
Post by: Monster Rain
 dogma wrote:I suppose it won't be too hard to sue Merck & Co..
Oh, wait, it is one of the largest pharmaceutical companies the the world.
Justice is expensive!
61774
Post by: Somedude593
So basically dont take any drug ever....... well back to leeches and alchemy then!
61627
Post by: KalashnikovMarine
Eh if we went back to the herb lore we lost during the witch trials and Inquisition we'd not only have more effective medicine but with less side effects too, but since the fethheads with the leeches burned all that information for being connected to witch craft I suppose we're SOL.
23223
Post by: Monster Rain
Dark Age herb lore is more effective than modern medicine, eh? 
You have to be trolling.
5470
Post by: sebster
 KalashnikovMarine wrote:Eh if we went back to the herb lore we lost during the witch trials and Inquisition we'd not only have more effective medicine but with less side effects too
Yeah, no. None of what you just said has anything to do with reality.
38279
Post by: Mr Hyena
KalashnikovMarine wrote:Eh if we went back to the herb lore we lost during the witch trials and Inquisition we'd not only have more effective medicine but with less side effects too, but since the fethheads with the leeches burned all that information for being connected to witch craft I suppose we're SOL.
Quack science is bad science.
61627
Post by: KalashnikovMarine
"We'd rather believe people receiving kick backs from large corporations that have absolutely no vested interest in our health or well being to shove pills down our throats that in many cases are more dangerous then the condition they are being used to treat, then accept the possibility that natural remedies used to treat a wide variety of ailments for millenia might actually be effective. We will do this while taking herbal supplements to promote health and well being."
Is how all that translated.
Just remember, the wonder drug penacilin is a natural remedy.
4042
Post by: Da Boss
An overwhelming number of modern drugs also come from natural molecules.
Herb lore, are you for real. If middle ages herb lore was so effective why didn't the death rate decline until recently? Herbs are in many cases all well and good, but properly engineered drugs are what is needed to treat complex conditions.
On this case, hmph. Unless you can sue the original molecule creator, I think this strips another layer of protection from people in the fight against Big Pharma, which is already distressingly one sided.
61774
Post by: Somedude593
Herb lore is just a less complex delivery system for the drugs we all take now... malaria is now treated with a drug called conine, before that locals in the tropics used to chew on a tree bark that released the same chemical.. sure it was less effective but it got tue job done....... three things have changed herb lore into the pharmaceuticals we know today 1. Mass production ( greater access, synthetic production of formerly herbal molecules) 2. Global Communications/trade (easier for cures to be spread) 3.Application method (pills/ hypodermic needles). These things have only been achieved fairly recently. However this is a topic for another thread that i might be happy to start. PS: I got ur back kalishnikov
23223
Post by: Monster Rain
KalashnikovMarine wrote:"We'd rather believe people receiving kick backs from large corporations that have absolutely no vested interest in our health or well being to shove pills down our throats that in many cases are more dangerous then the condition they are being used to treat, then accept the possibility that natural remedies used to treat a wide variety of ailments for millenia might actually be effective. We will do this while taking herbal supplements to promote health and well being."
Is how all that translated.
Just remember, the wonder drug penacilin is a natural remedy.
The ignorance here is beyond all redemption.
You and your cohort don't seem to have the vaguest idea what you're talking about.
5534
Post by: dogma
No it isn't. At least not according to your implied distinction between "natural" and "artificial".
61627
Post by: KalashnikovMarine
Not to mention most herb lore and traditional medicine in Europe got stamped out during the Middle Ages under the auspices of the Catholic church. It was replaced by the much more modern and sensible system of men in goofy hats sticking leeches on you. So we'll never really know what exactly was lost in many cases.
As to the death rate declining, I'd guess stable food sources, sanitation (Hey guys! What if we stop keeping the bodies in the drinking water?) and the spread of machinery which makes even the few remaining traditional trades like farming significantly less brutal to spend a life time at have just as much to do with it as being able to pick up a scrip for Zoloft at Walgreens. (Or your Pharmacy of choice)
23223
Post by: Monster Rain
And chemtrails!
91
Post by: Hordini
Dude, don't post that here! The NSA is watching!
61774
Post by: Somedude593
Monster Rain wrote: KalashnikovMarine wrote:"We'd rather believe people receiving kick backs from large corporations that have absolutely no vested interest in our health or well being to shove pills down our throats that in many cases are more dangerous then the condition they are being used to treat, then accept the possibility that natural remedies used to treat a wide variety of ailments for millenia might actually be effective. We will do this while taking herbal supplements to promote health and well being."
Is how all that translated.
Just remember, the wonder drug penacilin is a natural remedy.
The ignorance here is beyond all redemption.
You and your cohort don't seem to have the vaguest idea what you're talking about.
I would legitimately like for you to make what you think on how modern medicine is distinctly seperate from herb lore ( and not a modernization of it as i think it is). Also i dont like being a cohort thank you very much  but if we really want to get into this a seperate thread might be required.
23223
Post by: Monster Rain
It's the reptilians you should be worried about. Them and the grays are the ones what put the autism in the vaccines.
Freemasons! They're up to something too.
Wake up, sheeple!
91
Post by: Hordini
I can neither confirm nor deny.
61627
Post by: KalashnikovMarine
See man the chem trails are all just a sign of the problem, Monsanto and Big Pharma are just puppets of a larger and bigger evil, why do you think the Federal courts have passed laws protecting them and their products at every possible turn? Sure you see a tort law victory here and there but nothing changes, they keep pumping the same weird drugs approved by the so called "FDA", which is pretty much just a lobbyist bought and paid for by Monsanto and Big Pharma's puppet masters at this point, so that we don't even know what healthy feels or looks like any more! Hey man you look down, have a pill. You look angry, take a pill. Are you stressed? Another pill! You name it there's a pill for that. Are you just feeling... okay? Holy gak! Take this pill before it's too late! Meanwhile each pill being shoved down your throat has about six pages of side effects that are doing god knows what to your internal chemistry, and will probably require, you guessed it! More pills to fix! Over medicated, under educated pliable sheeple, the western world's down the drain with the twist of a pill bottle.
91
Post by: Hordini
Why, oh why didn't I take the blue pill?
61627
Post by: KalashnikovMarine
Because the grays put a chip in your grandfather's head back in the 60s.
23223
Post by: Monster Rain
Alex Jones has much to answer for.
61627
Post by: KalashnikovMarine
You bet he does, he's a Master Mason. His entire purpose is to create a lot of fuss and noise and keep everyone distracted from what's really going on. Wheels within wheels my friends, wheels within wheels.
61774
Post by: Somedude593
stay classy dakka, or da guvmint will put you on the purge list when the NWO rises...( i seriously would have likes to have a discussion the medicine thing though but the internet is perhaps the wrong place)
59752
Post by: Steve steveson
FDA says drug is ok. Original creator says drug is ok. Company produces box based on this. Can't sue company that relied on this information rather than doing its own testing. I see no problem with this.
Also, herb lore? Witch trials? The anti science here is just depressing. I think I need some henbane and mercury to make me a little more sanguine.
4042
Post by: Da Boss
KM:
Big Pharma is undoubtably corrupt. It has been shown to hide unfavourable evidence, disregard negative results or fail to publish it, to make invalid or useless comparisons, to tamper with trial data and to generally behave in an unscrupulous and "evil" fashion. That is beyond dispute, I reckon.
However, to take this problem, which is a massive, serious problem, and to think the answer is to go back to using "herblore" rather than evidence based medicine utilising the trememdous advances in our understanding of diseases and how our own biochemistry works, is flat out crazy.
I am dead against "A pill for every ill" culture, I am dead against marketing of Pharmaceuticals. But NEITHER of those are a problem with the science behind drugs, neither of those are an excuse to back track to "natural" remedies which are "better" because of some body of evidence we have never seen. They are both problems of culture and regulation. Some herbs may be useful in the treatment of conditions, I do not dispute that. But they are in no way a replacement for evidence based medicine. When herbs and plant or animal extracts work, medicine adopts them.
What amazes me about these sorts of medical conspiracy theories is that people with very little expertise begin to assume that they know better than the many thousands of experts who have dedicated their lives to a particular field. It is a form of delusion.
Edit: A friend of my brothers recently died from Malaria because the lady in the Pharmacy recommended "natural solutions" of dubious efficacy to him rather than what actually works- mosquito nets and insect repellent with proper malaria meds. It makes me angry when people propogate this sort of nonsense because it does cost lives. It also costs lives when Big Pharma lie and decieve intentionally, which is probably worse, but to combat that you don't need to adopt such an extreme stance that you also promote viewpoints that lead to harm.
5880
Post by: sqir666
Wow, I was going to comment. Apparently this thread escalated quickly.
5470
Post by: sebster
KalashnikovMarine wrote:Not to mention most herb lore and traditional medicine in Europe got stamped out during the Middle Ages under the auspices of the Catholic church.
Oh the burning times! Dude, the sources your rely on for history are crazies, and as a result you've ended up posting things in this thread which are crazy. It was replaced by the much more modern and sensible system of men in goofy hats sticking leeches on you. So we'll never really know what exactly was lost in many cases.
But that won't stop you speculating that it must have been totally awesome super cures. As to the death rate declining, I'd guess stable food sources, sanitation (Hey guys! What if we stop keeping the bodies in the drinking water?) and the spread of machinery which makes even the few remaining traditional trades like farming significantly less brutal to spend a life time at have just as much to do with it as being able to pick up a scrip for Zoloft at Walgreens. (Or your Pharmacy of choice)
Yeah, no. Those ideas didn't developed the polio vaccine. And they didn't produce the massive reduction in infant mortality we've seen in the last hundred years. Those things were achieved by the application of the scientific method to modern medicine.
25208
Post by: AlmightyWalrus
 sebster wrote:
Yeah, no. Those ideas didn't developed the polio vaccine. And they didn't produce the massive reduction in infant mortality we've seen in the last hundred years. Those things were achieved by the application of the scientific method to modern medicine.
Not to mention the eradication of smallpox.
5470
Post by: sebster
No, KalashnikovMarine is actually right about that one. Smallpox was defeated by a secret coven of witches who had worked in secret for centuries, away from the persecution of the Catholic Church*. It was only that big pharma had brainwashed us all with their science and reason that those witches couldn't get anyone to use their medicine when they told us it was eye of newt, that they had to set up pretend pharmaceutical companies to release their vaccine as a pretend sciency thing.
*Why is it always the Catholic Church? There wasn't exactly a shortage of Protestant nutters going about persecuting the gak out of everyone who wasn't Protestant, or in some cases just not quite as fanatical about Protestantism as they were. That's what's so fething boring about these new age conspiracy nuts - their choices of target are so cliche.
34390
Post by: whembly
sebster wrote:I can see the point, to be honest.
I mean, it's kind of silly to insist every company that wants to manufacture a generic brand drug needs to undertake its own testing of what is, basically, an identical product. Instead it should be enough to just take the work already done by the original company and the FDA and copy that warning label.
Yep... that's my read on this. This doesn't absolve the original patent holder from any liability if they were found fraudulent during the developement of their product.
To me, I see this as a function to keep the generic drug's cost lower.
37231
Post by: d-usa
The original article is so full of fail that I officially feel dumber for having even klicked on the link. The writer of the original link and the motto of that side should have made it clear that this story is complete BS: Whiteout Press: Independent News at its Best - If it's blacked-out, covered-up or censored, you can find it here! And even a cursory glance of the article should make you realize it is sensational garbage. There is just wonderful mental gymnastics that turn the actual facts of the ruling from this: 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.
To this: Supreme Court rules Drug Companies exempt from Lawsuits
It's not even worth going into the details of how this rulling was right, or how drug trials and labeling requirments work, when you are basing your initial complaint of an Alex Jones worthy masterpiece of an article.
25990
Post by: Chongara
sebster wrote:
No, KalashnikovMarine is actually right about that one. Smallpox was defeated by a secret coven of witches who had worked in secret for centuries, away from the persecution of the Catholic Church*. It was only that big pharma had brainwashed us all with their science and reason that those witches couldn't get anyone to use their medicine when they told us it was eye of newt, that they had to set up pretend pharmaceutical companies to release their vaccine as a pretend sciency thing.
Stop being brainwashed. Everyone knows intuitively that the world was better before everything had  chemicals in it.
1206
Post by: Easy E
So, if a Generic Drufg manufacturer puts a bunch of low-cost crap into their generic knock-off drug and you get sick/die from it; you are suppose to sue the person who made the original "Brand" version of the drug?
I'm not exactly a legal eagle, but how does that make any sense?
69173
Post by: Dreadclaw69
Because erectile dysfunction isn't an issue?
37231
Post by: d-usa
 Easy E wrote:So, if a Generic Drufg manufacturer puts a bunch of low-cost crap into their generic knock-off drug and you get sick/die from it; you are suppose to sue the person who made the original "Brand" version of the drug? I'm not exactly a legal eagle, but how does that make any sense?
Let's try this again, shall we: 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.
And of course we are talking about "side effects" in this case, not "manufacturing errors". The SCOTUS ruling didn't address somebody suing somebody because they made a crappy product. But if a stupid website writes a stupid article there will be people who are confused by it.
34390
Post by: whembly
Yep...d-usa has the right of this...
In other words, if the generic makers distributed drugs that were contaminated by their own manufacturing process... then the generic makers are liable. However, if they're made EXACTLY as the brand and labeled EXACTLY as the same way as the brand, then the original patent holder would be liable.
61627
Post by: KalashnikovMarine
sebster wrote: KalashnikovMarine wrote:Not to mention most herb lore and traditional medicine in Europe got stamped out during the Middle Ages under the auspices of the Catholic church.
Oh the burning times!
Dude, the sources your rely on for history are crazies, and as a result you've ended up posting things in this thread which are crazy.
I know you read selectively but I've been massively taking the piss this entire thread. You are tracking that right? That said, there is an argument that the European witch hunts, which mostly occurred under the Catholic Church through the 15th to 18th century were incredibly gender biased with traditional women's roles and tasks, which included traditional medicine being labeled as "witch craft". This is also right around the rise of so called "scientific" medicine. I put air quotes on that because medicine of the day was not much better then witchcraft considering leeches and stabbings were popular medical treatments. Any way an acquaintance of mine wrote her master's thesis on the concept of the witch hunts as gendercide, I'll see if I can dig a copy up some where if you're interested. When her paper was publicly discussed/critiqued on campus one of the odder counterpoints is that not enough people had died for it to qualify for a "cide" of any kind. The low number is approximately 60,000 deaths last I saw anything, so I suppose it depends on your own goal posts for that?
23223
Post by: Monster Rain
 AlmightyWalrus wrote: sebster wrote:
Yeah, no. Those ideas didn't developed the polio vaccine. And they didn't produce the massive reduction in infant mortality we've seen in the last hundred years. Those things were achieved by the application of the scientific method to modern medicine.
Not to mention the eradication of smallpox.
I used an eye of newt and a wolfsbane poultice.
No smallpox yet, so it must have worked!
33541
Post by: Rented Tritium
So here's the thing. It's a good ruling because generic manufacturers are already set up to be allowed to just copy a drug without testing it, since the testing was already done, so there's no reason for them to be responsible for the actual drug itself unless they've done something different. So in that sense, this is fine with me.
But on the other hand, this ruling creates a weird situation where a drug could eventually be discontinued by the original maker, such that there are ONLY generics. In which case the drug could keep getting made forever and nobody can ever be sued. Ostensibly, that's what the FDA is for, they could step in and halt sale of the drug and investigate, etc etc, but what if they're slow?
So basically, on principle this is fine, but it creates a corner case that we will have to deal with. The good news is that the corner case could be solved by legislation adjusting the FDA's role in the situation.
241
Post by: Ahtman
So the woman in the original case should refile but against the brand name manufacturer for not disclosing the side effect?
23223
Post by: Monster Rain
That's what it looks like based on my reading. Then again, I'm not a lawyer.
53375
Post by: hotsauceman1
Welp, back to chewing on bark to cure my illnesses, who is in?
70365
Post by: Gentleman_Jellyfish
This is why I get my news from Dakka. You guys pre-chew it for me.
23223
Post by: Monster Rain
This may be the most frightening thing I've ever read.
70365
Post by: Gentleman_Jellyfish
Weirdly, I actually found myself notably more depressed while I was a daily reader of the Seattle Times
299
Post by: Kilkrazy
If you read the data sheet on the original product, the side effect that this patient suffered is included. Thus I don't see how she could sue the original pharmaceutical company for non-disclosure of side effects.
69173
Post by: Dreadclaw69
 Rented Tritium wrote:So here's the thing. It's a good ruling because generic manufacturers are already set up to be allowed to just copy a drug without testing it, since the testing was already done, so there's no reason for them to be responsible for the actual drug itself unless they've done something different. So in that sense, this is fine with me.
But on the other hand, this ruling creates a weird situation where a drug could eventually be discontinued by the original maker, such that there are ONLY generics. In which case the drug could keep getting made forever and nobody can ever be sued. Ostensibly, that's what the FDA is for, they could step in and halt sale of the drug and investigate, etc etc, but what if they're slow?
So basically, on principle this is fine, but it creates a corner case that we will have to deal with. The good news is that the corner case could be solved by legislation adjusting the FDA's role in the situation.
That is actually a very good point that I hadn't considered. I was more concerned about a law suit with the Plaintiff suing the Original Manufacturer, and the Original Manufacturer trying to bring in the Generic Manufacturer into the proceedings trying to claim that they are liable based on their production methods.
241
Post by: Ahtman
 Kilkrazy wrote:If you read the data sheet on the original product, the side effect that this patient suffered is included. Thus I don't see how she could sue the original pharmaceutical company for non-disclosure of side effects.
From the article:
Karen Bartlett sued Mutual Pharma in New Hampshire state court, arguing that the drug company included no warning about the possible side effect. A court agreed and awarded her $21 million. The FDA went on to force both Mutual, as well as the original drug manufacturer Merck & Co., to include the side effect on the two drugs’ warning labels going forward.
How do we go from it isn't on the label to it is on it? Or is it a case where it is on the data sheet but isn't listed on the drug? It seems odd that the courts would agree that it wasn't there if it was there.
70365
Post by: Gentleman_Jellyfish
 Ahtman wrote: Kilkrazy wrote:If you read the data sheet on the original product, the side effect that this patient suffered is included. Thus I don't see how she could sue the original pharmaceutical company for non-disclosure of side effects.
From the article:
Karen Bartlett sued Mutual Pharma in New Hampshire state court, arguing that the drug company included no warning about the possible side effect. A court agreed and awarded her $21 million. The FDA went on to force both Mutual, as well as the original drug manufacturer Merck & Co., to include the side effect on the two drugs’ warning labels going forward.
How do we go from it isn't on the label to it is on it? Or is it a case where it is on the data sheet but isn't listed on the drug? It seems odd that the courts would agree that it wasn't there if it was there.
He could be referring to the Material Safety Data Sheet
http://www.sciencelab.com/msds.php?msdsId=9925155
Edit: Possibly misread your post Ahtman
5534
Post by: dogma
It isn't a direct Hitchhiker's reference, but it is spoken in the same vein.
Beware of the Leopard.
37231
Post by: d-usa
Well, you woldn't really go by the MSDS. When drugs are dispensed they usually include what we call a Monograph (the big long paper full of writing that everybody just throws out when they open a new bottle of drugs). The Monograph for the drug includes the following side effects: For the Consumer
Applies to sulindac: oral tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking sulindac: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using sulindac and call your doctor at once if you have a serious side effect such as:
chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
urinating less than usual or not at all;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
bruising, severe tingling, numbness, pain, muscle weakness.
Less serious side effects of sulindac may include:
upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;
dizziness, headache, nervousness;
skin itching or rash;
dry mouth;
increased sweating, runny nose;
blurred vision; or
ringing in your ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
So even if somebody reads the big giant piece of paper included in the box, it doesn't really mention that particular side effect. The Monograph does include the following: For Healthcare Professionals
....
Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
...
So while the insert, and the Physicians Desk Reference entry would mention Toxic Epiderman Necrolysis, it isn't really included as a warning or potentila side effect for patients. It makes a generic warming about "call your doctor if you get a rash. Which is a lot less severe than "call your doctor if your skin falls off". Or at least that is how it appears to me (somebody trained in handing out pills for a living). Although this doesn't change the fact that generic manufactures who follow the exact formulation and labeling as the brand name manufacturers shouldn't held liable for the testing done by the brand name manufacturer and the labeling approved by the FDA for that drug IMO.
70365
Post by: Gentleman_Jellyfish
 d-usa wrote:Well, you woldn't really go by the MSDS.
When drugs are dispensed they usually include what we call a Monograph (the big long paper full of writing that everybody just throws out when they open a new bottle of drugs).
Ah, thanks! I don't think I've ever bought medicine!
37231
Post by: d-usa
 Gentleman_Jellyfish wrote: d-usa wrote:Well, you woldn't really go by the MSDS.
When drugs are dispensed they usually include what we call a Monograph (the big long paper full of writing that everybody just throws out when they open a new bottle of drugs).
Ah, thanks! I don't think I've ever bought medicine!
Even if you did, 99% of the time it just gets thrown away with the packaging .
I truly wonder how many people actually read the papers they get with their drugs from the pharmacy.
1206
Post by: Easy E
d-usa wrote: Easy E wrote:So, if a Generic Drufg manufacturer puts a bunch of low-cost crap into their generic knock-off drug and you get sick/die from it; you are suppose to sue the person who made the original "Brand" version of the drug?
I'm not exactly a legal eagle, but how does that make any sense?
Let's try this again, shall we:
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.
And of course we are talking about "side effects" in this case, not "manufacturing errors". The SCOTUS ruling didn't address somebody suing somebody because they made a crappy product.
But if a stupid website writes a stupid article there will be people who are confused by it.
Thanks for the clarification.
However, it seems like this will raise R&D costs even more as the Brand maker won't want to get sued once the drug goes Generic. I'm not sure this is better, considering how much Big Pharma all ready complains about R&D issues.
Edit: Again, I'm far from knowledgable about this subject.
37231
Post by: d-usa
Looking through the information for the drug, it does seem like that particular side effect was a known possibility, it just doesn't appear that it was included in the "for the consumer" side effect list. So it's an interesting issue for sure, but not really anything the generic manufacturer should be liable for.
299
Post by: Kilkrazy
Ahtman wrote: Kilkrazy wrote:If you read the data sheet on the original product, the side effect that this patient suffered is included. Thus I don't see how she could sue the original pharmaceutical company for non-disclosure of side effects.
From the article:
Karen Bartlett sued Mutual Pharma in New Hampshire state court, arguing that the drug company included no warning about the possible side effect. A court agreed and awarded her $21 million. The FDA went on to force both Mutual, as well as the original drug manufacturer Merck & Co., to include the side effect on the two drugs’ warning labels going forward.
How do we go from it isn't on the label to it is on it? Or is it a case where it is on the data sheet but isn't listed on the drug? It seems odd that the courts would agree that it wasn't there if it was there.
If you read the list of clinical indications, you will see it couldn't possibly fit on a label. As is true for practically any drug. That is why doctors rely on data sheets and books like the British National Formulary, not labels, for writing prescriptions.
69173
Post by: Dreadclaw69
d-usa wrote:Looking through the information for the drug, it does seem like that particular side effect was a known possibility, it just doesn't appear that it was included in the "for the consumer" side effect list. So it's an interesting issue for sure, but not really anything the generic manufacturer should be liable for.
Looks like she has a reasonable case against the original manufacturer then if they were negligent in passing that information on to the customer.
19370
Post by: daedalus
d-usa wrote:
Even if you did, 99% of the time it just gets thrown away with the packaging .
I truly wonder how many people actually read the papers they get with their drugs from the pharmacy.
I drink often enough I usually scan the sheet for a big red "DO NOT DRINK ALCOHOL WITH THIS PRODUCT!", but I don't go through the entire thing unless I start having something strange happen to me and want to check for side effects.
69173
Post by: Dreadclaw69
I will admit to being boring and check side effects. I'd rather not take something that causes drowsiness if I have to drive
241
Post by: Ahtman
Kilkrazy wrote:If you read the list of clinical indications, you will see it couldn't possibly fit on a label. As is true for practically any drug. That is why doctors rely on data sheets and books like the British National Formulary, not labels, for writing prescriptions.
d-usa already covered it, but I also imagine there are a lot of things Doctors use that patients do not use. I don't think there was any confusion as to doctors being more versed in pharmacology and the texts relating to it.
5470
Post by: sebster
 whembly wrote:Yep... that's my read on this. This doesn't absolve the original patent holder from any liability if they were found fraudulent during the developement of their product.
To me, I see this as a function to keep the generic drug's cost lower.
It's also a basic issue of fairness. The generic manufacturer relied on the testing undertaken by the original company and the FDA, and put on the label all the warnings of the original. For them to be penalised because testing by other parties wasn't sufficient just seems really unfair, and would also introduce a lot of legal risk to generic manufacturers that they can't mitigate through any actions of their own. Automatically Appended Next Post: KalashnikovMarine wrote:I know you read selectively but I've been massively taking the piss this entire thread. You are tracking that right?
No, I hadn't. Because you recently claimed that tactical police units wear balaclavas out of shame, and in another thread you're arguing that you wouldn't let police in to your own home to aid in a hostage situation next door, just because.
At this point, I don't think it's possible to say 'oh that's just too crazy, KalashnikovMarine must be making a joke'.
That said, there is an argument that the European witch hunts, which mostly occurred under the Catholic Church through the 15th to 18th century were incredibly gender biased with traditional women's roles and tasks, which included traditional medicine being labeled as "witch craft". This is also right around the rise of so called "scientific" medicine. I put air quotes on that because medicine of the day was not much better then witchcraft considering leeches and stabbings were popular medical treatments. Any way an acquaintance of mine wrote her master's thesis on the concept of the witch hunts as gendercide, I'll see if I can dig a copy up some where if you're interested. When her paper was publicly discussed/critiqued on campus one of the odder counterpoints is that not enough people had died for it to qualify for a "cide" of any kind. The low number is approximately 60,000 deaths last I saw anything, so I suppose it depends on your own goal posts for that?
Hang on, so you weren't actually joking? Anyhow, it's weird that Catholic Church gets picked out in isolation for its oppressive activities, instead of being seen as it was - a single actor in a region that was full of oppression. I mean, go read about the reformation, and this idea of the Catholic Church alone being evil and nasty should disappear out of your head.
And yeah, the roughly 40,000 people killed as witches over roughly 400 years isn't actually that massive a number. A hundred people a year is, of course, a hundred too many, but if we lower the goal posts to the point where the deaths of roughly a hundred people a year across a region the size of Europe qualifies as a genocide, then basically everything was a genocide and the word has no meaning.
And finally, the idea that witches had this vast store of medicinal knowledge is pure imagination. The witches used the same half assed non-science as the leach doctors that replaced them. The assumption that their methods must have worked better is constructed from nothing other than your own assumption that witches were good and wise. Automatically Appended Next Post: Rented Tritium wrote:But on the other hand, this ruling creates a weird situation where a drug could eventually be discontinued by the original maker, such that there are ONLY generics. In which case the drug could keep getting made forever and nobody can ever be sued. Ostensibly, that's what the FDA is for, they could step in and halt sale of the drug and investigate, etc etc, but what if they're slow?
I think that's the point that you need to start considering a compensation scheme that isn't dependant on finding someone to blame.
91
Post by: Hordini
A lot of the people killed as witches weren't actually witches, either. I wouldn't be surprised if the majority of them weren't.
241
Post by: Ahtman
 Hordini wrote:A lot of the people killed as witches weren't actually witches, either. I wouldn't be surprised if the majority of them weren't.
It has been awhile but I recall a historical theory that the Salem Witch trials were essentially a land grab from women who had land. I'll have to see if I can find it.
23223
Post by: Monster Rain
I've definitely heard that before.
61627
Post by: KalashnikovMarine
sebster wrote: Automatically Appended Next Post: KalashnikovMarine wrote:I know you read selectively but I've been massively taking the piss this entire thread. You are tracking that right?
No, I hadn't. Because you recently claimed that tactical police units wear balaclavas out of shame, and in another thread you're arguing that you wouldn't let police in to your own home to aid in a hostage situation next door, just because. At this point, I don't think it's possible to say 'oh that's just too crazy, KalashnikovMarine must be making a joke'. That said, there is an argument that the European witch hunts, which mostly occurred under the Catholic Church through the 15th to 18th century were incredibly gender biased with traditional women's roles and tasks, which included traditional medicine being labeled as "witch craft". This is also right around the rise of so called "scientific" medicine. I put air quotes on that because medicine of the day was not much better then witchcraft considering leeches and stabbings were popular medical treatments. Any way an acquaintance of mine wrote her master's thesis on the concept of the witch hunts as gendercide, I'll see if I can dig a copy up some where if you're interested. When her paper was publicly discussed/critiqued on campus one of the odder counterpoints is that not enough people had died for it to qualify for a "cide" of any kind. The low number is approximately 60,000 deaths last I saw anything, so I suppose it depends on your own goal posts for that?
Hang on, so you weren't actually joking? Anyhow, it's weird that Catholic Church gets picked out in isolation for its oppressive activities, instead of being seen as it was - a single actor in a region that was full of oppression. I mean, go read about the reformation, and this idea of the Catholic Church alone being evil and nasty should disappear out of your head. And yeah, the roughly 40,000 people killed as witches over roughly 400 years isn't actually that massive a number. A hundred people a year is, of course, a hundred too many, but if we lower the goal posts to the point where the deaths of roughly a hundred people a year across a region the size of Europe qualifies as a genocide, then basically everything was a genocide and the word has no meaning. And finally, the idea that witches had this vast store of medicinal knowledge is pure imagination. The witches used the same half assed non-science as the leach doctors that replaced them. The assumption that their methods must have worked better is constructed from nothing other than your own assumption that witches were good and wise.
I don't assume any of that, the witch hunts with the possible gendercide theories are all valid historical arguments that have been made by many other people then myself, but since misinterpretation like what set off your hilarious little rant about the balacava and the need to force your ideals, morality and apparent hatred of both privacy and property rights while shoving your usually wrong interpretation of what others say down their throats, or didn't for that matter is par for the course I suppose I won't bother to get into it. And yes, the Catholic church gets a lot of spot light considering there was religious motivation behind much of the witch hunts and the protestant reformation didn't kick off for a full two centuries or so after the witch hunts began in earnest. Going with the low numbers that's 20,000 people, hunted down and executed for funsies. Or more accurately to manipulate fear to control and sway the masses of the age, like the sudden changes that one Lucifer who you might recall from the Bible suddenly underwent. Like it or not it's just history.
91
Post by: Hordini
Ahtman wrote: Hordini wrote:A lot of the people killed as witches weren't actually witches, either. I wouldn't be surprised if the majority of them weren't.
It has been awhile but I recall a historical theory that the Salem Witch trials were essentially a land grab from women who had land. I'll have to see if I can find it.
That's interesting. I hadn't heard the reasons behind it specifically, but I do recall hearing that many, if not all of the Salem "witches" weren't actually witches at all. Automatically Appended Next Post: KalashnikovMarine wrote:Or more accurately to manipulate fear to control and sway the masses of the age, like the sudden changes that one Lucifer who you might recall from the Bible suddenly underwent. Like it or not it's just history.
What sudden changes did Lucifer undergo in the Bible, and when did it happen? If I'm remember right, the name Lucifer is barely mentioned in the Bible. I think it pops up like once.
61627
Post by: KalashnikovMarine
Most if not all witches rounded up in any of the major witch hunts weren't witches in any sense of the term. Hell Joan of Arc was burned for witchcraft (on the grounds that she wore pants, seriously) and she's a Catholic saint.
It's not in the Bible, except maybe some creative edits in the new testament here and there, but the Church (in the total christian sense of the term not just the Catholics) influence, especially culturally in the Middle Ages is near total. The modern concept of Satan, and the individual Lucifer as we now know him was mostly invented by the Church during and around the Black Black Death in the mid 1300s, can't have the flock blaming God for all their problems, you need a bad guy. If you dig into the bible, the only appearances of Lucifer ends up with him acting more like Heaven's prosecuting attorney.
Otherwise his existence is confined to Hell, Heaven's supermax level. To really get the "Lord of Hell" stuff you have to wait till a creative young Italian by the name of Dante Aligihieri wrote the most culturally influential piece of slam poetry ever sometime in the early 1300s*, his Divina Commedia. Of course of those most people have only read, or heard about just one part of it, Inferno. A lot of the modern Western conception of hell, and the imagery we associate with it, namely the circles/levels, hell as a place of eternal torment for sin ruled by Satan/Lucifer/The Morningstar, etc come from there and not any actual Christian dogma.
*The Divine Comedy would not be fully published and gain recognition as a "master piece" until the mid 1500s, but the work did the rounds through out the twelfth and thirteenth centuries.
5470
Post by: sebster
KalashnikovMarine wrote:I don't assume any of that, the witch hunts with the possible gendercide theories are all valid historical arguments that have been made by many other people then myself, but since misinterpretation like what set off your hilarious little rant about the balacava
My little rant about the balaclava? Because you brought up out of the blue an idea that tactical police units wear balaclavas out of shame, and when I said that was nutty, you doubled down over and over again, insisting that it was true... that's become my little rant?
Dude, seriously, you're having problems with reality here. Not just in believing that tactical police wear balaclavas out of shame, but in your basic ability to remember recent events.
apparent hatred of both privacy and property rights
Apparent hatred of privacy and property rights? That's just not even a half plausible interpretation of that other thread. I mean, I said plain as day that if a person has no good reason to deny police access to their home, and it would help in resolving some situation, then they should. You disagreed, and now you think that means I hate privacy and property rights.
Real problems with reality.
And yes, the Catholic church gets a lot of spot light considering there was religious motivation behind much of the witch hunts and the protestant reformation didn't kick off for a full two centuries or so after the witch hunts began in earnest.
Yes, but when hundreds of thousands died in all kinds of religious persecution, worrying about the witches and looking at them without the context of the surrounding religious violence is inane.
Going with the low numbers that's 20,000 people, hunted down and executed for funsies. Or more accurately to manipulate fear to control and sway the masses of the age, like the sudden changes that one Lucifer who you might recall from the Bible suddenly underwent. Like it or not it's just history.
Of course its history. I already gave you a higher number. But guess what, 20,000 dead people over the course of 400 years is not major, shocking history, and sure as hell isn't a genocide. Automatically Appended Next Post: KalashnikovMarine wrote:It's not in the Bible, except maybe some creative edits in the new testament here and there, but the Church (in the total christian sense of the term not just the Catholics) influence, especially culturally in the Middle Ages is near total. The modern concept of Satan, and the individual Lucifer as we now know him was mostly invented by the Church during and around the Black Black Death in the mid 1300s, can't have the flock blaming God for all their problems, you need a bad guy. If you dig into the bible, the only appearances of Lucifer ends up with him acting more like Heaven's prosecuting attorney.
Sort of, but not really. You're right that many people's understanding of modern Christian lore is from stuff outside the bible, particularly when it comes to Satan and Hell (but also the nativity and many others), but it wasn't 'invented' by the Catholic Church as some conscious act.
Rather, the bible influences popular culture, it is used to tell exciting, imaginative tale. This is as true today as it was in the middle ages. These stories get quickly absorbed into the popular understanding of the bible, so that things like the three wise men unquestioned elements of the faith, despite being straight up fan fiction. Your point on Dante's Inferno is a classic example - it draws on the bible as a direct inspiration, but adds many imaginative elements, which rather quickly become a key part of how people come to understand their religion, those in the church included.
Fred Clark of the slacktivist, has been doing an epic analysis of the Left Behind books, and he made the point that despite the claims that Left Behind was directly inspired by the Bible and nothing else, he couldn't see how any of it would be possible if films like The Omen hadn't already been written.
61627
Post by: KalashnikovMarine
sebster wrote:
Going with the low numbers that's 20,000 people, hunted down and executed for funsies. Or more accurately to manipulate fear to control and sway the masses of the age, like the sudden changes that one Lucifer who you might recall from the Bible suddenly underwent. Like it or not it's just history.
Of course its history. I already gave you a higher number. But guess what, 20,000 dead people over the course of 400 years is not major, shocking history, and sure as hell isn't a genocide.
Nor did I say it was, I said the argument's been made in academic settings and without. Also I think the term used is "gendercide".
Are you sure you're not the one with a loose grip on reality?
5470
Post by: sebster
KalashnikovMarine wrote:Nor did I say it was, I said the argument's been made in academic settings and without. Also I think the term used is "gendercide".
There's all kinds of nonsense put forward in academic debates. Being well informed on an issue does not necessarily mean forming a sensible conclusion. That's basically why academic debate exists, because not everything put forward is reasonable and well considered, and so the process works (for the most part) to sift out the weaker stuff. As such, the measure of an argument having merit isn't just that it's been made, but that it's survived debate and has achieved acceptance within that specific field.
And gendercide is just wordplay, meaning the same thing but with a twist to note the kind of victim. For it to be appropriate, it would still have to be on a scale that would justify regular use of genocide, and no, a hundred people a year across Europe doesn't qualify.
Are you sure you're not the one with a loose grip on reality?
I'm pretty confident I'm not the one who's claimed that saying a person, absent a good reason, should allow police in to their home must hate privacy and personal property.
33125
Post by: Seaward
Man. I'm amazed that this thread has provided the answer to a question historians have been unable to agree on for decades: namely, the number of 'witches' killed during the period when the inquisition was active.
5470
Post by: sebster
I think it's really strange that a grown ass man can't tell the difference between using a number as a shorthand for the broad range of figures considerd by historians to the reasonably likely range, and thinking we have a specific answer.
61627
Post by: KalashnikovMarine
On that Sebster we can agree.
53002
Post by: Tibbsy
How did this thread get from drug companies to witch trials in the middle ages?
It seems nobody expected the Spanish Inquisition! *
*Sorry, I just wanted to make a Python joke...
33125
Post by: Seaward
I wouldn't. Estimates with credible support range from the high four digits to the low seven.
5470
Post by: sebster
 Seaward wrote:I wouldn't. Estimates with credible support range from the high four digits to the low seven.
Okay. You can continue your conversations on the subject repeating 'estimates with credible support range from the high four digits to the low seven' every time your point needs a quanity. The rest of us are probably going to carry on being sensible, though.
|
|
