Article Source: msnbc.com
from:msnbc.comRuling that drug makers can't be sued for failing to list warnings violates spirit of the law — and endangers consumers
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 Welcome to OBAMALAND
What does Obama have to do with this? Congress passed laws which required generic drugs to carry the same warnings as branded drugs, probably to try to ensure that all risks were identified, and neglected to account for information that might develop later. So they go back and fix it. Again, what does Obama have to do with this? My guess is if they fix it and don't add 4 thousand pages of amendments and pork to it, he will sign it.
Yankee-2004655, your "Obamaland" statement is ignorant. The two members of the court nominated by Obama (SOTOMAYOR and KAGAN) both dissented.
Just today (for my employer) I was reading one of the government requirements I must abide by. It requires a warning be included worded EXACTLY as the government provided. This meant I could neither add nor subtract anything. Now common sense indicates the entire warning was based on error, but that maters not.
My father lies in a nursing home, often unable to position himself on his bed because he's so fat. He didn't start that way. Nursing homes lose brownie points (or worse) with the state if their residents lose weight. The rules state nothing about gaining weight. So the staff come around 5 times a day with high calorie (and very tasty) food and urge residents to eat. We've asked them not to with my Dad, asking doesn't work. Seems the state has more of a long term influence.
This is the nature of government. One solution fits all. You must abide by it. Obamacare is the epitome of this, even to the point of being unconstitutional. It arises out of arrogance. You're fooling yourself if you think Congress meant anything other than that generic drug makers must use the original list. It's what they do, in their own ignorance, tell other people what to do.
AGAIN, what does President Obama's HCR bill do to encourage nursing homes to over feed seniors???? Medicare does not cover nursing homes, BTW.
yankee-2004655
A perfect example of the ignorance driving much of our thinking (or lack of) today. It's an easy catch-phrase that is stated in hopes of getting a slap on the back and a wink from your buddies that is based on total disrespect and a third grade mentality.
Yea, I guess a ruling by a COURT that is totally not connected to or influenced by the presidency, much less Obama himself, must represent something as sophomoric as "OBAMALAND".
And we stand for integrity? Wow.
Republican1,
The government makes mistakes... everyone does. And there are ways to correct those mistakes. This way failed us this time.
But you are wrong with regard to both intent and results. Their intent is to provide regulations... guidelines... so that we generally are protected from complete misrepresentations we have seen in the past. Their results, for the most part, are good.
Your father's plight is a good case in point. The failure here isn't necessarily the government's. That nursing home, in absence of what regulation does exist, would obviously be even more uncaring for a far majority of their patients if it weren't for that regulation.
The point is, are you saying that even more regulation is required to right this wrong? Do you mean that your father has been wronged by the lack of regulations on weight gain? Or is it really that the "private" provider here really doesn't care and really is the culprit here.
Maybe you expect too much from your government while complaining about the fact that its involved at all? Can't have it both ways.
Contrary to what the author of this article feels, the Supreme Court did the right thing. People are constantly complaining about activist judges who substitute their own views for the law. In this case, the Supreme Court judges followed the applicable law exactly and people are still complaining. The judges did what they are supposed to do. They even said in their opinion that they think the law needs to be fixed, but they still followed it as they should. There was nothing unconstitutional about the law, so the Supreme court judges had no choice but to follow it. If people think the law is wrong, take it up with the Legislative Branch, i.e. Congress. They are the ones responsible for writing the laws the courts uphold. The law says that the generic drug manufacturer must use the same labeling as the brand name drug. How can you have a law like that and then ask that people be allowed to sue generic drug manufacturers for doing just that. Regardless of state law, federal law takes precedence and the manufacturers correctly followed the federal law. If they had not done so, they would have risked losing their license to sell the drug in an FDA action against them for breaking federal law.
I for one do not want activist judges ignoring the laws passed by the legislative branch just because they think they are wrong. That is not their job. Their job is to enforce the laws written by the legislative branch. They did what they legally could in pointing out in their opinion that they thought the law needed to be fixed. Now it is up to the legislative branch to fix this problem.
It is interesting that the two Obama appointees dissented... they believe in legislating from the bench and would have Federal Law perverted because they are so much smarter than Congress or us, the people. It is up to the Congress to correct their mistake, not the Supreme Court. Bravo for the majority for having the sense to interpret the law (their job) rather than make law (Congress' job).
Dr. Kaplan's opinion sounds like a liberal viewpoint, but one that does not necessarily include the greatest good for the greatest number. He does not note that, by holding the generic drug maker accountable, the result will be that we will see likely a huge rise in the cost of generic meds, the present low cost of which is one of the few things holding the spiraling cost of pharmaceuticals in check.
There will always be an element of the unknown and the unforeseen in pharmaceutical practice, despite all we try to do to protect ourselves from these products. To adhere to the knowledge of the original manufacturer, ie, the company which truly has the best information on the product, seems reasonably fair to all.
no one said anything about the unforeseen. they are talking about possible side effects that a) might have been observed in the gap of time between the release of the original drug and the release of the generic. and b) side effects that only affect those patients taking the generic version of the drug. that second point is INCREDIBLY important, and highlights a little talked about fact: generic drugs are not an exact copy of the original. ever. some are so close as to be unnoticeable, but some generics are very different, and have hugely different side effects. i take a painkiller for arthritis, and there is the original percocet, and three major generic versions of my dosage. the original gives me stomach cramps and occasionally makes me vomit uncontrollably at any dosage. the generic with the script C on it might as well be a sugar pill, and i would swear it contains no painkiller OR tylenol. the other two generics say watson, and both work amazingly well, at half my prescribed dose. of course, these are my observations based on how they affect me, but the point is that they are VERY different medicines, even though they all claim to be the exact same thing. and this is an old, simple medicine.... what happens when they have to copy some complicated heart medicine? kinda scares me.
but the others were right- this just means the laws need fixing.
It's the law that generic makers have to follow the original manufacturer. It may be wrong to do so even if they know there's difference. But, as the court says, their hands are tied and they aren't allowed to changed them by law even if they could.
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 The Court did EXACTLY what it should have done: it interpretted and ruled on EXISTING LAW. They are coorect that federal rules trump state ones in this case. If that goes against common sense, it is the fault of the federal law, not the Court that is ruling based on what the law states.Â
If the Court ruled any other way, they would no longer be interpretting law, but would be changing law based on their opinions and ideology. The liberal 4 on the Court are always ready and willing to do just that. That is NOT the Court's job, and would be a serious perversion of our system of government!! Thankfully, there are still 5 conservative justices who know their role!
I hate this decision but they had to go with federal law. The answer must lie in the congress to change the law about prescription drug labels for peoples safety. A health care bill that allows for States to address these issues as well as having health insurance companies compete across state lines would go along way. If you belive in a free market. Maybe getting your drugs from Canada is a better way as well.They keep the labels up to date for the most part. They're less expensive as well.
The court was right to uphold, rather than revise or rewrite, the law. It's up to Congress to change the law if it doesn't accomplish its intended purpose. I don't know why it's so hard to understand that principle that four out of nine justices don't get it.
Very well said!
Actually I have to disagree with you. The Supreme Court's job is to interpret the laws passed by Congress-and the law is clear. Congress has stated generic drugs must have the "same label" regardless of whether additional information is available. The Court cannot, and SHOULD not, re-write this legislation. If ANYONE needs to address this issue, it is CONGRESS-which clearly passed (gee, what a surprise) an incredibly stupid law.
Consider it this way-if someone told you that you both had to and could not do something-what would YOU do? You, like the generic manufacturers, would be damned if you did and damned if you didn't. Since Federal law takes precedence the Federal Law controls.
Don't blame the Supreme Court for concluding that the letter of the law governs its decision-blame the idiots who wrote the law to begin with.
What this has to do is who has the right to regulate. The Constitution grants the right to Congress to regulate interstate commerce where this is coming from. For those who are wondering how this has anything to do with with interstate commerce the same argument justifies the health care law. To change the regulation it is going to have to fall under the Federal Government. In other words go to your congressman and demand that this is changed. The Supreme Courts job, amongst other things is to interpret the Constitution. This fails because of it.
@Cynic: You make the PERFECT point. The Supreme Court can't make, change or rescind laws; it can only interpret them. I'm surprised the author of the article missed (or failed to make) that point. I realize it was an opinion piece, but that glaring omission is irresponsible to say the least.
At any rate, the next thing to do is have Congress get off their lazy, bickering, partisan behinds and correct this stupidity!
I have to agree with Tom43491 and Political Cynic. The constitution states that Congress writes the laws. This does not seem too difficult to understand -- but I guess that 4 of 9 justices, as well as the author of this article just don't get it.
The court's job is to uphold the law (unless it's unconstitutional), not to "fix it" by revising or rewriting it. Congress has the responsibility to change it if it doesn't accomplish its intended purpose as written. If Congress spent its time tending to business instead of engaging in pointless political activities and sucking up for campaign contributions (or worse), such corrections could quickly and easily be made.
You just don't get it. The law is the law! The courts only rule on law not what anyone thinks is the right thing to do. And that's how it should be. Companies need to know what is required, not what can change because of what ever. Don't like it change the law.
This has to do with who can regulate not the law itself. I'm sorry but if you want to change this so the States have the right you will need to change the Constitution. Beware of what you wish for though.
Another article that is just babble without any research into the legal opinion. How the press gets away with stories like this written in the 'heat' of a decision is beyond sanity.
The FDA and many others are involved here including Congress. Â Â They worry about drug costs. Â And here a 'babbler' says to hell with the public, sue everyone. Â Â Guess who pays?
Another Babbler spouting off without full study of the opinion. How the press gets away with this is beyond sanity.
The FDA and congress are involved here also. Guess who pays for out of control and irresponsible lawsuits?
"adhere to a pedantic interpretation of the relationship between federal and state law rather than protecting your health and mine."
This is typical tripe. The court is supposed to interpret the law, period. If there is a problem with a law, then the other two branches try to do something about it. Legislating from the bench is something that nobody (at least nobody in their right mind) wants. I'm sure the justices care about the health of the public, but their job is to interpret. They interpreted. If you don't like their interpretation, deal with it through the legislature, but don't say that the courts should take values into account when interpreting a law. Flame away.
I have personally taken a brand name prescription drugs with tremendous success, then switched to the generic equivalents with crippling side-effects and/or decreased efficacy. Under the law, the drugs are supposed to have the same bio-equivalency, and yet many people who have taken them can tell you that they, very clearly, do not.
State laws should be consistent with Federal laws, the decision got that right - and yet this decision clearly says to me that the Federal law is flawed.
The FDA needs to step up its regulation of generic drugs - Canada does it just fine, with fully equivalent drugs available at similarly inexpensive prices. And yet each brand-name drug has fewer different versions of generic equivalents, because the majority of generic competitors available in the US don't meet Canada's rigorous standards. Their system is proof that limiting the competition doesn't raise generic prices, but it does make it much safer for consumers.
Somebody at the FDA: Please call Canada and find out how it's done? And then call Congress and get these Federal laws sorted out.
What do you expect from this right-wing largely GOP-appointed so-called "court"?
Your trying to state that State law supersides Federal law. Isn't that what your accusing the Republicans of doing all the time. I'm afraid it goes both ways. If you think that it doesn't you might as well forget about health care reform.
If the law needs to be changed, that is the job of the legislature. Judges must not write law.
And neither should they legislate from the bench by twisting the laws to benefit corporations over real people, but this is what they have done.
The present court is big businesses tool. G W Bush made sure of it.
this decision just doesn't make any sense at all. sounds like a double standard to me...
While I am no fan of generic drug manufacturers (I think they get away with far too lax of regulation), the majority opinion in this case is correct. Kudos to all the comments relaying the fact that the Supreme Court upholds and interprets the law, it does not change or rewrite the law. This case is simply a question of whether federal regulations preempt state regulations. If the two are in conflict, then yes, federal regulations win out. It is up to Congress to resolve this conflict, as defined in the Constitution.
It is actually quite embarrassing to see a highly-educated person from a highly-respected university write such an article. That Dr. Caplan cannot seem to grasp this concept is a sad indictment on our "thinking class".
The Fascist Five Strike Again! In issuing this ruling the conservative activists on the Supreme Court are trying to make the American public believe that generic drugs aren't as safe as the brand name and very much more expensive drugs made by the pharmaceutical companies that, along with the rest of corporate America, own these five lap dogs.
So what the court said was, the laws as written create a absurd situation. The thing is,absurd or not,they have to follow the law. Its not their decision on whether they like the result or not. Congress on the other hand has the option to fix this and they should.
How in the world can a Ph.D (the writer of this article) be so ignorant of our system of laws?
I am Democrat and lean more liberal than conservative; I believe the consumer must be protected.
But, even I must acknoweledge it is the Supreme Court's job to uphold the law, not change or make it. This is a wrong for our lawmakers to correct, not the Supreme Court. They were just upholding the law. Let Congress fix the law.
The court was wrong in Brown vs Board of Education.
This is a dumb game. It is the Supreme Court. They will make decisions you don't like.
LOL at the State's Right argument.
I don't think anyone has an idea of what happens when drugs are approved and tested.
Brand-name drugs go through years and millions of dollars of testing to ensure that the drugs are safe and effective (this is not the forum to discuss the merits of safe and effective).
Brand-name manufacturers receive patents to make sure they can recoup the dollars and time spent on all this safety testing.
Generic manufacturers - because we all know that the brand-name is safe and effective! - only prove that their version of the drug is equivalent (again, no more anecdotes about how you think the purple ones are better than the pink ones) to the brand name drug. Very very very little safety testing because the brand-name company did all the safety testing.
So, if our law states that only the brand-name company does the safety testing, and the law states that the generic must be equivalent to the brand-name, and the law states that the generic's label must be the same as the brand-name's safety label, then common sense would dictate that any safety issues need to be addressed with the company who did the safety testing - the brand-name manufacturer.
If we require generic manufacturers to do safety testing on par with brand-names, we shouldn't bother with producing generics anymore because they will be the same price as the brand-name.
Yes, issues are discovered with drugs once they are released into the marketplace, and even many years later when the generics are out. It took decades to realize that, for a lot of drugs, people of Asian ancestry can get more side effects because their livers don't process the drugs as efficiently - they are basically overdosing (again - this is only one liver enzyme system and a handful of drugs).
But, the good new is, we have processes in place for label changes! The brand manufacturer can change the label on its own, or the FDA can firmly suggest that it add (usually at this point, a black box) warning. Once that happens, all the generic manufacturers follow suit.
And, if the generic company finds a side effect, there is even a snazzy FDA hotline that anyone (patient, doctor, pharmacy, manufacturer) can call to report drug side effects! Then, when more than one call about a side effect comes in, they can easily trace and track the problem.
I'm sure we've all seen the 1800BADDRUG commercials. I can tell you that, without exception, every single side effect (even death!) I have heard on every single one of those commercials is listed in the prescribing information for the drug. The side effect that caused this lawsuit has been listed in the prescribing information for Metoclopramide (Reglan) for DECADES.
You get this information every time you fill a prescription for the first time (at least at a pharmacy that follows the law), and some pharmacies give it to you each time you fill. This is the piece of paper you rip off and throw away without reading.
Your doctor gets this huge, two-foot thick book with monthly updates that he/she never looks at. I really hope that info is officially on-line now. That thing was a bitch to update - ever fall in high school and your binder popped open? Imagine if your binder was 2 feet thick with the thin paper used in Bibles.
Your pharmacist gets a little folded up version of the same info the doctor has every time he/she orders a bottle of the drug. If you ask for the "prescribing information", they will most likely give it to you if they still have it. Additionally, their magic computer systems are loaded with all of the drug interactions the prescribing information lists (which is why it is a good idea to stick with one pharmacy).
And, of course, for the last 10 or more years, everyone has had access to all this information on the internet. You will find it in the "for prescribers" section on most drug websites.
So, why was all this money spent taking this issue to the supreme court? Because no one wants to be responsible for themselves? That when they check the "No, I don't have questions for the pharmacist" box and sign, and when they say "no" to the clerk asking them the question, that they really didn't mean it? That they took a gamble (any drug, even Tylenol and Aspirin, is a risk-to-benefit decision), and it didn't pay off for them, so they want to look around and go "hmmm, my doc and pharmacist have malpractice insurance, and it will probably be hard to sue them - I know! The evil drug companies! They have a lot of money! They should have to pay!"
Seriously, people! Personal responsibility!
Knowing all the prescribing information, including the info on the rare risk of TD, I personally took metoclopramide for nearly 12 years and never had any problems worse than dry mouth - much better than puking so hard that I was tearing holes in my esophagus! Yes, I am an anecdote, but so are these plaintiffs. BTW - my rabbit took it for years as well, and she lived lived to the ripe old age of 16.
In theory, you are correct, except for missing a few very important points:
1. Generic manufacturers have to prove that their drug contains the same concentration of active ingredient - but the brand name's delivery system remains patented and secret. The generic manufacturers have to, therefore, develop their own or guess as to the original's. This is where the majority of differences between efficacies and side effects occur, and why the safety profile of the brand name CANNOT be automatically considered for the generic.
2. The lawsuit exists (and many others, for that matter) because what "the law states" and what occurs in reality are not necessarily the same.
3. "Common sense" dictates that if there are safety issues with generics, after the brand name was proven safe, that there may be an issue with the generic manufacturers following said laws - not that the brand name manufacturer should automatically be liable for the generic's safety profile.
Ask any of those pharmacists or doctors you mentioned, and they'll tell you the same thing.
If laws were always followed, we wouldn't need police or courts.
skate,
I don't have to ask a pharmacist. I am one. In fact, I have a doctorate in it, so I guess I'm a doctor too.
1. Generic drugs have to prove both that they contain the same active ingredients, but also that they are bio-available within a slim margin of the original. So, your first point is not valid.
2. A generic manufacturer can't be held liable when no one reports side effects. I would think the plaintiffs would be better off suing their doctors for not reporting the side effects through the proper channels.
3. The problem is never that a generic has a side effect that the brand doesn't have (unless, of course, we are talking about a tainted lot- which we aren't). The problem is that relatively few people take brand name drugs. Once a drug goes off patent, millions more people start taking it. The problem is that there are side effects with the drug itself - brand name or generic - which aren't found until a sufficient quantity of people have taken the drug, which can take 20 years sometimes.
Think about it this way - aspirin as been around for over 150 years, and we are still finding new "side effects" of the drug (colon cancer prevention, cataract prevention, etc.)
The example I gave of Asian patients reacting differently to some drugs - the anti-ulcer drug I am thinking of had already gone off patent (been on the market for at least 20 years) before those side effects were known. Asian patients had been having these effects, and kept having these effects, whether they were taking the brand name drug or the generic version.
So, it is completely wrong to say that generics are having safety issues that brand name drugs are not. Saying that is unfair to patients, and it can scare patients away from taking generic drugs - drugs they would not be able to afford in the brand name. That is simply inflammatory propaganda.
The issue brought before the Supreme Court was that after a brand name drug's patent expires, side effects and other new drug information can be found about the active ingredient.
The Supreme Court found that it is still the brand-name drug's manufacturer's duty to change the labeling to reflect these changes, even if the patients who had the side effects were taking generic versions.
Which, basically means the Supreme Court thought we should continue doing exactly what we have been doing all along.
well we live in a great contry but for one thing it is based on profit at its peoples expense. The all mighty dollar even has parents sacraficeing the health and morals of their children just to have a lot of money. If u do not research and take your health in your own hands and trust what is proven to you then u too will be a victim of making the rich richer and your self the ticket as long as they can keep u around, fir the greedy love of money most humans in the us have. I feel so bad, people die, I was all most one of them. THANK YOU
Most browsers now have spell check.
If you would like people to make the attempt at reading your posts, I suggest that you try using it.
A grammar and style guide may not be a bad idea either.
Honestly someone has to read Article 1 Section 8 of the US Constitution. It applies to interstate commerce which is in play here. You may not like it but that is what in play here. Contact your Congressman to make the changes that should be required.