Holy Shit! New Law: Drug Companies exempt from Lawsuits -Supreme Court Ruling

[Fantastic Anarchist]

Last edited Tue Jul 9, 2013, 10:28 PM - Edit history (2)

Snuck right under the rader:

New Law: Drug Companies exempt from Lawsuits -Supreme Court Ruling

More PROOF.. Corporations IS OUR Government (Corporatism), using it as their revolving door exempting themsesevles from liability.

Supreme Court rules Drug Companies exempt from Lawsuits

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.

Drug companies failed to warn patients that toxic epidermal necrolysis was a side effect. But the Supreme Court ruled they’re still not liable for damages.

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.

http://www.whiteoutpress.com/articles/q32013/supreme-court-rules-drug-companies-exempt-from-lawsuits/

The meta link to White Out Press seems to be overloaded.

Here's a link to the google search for same topic:

https://www.google.com/search?q=supreme+court+rules+drug+companies+exempt+from+lawsuits&oq=supreme+court+rules+drug+companies+exempt+from+lawsuits&aqs=chrome.0.69i57j69i62.8272j0&sourceid=chrome&ie=UTF-8

Edit to add working link with special thanks to Tx4obama. There is also a link downthread to the Avalon project with full article.

Edit to replace non-working link with correct link. Again, thanks to Tx4obama.

[factsarenotfair]

1. I feel something tightening around my neck.

What could it be?

[kelliekat44]

62. Our necks. Tell me again why who is President doesn't really matter? nt

[geek tragedy]

2. It's the generic vs name brand distinction.

The issue is that under federal law, generic manufacturers aren't allowed to modify the warning language used in the name brand packaging. Not even a puncuation mark of difference.

So, the issue in that case was whether the federal law preempts state labeling requirements.

[Fantastic Anarchist]

5. Either way, generic vs name brand, the warning should be there.

Also, the reason for the verdict, that what the FDA says "takes precedent over facts," well, that's some extremely contorted logic there. Facts, schmacks, I tells ya!

[geek tragedy]

7. The solution is for Congress to write a better law.

The alternative would be that generic drugs wouldn't be available in states whose warning requirements exceed those of the FDA.

[Fantastic Anarchist]

11. I work for a CRO ...

CRO = Clinical Research Organization

In my experience, adverse events have to be reported to the FDA, not the state governments. So, if those adverse events were reported, it shouldn't matter whether the drug is generic or brand name, as the warning should apply to both.

[geek tragedy]

18. And that's the rub--the warning for both is exactly the same.

But only the name brand manufacturer can edit/revise the warning. They also face liability for deficiencies in that labeling.

[Fantastic Anarchist]

21. Which is confusing because ...

As a CRO, we have to report all adverse events to the FDA. The FDA then has to sign off on the drug (with full knowledge of all adverse events recorded). Wouldn't that require the drug manufacturer to label the name brand appropriately, and hence, the generic has to be labeled the exact same way?

[geek tragedy]

23. The original manufacturer is the only one who can change the language.

The crux of the problem is that with a generic there's one compan's product with another company's design and warning label.

Suing the generic manufacturer doesn't pressure the original manufacturer to change its label, since they're not getting sued.

Perversely, it helps the original manufacturer by imposing extra costs on the generic competition.

[Fantastic Anarchist]

25. Okay, I have some more information.

I should have qualified the fact that I work as a Productivity & Operations Analyst, so my knowledge on the medical side is rather limited. I just talked to a CRA (Clinical Research Associate), and from what I could gather is this:

Any adverse events (including serious adverse events) which are drug-related (which is decided by the PI <Principle Investigator> ) have to be reported to the IRB (Institutional Review Board), which then passes the information to the FDA. The FDA takes all data and essentially acts like a marketing firm if the drug is safe.

Now, with regard to the generic drug, the firm has to go through its own clinical trial (phase I), to test that its particular molecular structure is effective and safe.

I'm still not sure that the generic manufacturer has to have the same labeling requirements as the name brand manufacturer (considering the above - they could have differing results from the original).

I'll have to talk to our Drug Safety expert when he returns from vacation to gather more information.

But it stands to reason, that in either case, either company should be held culpable for off warning reactions, no?

[geek tragedy]

27. Except that the generic company doesn't choose its warning label.

It's required by federal law to use the exact same language as that used by the original manufacturer.

Generally, the tort system is supposed to work to cause people to stop doing bad things or to take necessary steps to protect the public. But, in the case where the generic manufacturer literally has no agency in the use of the label, it doesn't make much sense to blame them for it.

Moreover, the situation is one where the generic manufacturer is in a position where they can (a) obey federal but not state law or (b) obey state but not federal law; or (c) just not sell drugs in the state with that law.

(b) is right out, so the question is whether they can be sued for following federal law, or whether that federal law preempts the state laws. (c) means a big old mess, with some states having generic drugs but not others, with issues of cross-state border trafficking etc.

[Fantastic Anarchist]

29. I don't understand why the labeling requirements would have to be the same ...

... when the generic manufacturer still has to run a Phase I trial which could yield different results.

Now, I understand your position totally. However, there's got to be some kind of remedy, whether with the FDA's labeling requirements or with Congress.

I still have to talk to more people to find out more information, but we can agree that something is very, very wrong here?

[geek tragedy]

30. Oh, we agree that the law is all screwed up.

Unfortunately, Congress.

[godai]

32. Generic must show bioequivalence and must have exact labeling as innovator.

A bioequivalence study compares blood levels of brand vs generic. If not the same, FDA won't approve it.

[Fantastic Anarchist]

33. Thank you for the information.

Much appreciated.

[StrayKat]

36. It's a very broad range.

The agency's definition of bioequivalence is surprisingly broad: A generic's maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same. -CNN Money

[Fantastic Anarchist]

37. And thank you, too, for more information.

That's what a discussion board is all about.

Thanks.

[godai]

39. No, that's an old argument made by innovators. (Responding to#36)

It's a statistical test for bioequivalence, which allows some variation but nowhere near that large.. FDA checked years of bioquivalence studies and found differences of about 3%.

I know that this is just taken from the link but it's a classic innovator scare tactic to raise doubts about generic drugs. But, many innovator companies now also make generic drugs.

[StrayKat]

54. Read the article.

If you (or anyone following the thread) hasn't, it's a good read and relevant to the point about generics not being exactly identical to name brand. The link again: http://management.fortune.cnn.com/2013/01/10/generic-drugs-quality/

Likewise, if you have info on the years of FDA bioequivalence studies with a 3% difference, I'd be interested in taking a look.

Also, in some states, bioequivalent substitutions for name brands can be made by pharmacists without your knowledge or consent. Does that mean that forfeiture of your right to sue gets to be made without your knowledge by your pharmacist?

[godai]

58. Here you go...(response to #54)

The observed average differences between reference and generic products for AUC was 3.5% (JAMA,
Sept. 4, 1987, Vol. 258, No. 9). The second survey included 127
bioequivalence studies submitted to the agency in 273 ANDAs approved in 1997.
The three measures reviewed include AUC(0-t), AUC(0-inf), and Cmax. The observed
average differences between the reference and generic products were + 3.47%
(SD 2.84) for AUC(0-t), + 3.25% (SD 2.97) for AUC(0-inf), and + 4.29% (SD 3.72)
for Cmax (JAMA, Dec. 1, 1999, Vol. 282, No. 21).


http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm071436.pdf page x

-----------------------------------------------------------------
Generics aren't 'exactly identical' anymore than innovator separate lots of product are 'exactly identical'. Think about that. It's important to understand.

[StrayKat]

71. Access Denied.

The link you provided has restricted access. I tried pulling up another source from Google, but had no luck. From articles that reference the study, it seems to be a study from the 1980s that looked at drugs approved of in the '60s - '80s. The problem with generic Wellbutrin (which the FDA did actually rule as bioequivalent and later recall despite still maintaining bioequivalence) is more modern, as are some of the problems making substitutions with other meds. There are also some controversy and reported problems with more breakthrough seizures in some generic epilepsy meds. The 'game' has changed since the 1980s. Even the FDA is considering reworking its bioequivalency standards:

In April, in an 11-to-2 vote, members of the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology suggested that the agency’s confidence intervals for bioequivalence should be narrowed to a range of 90% to 111% from the current range of 80% to 125%, saying the current intervals were not sufficient for generic NTI drugs. Ms. Rice said the agency was considering the recommendation.

-Pharmacy Practice News

[godai]

73. No restrictions on the link.

http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm071436.pdf

The suggestion to narrow the CI is not new, for NTI drugs. The April vote is just another suggestion in this regard.

[Fantastic Anarchist]

59. You're last paragraph is a very interesting point. nt

[HiPointDem]

65. "it helps the original manufacturer by imposing extra costs on the generic competition."

i'd imagine that's the point.

[Fantastic Anarchist]

3. Look at this optimum phrase:

And if the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions.

We all know that the Supreme Court wasn't interested in the actual facts, but to blatantly say so, well, that came as a surprise.

I found a posting with the full article here:

http://projectavalon.net/forum4/showthread.php?60956-Supreme-Court-rules-Drug-Companies-exempt-from-Lawsuits

[onenote]

43. Would it bother you to know that the line you cite at the top of your post does not appear anywhere

in the court's opinion?

[Fantastic Anarchist]

52. No, it wouldn't bother me to know.

I haven't read the opinion yet. Between work and reading what I can, things slip through.

Strange question, though.

[onenote]

63. Why is it a strange question?

You describe the phrase in question as an "optimum" phrase and suggest that it is something that the court "blatantly" said.

I just thought youu might be interested that this "optimum" phrase (or anything close to it) does not appear in the court's opinion.

[Fantastic Anarchist]

74. It's strange to ask if I'd be bothered by new information.

Oh, you were trying to be snarky.

Hint: I got it the first time.

[Andy823]

4. Another reason

We need to make sure that in 2010 don't allow republicans to win the WH, if we do then be prepared for more of this kind of BS where corporations are exempt from paying for the damage they do to the people of this country. We need more liberal judges on the court, not more radical right wing idiots!

[Fantastic Anarchist]

6. I certainly don't want any right-wingers in government ...

... but do you think some Democrats (or the party as a whole) are exempt from our fury?

[snooper2]

8. Another ignorant "news" website that should be banned from DU..

No wonder you didn't want to link directly...

Who is trying to operate under the radar here Mr. Fantastic?

http://www.whiteoutpress.com/articles/q32013/supreme-court-rules-drug-companies-exempt-from-lawsuits/


Right below the stupid in this "article", we have-----



Recent Whiteout Press articles:

Michael Bloomberg accused of illegal Gun Trafficking

Plot to assassinate Occupy Leaders exposed further

7-Eleven raids prove US Slavery alive and well



I swear 30% of the population are just too stupid to use the Internet responsibly, that includes you Alex Jones wannabes, Countercrap, etc.,

[Fantastic Anarchist]

10. I tried to link to that site. It came up with an error message.

I have no idea about the site, nor its contents. I didn't try to hide anything, and in fact, provided a google search link so I could get the rest of the story.

I went through multiple sites to get the full story, and the one that I could find was the Avalon project which appears to be a message board (which I posted the link upthread).

I'm interested in the story, though, not where it came from. How about you?

I wasn't trying to be "under the radar," pal.

[SomethingFishy]

24. Ok here is the article from a "liberal" site..

http://projectavalon.net/forum4/showthread.php?60956-Supreme-Court-rules-Drug-Companies-exempt-from-Lawsuits

I swear 70% of the population has their head so far up their ass they can't see daylight.

[Fantastic Anarchist]

26. That site was the only one that had the full article ...

... as I couldn't get to the original.

Someone did provide the Supreme Court ruling in PDF form in this thread, though.

[indepat]

9. If anyone was napping, not realizing ours is a wholly-owned corporatist government, this ruling

should allay any doubt.

[kentuck]

12. Sue the doctors if,,,,

You get a bad drug. I think you will see a drop-off in new drug profits?

[Fantastic Anarchist]

13. Not sure how it would be the doctor's fault ...

... if they aren't made aware of the adverse reactions.

[DeschutesRiver]

14. Link to the Supreme Court decision

http://www.supremecourt.gov/opinions/12pdf/12-142_8njq.pdf

[Fantastic Anarchist]

16. Thank you.

[dmosh42]

15. personal bank acc'ts of justices need to be audited to see where the money's coming from!....

[Fantastic Anarchist]

17. I'm totally supportive of that.

I mean with all of the decisions coming out of that court (minus the rulings on DOMA and Prop 8), it certainly doesn't seem they have the peoples' interests at heart.

Like frogs on slow boil ...

[mountain grammy]

46. Ya think? But it doesn't matter, they are absolutely above the law

That said, their bank accounts should be public to at least confirm what we already know.

[onenote]

68. Supreme Court Justices are required to file financial disclosure forms

http://www.opensecrets.org/news/2011/02/supreme-court-justices-personal-finances.html

Are you saying that Supreme Court justices should be subjected to a level of scrutiny greater than that lower court judges? Members of Congress? The President?

[mountain grammy]

76. yes they are and Thomas's were brought up a few years ago

when he "forgot" his wife's $100,000+/year salary from the teabaggers, I think it was Americans for Prosperity.
Actually lower court justices are subjected to a greater level of scrutiny than supreme court justices. The supreme court justices police themselves and that's not working out so well.

[Scuba]

19. ...

http://www.whiteoutpress.com/articles/q32013/supreme-court-rules-drug-companies-exempt-from-lawsuits/

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.

And Republicans want to put corporations do their own FDA testing? What could possibly go wrong?

Bush stacked the FDA with corporate shills. I have to ask: Did Obama clean house?

http://journals.democraticunderground.com/Time%20for%20change/84

[EC]

20. One of the first things Walker and his crew did here in

WI was to pass a law disallowing us to sue medical equipment makers. If your pacemaker fails, tough shit..no remedy. If your electric wheelchair goes crazy and won't stop, bid deal, no liability for the maker.

[Fantastic Anarchist]

22. Unbelievable. nt

[Ilsa]

28. At what point will they figure out that

the serfs don't have anything to lose and might start committing suicide in places crowded with officials?

[TM99]

31. At least it wasn't acupuncture or homeopathy

because that stuff is far, far worse than flesh-eating modern medicine side-effects.

Thankfully we have the Supreme Court and the FDA to protect us from the Woo.

[godai]

34. This is for GENERIC drug companies only.

Not so surprising to me. Generic inherits innovator label. Innovator can be used if appropriate.

[reformist2]

35. Big Pharma imports cheap drugs made in China, now with impunity! What a sick country we live in.

[friendlyFRIEND]

38. weird how the OP says one thing and the story is 180 degrees off nt

[elleng]

40. Thanks. Discussed yesterday.

http://www.democraticunderground.com/?com=view_post&forum=1002&pid=3203879

For those who might want to understand:

My post, #6, 'The 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 Sgent's #10:'The drug company in this case had no control over the labeling on the drug, the prescribing information, or anything else. The wording was dictated to them by the FDA -- and they do not have standing to challenge that wording and remain a generic drug.

This lawsuit was not based on the idea that the drug company failed to deliver what was on the label, but rather that the label was incorrect. The problem is that the only person with the ability to change the label is either the original drug manufacturer through application or the FDA on its own initiative. The generic manufacturer has no ability otherwise.'

[Incitatus]

44. Thanks for the clarification. At first glance I was like, WTF. That makes more sense. nt

[elleng]

45. Glad you appreciate it.

Legal matters are often/usually complicated, and many are subject to 'big' headlines which get attention. Facts MUST follow, and readers should be willing to look further.

[Fantastic Anarchist]

53. Thanks for the information ...

... I'm at work, and was trying to read what I could while working at the same time. As I said upthread, the more information, the better.

[AAO]

41. "I love the smell of fascism in the morning!"

[ellennelle]

42. hyperbole much?

go here for the facts in this case:

http://www.scotusblog.com/2013/06/details-mutual-pharmaceutical-co-v-bartlett/

and, just a small point, but i've been pretty taken aback at the extreme views and outrage expressed here, and this post confirms my suspicion - voiced by others - that some folks here are giving too much ear to pauls, father and son.

if you google for this case, you'll find all the hyperbole in the paul sites.

figures.

calm down; we all know we're getting screwed and who's doing it, but it does none of us any good to lose site of the facts and the capacity to reason when we lose our collective nut.

[elleng]

47. THANK YOU and HI, ellennelle!

and WELCOME!

[ellennelle]

50. thx

& backatcha.

but, i hardly ever post anything, so forgive me if i don't keep up with this thread.

too much strang and durm of late around here, tho; had to say something.

will look for you when i do peek in, tho.

[elleng]

51. I'm quitting this thread too, I think;

Have said what I've said several times, here and in another thread.

Sturm und drang getting to me too.

[Fantastic Anarchist]

55. I'm at work ...

... found original link on Facebook, but couldn't read the whole article because the site was down. Then googled for the title of the article, and found a link that seemed to have the whole article (upthread). Now, again, I'm at work, and was trying to read, post, work, and digest as much information as possible. As you see upthread, the more information I got, the more it made sense (but I think there is still a very serious problem that Congress needs to address).

I have no use for "<P>auls, father and son." I really try to do my due diligence, but hey, I'm only human.

[Rex]

61. A few here want there to be a common enemy we can all rally around

and some see it in just about everything posted that they don't like or agree with.

[Fantastic Anarchist]

75. Yeah, I guess so it goes, eh?

Actually, what's interesting is that I learned a lot upthread. Discussion exposes people to information. I received new information and modified my stance accordingly.

Oh well, I guess I'm slated to be in the Chateau de Bow Bow with "Paulbots" and the like.

[BornLooser]

48. I'm at a loss...something somewhere is freezing over.

I mean besides these posers black hearts.

[mountain grammy]

49. I listened to Mike Papantonio talk about this last week.

Frankly, I don't think the outrage over this decision is hyperbole at all. The dissenters got it.

I don't think it's hyperbole when 5 justices continually do the bidding of corporations. They are owned! That's a fact!

[Fantastic Anarchist]

56. The crux of the argument makes sense as Elleng pointed out ...

... it only makes sense according to the laws in place. So, with that, there's validity in yours and my argument, as well as, to Elleng's.

The system is corrupt. So, my OP may have been a little off, but as a symptom of the whole, it stinks to high heaven that a patient can't get redress for being disfigured for life. So, I may have placed the blame in the wrong place, who knows - but again, to have such laws in place in the first place is egregious.

[HockeyMom]

57. Just say NO to medications

They just want to make $$$$ off you.

[Liberal Veteran]

64. Okay. As you request. Now, how do I deal with this pesky HIV thing I have?

[Avalux]

72. I worked for years helping develop antiretrovirals.

I'm proud of the work we did; not perfect by any means and often toxic. But we went from NOTHING, helplessly watching beautiful souls leave us to being able to manage HIV infection as a chronic disease (for most).

Keep taking your meds.

[Avalux]

60. Holy Shit! This OP is sensationalistic crap.

There's some really good discussion going on in the thread, which shouldn't get lost in the weeds.

A generic drug company does not formulate drugs independently. They are ultimately not responsible for their product, which is, by federal law, a therapeutic equivalent to the original formulation.

So let's run through a simplified drug development/approval scenario, and subsequent generic formulation approval:

1. Merck develops a new compound for hypertension and files a new drug application with the FDA to perform testing on humans. In vitro and animal testing results support the application and they're granted approval to proceed.

2. Phase I clinical trials begin with healthy humans, strictly to determine if the compound is safe. If the compound passes this hurdle, it moves into Phase II clinical trials.

3. If Phase II are successful, the compound, now drug, moves into Phase III clinical trials, where large numbers of people with hypertension will take the drug to collect efficacy and additional safety data.

4. A lot of data is collected after many clinical trials are performed over years and years and submitted to the FDA. The FDA will approve the drug if they determine, based upon the data presented by Merck, that the benefits outweigh the risks.

5. A 17 year patent is granted to Merck, which prevents another drug company from copying it.

6. When the patent is set to expire, a generic drug company will take the original hypertension drug, copy it and make their own formulation.

7. The generic drug company then files an abbreviated new drug application with the FDA. Since all the "pre" work has been done by Merck, the generic drug company is only required to perform clinical trials to prove bioequivalency. Often, this is only one clinical trial with a relatively small number of people.

8. If the generic drug company can prove therapeutic equivalence (80-125%) to the original hypertension drug, the FDA approves the generic formulation.

9. The generic formulation is required to have the exact same labeling and safety profile as the original drug developed and marketed by Merck, because they (Merck) have performed the safety and efficacy clinical trials; not the generic drug company.

SO....the generic drug company is only responsible for proving their version of Merck's hypertension drug is therapeutically equivalent. They are not responsible for the safety or efficacy data, including post-market surveillance. The burden is on Merck to report the safety data, change the labeling if needed, then the generic company follows suit. The chemical name of both drugs is the same.

You may not agree with the ruling, but by law, that's how it works, and has for a very long time. As long as everyone involved is following the rules and isn't withholding or confounding data, it's actually a really good system.

[zipplewrath]

66. Somewhere in between

There are a few very particular industries where the government TIGHTLY controls how the products are made and get to market. To deviate at all from their directions is a violation of law. The courts have generally found that in those cases, the companies are exempt from liability. Most military contractors are exempt because they are required to make their products EXACTLY as the design states. Pilots for airlines are required to fly airplanes EXACTLY as the FAR's require. As long as a company follows these rules, the government in effect holds the liability, not the manufacturer. The company here probably had itself covered because it did exactly what the government said it had to do. A successful lawsuit would have proven/shown that they did something they weren't suppose to do.

[Avalux]

69. Correct.

As long as the generic drug co. did everything required by the federal government, they are not liable.

[HiPointDem]

67. the ruling doesn't make any generalized principle such as you claim. it's specific to this

case, or any similar case where a generic manufacturer is sued for not having a warning label about a condition not labeled by the original manufacturer.

drug companies are not exempted from lawsuits.

[Berlum]

70. Ugly, Inc.

[graham4anything]

77. Another great decision from Ralph Nader's US Supreme Court. Thanks Ralph! NT

m: