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80% of drugs exempt from lawsuits

MaggieD

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This ruling was quietly handed down by SCOTUS -- effecting all generic drug manufacturers. Here's the story:

Sun, 07 Jul 2013 22:36 CDTWashington. 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.

Supreme Court rules drug companies exempt from lawsuits | Peace . Gold . Liberty

Personally, I think it's about time. The FDA is supposed to be protecting us against **** like this . . . and if a drug manufacturer is intentionally HIDING an adverse side effect? People should go to jail and huge fines exacted. But beyond that, I think people have to understand that warning labels mean, "Hey!!! If you take this drug?? All this **** could happen to you."

What do you think?
 

Ockham

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While I agree in that particular case the drug company should be forced to cough up a ton of money for pain, suffering and anything else that comes along as they seem to have purposely hidden side effects. I can't even fathom how anyone would have thought hiding such a thing was a good idea. Yet, I'm very dismayed at the common ambulance chasers that advertise on television almost as much as drug company advertise.



Now drug company's are big business and have motivations to only create and sell high priced drugs which provide high revenue and profits, so it's difficult to feel sorry for these drug company's yet, when the legal profession creates just as many lawsuits against these drug company's it's no wonder they need such high profits to help defend themselves against these legal yokels. Drugs which are effective but not expensive to make or sell sometimes get forgotten about.
 

Slyfox696

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This ruling was quietly handed down by SCOTUS -- effecting all generic drug manufacturers. Here's the story:



Supreme Court rules drug companies exempt from lawsuits | Peace . Gold . Liberty

Personally, I think it's about time. The FDA is supposed to be protecting us against **** like this . . . and if a drug manufacturer is intentionally HIDING an adverse side effect? People should go to jail and huge fines exacted. But beyond that, I think people have to understand that warning labels mean, "Hey!!! If you take this drug?? All this **** could happen to you."

What do you think?
I think if the drug maker intentionally hid the negative side effects which caused her condition, I have no idea how the drug company could not be held liable. That's the type of thing which people should be outraged about. A drug company intentionally hiding serious side effects to make a profit? There should be serious laws against that (though I'm not surprised there's not) and people should be going to jail.

It's one thing for the drugs to have side effects. It's one thing for there to be previously unknown side effects. But intentionally hiding side effects, especially on this serious of a scale, should be a crime.
 

RabidAlpaca

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I think they should be required to release their statistical trials and all side effects of the drug. When a consumer is looking to take a drug, he needs to be able to weigh the benefits vs the risks. For example, if I am having heart problems, and I look at a fictitious drug called 'Alpac', which says 1 in 100 people will be subject to necrosis, then I might consider still taking it because the benefits for my heart far outweigh the 1 in 100 risk.

However, if the risk were 1 in 10, I may think it might not be worth the risk. With rulings like this, the pharmaceutical companies have yet another layer of deceit they can throw over their products making it near impossible for the average consumer to make educated decisions.
 

vvx

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Generic drug manufacturers were required to provide the same drug information as the name brand drug. So on the one hand they were not allowed to include additional warnings that the name brand drug did not include. Yet on the other hand could be sued for not including the additional warnings that they weren't allowed to include.

Here's a detailed article on the subject and a partial quote.

But the maker of a generic drug can not redesign it; federal law requires that it must be identical to the brand name version for it to be sold. Therefore, Justice Alito reasoned, the only other way for a generic drug company to reduce the risk would be to strengthen the warning for consumer. Pliva v. Mensing, though, held that generic drug companies may not change the warning label, but instead must include exactly the same warning label approved for the brand name drug.


Chemerinsky: Paradox in drug injury cases must be solved by Congress, says SCOTUS
 
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MaggieD

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I think if the drug maker intentionally hid the negative side effects which caused her condition, I have no idea how the drug company could not be held liable. That's the type of thing which people should be outraged about. A drug company intentionally hiding serious side effects to make a profit? There should be serious laws against that (though I'm not surprised there's not) and people should be going to jail.

It's one thing for the drugs to have side effects. It's one thing for there to be previously unknown side effects. But intentionally hiding side effects, especially on this serious of a scale, should be a crime.

I agree with you. These are generic manufacturers involved in this ruling. My guess is that the side effect wasn't known, is now as was (perhaps) proven. So I'm totally with you. I just think this was a previously unknown side effect.

It's always seemed very unfair to me that a drug manufacturer can be sued after a drug has been completely above-board tested, all side effects listed that they're aware of, and then attorneys get rich suing them into extinction AND making bringing a new drug to market prohibitively expensive.

There's work to be done in this area. This is a good start, in my opinion.
 

MaggieD

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I think they should be required to release their statistical trials and all side effects of the drug. When a consumer is looking to take a drug, he needs to be able to weigh the benefits vs the risks. For example, if I am having heart problems, and I look at a fictitious drug called 'Alpac', which says 1 in 100 people will be subject to necrosis, then I might consider still taking it because the benefits for my heart far outweigh the 1 in 100 risk.

However, if the risk were 1 in 10, I may think it might not be worth the risk. With rulings like this, the pharmaceutical companies have yet another layer of deceit they can throw over their products making it near impossible for the average consumer to make educated decisions.

Just to clarify, a 1 in 10 risk of necrosis drug would never make it CLOSE to market.
 

CanadaJohn

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This ruling was quietly handed down by SCOTUS -- effecting all generic drug manufacturers. Here's the story:



Supreme Court rules drug companies exempt from lawsuits | Peace . Gold . Liberty

Personally, I think it's about time. The FDA is supposed to be protecting us against **** like this . . . and if a drug manufacturer is intentionally HIDING an adverse side effect? People should go to jail and huge fines exacted. But beyond that, I think people have to understand that warning labels mean, "Hey!!! If you take this drug?? All this **** could happen to you."

What do you think?

While I feel for this young lady and the pain she's suffered, in addition to any other person who's suffered similarly, I have to agree with the Supreme Court in this case and say the court is simply following the law that exists and refreshingly was not attempting to rewrite the law from the bench. Based on the outcome of this case, members of Congress and/or the President's administration should be looking to create or amend relevant legislation to make sure that in the future such lawsuits can be heard and be successful. It may be a good idea to also allow the federal government, in this case its agency, the FDA, to be sued jointly for any negligence on their part.
 

MaggieD

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While I feel for this young lady and the pain she's suffered, in addition to any other person who's suffered similarly, I have to agree with the Supreme Court in this case and say the court is simply following the law that exists and refreshingly was not attempting to rewrite the law from the bench. Based on the outcome of this case, members of Congress and/or the President's administration should be looking to create or amend relevant legislation to make sure that in the future such lawsuits can be heard and be successful. It may be a good idea to also allow the federal government, in this case its agency, the FDA, to be sued jointly for any negligence on their part.

The government will NEVER allow the FDA to be held civilly liable; nor should they, in my opinion. You and I are usually in agreement. In this particular instance, I disagree with you across the board. But what fun would it be if we always agreed?? ;)
 

CanadaJohn

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The government will NEVER allow the FDA to be held civilly liable; nor should they, in my opinion. You and I are usually in agreement. In this particular instance, I disagree with you across the board. But what fun would it be if we always agreed?? ;)

Oh, I don't disagree that the federal government will ever allow itself or an agency of its own to be held civilly liable - but it should. And the people making the decisions should be held criminally liable as well. Perhaps then, they would spend less time conferencing, smoozing, wining and dining on the taxpayer's dime and actually doing the work required of them. You just have to look at the goings on at the GAO in the past couple of years to know that federal employees apparently have no accountability attached to their employment.
 

MaggieD

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It was an example, as part of a point that obviously went over your head.

There's also no drug called "Alpac"(a).

Yeah, I understood that, RA. Your example was great. I just wanted to point out that your use of 1 in 100 was way above what would be ever be allowed for something as serious as necrosis.
 
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