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Supreme Court rules Drug Companies exempt from Lawsuits

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July 7, 2013

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.



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.


Immediately upon the Supreme Court’s ruling, both drug manufacturers and Wall Street investors were celebrating. As one financial analyst pointed out, drug company profits should skyrocket going forward. Not only do the pharmaceutical companies no longer have to worry about safety or side effects, they are exempt from the multi-million dollar court-imposed settlements awarded to victims of their drugs.

One industry critic was quoted by Reuters after the verdict. "Today's court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients," Michael Carome, director of Public Citizen's Health Research Group told the news outlet.

Senate Judiciary Committee Chairman Patrick Leahy (D-VT) was quick to react to the ruling by writing a stern letter to FDA Commissioner Margaret Hamburg, "A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug.”

But an attorney for the drug companies, Jay P. Lefkowitz, took the opposing position saying, “It makes much more sense to rely on the judgments of the scientific and medical experts at the FDA, who look at drug issues for the nation at large, than those of a single state court jury that only has in front of it the terribly unfortunate circumstances of an adverse drug reaction."

In other words, if the FDA says something is safe, it doesn’t matter if that decision is wrong or the result of lies, fraud or deception on the part of the world’s pharmaceutical companies. And there’s no way to sue the FDA for being wrong and costing millions of unsuspecting Americans their lives. That result leaves 240 million Americans unprotected from an industry responsible for more preventable deaths in the US than any other cause.

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

http://www.reuters.com/article/2013/06/24/usa-court-generics-idUSL2N0F00K820130624

by on Jul. 8, 2013 at 2:16 AM
Replies (41-50):
Aestas
by Gold Member on Jul. 9, 2013 at 2:51 AM

WTF. Welcome to Corporate America, where actual people don't count for shit.

Aestas
by Gold Member on Jul. 9, 2013 at 2:58 AM

So patients should simply absorb the costs and the consequences?

For people who were blown away to learn recently that the 11 largest global pharmaceutical companies made an astonishing $711 billion in profits over the last decade, here's another measure of the industry's greed: the same companies paid their chief executive officers a combined $1.57 billion in that period.

http://www.huffingtonpost.com/ethan-rome/big-pharma-ceo-pay_b_3236641.html

Quoting unspecified42:

The problem of that if the generic medications aren't able to just use the same warnings as the name brand, they will have to do all of the research over again and poof, no affordable medications.

There is no such thing as a free lunch, folks. Medication development isn't free. Research isn't free. Clinical trials aren't free. FDA approval isn't free.

Don't like it? Find a different way to run healthcare in America. Please. No shit it doesn't work, but imagine the impact of no longer having inexpensive medications.


Aestas
by Gold Member on Jul. 9, 2013 at 3:03 AM

But you are warned of that risk when you decide to take the BC; it's right there in the pamplet that comes with it.

This woman was not warned that toxic epidermal necrolysis was a possible side effect, and that information was not on the label.

Besides, what motivates drug companies to monitor their products for safety or develop better and safer products when they can get away with selling stuff that can seriously harm or kill us with no consequences? They don't give a shit if we die, all that matters is the bottom line.

Quoting LaughCryLive:

I agree.

Also, I am so sick of all these drug lawsuits. Everyone knows birth control causes clots. Don't take it and get a clot and sue!!!

LaughCryLive
by Silver Member on Jul. 9, 2013 at 3:04 AM
I don't like big pharma but the drug insert says that it does not list all side effects.


Quoting Aestas:

But you are warned of that risk when you decide to take the BC; it's right there in the pamplet that comes with it.

This woman was not warned that toxic epidermal necrolysis was a possible side effect, and that information was not on the label.

Besides, what motivates drug companies to monitor their products for safety or develop better and safer products when they can get away with selling stuff that can seriously harm or kill us with no consequences? They don't give a shit if we die, all that matters is the bottom line.

Quoting LaughCryLive:

I agree.



Also, I am so sick of all these drug lawsuits. Everyone knows birth control causes clots. Don't take it and get a clot and sue!!!



Aestas
by Gold Member on Jul. 9, 2013 at 3:25 AM

How do you figure? I broke my back about ten years ago. That whole ordeal would have cost me $10k+ out of pocket if I hadn't had insurance at the time.

I'm currently pregnant with my second child. I am giving birth at a birthing center with a midwife, naturally with no drugs. I get acupunture treatments to help me with any issues that arise (morning sickness, pain, etc.). How would I pay for any of this without insurance?

Quoting Koltie6:

Wouldn't need insurance if we ate clean avoided Rx drugs etc.

Aestas
by Gold Member on Jul. 9, 2013 at 3:29 AM

True enough, but it should be their responsibility to ensure the safety of their products and inform the consumer of possible risks. They make a ton of money off of selling these drugs, and without measures to ensure they are doing their best to make them as safe as possible and be honest with consumers, why should they bother? It's no skin off their back, as long as they can't be held responsible.

Quoting LaughCryLive:

I don't like big pharma but the drug insert says that it does not list all side effects.


Quoting Aestas:

But you are warned of that risk when you decide to take the BC; it's right there in the pamplet that comes with it.

This woman was not warned that toxic epidermal necrolysis was a possible side effect, and that information was not on the label.

Besides, what motivates drug companies to monitor their products for safety or develop better and safer products when they can get away with selling stuff that can seriously harm or kill us with no consequences? They don't give a shit if we die, all that matters is the bottom line.

Quoting LaughCryLive:

I agree.



Also, I am so sick of all these drug lawsuits. Everyone knows birth control causes clots. Don't take it and get a clot and sue!!!




LaughCryLive
by Silver Member on Jul. 9, 2013 at 3:33 AM
The risk of this happening is so minute that to say the drug is dangerous is just silly. Everyone should realize that medications have bad side effects but its extreme rare.


Quoting Aestas:

True enough, but it should be their responsibility to ensure the safety of their products and inform the consumer of possible risks. They make a ton of money off of selling these drugs, and without measures to ensure they are doing their best to make them as safe as possible and be honest with consumers, why should they bother? It's no skin off their back, as long as they can't be held responsible.

Quoting LaughCryLive:

I don't like big pharma but the drug insert says that it does not list all side effects.





Quoting Aestas:

But you are warned of that risk when you decide to take the BC; it's right there in the pamplet that comes with it.

This woman was not warned that toxic epidermal necrolysis was a possible side effect, and that information was not on the label.

Besides, what motivates drug companies to monitor their products for safety or develop better and safer products when they can get away with selling stuff that can seriously harm or kill us with no consequences? They don't give a shit if we die, all that matters is the bottom line.

Quoting LaughCryLive:

I agree.





Also, I am so sick of all these drug lawsuits. Everyone knows birth control causes clots. Don't take it and get a clot and sue!!!







Aestas
by Gold Member on Jul. 9, 2013 at 3:50 AM
1 mom liked this

Right, I'm not saying the drug is dangerous for most people, just that the drug companies should be liable for the safety of their products. If you are the one person whose life is completely destroyed by the drug (or who loses a loved one to the drug's side effects), how are you going to pay for that? What is your life worth?

The $21 million she was initially awarded does not make up for the fact that her life is destroyed and she lives in constant pain, but it can at least pay for her medical bills and her care and make up for lost wages. That amount of money is nothing for a big drug company, but for her, it's the difference between life and death. Why shouldn't they be held responsible?

If I sell you an undercooked chicken sandwich, and you get salmonella and miscarry as a result, I'm liable for that loss. Why should they be any different?

Quoting LaughCryLive:

The risk of this happening is so minute that to say the drug is dangerous is just silly. Everyone should realize that medications have bad side effects but its extreme rare.


Quoting Aestas:

True enough, but it should be their responsibility to ensure the safety of their products and inform the consumer of possible risks. They make a ton of money off of selling these drugs, and without measures to ensure they are doing their best to make them as safe as possible and be honest with consumers, why should they bother? It's no skin off their back, as long as they can't be held responsible.

LaughCryLive
by Silver Member on Jul. 9, 2013 at 4:05 AM
I guess I just don't get the blame mentality.


Quoting Aestas:

Right, I'm not saying the drug is dangerous for most people, just that the drug companies should be liable for the safety of their products. If you are the one person whose life is completely destroyed by the drug (or who loses a loved one to the drug's side effects), how are you going to pay for that? What is your life worth?

The $21 million she was initially awarded does not make up for the fact that her life is destroyed and she lives in constant pain, but it can at least pay for her medical bills and her care and make up for lost wages. That amount of money is nothing for a big drug company, but for her, it's the difference between life and death. Why shouldn't they be held responsible?

If I sell you an undercooked chicken sandwich, and you get salmonella and miscarry as a result, I'm liable for that loss. Why should they be any different?

Quoting LaughCryLive:

The risk of this happening is so minute that to say the drug is dangerous is just silly. Everyone should realize that medications have bad side effects but its extreme rare.





Quoting Aestas:

True enough, but it should be their responsibility to ensure the safety of their products and inform the consumer of possible risks. They make a ton of money off of selling these drugs, and without measures to ensure they are doing their best to make them as safe as possible and be honest with consumers, why should they bother? It's no skin off their back, as long as they can't be held responsible.


smalltownmom03
by Member on Jul. 9, 2013 at 4:30 AM
There isn't enough money to be made in natural medicine. My aunt had a rare form of arthritis and there are only two medicines for it. Both will cause kidney failure. The dr told her that if she took either of them when (not if) her kidneys started to fail they would treat that. So she started learning everything she could about natural remedies. After changing her diet she has very few symptoms. The only time she has any pain is when she eats something she shouldnt.


Quoting ..MoonShine..:

They are around. Alternative docs, herbslists. Generally, indurance won't pay for those, though.



Quoting jehosoba84:


Quoting Koltie6:

Don't use prescription drugs! There are viable alternatives including diet and lifestyle changes. We are a pill popping nation. This does not excuse the drug companies thou. They are well aware of the dangers of most of these drugs and the FDA is a joke.

Yep! I just wish the days of using fresh natural herbs would come back. All areas having a local medicine woman, if you will. lol       

People would be amazed at the illnesses/cancers that would disappear if we would only stop ingesting all these drugs. And i'm not referring only to Rx drugs. I'm talking about the drugs in our meat, our veggies, our shampoos, our everything. 


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