Supreme Court rules Drug Companies exempt from Lawsuits

[Peace Piper]

*** Note: This was first reported last week. A site search of this forum did not return any related posts.

Supreme Court rules Drug Companies exempt from Lawsuits
July 7, 2013 whiteoutpress.com

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.

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

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Woman who was left blind and disfigured by prescription drug loses fight for $21m payout
By Daily Mail Reporter PUBLISHED: 11:08 EST, 29 June 2013

http://i.dailymail.co.uk/i/pix/2013/06/29/article-2351558-1A92F240000005DC-168_634x462.jpg


Karen Bartlett, suffered horrific injuries after taking a generic version of an anti-inflammatory drug, sulindac, for shoulder pain

Two-thirds of her skin fell off and she was left blind and disfigured

By a narrow 5-to-4 margin, the Supreme court overturned lower court rulings that had awarded a her $21 million for pain and suffering



A woman who was left burned and blinded, nine years after taking a prescription drug, has lost her legal fight for compensation.

Karen Bartlett took a drug to ease shoulder pain back in 2004, but this week the Supreme Court ruled that Mutual Pharmaceutical Co., the maker of the drug should not be held responsible for her injuries because the company had made the brand drug's formula and warning label.

'I was numb,' Bartlett told ABC News of the moment her lawyer delivered the news. 'I don't even have words to describe it because I can't believe that they would do that.'

The court ruled Monday that generic drug makers could not be sued by patients over defective drug design because they're required by federal law to copy their brand-name counterparts.

The ruling overturns a verdict from Bartlett's 2010 New Hampshire Superior Court trial in which a jury awarded her $21 million in damages.... >>MORE
http://www.dailymail.co.uk/news/article-2351558/Woman-left-blind-disfigured-prescription-drug-loses-fight-21m-payout.html

[WM_in_MO]

We live in hell.

[aGameOfThrones]

http://ionetheurbandaily.files.wordpress.com/2010/07/biggums.gif

[HOLLYWOOD]

Just Wait... OBAMA CARE

We Are Fucked

[angelatc]

inflammatory title is inflammatory. Read the article. The company making the generic drug was forbidden by law from including the warning.

Generic drug manufacturers are required to use exactly the same ingredients and the same labeling as the original. They are not allowed to make any changes.


Federal law prohibited Mutual from taking the remedial action required to avoid liability under New Hampshire law,' Justice Samuel A. Alito declared. '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.

[tod evans]

Get the feds out of the drug business!

All of them, legal and illegal.

[matt0611]

I feel like I don't have information about this to get pissed off...

So she took and generic drug and had some kind of side rare side-effect right?

Its not like the generic drug maker put some kind of poison in the drug by accident or something. They made it correctly it just seems like she had some rare reaction.

What was the generic drug maker supposed to do?

I don't really see why she should get $21 million from the drug maker.

I mean I feel bad for her certainly but what did the generic drug maker do wrong?

Unless I'm misunderstanding something here?

[Neil Desmond]

Alright, then I guess they're implying that either the "brand name" maker of a drug is liable for its drugs, even if it's a "generic brand" that was used, or that the FDA is liable.

[pcosmar]

Get the feds out of the drug business!

All of them, legal and illegal.

Agree with the sentiment.
Not gonna happen.

[susano]

OMG, this is so fucked up. She probably couldn't sue the original (name brand) mfg because she took the generic and CONgress made sure she couldn't touch the generic mfg because these kinds of laws are meant to protect big pharma (the generic mfg is Merk) who pays them and the FDA and the 'scientists' off. Additionally, Alito and the other four just shit all over New Hampshire's law by falsely claiming the federal law and an agency (FDA) trump it. No doubt that faulty logic is based upon the commerce clause which was never meant to mean any such thing. These fucking judges just took away this woman's only legal recourse.

What a perfectly fascist decision.

[Dr.3D]

OMG, this is so fucked up. She probably couldn't sue the original (name brand) mfg because she took the generic and CONgress made sure she couldn't touch the generic mfg because these kinds of laws are meant to protect big pharma (the generic mfg is Merk) who pays them and the FDA and the 'scientists' off. Additionally, Alito and the other four just shit all over New Hampshire's law by falsely claiming the federal law and an agency (FDA) trump it. No doubt that faulty logic is based upon the commerce clause which was never meant to mean any such thing. These fucking judges just took away this woman's only legal recourse.

What a perfectly fascist decision.

Obviously, those judges have been dranking something.

[dillo]

sounds like its more of SCOTUS being against strict product liability, which I would be in favor of.

[Zippyjuan]

FDA responce: http://www.cbsnews.com/8301-204_162-57592438/fda-to-allow-generic-drug-companies-to-update-own-warning-information/



FDA to allow generic drug companies to update own warning information

The Food and Drug Administration announced that they plan to allow generic drug companies to update safety information on their products on their own.

The potential new rule was announced on the Office of Management and Budget website on Wednesday. In addition, the rule would also make it so that all manufacturers of the same drug would have to change their warning labels as long as the FDA approved safety changes for one manufacturer.

The FDA hopes to publish a proposal for the new regulation in September, at which time it will be open for public comment.

Currently, only brand-name drug companies can update their safety information without FDA approval if they find out that there is a potential issue. Generic companies cannot make additions to their safety labels unless the FDA orders it or the brand-name manufacturer has already done so.

"We are extremely pleased to see that the Food and Drug Administration (FDA) today announced its plan to issue a proposed rule to revise FDA regulations about prescription drug labeling. When finalized, the revisions will fill a regulatory gap that poses a risk to patient safety," Dr. Sidney Wolfe, founder and senior adviser of the Public Citizen's Health Research Group, said in a statement.

The Public Citizen's Health Research Group submitted a citizen petition to the FDA in 2011 to allow generic companies to address potential dangers based on evidence they find. The organization said at that time that out of the 4,653 FDA approved drugs with different ingredients, strengths and delivery methods, more than half -- 2,438 -- are available in generic form. Furthermore, 1,062 of those medications are only available in generic form.

A 5-4 U.S. Supreme Court decision in 2011 said that generic drug makers cannot be sued for not warning patients about side effects as long as they copy the exact safety information listed on the brand-name product. They cited a federal law that requires generic drugs to have the same warnings as the brand name products as the reason behind their ruling.

However, generic drug manufacturers may discover potential risks with their product after it is on the market, the Public Citizen's Health Research Group noted. If they were to wait for the brand-name company to make the changes, it could put many people at risk.

"It is a first step toward acknowledging that there is a problem with the current system," Michael Johnson, a lawyer who represented one of the patients who sued generic drug companies in the 2011 Supreme Court case, said to the New York Times. "It doesn't make sense to have one set of rules for the name brand and another set of rules for the generics."

The Generic Pharmaceutical Association said they believed that the warning labels should be the responsibility of the FDA, not individual companies.

"Decisions on safety and efficacy of prescription drugs should rest in the hands of the FDA, the only body with the scientific knowledge, regulatory experience and complete data that is needed to make these decisions," Ralph Neas, president of the Generic Pharmaceutical Association, told USA Today.

[kcchiefs6465]

FDA responce:
Thank God. Someone could have gotten seriously injured.

[Zippyjuan]

OMG, this is so fucked up. She probably couldn't sue the original (name brand) mfg because she took the generic and CONgress made sure she couldn't touch the generic mfg because these kinds of laws are meant to protect big pharma (the generic mfg is Merk) who pays them and the FDA and the 'scientists' off. Additionally, Alito and the other four just shit all over New Hampshire's law by falsely claiming the federal law and an agency (FDA) trump it. No doubt that faulty logic is based upon the commerce clause which was never meant to mean any such thing. These fucking judges just took away this woman's only legal recourse.

What a perfectly fascist decision.

The generic company is not Merk. It is Mutual Pharmaceuticals.

[donnay]

The legal loophole is they warn you of possible side effects. Don't you people pay attention to the commercials Big pHARMa puts out? Let's face it the drug recipe was correct--she isn't suffering from inflammation any more. :rolleyes: States trump federal laws!!!


Supreme Court Expands Accountability Loophole for Big Pharma

Millions of Americans have no idea that their rights have been eroded by a recent series of Supreme Court rulings. These recent decisions have enlarged the loopholes that drug and device companies use to prevent American consumers from holding them accountable.

Bartlett v. Mutual Pharmaceutical Co.

Karen Bartlett, a New Hampshire woman, suffered from shoulder pain and was prescribed a generic drug, sulindac. Soon after, she developed Stevens-Johnson Syndrome (SJS), a life-threatening and unbelievably painful condition that causes the skin to burn from the inside out. Ms. Bartlett spent weeks in a burn unit and a medically-induced coma, covered in gauze. Sixty percent of her skin burned off and left her permanently disfigured. After 13 eye surgeries and numerous cornea implants, she was left legally blind and will need care for the rest of her life.

SJS was a direct result of taking this generic drug, but the label did not warn of this potential side effect. Two lower courts in New Hampshire found that sulindac is unreasonably dangerous and awarded Ms. Bartlett a $21 million verdict for her injuries. Mutual Pharmaceutical appealed this verdict, arguing that her state-law claim was preempted by federal law, and the case landed in the hands of the Supreme Court.

Last week, the U.S. Supreme Court issued a 5-4 decision in Mutual Pharmaceutical v. Bartlett, which struck down this verdict on federal preemption grounds. The Court decided generic manufacturers cannot be held responsible for failing to warn of side effects caused by a drug’s design, since they are only making “a copy.” Generic manufacturers had indicated that because the design of a generic drug and the labeling that goes with it must be copies of the brand name drug, generic manufacturers are legally unable to provide alternate designs or warnings. Therefore, no one could be held responsible.

This is the second Supreme Court decision giving generic manufacturers immunity. Our prior firm, Goldenberg & Johnson, took the generic drug case of Pliva v. Mensing to the U.S. Supreme Court and lost on similar “logic.”

“It has been two years since the Supreme Court granted generic drug companies immunity for their drugs’ warning labels in Pliva v. Mensing. Today the Supreme Court expanded that immunity [to include the design of a generic drug]. It is time for the FDA to address the huge disparity between generic and brand drug makers’ responsibility” said Mary Alice McLarty, American Association for Justice President.

In light of this decision, Public Citizen issued a report highlighting the number of potential side effects that are not discovered until years after drugs have been on the market. By that time, the patent on the brand name drug has usually expired, so most consumers end up purchasing the cheaper, generic version of the drug. If generic manufacturers are not required or allowed to warn for these new risks, who is?

The concept of drug and device preemption compromises the rights of every person who has ever used a medical device or taken a prescription drug. According to NPR, 75% of all drugs used in the U.S. are generic. That means, despite the egregious conduct of these generic manufacturers, they cannot be held accountable by any of us if we are harmed by their products. However, if you are taking a brand name drug, under the U.S. Supreme Court case of Wyeth v. Levine, you can hold a manufacturer responsible for any injuries you sustain from taking the drug.

This absurd result must now be addressed by Congress. Senator Leahy and Senator Landrieu have already sent letters to the Food and Drug Administration, calling on the agency to address the gap in accountability between brand name makers and generic. After the Mutual v. Bartlett decision, another letter from congress members addressed the problem and pressed the FDA to do something. We urge you to contact your senators and congressmen to ensure that your rights are protected in the future. You can easily do so using American Association for Justice’s “Take Action” contact page here.



http://www.youtube.com/watch?v=xX5Ik_NvYKE

Other Resources:

http://www.takejusticeback.com/Generic_Drugs

http://www.justice.org/cps/rde/xchg/justice/hs.xsl/21337.htm

http://www.nytimes.com/2013/06/25/business/justices-rule-generic-makers-not-liable-for-drugs-design.html?_r=1&


Source:
http://defectivedruganddeviceresourcecenter.com/2013/07/02/supreme-court-expands-accountability-loophole-for-big-pharma/

[Keith and stuff]

The top fed court says that fed law is over NH law. Annoying and not surprising.

[RCA]

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.

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

[angelatc]

http://www.ronpaulforums.com/showthread.php?420598-Supreme-Court-rules-Drug-Companies-exempt-from-Lawsuits&highlight=inflammatory

[angelatc]

I feel like I don't have information about this to get pissed off...

So she took and generic drug and had some kind of side rare side-effect right?

Its not like the generic drug maker put some kind of poison in the drug by accident or something. They made it correctly it just seems like she had some rare reaction.

What was the generic drug maker supposed to do?

I don't really see why she should get $21 million from the drug maker.

I mean I feel bad for her certainly but what did the generic drug maker do wrong?

Unless I'm misunderstanding something here?


That' sort of how i feel about it. It's a tragedy, but they didn't really do anything wrong. They weren't negligent, and they certainly were not malicious.

[RCA]

That post was 1/2 minute before mine. I checked first and it wasn't there, it must have appeared as I was submitting. Mod please merge the threads.

[Natural Citizen]

Well. After reading the Monsanto threads, I think most here support this kind of corporate hijacking of representation via the courts and branches of government that used to serve the people. The real ones, anyhow. In fact, I had specifically brought up the facts regarding the pharma industry when it comes to representation since it was directly relevant per processes. Who wins...who loses.....why. Nobody cares. Or too few care, I would say.