Join the Meeting Place for Moms!
Talk to other moms, share advice, and have fun!

(minimum 6 characters)

Current Events & Hot Topics Current Events & Hot Topics

Supreme Court rules Drug Companies exempt from Lawsuits

Posted by   + Show Post

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 (31-40):
Friday
by HRH of MJ on Jul. 8, 2013 at 3:11 PM


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!!!


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.

I have a friend who has Type 2 Diabetes, caused by an rx she took. They are having a hard time controlling it and she has other related problems now too. This will shorten her life and the $100k she received won't chane that.

If it can be proven that the company was aware of a possible side effect and didn't disclose it, they should be liable. If the brand company didn't dislose the side effect to the generic company, they should be liable to them as well.

 


Thank God......it's Friday!!!

Friday
by HRH of MJ on Jul. 8, 2013 at 3:12 PM


Quoting LaughCryLive:

Clots from birth control i on TV and the inserts. It's not the companies problem if they provide you with the information and you choose to ignore it.


Quoting GirlWithANikon:

I think it is unfair to say everyone knows birth control causes clots, or like wise of other medications. I know birth control causes clots but if I suddenly came down with something I have no experience with how would I know what the medications side effects are if they are not on the inserts or company website? I am also assuming that if they do not provide these warnings due to research you cannot call and ask and be told it just may eat your flesh.

It sounds insane to look at all the basic things people in America do not know and then assume everyone knows medication side effects.



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!!!





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.






That I agree with.

 


Thank God......it's Friday!!!

Friday
by HRH of MJ on Jul. 8, 2013 at 3:15 PM


Quoting meriana:



Quoting LaughCryLive:

Clots from birth control i on TV and the inserts. It's not the companies problem if they provide you with the information and you choose to ignore it.


Quoting GirlWithANikon:

I think it is unfair to say everyone knows birth control causes clots, or like wise of other medications. I know birth control causes clots but if I suddenly came down with something I have no experience with how would I know what the medications side effects are if they are not on the inserts or company website? I am also assuming that if they do not provide these warnings due to research you cannot call and ask and be told it just may eat your flesh.

It sounds insane to look at all the basic things people in America do not know and then assume everyone knows medication side effects.



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!!!





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.







 

I don't think it's so much an issue of ignoring warnings as it is a trust issue. Most people trust their doctors, they listen to them and tend to do what he/she says. (They have all that education and knowledge, after all). Doctors typically greatly downplay any possible side effects when prescribing any kind of medication. Most doctors will spend far more time telling a patient how something will benefit them than talking about possible side effects in order to get the patient comfortable with taking/doing what is prescribed. I'm sure everyone here has heard their doctor say things like: "the benefits outweigh the risk", or other things which leave one with the impression that an adverse event from doing as the doctor says is like a 1 in a million chance. For most people that's pretty much saying an adverse reaction simply won't happen and/or taking the attitude that it could isn't in the realm of realistic thinking

That's because many are bought off by rx companies. I worked in a docs office, seen it myself.

 


Thank God......it's Friday!!!

Friday
by HRH of MJ on Jul. 8, 2013 at 3:17 PM


Quoting idunno1234:

This article's already 8 years old but things have only gotten worse.  FDA's relationship with the pharmaceutical companies is undeniable and scary as shit.

 

Conflicts of Interest: Monitoring the FDA’s Relationship With Pharmaceutical Companies

1 November 2005 No Comments

In a culture of increasing reliance on pharmaceutical drugs, the Food and Drug Administration (FDA) consistently demonstrates its inability to properly protect the public from the harmful, and sometimes fatal, side effects of medications. There are myriad explanations, but one that draws regular criticism is the FDA’s cozy relationship with the pharmaceutical industry.

According to Linda Sherman, the Director of the Advisory Committee Oversight and Managements Staff for the FDA, the agency operates because the public “entrusts the FDA to safeguard its health and safety by making timely and credible independent scientific decisions on products that it regulates.” Its future priorities are to assure safe food supplies and medical products, manage emerging hazards, and bring new technologies to market.

The FDA has historically shown a tendency to be more reactive than proactive in its role. One example is the marketing of the elixir of sulfanilamide in 1936, which contained the poisonous solvent diethylene glycol, and killed 107 people, including children. This tragedy demonstrated the FDA’s need to test drugs before allowing them to be marketed. In response, the Federal Food, Drug and Cosmetic Act was enacted the following year.

The Food, Drug and Cosmetic Act was created in order to control cosmetic and medical products, and to require that these products be labeled with safety directions for consumers. Furthermore, all new drugs required pre-market approval. This meant that the burden of proof was placed on the drug companies, and that they would have to demonstrate a drug’s safety to the FDA before placing it on the market. It also ensured that no abuses in food quality and packaging would occur. It regulated against false advertising, and set standards for food products. Finally, the law addressed tolerances for poisonous substances and authorized factory inspections.

Another example of the FDA’s tendency to be reactive is the 1962 thalidomide disaster. Thalidomide, a sleeping pill, was found to cause birth defects in thousands of infants. Although this did not occur in the U.S., in the same year, the Kefauver-Harris Drug Amendments were designed to ensure the efficacy and safety of all drugs marketed since 1938. This legislation also gave the FDA the power to regulate the advertising of prescription drugs, a prior responsibility of the Federal Trade Commission. Finally, the amendments gave the FDA more authority to monitor the manufacturing practices of drug companies, and allowed the FDA to place stricter controls on drug trials.

To be fair, the FDA’s post-approval drug safety surveillance is by no means an easy task. After all, the current healthcare system is highly decentralized and patients often take prescription drugs from more than one hospital and use over-the-counter drugs as well. The unreliability of post-approval drug safety continues today.

Much of the current criticism of the FDA revolves around the Vioxx scandal, in which Merck & Co. pulled Vioxx from the market on September 30, 2004 after realizing that users showed a marked increase in the risk of heart attacks and strokes. Soon after Vioxx entered the market, an internal study named VIGOR (Vioxx Gastrointestinal Outcome Studies) showed a decrease in the likelihood of gastroduodenal perforations, ulcers, and bleedings, but demonstrated a substantial fraction of heart attacks in certain patients.

The results of this study were not considered by the FDA to be significant due to several factors. As John Calfee, resident scholar at the American Enterprise Institute for Public Policy Research, explained before the House Committee on Government Reform, “because heart attacks were not a pre-defined endpoint in the VIGOR trial, because Vioxx had been compared to naproxen [e.g. the pain-medicine, Aleve] . . . because other trial [s] involving both Vioxx and Celebrex had not revealed significant cardiovascular problems, it was by no means obvious that Vioxx would in fact cause excess heart attacks compared to placebos. Obvious alternatives were that the result was partly a statistical fluke or that the comparator, naproxen, was instead cardio-protective. Subsequent research strongly suggested that naproxen is at least moderately cardio-protective.”

However, it was only after a three-year clinical trial in cancer prevention, which showed a significant increase in heart attacks and other cardiovascular conditions, that Merck withdrew Vioxx from the market, five years after its debut. Merck did so in response to the study, believing that the cardiovascular risks involved with Vioxx were unique to other drugs of its class.

The question then arises: what should the FDA have done? Defenders of Vioxx and the FDA, including Calfee, suggest that the agency had few options before Merck’s voluntary withdrawal because the initial VIGOR trials showed results that were highly debated within the academic and medical communities. Critics of the FDA use Vioxx as an example of the FDA being too close to the industry and thus curtailing proper safety considerations in order to help manufacturers release their drugs faster.

Regardless of the stance one takes, it is clear that there are aspects of the FDA’s practices that arouse suspicion and indicate a lack of sensitivity for public safety in deference to the wishes of the pharmaceutical industry. The FDA has long been criticized for the apparent conflicts of interest between its advisory panels and pharmaceutical companies, especially in decisions regarding which drugs are put up for sale, how warning labels are worded, and how drug studies are designed.

The FDA is composed of 30 advisory committees that are divided by product, such as food, devices, and drugs, and by body systems, such as cardiovascular or gastrointestinal products. The role of these committees, according to Sherman, is to “offer the FDA the very best advice possible [and to] lend credibility to the FDA decision-making processes by having public discussions of controversial topics.” Furthermore, these committees are designed to be balanced by “respected academicians, clinicians, consumer advocacy group representatives, and Celebrex had not revealed industry representatives, and patients or their caregivers.”

To serve on these committees, members must not have any financial or intellectual biases. Financial conflicts arise when a committee member stands to gain or lose financially as a direct result of an action taken by the committee. Intellectual biases arise when a committee member is somehow involved with the creation of the drug or company that is being evaluated. Because members of these committees work on the cutting edge of research and development, however, they are often hired by the industry as consultants before they serve on the committees.

To resolve this, 18 U.s.c. section 208 allows the FDA to balance an individual’s expertise against potential financial conflicts and to issue waivers in cases in which the former outweighs the latter. This rule is intended only for exceptional cases.

A USA Today special investigation reveals a different story, however. Between January 1, 1998 and June 30, 2000, the FDA issued 803 conflict of interest waivers. On 71 other occasions, waivers were not issued even though members had financial conflicts. In fact, in the 57 meetings on regulatory policy during this time period, committee members were found to have some sort of conflict 91% of the time. Moreover, if the topic being discussed is distinct from a committee member’s specialty, he or she can be paid up to $50,000 a year without having to disclose the existence of a financial conflict. In cases where a specific company is appearing before the committee, a committee member can own up to $5,000 in stock of that company.

Finally, although Sherman reassures that the committees are diverse in their composition, the consumer representatives—supposedly representing consumer interest—sometimes have the closest ties with pharmaceutical companies. One example is the FDA Anti-Infective Drug Advisory committee, which determined whether Levaquin, a Johnson & Johnson product, should be approved. One committee member, Keith Rodvold, had worked as a consultant for Johnson & Johnson’s anti- infective drug advisory board in the past. His work for the company was primarily in designing and analyzing the clinical trials for Levaquin, the same drug that he was to assess.

Although the importance of having experts and independent advisory committees are clear, and close ties to the manufacturing companies is to be anticipated, what is put into practice does not always seem to put the public interest first. A related concern is that the FDA tends to overwhelmingly follow the recommendations of the committees in major decisions of drug regulation. In fact, the FDA has only overridden an advisory committee’s recommendation once in recent years, regarding the approval of the flu drug Relenza in 1999.

When both the pharmaceutical companies and the FDA require the expertise of the best scientists, conflicts of interest seem inevitable. However, there is a degree to which it is acceptable to blur the line between pharmaceutical companies and the FDA. Since the wealth of expertise is limited, both sides must share this resource. Regardless, when the health and safety of the public seems to be in persistent danger, it is imperative to take a closer and more critical look at the practices employed by the FDA to keep this line as clear as possible.

Best. Govt. Money. Can. Buy.

 


Thank God......it's Friday!!!

TranquilMind
by Platinum Member on Jul. 8, 2013 at 3:29 PM

 Drug companies are right up there with Monsanto in ethical behavior. 

The big ones, GlaxoSmithKline, Merck, and Pfizer pay BILLIONS in settlements - a drop in the bucket compared to their profits. 

Koltie6
by Bronze Member on Jul. 8, 2013 at 3:44 PM
Wouldn't need insurance if we ate clean avoided Rx drugs etc.


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. 


SherryBerry106
by on Jul. 8, 2013 at 5:08 PM

 

That's true, we have devolved into a really stupid country in the last 50 years or so.

Quoting GirlWithANikon:

I think it is unfair to say everyone knows birth control causes clots, or like wise of other medications. I know birth control causes clots but if I suddenly came down with something I have no experience with how would I know what the medications side effects are if they are not on the inserts or company website? I am also assuming that if they do not provide these warnings due to research you cannot call and ask and be told it just may eat your flesh.

It sounds insane to look at all the basic things people in America do not know and then assume everyone knows medication side effects.

 

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!!!


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.

 

 


 

jehosoba84
by Jenn on Jul. 8, 2013 at 9:45 PM

Bumping for those who have not seen this chilling bit of news.


snookyfritz
by Platinum Member on Jul. 8, 2013 at 9:51 PM

If you can't sue the generic company are you able to sue the original pharmaceutical company?  I am a bit confused

funnymommy71
by Member on Jul. 8, 2013 at 11:47 PM

 

I agree with you on the most part.  But, there are diseases that ppl get for no fault of their own that must take terribly expensive meds to live.   My Sister for one- (horrific side effects but life giving) as many ppl know.  Big Pharma is a gigantic cess pool of greedy bastards and the FDA is no longer in bed but married to them.  SCOTUS is beyond words here.  I am truly afraid now.......

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.


 

Add your quick reply below:
You must be a member to reply to this post.
Join the Meeting Place for Moms!
Talk to other moms, share advice, and have fun!

(minimum 6 characters)

close Join now to connect to
other members!
Connect with Facebook or Sign Up Using Email

Already Joined? LOG IN