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The Tragedy of Supremely Bad Law

The press hailed it as a victory for patients. People harmed by drugs can sue the manufacturers, the Supreme Court recently ruled, even when the firms have scrupulously complied with all FDA rules.

But the decision will prove to be a pyrrhic victory for patients. In the long run it will hurt countless thousands desperately needing innovative drug treatments.

In dissent, Justice Samuel Alito pointed out that the case, Wyeth v. Levine "illustrates that tragic facts make bad law." The tragedy was that Diana Levine, a musician in Vermont, lost her arm due to gangrene after a physician's assistant injected her with Phenergan, an anti-nausea drug made by Wyeth that's been on the market since 1955. The assistant ignored no fewer than six warnings on the drug's FDA-approved label, stating that injection into an artery could cause gangrene and that the use of an IV heightened the risk of mis-injection. (The assistant also injected twice the maximum labeled dosage and ignored Levine's complaints of extreme pain, which the label stated indicated injection into an artery.)

Quite appropriately, Levine collected damages for medical malpractice from the clinic and the medical practitioners who caused her injuries.

But then she sued Wyeth claiming that the warnings on the drug's label were not enough, that IV administration should have been contra-indicated -- that is, eliminated -- as a means of injection. Wyeth argued that it should not be liable to state tort actions when its label clearly and succinctly warned about the dangers of misuse in language approved by the FDA, the agency charged by federal law with determining the safety of drugs marketed to the American public. A Vermont jury awarded Levine $7.4 million.

In affirming that decision, the Supreme Court has opened up pharmaceutical companies to being whipsawed "with 50 (or more) potentially conflicting rules," Alito noted. In effect, the ruling leaves tort juries in every state "rather than the FDA…ultimately responsible for regulating warning labels for prescription drugs."

The long-term result: fewer innovative drugs will be brought to market. If federal approval no longer protects drug companies from lawsuits, the already enormous costs of developing, testing, and marketing new drugs will rise even higher. Drug makers will have no choice but to pull the plug on potentially beneficial treatments that present too great a legal risk. The patients these drugs would have helped will suffer needlessly.

Indeed, some drugs already helping patients with severe health problems may get pulled off the market. That's likely if even a very small number of users suffer side effects that will allow them to file costly tort claims against the manufacturers. Sure, the FDA-approved warning labels made those risks known in advance. But after Wyeth v. Levine, that doesn't much matter. And keep in mind that the potential side effects of some drugs, such as those used for chemotherapy, are much more serious than those associated with Phenergan. This case opens up potential liability for some of the most effective drugs developed in recent years to treat serious, debilitating illnesses.

It has happened before. Runaway litigation has drastically reduced the number of anti-nausea drugs available to U.S. patients, even though European health care systems use them with few negative consequences. Patients who would have benefited most -- but have been denied relief -- include those with serious conditions like cancer and AIDS.

State juries are simply not equipped to perform the kind of harm-benefit balancing test that the FDA and its experts apply when they examine new drugs. As Justice Alito observed, "Juries tend to focus on the risk of a particular product's design or warning label" for one particular person who may have been injured. They do not look at the overall benefit a particular drug may offer a multitude of patients. The FDA, however, takes the long view. Its drug-approval determinations consider the interests of all potential users including, most importantly, those who would suffer without new medical treatment if "juries in all 50 states were free to contradict" the FDA's expert determinations.

The Supreme Court's decision will inevitably lead pharmaceutical firms to pull drugs off the market, particularly those developed for relatively small populations of sufferers. The risk of tort liability suits in 50 different states will be too great to keep selling many of them. And that risk, no doubt, will stifle the development of new drugs for a wide variety of diseases.

That's a tragedy that will long overshadow what happened to Ms. Levine. This "bad law" will lead to many more tragic facts.

Letter to the Editor

Hans A. von Spakovsky, a former Justice Department official, is a Legal Scholar at the Heritage Foundation.

Comments

Gill O'Teen| 3.30.09 @ 10:12AM

Whenever I read or hear comments that surely our supreme court will render much of the garbage imposed upon us by the other branches of government unconstitutional, which it surely is, I laugh. This gaggle of black robes has been trashing the constitution for years, and itself is guilty of legislating from the bench.

macdaddy| 3.30.09 @ 10:13AM

What is Mr. Spakovsky worried about? The One will have plenty of medicines for us all. All we will ever need. The One will provide. Rest assured that Obama is licking his chops over this ruling.

Pingback| 3.30.09 @ 11:00AM

The American Spectator : The Tragedy of Supremely Bad Law | Articles Of Law links to this page. Here’s an excerpt:

…lost her arm due to gangrene after a physician’s assistant injected her with Phenergan, an anti-nausea drug made by Wyeth … Read more from the original source:  The American Spectator : The Tragedy of Supremely Bad Law Utah Governor Vetoes Video Gaming Law, Noting Unintended … If we’re caught breaking the law….we’ll just change it! Scattershot 2009-03-30 Obama racial…

jharp| 3.30.09 @ 11:01AM

Always find it amusing that you wingnut jackasses want the government deciding things instead of a jury of our peers. Isn't that one of our very precious rights, to have a judge and jury hear our case?

Not in wingnuttia. According to the wingnut brain our government knows what is best. No need to get a pesky jury involved.

Why do you hate America?

David| 3.30.09 @ 11:07AM

The Court's opinion made the point that the FDA approval establishes a floor, not a ceiling regarding labeling and warnings. I agree, and think that ultimately it is the drug manufacturer who bears responsibility for the label it puts on its product - not the FDA.

jharp| 3.30.09 @ 11:22AM

David,

You are correct and I'd think even a wingnut could see it.

There is only one way to get the attention of the marketers of dangerous drugs. And it is through their wallet.

And it still blows my mind that right wingers think the FDA should be the final word, not the law and not a jury of your peers.

jharp| 3.30.09 @ 12:11PM

By Hans A. von Spakovsky ,

"The Tragedy of Supremely Bad Law"

And just a reminder Hans, the tragedy is a woman lost her arm. How do you think you'd feel if you lost your arm because of a dangerous drug that didn't contain sufficient warnings?

You sicken me with your right wing hackery.

Big Leo| 3.30.09 @ 12:37PM

Virtually every effective major drug has side effects. Somebody is going to be made ill or even die from these side effects. But a million people will benefit. Taking drugs has its risks, and we are informed of these risks. When I am given a drug I ask the doctor about the risks. I ask about how to recognize them . I even read the paper with the little tiny print that comes with the drugs.

Hysterical bloviating about "makers of dangerous drugs' is just that-- and meaningless. ALL drugs are potentially dangerous. If drug manufacturers spend hundreds of millions of dollars on drug testing, list the side effects found and market the drug, they should be found blameless if one of the side effects harms me. If they are not, why would they want to spend money on development and where will the new drugs come from?

jaywhite| 3.30.09 @ 1:10PM

Although it goes against my conservative beliefs ,I agree with the supreme court decision. Big Pharma (Pharmaceutical Companies) have total control over medicine in this country. Obama's desire to control the country is no different than the control Big Pharma has. They regularly hide terrible side effects such as diabetes mellitus so they can sell new versions of the same drugs which are generic. Except they charge $20 per pill ,when older drugs which is many cases are equal, if not better, cost 50 cents a pill. Big Pharma always talks about "Drug development" .
This is total BS. It is not in their economic interest to develop a really new drug unless someone else such as the Federal government foots the bill. Otherwise, they just tweak an existing generic drug so they raise the price 40x while offering almost the same exact drug.

Big Leo| 3.30.09 @ 1:16PM

The US drug companies lead the world in development of new drugs. The type of regulation and high development costs limit European development greatly (excepting Switzerland).

European standards for approving a new drug are lower than ours, not higher, which is the only reason they are able to develop any drugs whatsoever. Our drug industry spends more on development than any other, and it gets results, even though the FDA requirements are so high. They can't hide side effects--- they are part of the public record in the FDA approval process.

Again, ALL drugs are potentially harmful. I have a serious allergic reaction to an over the counter drug that put me in the hospital. I didn't sue. It's listed on that little paper that nobody reads.

jharp| 3.30.09 @ 1:59PM

"Obama's desire to control the country is no different than the control Big Pharma has."

And both choices are bad. The huge difference is we get to vote Obama out of office if we disapprove.

Big Pharma, on the other hand, we have no say in. As a matter of fact, Big Pharma is duty bound to squeeze us for every for every dime of profit possible.

jharp| 3.30.09 @ 2:03PM

"It is not in their economic interest to develop a really new drug unless someone else such as the Federal government foots the bill."

And that is exactly how the game is played. The federal government finances the research. Big Pharma reaps the profits.

And the defense given by Big Pharma is American's get a new drug from it.

jharp| 3.30.09 @ 2:11PM

Big Dope,

Read it again.

"But then she sued Wyeth claiming that the warnings on the drug's label were not enough, that IV administration should have been contra-indicated -- that is, eliminated -- as a means of injection. Wyeth argued that it should not be liable to state tort actions when its label clearly and succinctly warned about the dangers of misuse in language approved by the FDA, the agency charged by federal law with determining the safety of drugs marketed to the American public. A Vermont jury awarded Levine $7.4 million. "

The jury agreed with her. She won. And I'll bet you a dime that the IV administration is now banned on the label. And if it would have been earlier she's still have her arm.

"I have a serious allergic reaction to an over the counter drug that put me in the hospital. I didn't sue. It's listed on that little paper that nobody reads."

What kind of stupid idiot takes a drug the he is allergic to? And no kidding you didn't sue. You had no case. Being stupid is not grounds to sue.

Big Leo| 3.30.09 @ 2:28PM

The proof of your incredible lack of logic is one statement: "What kind of stupid idiot takes a drug the he is allergic to?" Since I am allergic to nothing else but this drug, how would I know I was allergic unless I took it? That posting alone demonstrates your intelligence.

If EVERY possible problem were listed on a product, drug or otherwise, there would be so much information the PROBABLE dangers would be drowned in a sea of very remote possibilities.

Try reading an annual report of any big drug company and see how much they spend on development and research. Then try to make a rational statement.

jharp| 3.30.09 @ 2:51PM

"Try reading an annual report of any big drug company and see how much they spend on development and research."

I'll one better you. My good friend and both of my neighbors are all three big shots in R & D for a major Pharma Co. And all three have confirmed exactly to me how the federal government pays for the research and big Pharma reaps the profits.

Not all of course, but most of the big breakthroughs lately have been at taxpayer expense. See AIDS drugs.

" Then try to make a rational statement. "

You are an idiot.

jharp| 3.30.09 @ 2:58PM

"Since I am allergic to nothing else but this drug, how would I know I was allergic unless I took it?"

"I have a serious allergic reaction to an over the counter drug that put me in the hospital. I didn't sue. It's listed on that little paper that nobody reads."

So what is listed on that little paper that nobody reads? That anyone can have an allergic reaction to it?

No kidding? Pea brain. It is not grounds to sue. There is nothing negligent in their marketing and implementation of that drug.

Unlike the Wyeth case where THE JURY FOUND THAT WYETH WAS NEGLIGENT in the labeling instructions.

Good grief, the stupid just keeps humming along here.

Big Leo| 3.30.09 @ 3:07PM

One of my neighbors was the president of Merck, and he said otherwise. So did his annual report. The other difference is, my neighbors aren't imaginary.

Marc Jeric| 3.30.09 @ 3:11PM

It's fun to read the commie spewings in these comments. What is wrong in this country - trial lawyers! Japan has 10,000 lawyers, Germany 15,000, Great Brittain 8,000 - we have 1,100,000 lawyers. How come? Well, the United States is the only country in the civilized world where one can sue anybody and, when losing, just go away and sue somebody else. In all other countries the loser automatically pays all the costs, direct and indirect, of the courts and of the defendant. Have you seen the trial lawyers hyenas trolling the TV adds for "victims"? American "Big Pharma" is the only hope the world has of conquering killer deseases - and they invest their own money in research. Government-paid scientists are 90% private enterprise rejects - see globaloney warming hoax for example!

Big Leo| 3.30.09 @ 3:24PM

Marc, I always enjoy your posts. When you said, "Government-paid scientists are 90% private enterprise rejects " you didn't go far enough. With few exceptions, government-paid anybodies are private enterprise rejects. In my years working in nonprofits, I had frequent contacts with government agencies and regulations: it is all the Circumlocution Office, which I was reminded of while watching "Little Dorrit" last night on PBS. As the immortal Ray Stans said in Ghostbusters, "I've worked in the private sector-- they demand results!"

Remember how trial lawyers bankrupted Corning and several other companies over the breast implant insanity. There was zero scientific evidence, but sympathetic juries-- and tens of thousands of people lost their jobs. And was there anything more disgusting than John Edwards making tens of millions suing doctors for not ordering caesarians and equating that with various childhood disabilities? Again, no evidence-- and worse, now doctors perform unnecessary and dangerous caesarians to prevent lawsuits? How many mothers have died or been seriously harmed to protect doctors from John Edwards and other science-challenged lawyers and the clueless juries?

It is tragic to think that the development of life saving drugs will be delayed or prevented because of an out of control tort system.

Think First| 3.30.09 @ 3:29PM

FINALLY! Something rational happened in court to the drug companies. What so few understand here is the FDA has long been proven to be a rubber stamp to drug companies. While appearing to follow strict guidelines, they in fact allow drug companies to submit their own studies as scientific fact instead of insisting on verifiable INDEPENDENT studies. If it was known this medicine should not be injected into an artery, why wasn't it on the warning label already? DUH!

Drug companies regularly skew results or use only tests confirming their medication as helpful and minimizing risks. While being touted as a fierce defender of our safety, they in fact have proven to be completely absent any desire but to enrich themselves at patient expense. At last verifiable count, 75% of the FDA panel was either a part time or full time consultant for a drug company or one of it's subsidiaries.

Sound like the people you want looking out for you?

And Jharp, sometimes one does not know if you are allergic to a medication until you take it. It is unfortunate but true. Again, the important hints and things to look for in a patients history that might give the Doc a clue to watch when prescribing for a patient, are often NOT included or mentioned anywhere in the literature sent with or provided by the drug company.

My Mom was an RN and office manager for 2 cardiologists and 2 GP's. One of the most frustrating things for all of them was that in this supposed modern medical time, prescribing a drug still relied heavily on trial and error to see what would work and a patient is not allergic to because the info about the drugs had little common sense info about what to watch for. Many times it was only in comparing notes with other Docs over time, they developed an instinct of what to watch for. All four have since retired in frustration however as they watched their once proud profession descend into bought and paid for drug company shills.

Acetaminophen, used in many pain killers, has now taken over the top spot as the major cause of liver damage and cause of organ replacement. Is it on the warning label?

Big Leo| 3.30.09 @ 3:49PM

Warnings about possible liver damage was on the label of an acetaminophen product I saw a couple of years ago. That's one of the reasons I don't take it.

Drug companies do not promote drugs they know to be dangerous for the big profits for one simple reason. It is not profitable for them to do so. The bad publicity would kill them. Even the false bad publicity caused by rabid trial lawyers eager for another Dalkon Shield judgment is damaging. Now-- ALL effective drugs are dangerous. People will suffer side effects. Some very few people will die. But for every drug that is approved, hundreds or thousands fall by the wayside because they prove to be either ineffective or have too many dangerous side effects. The idea that there is some sort of huge conspiracy between government and drug companies to hide egregiously dangerous tests results on new drugs isn't supported by facts, but by conspiracy theories.

jharp| 3.30.09 @ 3:58PM

"And Jharp, sometimes one does not know if you are allergic to a medication until you take it. "

I'm aware and wonder why you thought I wasn't.

And also one can develop allergies at any point in their life.

I was simply asking Big leo why he posted this."I have a serious allergic reaction to an over the counter drug that put me in the hospital. I didn't sue. It's listed on that little paper that nobody reads."

So what is listed on that little paper that nobody reads? That anyone can have an allergic reaction to it?

No kidding? Pea brain. It is not grounds to sue. There is nothing negligent in their marketing and implementation of that drug.

And you're post is spot on, Think First. And the ONLY thing these drug companies listen to is money. It is the very reason for their existence.

Alpfrodo| 3.30.09 @ 4:12PM

Big Leo, I would not worry too much about the big drug companies. Remember that Merck had “Vioxx” on the market for about 5 years making $2.5 Billion dollars each year. The FDA said that over 126,000 people were injured or died while taking Vioxx. That is 126,000 people whose lives were disrupted or ended. Many of those people are no longer income producing people. Many are now relying on the government to take care of them. Of those 126,000 people about 56,000 sued Merck. That was in 2004 and as of today (5 years later) fewer than 20,000 of those people have received a dime from Merck. Merck has agreed to pay $4.85 Billion dollars in settlement money to make those people go away. Let’s see, $2.5 Billion dollars a year for 5 years comes to about $12.5 Billion dollars less $4.85 Billion to cover up their lies to the FDA leaves them with a profit of about $7.65Billion dollars. In spite of all these law suits, they still have managed to put out another new “block buster” drug, “Gardasil”. At over $100.00 per shot, I’m sure they will do really well with this new drug. Oh, by the way, so far only about 27 girls and young women have dies after taking the shots, and only a few thousand are experiencing serious adverse side effects. I would also mention that the FDA approved both of these drugs and said they were safe based on the research Merck gave them. It’s not so much what’s on the warning label, but what was left off the warning label.

Big Leo| 3.30.09 @ 4:17PM

I'm always puzzled when some droll troll shouts triumphantly that the capitalists' only interest is making money and that this is the reason for their existence. It's true, of course. Any company that went into business to lose money wouldn't last more than five minutes, tops.

That raises the question as to how to make money. The best way is to provide a service or product that people need and want. This is achieved by creating a service or product of high quality and letting people know you have it-- i.e., marketing it successfully. It's the same challenge from operating a lawn mowing service to operating a big multinational company. If you don't meet the challenge, you aren't in business any more.

If you as a big company or a lawn mowing service do this well, you will become rich. If you don't, you will ask for a government bailout.

I want the drug companies to do well. I want them to make a good profit so they can do more research and make more and better drugs. I don't mind paying the people who keep this complex process working smoothly, and paying them well. And if you want to convince me that all the drug companies are some kind of conspiracy, you need better arguments than the ones I see here.

Big Leo| 3.30.09 @ 4:24PM

jharp said that the drug company was wrong because they didn't post a warning on the label. When I mentioned that I didn't sue and that there was a warning about possible allergic reactions, he said "It is not grounds to sue. There is nothing negligent in their marketing and implementation of that drug. "

Well, there were ample warning labels on the drug named in the article. "The assistant ignored no fewer than six warnings on the drug's FDA-approved label, stating that injection into an artery could cause gangrene and that the use of an IV heightened the risk of mis-injection. (The assistant also injected twice the maximum labeled dosage and ignored Levine's complaints of extreme pain, which the label stated indicated injection into an artery.) "

So, by your own words and your poor reading skills, you are wrong. The same warnings that precluded me from suing should have precluded the unfortunate woman from suing.

The discussion is over, jharp. Your own words have contradicted your entire premise. And please read your earlier posts if you bother to reply.

Jharp the liberal troll| 3.30.09 @ 4:26PM

I am sorry I am so rude. I am only following orders.

Big Leo| 3.30.09 @ 4:29PM

I accept your apology, jharp. Let this be a lesson to you, and don't come back until you graduate high school and get a little more life experience and education.

Think First| 3.30.09 @ 5:16PM

Okay let's get this straight out of the box. Many cases are being awarded over pretty stupid stuff. Like the woman who sued McDonalds for spilling hot coffee because it didn't have a warning label and then actually won? How ignorant can people be! I would have thought any rational person would have laughed this case out of even being allowed in court.

Sometimes it is not that the warning exists, it is how effective is that warning? Obviously this "nurse" is an idiot and deserved being sued. The drug company is not immune if the warning needed to be more forceful and clear. Having worked for three hospitals and several Docs offices as a computer consultant, I know most nurses and Docs take great pains to get things right the first time. However I also know the warning labels on these things border on the patently absurd at times as they often took great fun in showing me.

What we would think would need an urgent, immense warning clearly stating the risks, in fact gets an aside on the bottom. Then that warning is further watered down by wording which minimizes the actual danger. I have a hard time believing a case that made it all the way to the Supreme Court is that cut and dried. Obviously a lot of smart, careful and informed people did make a decision. On one hand I am dubious of the frivolous lawsuits our system is inundated with and yet cautious we err on the side of allowing companies be exempt by a joke like the FDA.

Dr. Mercola, at his website and newsletter has documented the rise of the drug industry, the money behind it, the rise of certifying Docs "in the public interest" when in fact it was a concerted effort to the stem the loss from big investors because natural remedies and supplements were proving more effective than the big pharma medicines. While there are good and bad on both sides, supplements won't kill you. Prescription drugs can and do. I have watched far too many friends end up in the hospital after repeated attempts to cure a sinus infection with stronger and harsher antibiotics have failed and left them in a sorry state. They finally listen to me and try Oil of Oregano, a few drops a few times a day and in a week or two it's gone. No side affects, no killing of most of your immune system in your gut, no long term damage to recover from. One person in particular has even been on IV only drips to see them constantly returning. He has not had a recurrence in 4 months now. Unheard of for him. However it cannot be patented either. Statins have long been known to deplete the body of Co-Q10 which your heart has to have to function normally, yet IN NOT ONE is it listed as a warning. The list goes on but I think you get the picture. We assume only big pharma can protect us with it's little pills. Looking for a cure all so we don't have to take care of ourselves, be responsible for our own health, our own eating habits, our exercise or lack thereof.

We scream against efforts to restrict our economic and social freedoms yet swallow hook line and sinker the magic of modern medicine. In many ways this case is a response, right or wrong, to the complete tyranny of modern medicine. Take our meds or we won't help you! Vitamins are a scam! Supplements are unhealthy and need to be "prescribed" because we know best!

Obama may have finally woken a lot of people up to the very real threat of the statists' agenda, but have you woken up to the other ones you're swallowing in good faith?

Big Leo| 3.30.09 @ 5:28PM

Let's focus and stick to this case. The warning was there and was repeated SIX TIMES. How much more emphatic and clear could the warning be? The problem was not that the warning wasn't clear, it was that the medical technician or doctor ignored the warning and the patient's complaint of pain, which should have alerted them to the problem.

The drug company was not at fault here. Nor was the patient. Who was at fault was the technician and/or the doctor.

Big Leo| 3.30.09 @ 5:43PM

Think first says, "...natural remedies and supplements were proving more effective than the big pharma medicines. While there are good and bad on both sides, supplements won't kill you..."

In actual practice, folk and herbal cures have killed a number of people over the last thirty years or so. Remember tryptophan, for example. Some herbs do contain drugs which have a healing effect on various diseases. Most do not. The problem is dosage and the lack of actual testing to prove effectiveness. Foxglove contains digitalis, which is useful in treating heart disease, but how much digitalis is in any individual plant is highly variable and use of the plant alone is dangerous. This is true of a number of natural remedies. Fortunately, most natural remedies and supplements are useless and harmless. If you wish to tell me they are useful, you need to quote studies that show that they are. We've already proven that megadoses of Vitamin C are uselss in preventing colds, for example.

Frankly, I'm slow to take any sort of drug. I want to know all about anything I'm going to put into my body, and I especially want to know its effectiveness and risks, not by hearsay but by test.

jharp| 3.30.09 @ 5:50PM

"Well, there were ample warning labels on the drug named in the article."

No, there weren't. That is exactly what the jury based their verdict on.

And a woman lost an arm because of it. And Wyeth paid 7.4 million.

jharp| 3.30.09 @ 5:55PM

"Like the woman who sued McDonalds for spilling hot coffee because it didn't have a warning label and then actually won? "

ThinkFirst,

You made an intelligent post and followed with a stupid one.

The McDonald's coffee judgment had nothing to do with any warning labels. It had to do with serving a dangerous product. Kind of like advertising a hot shower and then scalding someone.

The McDonald's coffee verdict was just.

Alpfrodo| 3.30.09 @ 6:15PM

Hey Think First. Why don’t you read about the McDonalds coffee case before you say it is “stupid stuff”. Here is a link. http://en.wikipedia.org/wiki/Liebeck_v._McDonald's_Restaurants

Big Leo| 3.30.09 @ 7:12PM

""The assistant ignored no fewer than six warnings on the drug's FDA-approved label, stating that injection into an artery could cause gangrene and that the use of an IV heightened the risk of mis-injection." There were six warnings. How many are ample?

Juries make poor decisions about scientific matters all the time. There simply aren't enough people who have even done well in high school science to make informed decisions. This is one of those poor decisions.

I bought a fishing lure with four ferocious treble hooks the other day. There was a warning label, "Do not put in mouth." Of course, there was only one warning, so I think I'll go and chow down on it now, maybe with one of those pork rind baits that look like frogs. Then I'll sue. If six warnings aren't ample, then one surely isn't. Hope jharp is on the jury.

jharp| 3.30.09 @ 8:20PM

Big Leo| 3.30.09 @ 7:12PM

""The assistant ignored no fewer than six warnings on the drug's FDA-approved label, stating that injection into an artery could cause gangrene and that the use of an IV heightened the risk of mis-injection." There were six warnings. How many are ample?

You just don't get it. Do you?

It doesn't matter if the assistant ignored six warnings.

The warning that the jury found lacking was that the drug shouldn't be administered through an IV.

And that makes sense to me. And I'll bet that the warning is there now. And I'll bet it makes things safer.

Big Leo| 3.30.09 @ 8:35PM

Try to sharpen your reading skills with this, "The assistant ignored no fewer than six warnings on the drug's FDA-approved label, stating that injection into an artery could cause gangrene and that the use of an IV heightened the risk of mis-injection."

You said, "The warning that the jury found lacking was that the drug shouldn't be administered through an IV. " There were six warnings specifically mentioning administration through an IV. That's what the reading says. Are you telling us that now there are seven? Or don't you have the level of reading comprehension necessary to know there were six specific warning?

jharp the liberal troll| 3.30.09 @ 8:43PM

Sorry I was wrong again. The McDonalds suit was unjust. The lady's stupid son gave her the coffee with cream and she tried to hold the coffee between her legs and add cream while he drove the car. This was just another example of a deep pocket's law suit. I will literally say anything to make my rediculous points. Somebody needs to stop me before I hurt myself. Why I am I such a fool?

DaveS| 3.30.09 @ 8:56PM

Alito has it exactly right. If Wyeth made oxygen and its administration was mishandled, they'd be liable? Sad case, but it's a malpractice case and not a product tort case. If you believe the opposite, then drugs made and labeled with warnings that they never be used would be the only ones not subject to tort. Is that what you want, the zero risk )zero use) drug? If so, get some sleep and stop your current meds.

Pingback| 3.30.09 @ 8:58PM

Self Talk Analysis › Update on 3/27 Post–Are you on Drugs? links to this page. Here’s an excerpt:

telling yourself true? Skip to content Home About Update on 3/27 Post–Are you on Drugs? If you try to beat up on the drug companies, there will be no winners, only losers.  On 3/30 I found this article which pretty much sums it up.  As drug companies prosper, more dollars are used for research and development of new life saving medications.  If you’re using generic drugs, you may save some…

ChipD| 3.30.09 @ 9:24PM

I am not familiar enough with medicine or the facts of the case to know if the jury made the right decision;
but as to the larger issue- this decision is not so ground-breaking.
If an architect and contractor both follow scrupulously the building codes, but someone gets injured, they can still both be held liable for a faulty design.
As one of the SCOTUS observed, regulations are a floor, not a ceiling- there was nothing preventing the maker from going above and beyond what the FDA demanded.

Big Leo| 3.30.09 @ 9:31PM

ChipD,
You said, "regulations are a floor, not a ceiling- there was nothing preventing the maker from going above and beyond what the FDA demanded. " True, but there were six very specific warnings. How many is enough? If a jury can decide , then no warnings are sufficient and no company will produce any drugs since they are not protected from suit regardless of how clearly they state the danger. No new cures will be found, and millions of people will die unnecessarily. This is the practical result of applying that principle to drug production.

Think First| 3.30.09 @ 10:13PM

I've been off studying this case as much as I can and finding out about the medication. Considering how much information is available on this drug, the clarity and number of warnings, how this ever made it this far is a joke and I stand corrected. My bad.

The supplement statement stands as there has been a HUGE impetus world wide to discredit supplements. All the deaths supposedly attributed to supplements have been proven to actually have other causes once full testing and autopsy results were known. Prescription drugs however have moved up to 9th on largest causes of death in the US. Combine that with hospital and Doctor incompetence and they are number 1 by a wide margin.

It doesn't make this case correct or right.

jharp| 3.30.09 @ 10:36PM

"You said, "The warning that the jury found lacking was that the drug shouldn't be administered through an IV. " There were six warnings specifically mentioning administration through an IV. That's what the reading says."

Now we're getting somewhere and thanks for your response. Though reasonably well thought out you still don't get it.

What the jury found, and I agree with is their should have been a warning that the drug SHOULD NOT BE ADMINISTERED INTRAVENOUSLY PERIOD, and that Wyeth is thus culpable.

And again, thanks for a reasonable debate.

And I'm having trouble posting on the other threads. I believe TAS has become as cowardly as the other wingnut blogs and banned me.

Oh well, it's your loss. And good luck with traffic. That special election in NY tomorrow ain't looking too good for ya, huh?

Hilarious. And the wingnuts think they have a chance in 2010. The bleeding has only begun.

And it is specifically because of the wingnut BS that is pushed on sites exactly like this.

Dai Alanye| 3.30.09 @ 11:48PM

The ultimate basis for many of these bizarre lawsuits is the "deep pockets" theory that was successfully advanced many decades ago—in the '60s, I believe. What it does, in essence, is allow a plaintiff to not only go after the immediate person or entity responsible for an error but to advance the case against a distant party with no conceivable responsibility, but with the assets to pay a large award.

In other words, it is a method whereby lawyers can monumentally increase their fees. It has proven very popular, and is now accepted by all courts. And courts, as we know, are run by judges who are themselves lawyers.

An additional difficulty in the pursuit of true justice is that juries are all too often composed of ignorant and biased souls like jharp, as plaintiff lawyers attempt to challenge those potential jurors who are knowledgeable and difficult to mislead.

Big Leo| 3.30.09 @ 11:54PM

The lawsuits usually don't benefit the person suing as much as it benefits the lawyers. Their contingency fees are spectacular.

jharp| 3.31.09 @ 12:43AM

Big Leo| 3.30.09 @ 11:54PM

"The lawsuits usually don't benefit the person suing as much as it benefits the lawyers. Their contingency fees are spectacular."

Maybe so. So what do you propose we do about it?

Ms. Levine lost an arm. The jury found Wyeth partly responsible. As a result of Ms. Levine's lawsuit it's a lot likely to happen again. And Ms. Levine get's a little reparation, though I'm sure she'd rather have her arm back.

And your complaint is the lawyers benefit too much?

Why don't you take on cases like Ms. Levine's and do it for less? Then everyone will be happy.

Right?

Big Leo| 3.31.09 @ 12:49AM

I'm not a lawyer. And if I were, I would not take on cases like this one, which results in irreparable harm to the people who make the drugs that cure us. I would represent the drug companies that are being victimized by cheap shysters. Your support of this absurd and destructive suit is motivated solely by your hatred of the capitalist system, and indeed, of all productive members of society. For fifty-four years this drug and the warnings attached have helped hundreds of thousands. IF suits like this continue, the drugs that would cure us won't be there. And it will be the fault of lawyers and juries like the ones in this case, and people like you.

lynnrockets| 3.31.09 @ 1:05AM

Liberal trial lawyers like John 'the Breck girl' are the real skunks in this mess. Glorified ambulance chasers.

CH| 3.31.09 @ 1:07AM

Liberals are nihilists, Big Leo--they thrive on chaos. Sick bastards.

jharp| 3.31.09 @ 1:07AM

Big Leo| 3.31.09 @ 12:49AM

"I'm not a lawyer. And if I were, I would not take on cases like this one, which results in irreparable harm to the people who make the drugs that cure us."

You wingnut hackery is shameful.

Ms. Levine lost her arm. And she is a musician so I guessing that makes it even worse.

Wyeth lost about one tenth of one days sales.

That'd be 7.4 million out of 22 billion.

You are either an uneducated fool. Or a sick twisted vile repulsive piece of scum.

Tell me jackass. Who suffered irreparable harm.

Ms. Levine who lost her arm.

Or Wyeth who lost one tenth of one days sales.

Good God you wingnuts repulse me.

jaywhite| 3.31.09 @ 2:24AM

Big Pharma " won't develop new drugs" if they can't charge $400/month for each medicine. Big Pharma does more damage than good. A perfect example was the drug Neurontin. There was not a shred of evidence it was effective in bipolar disorder. But, their slick talking ,professional BS artists, told psychiatrists it was a "wonder drug" without drug-drug interactions etc. Who knows how much damage this fraud caused. Bipolar has up to 25% suicide rate. Patients were taken off proven drugs such as Lithium to be on a placebo.
This fraud was so outrageous that even Big Pharma's puppets in the FDA fined the manufacturer approximately $450 million. It sounds like they were punished for their criminal fraud ,however, the manufacturer made over $1 billion in sales of Neurontin as a "mood stabilizer".

Crusader| 3.31.09 @ 9:25AM

Big Pharma this, Big Pharma that. You know, just like with anything, if there's not a market for it, it doesn't get sold.

Americans are fat and lazy and want a pill for everything. Hell I know people who have 2, 3 pill boxes a week now for all of their various "ailments" that magically can be treated with a little pill.

How about this prescription:

Balance in life. Moderation. A little exercise. Spirituality.

I'll only charge you $200/month.

Vike| 3.31.09 @ 9:32AM

Where the rubber meets the road is simply when a doctor recommends a drug. Most of us rely totally on his or her knowledge and a traditional trust of their profession. They may point out the possible side effects and drive home the known dangers via labels, but they usually have weighed the risk for us. We came in to get well. I cannot imagine a physician knowingly writing a px that the dangers are so inherent that we pass. I am certain, democrat in power or not, that as long as we have some degree of free enterprise, Pharmas will continue to find a need, fill it at a profit. The gov't will "oversee" and nothing changes.
My wife was prescribed Premarin for hot flashes. She has no idea whether she read the label or was given any warnings. She simply trusted her doctor. Ten years later she developed breast cancer. Her doctors told her Premarin certainly advanced her disease if not caused it. Do we sue? If so, who?

Big Leo| 3.31.09 @ 11:04AM

I can only repeat the obvious; if drug companies can be sued for side effects they specifically warn against on the label (six times), then there are no protections and they will not be able or willing to do the research on new drugs. This drug was out there for fifty-four years so it is apparently very effective. Also, ALL DRUGS HAVE POTENTIAL DANGERS. If you want a safe drug, have a glass of distilled water-- but don't drink too much of it.

The major expense in drugs is not their manufacture, but their development. It can easily take ten years to put a new drug on the market, and the testing for each drug, most of which never make it, runs into the hundreds of millions of dollars. Take away the incentive to develop new drugs and you won't have them.

jharp| 3.31.09 @ 11:19AM

So how about a response to make query Leo?

Who suffered irreparable harm here?

Ms.Levine who lost her arm?

Or Wyeth who lost 1/10 of one days sales?

jharp| 3.31.09 @ 11:23AM

And one thing you can't seem to get through your troglodyte brain.

The jury found that the one warning that wasn't given was that THE DRUG SHOULDN'T BE ADMINISTERED INTRAVENOUSLY.

It doesn't matter if there were 16 other warnings given. The one warning that would have prevented the problem or at the least prevented Wyeth from being held liable. WASN'T THERE.

Get it?

Big Leo| 3.31.09 @ 11:41AM

I'll respond to you one more time, jharp, and belabor the obvious. The warning that the drug shouldn't be administered intravenously was there six times. Your reading skills are flawed. And it isn't either Wyeth or Levine who will be most harmed. It is the millions of people who will suffer if new drugs aren't developed because of this decision and the hundreds more similar decisions which will follow if trial lawyers have their way.

Got it? Goodbye.

jharp| 3.31.09 @ 11:53AM

"The warning that the drug shouldn't be administered intravenously was there six times. "

So the Big Dope Leo simply flat out lies and runs.

No Leo, there was no such warning. That is why the jury held Wyeth liable.

"I'm not a lawyer. And if I were, I would not take on cases like this one, which results in irreparable harm to the people who make the drugs that cure us."

"And it isn't either Wyeth or Levine who will be most harmed. "

And I'm glad to see you admit that the damage suffered by Wyeth was peanuts. Contrary to your post above.

Big Leo| 3.31.09 @ 12:49PM

It's useless to argue with someone who can't read a simple sentence. "The assistant ignored no fewer than six warnings on the drug's FDA-approved label, stating that injection into an artery could cause gangrene and that the use of an IV heightened the risk of mis-injection."

jharp| 3.31.09 @ 2:36PM

"The assistant ignored no fewer than six warnings on the drug's FDA-approved label, stating that injection into an artery could cause gangrene and that the use of an IV heightened the risk of mis-injection." "

That is true. And the assistant and the hospital were found to be liable.

And Wyeth, by failing to warn that the drug should not be administered intravenously, was also found to be liable.

It doesn't matter if Wyeth had 6 hundred warnings on the drug.

They jury found it didn't have the proper warning, THAT THE DRUG SHOULD NOT BE ADMINISTERED INTRAVENOUSLY.

Good Grief. You are one think headed dolt.

Big Leo| 3.31.09 @ 2:47PM

Don't ever change, harp. You're perfect the way you are.

lynnrockets| 3.31.09 @ 4:08PM

Big Leo--if you wrestle with a skunk, you'll smell like one. It's a beautiful day outside, why waste your time and energy with a mentally ill loser?

Vike| 3.31.09 @ 6:42PM

I'll tell my wife "tough titty" cuz she t00k the drug. Oops, can't.. they were taken by the masectomy.

ruth| 3.31.09 @ 11:25PM

I'm sorry about your wife, Vike. Can she get reconstructive surgery? My friend did after her masectomy--you should see the knockers on that girl now! She loves them. But your wife is alive, right? Each day is the only day that matters, and nothin's guaranteed. Love her to bits right now. God bless you both.

Vike| 4.1.09 @ 12:27PM

Tks Ruth. yes, I'm glad she is alive. and yes, she had reconstructive surgery and looks great. I never cared whether she had the surgery or not. I am, however, major pissed off that she went thru hell for 3 years and still lives in fear of a probable reoccurence. When I think that the Hot Flash drug Premarin CAUSED her cancer, I get truly upset. To me Caveat Emptor should not apply to drugs. and once again I'll ask; should I sue and if so: Who?

ruth| 4.1.09 @ 3:56PM

Trust me, she cares. Glad she looks great--it's important for recovery. Consult an attorney, some specialize in this sort of case. Good luck!

Pat| 4.2.09 @ 6:04PM

Wow, all you people applauding this decision are crazy. When you are in need of a drug that has been pulled because quack physicians misused it, remember this: YOU ASKED FOR IT.

Vike| 4.2.09 @ 6:47PM

Pat. How do I recognize a quack?

Pingback| 4.4.09 @ 1:55AM

Jury Experiences links to this page. Here’s an excerpt:

…users including, most importantly, those who would suffer without new medical treatment if “juries in all 50 states were free to contradict” the FDA’s expert determinations. Read the rest… Submit this post to del.icio.us or other social-networking sites. This entry was posted on Saturday, April 4th, 2009 at 1:55 am and is filed under Appeals, Civil Trials, Court Decisions, Jury…

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