22 Comments

Frank re-tates Justice Breyer’s comment (see Examiner article) regarding medical devices that “untrained juries who hear only the sad stories of side effects” is cause for not allowing juries to decide on cases involving “larger policy issues.” In other words, take the ever dwindling power away from the people and continue to place that power in the hands of the rich and powerful. Our justice system was intended to keep the power with the people as a check on the rich and powerful. Justice Breyer’s comment, as well as Frank’s insinuation, is out of line. What is in fact being stated here is that the people are not educated enough to decide what is right and what is wrong. Biased comments like these from Frank and Breyer are the reasons inequality exists in as large a deficit as it does and further widens the gap between the classes.

Someone should devise an odds scheme on cases like this and post an over/under in Vegas.

Juries–who usually aren’t allowed to hear the relevant cost-benefit analyses when they make their decisions, which are largely dictated by a non-expert judge’s rulings and jury instructions–aren’t “the people.” They don’t answer to the people, and aren’t elected by anybody–and even if they were, the game show that is our product liability adversarial system is a poor way to make these public policy decisions. Preemption keeps the power with our elected officials, who do answer to the people.

(Separately, there is no historical basis for the statement “Our justice system was intended to keep the power with the people as a check on the rich and powerful.” Jury service was restricted to white males, who were usually wealthier than the average white male citizen. For better or worse, the jury system certainly was not intended as a means of wealth redistribution, much less drug regulation.)

For Earl:

“What is in fact being stated here is that the people are not educated enough to decide what is right and what is wrong.”

A trial should never be about right and wrong. Take a run of the mill murder for example. We know that somebody’s life was taken, and that is usually wrong. The question at trial is weather there is a theory that explains, beyond reasonable doubt, who did the crime.

With medical devices and drugs, the question is whether manufacture was done with due care. That is a technical question that is best answered by panels of experts.

You also make the common mistake of confuseing intelligence with education. My observation is that few people use reason; habits and rules are sufficient for almost all of life. Consider the Friedman case (See the “Capturing the Friedmans” movie). A horrendous trial was carried out in a very highly educated community whose members could not apply reason to facts.

What is in fact being stated here is that the people are not educated enough to decide what is right and what is wrong.

It’s not that “the people” aren’t educated, etc, it’s that the people who are allowed on the jury and then given highly skewed data to work with aren’t able to miraculousy divine the truth about the situation.

Our jury selection process and the rules of evidence that keep highly relevant facts out of their reach account for much of the jury problems we see.

Juries that were actually representative of society would produce (on average) MUCH better results.

None have you have read the facts in this case. They are not even stated correctly in this blog. You see a large jury verdict and assume that the jury was irrational. These drug companies knew of the possible compulsive side effect and deliberately failed to warn the Parkinsen’s patients. These people are in a vulerable state and if they had known of this side effect they could have made decision on whether or not to take this drug.

Call it what you want. The jury was given both sides of the story by highly intelligent lawyers and experts.

I’m sorry you think you are smarter than the average jury. In many ways, passing judgement without all the facts is more ignorant.

Why don’t you post your real name?

@6 is wrong. I have read the facts in this case, and you can, too: trial brief and motion for judgment of law. The anonymous poster has misstated facts on his own (and irrelevant ones at that), but does not identify what he thinks I got wrong.

Sorry to be late to the party. Two quibbles, Ted.

First, you forgot to include “property owners” in your description of eligible jurors in the old days. Minor error.

The major error is when you say that preemption puts the power in the hands of elected officials. No one at the FDA is an elected official.

The FDA is part of the executive branch, and its officials are appointed by the president, who is answerable to the public. And the standards the FDA uses are established by laws passed by elected officials.

If you’re making a non-delegation doctrine argument, well, I never thought of you as a Constitution-in-exile type, but we can cross that bridge when you’re clearer why you think the FDA isn’t more answerable to the public than a jury.

Wow, started some good conversations here. Ted, you are correct and I was misspoken concerning jury selection in the beginning. However, its initial “intention” is implied by the fact that we have juries. Your jury selection comments are obviously correct as well, but that is a problem which needs to be fixed, don’t you think? Rather than take the power away from “the people” equip the people with the correct facts of the case so they (or we) can make an intelligent decision. Politicians are supposed to answer to the people, however, we all know that they answer to the highest bidder in many cases. Some are honest, but even they must compromise in order to keep their jobs. The reason for experts in a trial is to give the jury the facts. If we allow politicians all the power, they will take it. “The People” have a RIGHT to know and a RIGHT to hear, vote, and decide what is best for the public. Cost-benefit analysis: Irrelevant in this case. Only 1% of the people taking the drug were affected by the compulsive gambling side effect. The fact is that those who knew about it did not warn anyone. The drug would still have made as much money as it did despite this side effect.

When you referred to Teen Suicide, you used an apples to oranges comparison. Suicide = death, whereas gambling = loss of money. There is a big difference between the two. Failure to warn is a crime whether you believe it or not. Duty to warn is a responsibility and a fact of law. A side effect is a side effect whether it affects 1% or 100% and therefore ought to be listed. If gambling, or compulsive disorder, had been listed the company would have avoided a lawsuit. The fact is they knew about the side effect and failed to warn–a crime.

Wealth redistribution is not a function of the jury, yes, but punitive damages are meant to keep the wealthy from taking advantage of those not so wealthy (I know there is more to punitive awards than this). I have read the facts of the case and although I find your opinions valid, you have erred on the side of the wealthy and powerful.

Let the juries hear the facts. If the juries are not hearing the facts, I suppose there is a problem with the system. Guess who controls that system? Politicians–what do you know!

@6 and @8: Ted, why do you say @6 is wrong and irrelevant and misstates facts? Maybe the bit about the jury hearing both sides completely? You know as well as @6 that the lawyers objections and judges (sustaining and over-ruling) evidence are the reasons juries do not hear some of the relevant facts. However, they did hear expert testimony and that testimony tells us that the drug companies knew about the side effect. Perhaps @6 was not clear, but blogs are hardly clear to the reader what the writer actually meant. I do not see where @6 was telling you, Ted Frank, personally what you got wrong. It reads to me as if he/she is telling all of us that we got it wrong; he/she assumes we have not read the facts of the case. Thank you, by the way, for providing a link to the brief and motion.

@8: Again, thank you for the links, however, they are defendant’s links. If I can find the Plaintiff’s links, I will provide them in the interest of two sides to every story.

Earl,

What, exactly, should the drug company have done?
They added a warning and the responsibility should then be with the Dr.

Steve, @14

I answered this question. But, just in case you missed it: They (the drug company(ies)) added this warning after July of 2005 when it was brought to their attention by the “right” people. There is evidence that they knew about the side effect before marketing (pre-1996 or so). Duty to warn would have avoided the lawsuit by placing the warning in the marketing material. The drug has been out since 1996 or so and it took almost 10 years for them to add the warning. AFTER the warning was added, you would be correct; the Dr. has the duty to warn. In the above case the Dr. did not know of the side effect until after July of 2005.

Here is the link to the plaintiff’s position for those you interested in reading it.

http://www.pharmalot.com/wp-content/uploads/2008/08/charbonneau-mirapex-suit.pdf

Leaving aside that the plaintiffs’ own complaint shows that the scientific studies suggesting a Mirapex-gambling link were published in 2005 (not 1996), the fact remains that Charbonneau continued taking Mirapex after the warning was on the label, so any failure to warn could not be the cause of his gambling–his doctor plainly thought the benefit of Mirapex was more important than the potential risk of a side effect.

And even that leaves aside the fact that Charbonneau was a gambler even when he wasn’t taking Mirapex.

And even that leaves aside the inappropriateness of a damages claim to reimburse someone for their gambling.

And even that leaves aside the fact that state failure-to-warn claims are legally inappropriate by frustrating the FDA regulatory scheme.

There are lots of compulsions. Why would a drug cause compulsive gambling and not compulsive hand washing or the compulsive viewing of pornography or … . There are lots of compulsions; commenting on Overlawyers.com could be one I suppose.

I have always been a non risk taker. That is, until 7 years ago.

I year into my diagnosis of Parkinson’s Disease, I started gambling online. At first it was every once in a while because I enjoyed it. As time progressed, I started gambling more and more, until I got to the point that I could not pay all the debts I had incurred. Funny part is, I was not enjoying it anymore. It was just something I needed to do. I would win big and then give it all back plus more. Irrational behaviour at it’s best. Stupified at it’s worse. Sneaky at an all-time high. I would gamble all night so no one knew it was happening.

Imagine my surprise in August of 2003, when I saw the headline on Yahoo “Parkinson’s Drug causes compulsive gambling”, clicked on the link and the name “Mirapex” slaps my right on the face. HUH? How could that be. DRugs cause belly aches or head aches or rashes. They don’t give one a personality make-over…..or did they?

I was diagnosed in 2000. Started taking Mirapex in 2000. Started gambling in 2001. Gambled like crazy for 2 years as I titrated up to 3 mg a day).

Lost a fortune that I haven’t even put a dent into paying off. I have spent the last five years paying for the drug company’s sins. That’s five years of my life that I haven’t been able to fully enjoy and that won’t come back because my illness has progressed. At least 5 wonderful vacations I missed, and countless other things I would have been able to do. You know the old saying….”No monies…..no funnies”.

The compulsive behaviour stopped in 2003 as soon as I stopped taking Mirapex, and I am back to being a non-risk taker. In my book 2 + 2 = 4 No?

So guys….you tell me. I am meeting my responsibility in this situation by trying to pay off those debts. Now it’s the drug company’s turn to be responsible and pay me for my losses, the pain and suffering I have incurred, and they should be punished for withholding the info they had about the compulsive aspects of this drug. All the legal mumbo jumbo pales in comparison to MY experience with this terrible drug. So please don’t paint us all with the same brush, Ted Frank.

Oh, one more thing. You think the punitive damages were too much. Fine. Maybe then instead of the drug company parting with it’s ill-begotten money, some of those decision making execs should go to jail for their criminal behaviour.

Of course, the issue here is that the drug company didn’t do anything wrong. A drug approved by regulators worldwide has a possible quirky weird side effect of personality changes. When scientific evidence of that side effect came to light, a warning was added. The drug doesn’t remove free will.

“The drug doesn’t remove free will.”

Actually, if you reread what I wrote, that’s exactly what it did. I could not will myself away even though I no longer found enjoyment in gambling. You have no idea how powerful that drug is. To this day, when I think back, the only thing I can remember about those 3 years, is the gambling. Nothing else. I certainly understand some not being able to comprehend that state of mind. I can’t even explain it and I went through it.

The drug companies knew way before 2005. Had I been aware of this side effect, my life would be totally different now. Do you have any idea what stress does to a Parkinson’s patient? Read up on it.

I did learn 2 valuable lessons though. I won’t even take a sugar pill now, without researching it and the pharmaceuticals are not our friends and should not be trusted.