Legal Question

WalkingContradiction · Nov 10, 2010

In the end of my book, I want to include a large-scale law suit. It's not a book on lawyers, and the law suit is only followed on tv, maybe one hearing actually described in details, so the information doesn't need to be perfect. But still, I need to get an idea of how this stuff works.

The problem is that the only stuff I've heard about the American court system comes from movies and the series 'Boston Legal', and I doubt that this is very accurate information.

My book is set in either, Utah, Arizona or Colorado, not sure yet (this could be important, right?). This would be where the seat of the company that gets sued is. It's a pharmaceutical company that used drugs on probands the wrong way (basically using the probands for another kind of research they didn't agree to), so it possibly violates constitutional rights. Especially since the drug turns out to slightly alter the probands personalities. Unfortunately I can't go into more details because that would give away too much of the plot.

So I'm wondering what kind of law suit would result (if the probands sue the company). Does it go to the state court first? What would be the common precedure? How could it go to the Supreme Court? The case has some interesting consequences on personal liberty, and I would love to write it as a Supreme Court Case, altough I'm afraid this might make it too complicated.

So are there any legal experts here that could help me out? I would really appreciate it! I'm thankful for every bit of information.

GeorgeK · Nov 10, 2010

I don't know about the law aspect, but the medical side would have had waivers done such that unless the researchers knowingly falsified data to hide an expected outcome, I doubt that they'd hava a case. In that kind of situation, I think you would need to prove malicious intent.

WalkingContradiction · Nov 10, 2010

GeorgeK said:
I don't know about the law aspect, but the medical side would have had waivers done such that unless the researchers knowingly falsified data to hide an expected outcome, I doubt that they'd hava a case. In that kind of situation, I think you would need to prove malicious intent.

There's no falsified data, but the company didn't disclose their secret intention. They superficially tested what they said they would, and secretly, they tested something else. There are some ambigous phrases in the signed waivers that the company's lawyers can use for a defense, but it won't be enough. People weren't actually harmed because of it, but they had slight changes in personality.

It's not the real scenario, but imagine it as follows: You sign up for a routine study for say a new caughing medicine, the medicine works well for most of the patients, no 'bad' side effects, but all patients suddenly really like the color 'pink', and that wasn't just a side effect but something the company actually intended.

milly · Nov 10, 2010

if you have specific questions, PM me and I'd be happy to see if I can help...this is the actually the type of law I practice on the plaintiff's side...and yes, the state in which this is set is important since the law to be applied can affect the cause of action being pursued and the rules that govern any trial on that cause of action

Cathy C · Nov 10, 2010

First, in Colorado (where I practiced as a certified litigation paralegal for 20+ years) a case like this would be filed in Federal District Court because the sale of the drugs would cross state lines. It would likely appear first as a class action suit if individual customers are suing, unless it starts as a criminal matter. A criminal matter WOULD be in state court first--at least in Colorado. The District Attorney for an individual group of counties would file charges against both the company and any individual officers it feels would be subject to "piercing the corporate veil". Basically, that means that the officer of the company did something that pulls away the corporate protection of "just doing my job, sir" to become something both willful and illegal.

What specific questions do you have? I know the laws in Utah and Wyoming are fairly similar to Colorado and the Federal District Rules are for sure, so I could probably answer a few questions or direct you to the right spot.

WalkingContradiction · Nov 10, 2010

milly said:
if you have specific questions, PM me and I'd be happy to see if I can help...this is the actually the type of law I practice on the plaintiff's side...and yes, the state in which this is set is important since the law to be applied can affect the cause of action being pursued and the rules that govern any trial on that cause of action

Thanks a lot for the offer. I need to think things through for the specific questions, I'm still far away from getting to that point in the story. But I'll remember you once I have some more details.

Cathy C said:
First, in Colorado (where I practiced as a certified litigation paralegal for 20+ years) a case like this would be filed in Federal District Court because the sale of the drugs would cross state lines.

The company is very new and not even selling anything yet. Would that change things?

It would likely appear first as a class action suit if individual customers are suing, unless it starts as a criminal matter.

I don't think it's criminal, nobody actually got hurt, and the company's motivations were scientific and monetary. And only a handful (management and head of science department) knew of the secret research. So it would be class action.. That's without jury, right?

What specific questions do you have? I know the laws in Utah and Wyoming are fairly similar to Colorado and the Federal District Rules are for sure, so I could probably answer a few questions or direct you to the right spot.

Thanks, well at this stage, I simply want to know what the basic procedure would be. The protagonist of the book was in the proband group, and he would testify as one of several witnesses.

There are 140 probands that participated in the study, is it enough if they hand in a written testimony, or do they all have to appear before the judge and testify? The protagonist is one of the probands, and the main witness (he has connections to the head of science and found out about the whole deal), so he certainly has to appear in court, right?

How many days would such a trial last (only roughly)? Do they have court sessions every day, or only once a week?

And finally how would the case go to the Supreme Court, if that's even possible? It would from the very beginning on create a lot of media attention, the subject is very polarizing and threatening concepts of 'free will' and such. Why do cases go to the SC in the first place? Does it happen when the losing side simply keeps refusing to acknowledge the sentence and appeals to higher courts? Or does the subject matter play a role, and 'new' cases like the one here would go to higher courts automatically because of its significance for jurisdiction in future cases?

Kenn · Nov 10, 2010

I don't know anything about the US legal system, but I know that drug companies need to get approval to undertake tests. There are various ethics committees that have to be consulted and there are a number of Acts in place to protect those being tested. To change the trial without approval might well mean somebody ending up in prison. There would certainly be compensation clauses included when granting approval and a change in personality would be regarded as harm. This is not the kind of thing a drug company would do without a very large financial incentive. If the harm was caused by the drug being tested however, that is a different issue.

A major concern has been that drug companies have moved such experimental research overseas to get around the ethical issues. At least they have been widely accused of that. Certainly, medical ethics seems to figure quite highly in any research proposals (to the extent of paranoia, it seems to me).

WalkingContradiction · Nov 10, 2010

The case is a bit less severe as I made it sound. And the company has got a strong motivation, so that shouldn't be a problem.

Kenn · Nov 10, 2010

That wouldn't satisfy the ethics committee, though. I think they have an interest even if there are only questionnaires involved. You can probably work around it, but I am not sure how. Another problem you will have is in proving the cause of the personality changes (especially if another drug is involved).

One thing worth thinking about is why the drug company is being secretive about the trial. Is it because it would be regarded as unethical or is it purely because of commercial sensitivity?

Cathy C · Nov 10, 2010

WalkingContradiction said:
The company is very new and not even selling anything yet. Would that change things?

So it's still in the research stage? Yeah, that would change things.

I don't think it's criminal, nobody actually got hurt, and the company's motivations were scientific and monetary. And only a handful (management and head of science department) knew of the secret research. So it would be class action.. That's without jury, right?

No, it can have a jury. A "class action" means that a group of people (more than 100, which you have) is deemed to be a "class" by the court who have the same or similar complaints. Like, prisoners in a prison who sue for inhumane conditions are a single class, or people who are harmed by bad drugs are a single class. So the probants (which isn't a term used much here in the U.S. Usually, it's "research subject" or "test subject") would be a single class.

Thanks, well at this stage, I simply want to know what the basic procedure would be. The protagonist of the book was in the proband group, and he would testify as one of several witnesses.

There are 140 probands that participated in the study, is it enough if they hand in a written testimony, or do they all have to appear before the judge and testify? The protagonist is one of the probands, and the main witness (he has connections to the head of science and found out about the whole deal), so he certainly has to appear in court, right?

He could have his deposition taken, which isn't in court. Often, class actions are tediously long and the attorney for the class appears with multiple depositions. But your protagonist could be one of a few witnesses if you'd like.

How many days would such a trial last (only roughly)? Do they have court sessions every day, or only once a week?

Court cases for product liability or other claims such as this can go on for weeks. Trial is normally M-F and start at 9:00 a.m. (but this can vary by judge)

And finally how would the case go to the Supreme Court, if that's even possible? It would from the very beginning on create a lot of media attention, the subject is very polarizing and threatening concepts of 'free will' and such. Why do cases go to the SC in the first place? Does it happen when the losing side simply keeps refusing to acknowledge the sentence and appeals to higher courts? Or does the subject matter play a role, and 'new' cases like the one here would go to higher courts automatically because of its significance for jurisdiction in future cases?

As a court of first jurisdiction, the Supreme Court doesn't hear many things unless they're international treaty or interstate commerce matters. It's possible that with a constitutional issue, they might do so, but probably they'd make it go through the Federal District Court and Appellate court process first. It's possible but unlikely.

GeorgeK · Nov 10, 2010

WalkingContradiction said:
There's no falsified data, but the company didn't disclose their secret intention. They superficially tested what they said they would, and secretly, they tested something else. There are some ambigous phrases in the signed waivers that the company's lawyers can use for a defense, but it won't be enough. People weren't actually harmed because of it, but they had slight changes in personality.

It's not the real scenario, but imagine it as follows: You sign up for a routine study for say a new caughing medicine, the medicine works well for most of the patients, no 'bad' side effects, but all patients suddenly really like the color 'pink', and that wasn't just a side effect but something the company actually intended.

It's fairly common in research studies to have a broad net cast method particularly with side effects and questionaires. Look at Viagra. They were marketing it for cardiac reasons (which it basically failed), and only when someone tracked down why almost all of the test patients refused to give back their unused medication, but the placebo patients did give them back that they said, hmmmm.

If as you say, "nobody was harmed," then whatever the litigation is about, it could not be one of medical malpractice, because that requires an injury (among other things). Civil cases, though, I've heard of one family suing a boyfriend's parents because their daughter didn't have fun at her prom.

PeterL · Nov 10, 2010

I think that you should pay attention to Cathy, but this is a work of fiction, so you can play with a lot. The procedures that you have seen on TV and in movies is largely correct, but I can only speak from my experience as an expert witness.

If you have access to a law library, you might want to look at the reporter for a Federal district court. It will give you a good idea of how the decisionslook; although it will not give all of the testimony.

WalkingContradiction · Nov 10, 2010

Thanks everyone so far.

Haha I didn't know that about Viagra.

I'm definitely dropping the idea with the Supreme Court, the law suit is not the center of the story, I want to use it as a plot device to highlight a controversy. It shouldn't take away all the attention from the rest of the story..

Altough, I'm kinda tempted to go into details with the jury, if there is one. That would be very interesting.

The company might actually win the law suit.. I'm good for all the problems you have pointed out, except maybe the company's motivation for keeping it secret, I need to think that through a bit more. But I see how it might work now.

PeterL · Nov 10, 2010

WalkingContradiction said:
I'm definitely dropping the idea with the Supreme Court, the law suit is not the center of the story, I want to use it as a plot device to highlight a controversy. It shouldn't take away all the attention from the rest of the story..

Altough, I'm kinda tempted to go into details with the jury, if there is one. That would be very interesting.

The company might actually win the law suit.. I'm good for all the problems you have pointed out, except maybe the company's motivation for keeping it secret, I need to think that through a bit more. But I see how it might work now.

As a plot device a trial can be very good. It would give you a chance to do exposition with some tension. You might have the trial move the plot along, as the witnesses testify, one after another.

Georgina · Nov 11, 2010

This week's The Good Wife (2x06) dealt with a class action suit against a pharmaceutical company. Fictioned up, obviously, but it might give you some ideas if you track it down.

Cheers.

Tsu Dho Nimh · Nov 11, 2010

WalkingContradiction said:
My book is set in either, Utah, Arizona or Colorado, not sure yet (this could be important, right?). This would be where the seat of the company that gets sued is. It's a pharmaceutical company that used drugs on probands the wrong way (basically using the probands for another kind of research they didn't agree to), so it possibly violates constitutional rights. Especially since the drug turns out to slightly alter the probands personalities. Unfortunately I can't go into more details because that would give away too much of the plot.

Can you at least tell us what the suit has to do for your plot? What is its function. Does it wrap up the plot?

Where are ALL of the probands are located? Are any of them minors? Mentally disabled?

So I'm wondering what kind of law suit would result (if the probands sue the company). Does it go to the state court first? What would be the common precedure? How could it go to the Supreme Court? The case has some interesting consequences on personal liberty, and I would love to write it as a Supreme Court Case, altough I'm afraid this might make it too complicated.

Where the suit is filed depends on where the litigious probands are. Will it be a class action suit?

Also, medical research has to pass an IRB (Institutional Research Board) and the requirements are stringent. If the researchers were playing fast and loose with the subjects, they might end up with criminal charges against them by the feds as well as the suits by the research subjects.

If they are misusing research subjects, there are no Supreme-worthy issues.
Constitutional rights have nothing to do with it.

Adverse events in clinical trials are one thing. Adverse events because you weren't told the truth about the trial is malpractice.

Not to mention violating a bunch of federal regulations having to do with how to conduct medical research.
http://prsinfo.clinicaltrials.gov/fdaaa.html has links to the relevant laws.

WalkingContradiction · Nov 11, 2010

Thanks Georgina, I don't know that series, but I'll watch the episode.

Tsu Dho Nimh, the law suit is there to highlight a major theme. It becomes a huge media story, and the underlying questions are then discussed nationwide. And yes, it does wrap up the plot, I think the last scene will be an argument between the MC and the head of the science department of that company.

The probands are university students in the same state as the company is in. The MC might be from a different state and going to a different college.

And yes, I think it would be a class action suit.

suki · Nov 11, 2010

I have to say, I'd expect that any trials would have required a very broad release to be signed by the participants, and they pretty much would cover everything. So, you have some experts here, talk to them. Because I'm scratching my head as to how there could be a law suit at all short of intentional harm or fraud. And not disclosing your true intentions isn't fraud - it's proprietary information.

So, unless the company lied to the FDA, I'd be skeptical. So, draw on your available experts to make sure you get the details right.

~suki

WalkingContradiction · Nov 11, 2010

Thanks, but I'm more concerned about the actual court procedure than the charges. I think I can make a good case for the charges, I thought that part through already

Legal Question

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GeorgeK

ever seeking

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milly

seeing sparks

Cathy C

Ooo! Shiny new cover!

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Kenn

New kid, be gentle!

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Kenn

New kid, be gentle!

Cathy C

Ooo! Shiny new cover!

GeorgeK

ever seeking

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Georgina

Sushi at midnight

Tsu Dho Nimh

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