Drug Lawsuit / malpractice

[Mass_Shyster]

Not to be pedantic, but if it is a "known" side effect (as opposed to "a side effect"), where is the failure to warn claim coming from?

• Manufacturer knows of danger.(known side effect)
• Manufacturer fails to adequately warn consumer (failure to warn).
• Consumer is harmed by dangerous condition (damages).

 

[ecmst12]

And if the patient knew or should have known about the potential for the side effect, then they were warned just fine. That's the whole point about it being a KNOWN side effect. And currently, with the wealth of information given out every time you get a prescription filled, any patient that doesn't know what the side effects and risks for their medications are only has himself to blame. 10 years ago before they started doing that, a failure to warn claim might have had success, but there have been MANY MANY measures put into place to prevent such claims since then.

 

[tranquility]

This is a drug study. One where the OP was aware of a small risk of a certain type of cancer. Not that the drug causes that cancer, but that there seems a non-random correlation between those who take the drug and those who get the cancer. OP was warned of this and all other side effects found in the first phases of the study and still chose to participate.

Where do you think the risk statistics come from?

While there are some evil drug companies who violate ethical protocols of drug testing for profit, that does not seem what has happened here. (Absent anything more.) There is no negligence as far as we can tell, we're just thinking of a strict liability under product liability. But, like a knife, some things can't be made safely. I'm thinking experimental drugs would fall under that as well as the warning of known risks. C'mon. If adverse results cause huge liability, we might as well forget about any new drugs ever coming on line.

 

[ecmst12]

And don't forget the drug company is paying for his cancer treatment. Which is of course the right thing to do in terms of not getting a reputation that would deter people from volunteering for any future studies, I'm sure they are not offering up their money for altruistic reasons. But the only thing that matters for OP is that he won't be left thousands in debt because he participated in the study. If that's not enough, well, I guess it's just too bad!

 

[Adam G]

How could one (successfully) sue for a risk they knowingly assumed?

Assumption of risk is an affirmative defense, not necessarily a get out of jail free card for the defendant. Most often it's a mitigating factor.

 

[Adam G]

This is a drug study. One where the OP was aware of a small risk of a certain type of cancer. Not that the drug causes that cancer, but that there seems a non-random correlation between those who take the drug and those who get the cancer. OP was warned of this and all other side effects found in the first phases of the study and still chose to participate.

Where do you think the risk statistics come from?

While there are some evil drug companies who violate ethical protocols of drug testing for profit, that does not seem what has happened here. (Absent anything more.) There is no negligence as far as we can tell, we're just thinking of a strict liability under product liability. But, like a knife, some things can't be made safely. I'm thinking experimental drugs would fall under that as well as the warning of known risks. C'mon. If adverse results cause huge liability, we might as well forget about any new drugs ever coming on line.

It's tricky and revolves around whether or not the participant gave knowing, informed consent when beginning with the trial.

http://online.wsj.com/article/SB120173515260330205.html

In my experience, you can get a judge to buy the argument that the injured party didn't know what he/she was signing when he/she signed the release/consent/whatever. Somewhat ironically, it's harder to make that argument to the judge if the injured party is an attorney.

 

[Zigner]

It's tricky and revolves around whether or not the participant gave knowing, informed consent when beginning with the trial.

http://online.wsj.com/article/SB120173515260330205.html

In my experience, you can get a judge to buy the argument that the injured party didn't know what he/she was signing when he/she signed the release/consent/whatever. Somewhat ironically, it's harder to make that argument to the judge if the injured party is an attorney.

Also ironic is that the OP already told us that she was aware of this risk and gave consent.

 

[Adam G]

Also ironic is that the OP already told us that she was aware of this risk and gave consent.

Consent is worthless and legally without effect. Knowing consent means that he knew of the risk before giving consent. Show me in the OP where he said he knew the risk ahead of time?

OP, do you have the paperwork you signed when you started the clinical trial?

 

[Adam G]

By being part of the study, you specifically acknowledged awareness of the possible side effects and specifically waived your rights for compensation based on those side effects.

This is awful advice.

 

[Zigner]

This is awful advice.

Good Grief!

 

[Adam G]

Good Grief!

Pro tip: you don't have the first clue what OP signed or didn't sign.

 

[Zigner]

Pro tip: you don't have the first clue what OP signed or didn't sign.

It does our OP no good to throw out red herrings. Good day.

 

[ecmst12]

I have participated in drug studies before. Not only did OP sign paperwork, but there would have been EXTENSIVE verbal discussion and teaching prior to starting the study. He is not going to be able to credibly claim ignorance.

 

[Adam G]

It does our OP no good to throw out red herrings. Good day.

This makes no sense. Good day.

 

[You Are Guilty]

• Manufacturer knows of danger.(known side effect)
• Manufacturer fails to adequately warn consumer (failure to warn).
• Consumer is harmed by dangerous condition (damages).

Aha. I was referring to the second link (danger known to consumer) in the chain, but you were referring to the first (danger known to manufacturer). Issue averted.

Incidentally, I would say this falls more under a "consent" framework than "assumption of risk". I would love to see the papers the OP signed when agreeing to participate.