Drug Lawsuit / malpractice

[Adam G]

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.

I dont get this. Why are there ever lawsuits against drug makers in clinical trials? Cant you say that about every clinical trial participant in history?

 

[ecmst12]

I feel pretty confident about saying it about any clinical trials going on RIGHT NOW.

 

[Adam G]

I feel pretty confident about saying it about any clinical trials going on RIGHT NOW.

Right, that's my point. The wording that the drug company's lawyers put on the page in tiny font is only half the battle. If the message doesn't get to the participant, for whatever reason, then that's a problem in terms of consent.

 

[ecmst12]

Which is why I explained that he would have been verbally taught and counseled in addition to the paperwork he signed. They would not have just dumped the papers in front of him and walked away to let him figure it out himself.

 

[Proserpina]

Having worked both "for" and "against" the FDA wrt clinical trials and litigation therein (I was an employed by the manufacturer of a particular drug, then worked at the same company - doing the opposite job, practically - as a contractor. I've also worked for a CRO), I can pretty much guarantee you that the patient signs an informed consent form and the risks are verbally outlined, and with most CROs/investigator sites, there's ANOTHER form the patient signs separately to confirm that the risks have been outlined and the patient understands.

Incidentally if we don't get those forms, the patient is rejected for the trial period - even if they fit every other criteria.

I agree with emc - claiming ignorance is just not going to be viable in the OP's scenario.

 

[Adam G]

Which is why I explained that he would have been verbally taught and counseled in addition to the paperwork he signed. They would not have just dumped the papers in front of him and walked away to let him figure it out himself.

Before she passed away, my mom participated in a clinical trial for an Alzheimer's medication. This was prior to me being appointed her guardian. Knowing consent or no?

 

[Zigner]

Before she passed away, my mom participated in a clinical trial for an Alzheimer's medication. This was prior to me being appointed her guardian. Knowing consent or no?

Please don't hijack threads - If you have a question, start your own thread.

 

[Adam G]

Please don't hijack threads - If you have a question, start your own thread.

We've been talking about informed consent for two pages. I'm not the one saying it's a black and white issue. If you can't figure out the connection, it's not my job to dumb it down for you.

 

[tranquility]

So, is it your claim we should just let Alzheimer patients die without any hope of a cure or delaying medication? Or, should we get all people conserved first, just to make sure?

There are public policy reasons for the way the law is. We all agree that under some facts a drug company could be liable. However, we could just compare the number of people who suffer from some effect of experimental drugs to the number of successful lawsuits and find the facts needed for success are pretty rare and extreme. There is nothing in the OP's posts which indicate such facts.

 

[Zigner]

Please don't hijack threads - If you have a question, start your own thread.

The point is that your dead relative's situation has NOTHING to do with this thread. Unless, of course, she is able to post here.

 

[Adam G]

So, is it your claim we should just let Alzheimer patients die without any hope of a cure or delaying medication? Or, should we get all people conserved first, just to make sure?

Impressive strawman. Knock it down for us.

There are public policy reasons for the way the law is. We all agree that under some facts a drug company could be liable.

I've been trying for two pages to get certain posters who will remain nameless to admit just that. People run into the thread and immediately post OMG LULZ UVE GOT NO CASE!1 and only a few days later realize that maybe it isn't so clear cut. Whether they admit it or not is another matter.

 

[Zigner]

There is nothing in the OP's posts which indicate such facts.

Agreed - even in light of Adam's attempts to fabricate them.

 

[Adam G]

I am not an attorney.

Truly shocking.