Clinical Trial Causes Permanent Scars

[Cheung]

    i enrolled in a clinical trial 2 and 1/2 years ago in which they were taking three skin biopsies from the back of our necks.  we were the first group that had done this on and were a group of 8 or 9.   

we were told repeatedly that the scars would heal within three months.  i still have them and so do the four people we were able to contact from the study.   one of us researched and was told they have no record of us complaining, even though we did in writing before we left and they told us our complaints would go into the rest of our files which they keep for years.  we even had a meeting with the staff in which notes were taken from both parties.   Yes the consent form said there was a "possibility" if a scar at the site, but everyone i know of has permanent scars now, isn't that more than a mere possibility.  besides i met a lawyer who used to be a dr., and he said he understands that if one gets a biopsy they should expect to have a scar.  if that's true then there paperwork should say that.   they also told us that atleast one person performing the surgery never did one before.   i was going to go to small claims, and ask for the $3000 which an official org. states laser resurfacing would cost, but i feel it is not just compensation.  my friend is currently settling with them out of small claims.  do you think i could receive better restitution settling out of small claims court?  

there is myself and one more willing to be witnesses for eachother, which means i think we would be suing together.  any advice is appreciated.   thank you.

ANSWER: Sure wish you provided the most important information which would be(1)what was the purpose of the study and(2), were you selected because you had some medical problem in the area and this was an investigational treatment?  Also, how big is the scar? If it is small, I don't see much in the way of damages. It is not like it is on your forehead. In any event, I don't think much of your cases, in Small Claims or elsewhere.  Firstly, if you were concerned about scarring in that out of the way place and knew you would be having some kind of incision back there, then legally you assume some risk. Also, if the paperwork warned of the possibility of scarring, I think that is dispositive of the matter, against your claim. Unless of course the incision/biopsy was much larger than they said it would be. I think you took the risk and the damages are slight.

[Nicolas]

this: even if you were awarded $3,000, would you actually go have the scar revised? I doubt it. The scar will fade over time anyhow and I  think you realize that. That is why even if they minimized the scarring risk too much, your damages are just too small to impress anyone. Sorry but that is my frank answer. But go ahead and sue, not much to lose except some small costs. Case would be based on breach or contract or fraud. Not medical malpractice of course.

---------- FOLLOW-UP ----------

 follow up:  breach of contract, fraud or bodily harm, right?  the study was for healthy people testing a drug through the sweat glands/skin.   the fact that they "lost" all of our complaints to me is a big sign of deception or atleast mishandling of records.   they have no record of any of us being concerned.  they called me about 6 months later and i told them i still have scars and they said, 'ok, thank you' and hung up.   when i have short hair, i get questioned about it.  one of us was considering modeling and feels he couldn't do that now.      anyway, those our just my perspective and i thank you for the legal perspective.   i meant to ask about civil court, not small claims.  that was what i was considering.   they say 75% of cases are settled- do you think i have a chance to settle in civil court?  thanks again.

[ellsworth6]

Small Claims Court is a "civil" court, but it has a monetary limit you can ask for(varies from State to State, usually at least $5,000) and no lawyers allowed. The fact that they "lost" your complaints is not a basis for a suit but certainly something you can report to the FDA, to keep them honest, and if you are sufficiently motivated. How a small scar on the back of the neck can hurt a modeling career is a mystery to me. The scar will fade, makeup can be used to cover it, and I can't think of a picture of a model where the back of the neck could be seen.  Cases get settled, whether in Small Claims or a higher court because most of the facts are not disputed and one party concedes some liability/responsibility for the damages. There is no sense going above Small Claims Ct. because that would require a lawyer, unless you have lots of time on your hands, there would be legal fees to pay, and the damages do not exceed Small Claims anyhow. Go ahead a sue in Small Claims. Ask for the limit based on breech of contract and negligent and intentional misrepresentation(based on assurances of no scar). However, you were warned about scarring and that is why I don't think the case will succeed.