Parexel medical testing

[Jackknows]

This is what happened...

Went for a prescreen for a medical trial. They told me that something in my blood results would probably exclude me from said trial, and they needed to check with the the study sponsor whether it was acceptable for them.

Then they told me the following week they could invite me to the trial. Not even as a reserve - as one of the people to be dosed on the actual trial.

Three weeks later, having made all the necessary sacrifices i.e. no alcohol, no exercise, no certain food groups, etc, I went in for the first day of trial.

They found the EXACT SAME issue with my blood results that day, and told me they could offer to swap me with one of the reserves there, and I would probably not be part of the trial. I asked them why they did not just exclude me after the prescreen, as the results from the prescreen showed this same issue, they told me it was their mistake in inviting me.

So obviously I was not part of the trial.

The issue I have with them is that I was screening with two other trial places, and told them both I could not do their trials because I was signed up with this one. Obviously, for safety, you can only do one trial every six months. It is one of the terms you accept when prescreening with Parexel.

I contacted the drug sponsor directly, and found out, in emails which were part of a DSAR request, that they emailed the sponsor, the sponsor told them they would rather I was not doing the trial, and they emailed back to confirm they would not invite me.

I have also gotten lucky and received a statement from someone else off the internet that I found, who had exactly the same thing happen to them from the same place.

Finally, I started a legal claim, which is going through the small claims right now. They stated in their defence that a difference in the blood results, between the prescreen and day one bloods, was the reason they tried to relegate me to reserve, and then sent me home.

Got statements from two doctors that clarify there is zero difference. It is nonsense.

I am claiming for the £5,500 worth of the trial that they led me to believe I was eligible for when I was not. I can also prove that the other trials I could have done at that time were worth £4,400 and £5,000 respectively.

Was just hoping someone could help me nail down precise case / wording, moving forward. I am thinking the claim would be loss of opportunity. And breach of contract, as they were expected to be competent in how they handled me and I made sacrifices etc based on my reasonable expectations.

What do you think?

[dslippy]

You seem to be a bit ahead of yourself. You do not say what your claim states as it stands.

[Jackknows]

Parexel invited me join a clinical trial - then 20 days later admitted they never should have, as I failed the prescreen. Sheer negligence.

Claim is for Negligent Misrepresentation, Breach of Contract, and in tort (Negligent Misstatement), as well as medical malpractice.

[atticus]

Was there any kind of written agreement, with terms etc?

[Jackknows]

I guess the two main ones would be 1) no studies can be done elsewhere (I pulled out of the other 2 I was invited to do) and 2) study doctors can send you home at any time they deem fit for your safety.

I would argue that 2) dose not excuse negligence and I have a right to expect reasonable treatment. i.e. I did a prescreen precisely to make sure I was eligible for the trial, and it was their (serious and admitted) mistake in inviting me back. They should have applied the whole safety rule after the prescreen, not when I turned up for the trial weeks later. I put my faith in their due diligence and status as learned and competent medical professionals. I think it was reasonable of me to assume that they knew what they were doing. Prescreens are precisely there to ensure nobody has their time and energy wasted.

[atticus]

Your guess has not provided any indication what was actually agreed and on what terms, although it appears that there was something in writing.

[Jackknows]

These would be the relevant terms that were agreed:

"I freely and voluntarily consent to participate in the study and understand that I am free to withdraw at any time without giving a reason, without my legal rights being affected and I understand that the doctors or Sponsor may stop the study or my participation in the study at any time without my consent."

"I understand that when volunteering to take part in this study I should not give up/turn down any offer of employment nor make any financial commitment on the expectation of receiving a study payment as I am not guaranteed a place on the study, and that occasionally studies are postponed or cancelled."

"I agree that a decision about whether I am considered eligible for check-in will be made after a doctor has reviewed all results for the screening visit."


Finally, obviously I agreed to not take part in any other studies at the same time as this one. Hence my telling the two other places I could not proceed with their trials, after I was offered a confirmed place with Parexel following the prescreen.


Their defence basically relies on the above, but they also try to make out there was a material difference between my blood results at the prescreen and on the first day of the actual trial. This is why, after turning up on day one of the trial, to be dosed, I was asked to be relegated to a reserve, and then, after they accepted they should never have asked me to do the trial, I was sent home.

Interestingly, they then sent me an email offering me a payment for the first day, as if THEY HAD SENT ME HOME.

There are two levels of payment - one is if you are a reserve who goes home, or fails your screening on day one of the trial, which is basically a 'you mucked up/we warned you this might happen' lower payment. The higher one is if, through no fault of your own, you go home i.e. the study is suddenly halted. This payment is per day, pro rata - so the full study payment, divided over, say, the 15 days the trial lasts.

They then made out this offer was a "mistake" - basically because they realised that if they acknowledged they were at fault, they could be held liable for the full amount, as I had made sacrifices to attend, and planned to be there for two weeks.


To recap:

***They have lied to the court in their defence about there being a material difference in my blood results, and I can prove this.
***They acknowledged, on the first day I attended the trial, they had mistakenly invited me to be dosed (not a reserve - actually dosed, which is further proof of the oversight). Further proof of this is the email chain between the study doctor and the sponsor, where the sponsor tells them they don't want me on the trial, and they acknowledge I will NOT be invited, on this basis.
***I have a statement from another person they did the exact same thing to.
***They offered the payment mentioned above, and then tried to reverse this, as a "mistake."

Well it might have been a mistake in your eyes, but the only mistake made was that you accepted you were liable.

I believe I have grounds to pursue compensation, either A) the full study payment, as I was led to believe, through their negligence, I could expect it, and/or B) compensation equal to the amount I could have made with the other medical testing companies before withdrawing from those trials.

I am also thinking that these are medical practitioners and this kind of mistake is malpractice, or something quite similar, and it is reasonable for me to expect these professionals to be competent and not be making such massive errors/omissions.

They have also sent me to an Ethics committee to take my complaints about this further, but this place told me they are pulling my leg. I emailed them and told them this. They sent me back to them. I asked what is the official process for making my complaint known to this ethics committee - and they've ignored that email.

Thoughts?

[Jackknows]

Bumpety bump-bump. Received the signed witness statement from the other person this happened to today. Exact same thing. He's a policeman, btw. Has been for five years. WS mentions this.

He too was asked to be part of the main dosing group, then on the day of dosing, weeks later, they told me was being relegated to be a reserve because of the exact same issue they found in his prescreen.

I also just recorded a call identical to one I had with their staff after I was invited to do the final part of the trial. I confirmed that you are told from when invited whether you are a reserve, or part of the main group to be dosed. Obvs this is important because reserves only end up on the trial if they are replacing someone who is initially invited to be dosed, but for whatever reason, such as blood results showing drugs, etc, they are removed on the actual first day.

I would not have wasted my time if I was asked to be a reserve.

[Jackknows]

I don't suppose anyone has a few minutes to give their opinion? I'm not legal savvy so it would really help and be appreciated.

[Lord Byron]

ha...

[Lord Byron]

Help!

Hearing date set for March 1st, and Witness Statements etc due 17th Feb.

Is it possibly an intention to form a contract case?

[Lord Byron]

Come on guys

[Lord Byron]

BUMP

[Lord Byron]

They might have had the right to withdraw me "for any reason", but the reason they withdrew me for was identified as a potential reason in the prescreen appointment. That is what prescreens are for. Their benefit, and mine. Having then invited me back and confirmed that the potential issues were not a reason to exclude me, they made a commitment that this would be one reason I would not later on be sent home - they varied the terms therefore, to "we have the right to exclude you for any reason - apart from this one, which we have led you to believe will not be a reason to exclude you".

Anyone throw me a bone here?

[Lord Byron]

atticus any thoughts?