No Fault Compensation

Claims for injuries suffered during a clinical trial are usually brought via a no-fault compensation scheme.  These are, for the most part, managed in accordance with the Association of British Pharmaceutical Industry Clinical Trial Compensation Guidelines.  Given that under these guidelines, no breach of duty is required to be shown for a Claimant to recover, can an argument be made to say that consent is, for litigation purposes at least, irrelevant?

The ABPI Guidelines state at section 4:

4.2: “Compensation may be abated, or in certain circumstances excluded, in the light of the following factors…:

• 4.2.1:   the seriousness of the disease being treated, the degree of probability that adverse events will occur and their seriousness, any warnings and precautions given (emphasis added);
• 4.2.2:   the risk and benefits of established treatments relative to those known or suspected of the medical device.

Why is Consent Important?

There are two fact specific questions to explain this:

1. What is the risk:benefit ratio; and
2. What discussion has taken place regarding the risks and potential complications.

In relation to the former, if a participant is suffering from a serious condition and the clinical trial may treat that disease (commonly seen in cancer trials for example), then the risk:benefit ratio may weigh towards the benefit.  As a converse, there may be a trial undertaken in healthy volunteers, who have no underlying condition and will receive no benefit from the trial.  In such a trial, the ratio weighs heavily to risk. 

Where the ratio weighs towards benefit, the ABPI Guidelines advise that because the participant could receive a significant benefit, they should accept a level of risk in proceeding with that trial.  Where does consent fit in?

The Guidelines explain “…As an extreme example, there may be a patient suffering from a serious or life-threatening disease who is warned of a certain defined risk of adverse reaction. Participation in the trial is then based on an expectation that…participation may be…associated with [a better outcome than] alternative treatment.  It is therefore, reasonable that the patient accepts the high risk and should not expect compensation for the occurrence of the adverse reaction of which he or she was told” (emphasis added).

What this means in practice is that, if the trial is one where there is a potential benefit to the participant and that participant suffers an adverse event that they have not been warned about, there will be limited opportunity to abate the level of damages.  However, if that same participant had been specifically warned of that particular potential adverse outcome, then there would be an opportunity to reduce the level of damages payable, or in extreme cases, avoid all damages.    

How to Consent in a Clinical trial

We are looking at this from a claim perspective, but as clinicians, the consent process should be robust for the same reasons as consent is undertaken in any clinical scenario.  As such, the usual consent principles following Montgomery should apply.  This means that it is important to consider the tranche of participants (e.g. does the trial include a particularly vulnerable group of patients); and the individual (e.g. is there something that is of particular importance to the individual being consented).  Clearly in a clinical trial setting, there may be knowledge gaps that the trial is seeking to fill and that can be made clear to the patient.  Therefore, a standard Patient Information Leaflet is important as part of the consent process, but it should not be the entire consent process.

How Capsticks Can Help

Capsticks are routinely instructed to assist Insurers and their Insured in relation to claims that follow an injury suffered as a result of a clinical trial.  We can assist with the management of these claims and can advise in relation to minimising risk of claim in a clinical trial process. For any further guidance relating to the issues discussed, please contact Ed Mellor or Majid Hassan.