[2024] EWHC 1071 (TCC)

The claimant's response to the defendants' application was to make her own application on 21st March 2024 seeking summary judgment on a claim for over £130 million, on the basis that the experts agreed that Exsig failed at an unacceptable rate and, therefore, lacked robustness so that the claimant's case on breach was made out and the defendants' defence on this alleged breach had no real prospect of success. Again, determination of that application was left until the pre-trial review.

The claimant relies on a number of passages in the joint statement of the experts which I will paraphrase. The passages are to the effect that if the IEC is not detected it suggests that there is something wrong with the reaction and, consequently, a negative Covid result should not be trusted, the run considered invalid and the test repeated. With the exception of Portsmouth, all laboratories had a more than 10% failure rate, with four laboratories experiencing greater than 25% invalid runs which would indicate, the experts said, that the Exsig COVID-19 test was not sufficiently robust.

They referred to the WHO Guidelines that stated that an acceptable criterion for invalid results in point of care tests should be less than 2%. They provided in Figure 2 in the joint statement a graphical illustration of the number of invalid test results and said that they were not aware of any standard where the failure rate outlined in Figure 2 would be considered acceptable for a diagnostic test.

Most particularly, towards the end of the joint statement, they said this:

"However, the technical failure rate of the TVG study data indicated a significant problem with the method's robustness. The conclusion of the findings from the seven laboratories are further supported by e-mails from Novacyt (PD) (both internally and to NHS laboratories) illustrating steps to rectify what they admit was an issue due to run failures (namely how the optimiser was dispensed and the revoking of software update v 2.7 fast cycling protocol with 2.10.01). This suggests the exsig COVID-19 Direct was not working as intended and that the IFU protocol and software updates were more to blame than the NHS laboratory staff, who were running other diagnostic tests on a routine basis. However, it is not clear if the potential improvements were implemented by all the NHS laboratories."

Importantly, as I understand it, the claimant contends that the agreed lack of robustness evidenced in those statements and others in the joint statement is itself sufficient to establish a breach of contract, that is that the Exsig kits are not of good quality and free from defects, irrespective of the underlying cause of that lack of robustness.

Although I do not propose to repeat them here, in Mr. Heppinstall KC's skeleton argument a number of authorities are cited for the over-arching proposition that it is necessary only to establish the existence of a defect and not the cause of the defect in order to establish a breach of contract.

The defendants say that that contention is not relevant in this case. I have outlined the nature of the defendants' case including that there is no contractual requirement of robustness and that it is a meaningless or vague term which is the subject of two further definitions in the joint statement which differ from the pleaded case. The defendants, as I have indicated, also say that the rate of invalid test results does not evidence a flaw in the kits themselves and/or that the kits were not of good quality.

Returning to the last passage that I set out from the joint statement, the defendants submit that kits may not have worked as intended because of what the experts refer to as the IFU Protocol, software updates and performance of NHS staff. In other words, the testing may have lacked robustness for reasons other than the kits themselves.

If the cause of IEC failures was software updates, those, Mr Twigger says, are not encompassed by the terms of the Limited Warranty. If the cause was performance of NHS staff - albeit the experts' conclusion is that the protocol and software updates were more to blame than the laboratory staff - that is also not something for which the defendants are responsible. I do not propose to repeat the entirety of Mr. Twigger's submissions, both in writing and orally, but he also points to a number of other possible causes of invalid tests which are referred to in the joint statement.

Mr. Twigger says that the reference to the IFU Protocol is itself unclear. It does not appear to refer to the Instructions for Use, which is not a protocol, and seems to refer to other protocols which were the subject matter of e-mail exchanges which the experts refer to in other passages in the joint statement.

As to the reference to the IFU Protocol in the passage I have quoted, Mr. Twigger suggests that the experts seem to be referring to the step in the Instructions for Use which involves the pipetting of two microlitres of PCR optimiser. He says that the experts appear to assume that the optimiser is difficult to pipette in such small quantities because of its viscosity but that that is based on a misconception that it was a viscous liquid. If it is not in fact a viscous liquid, it is not difficult to pipette in that small quantity, and if staff had a difficulty in pipetting it, that would be a human error and not evidence of any lack of robustness in the testing kits.

The claimant's answer to what I might call the human error point – and there are other examples of potential human error -- is Figure 2 in the joint statement and which shows a level of invalid results which the experts say could not be acceptable. The claimant argues that that in itself demonstrates that the invalid results must be the result of a flaw in the kits and not human error.

The defendants say not only that that is a factual inference that cannot properly be drawn but that Figure 2 does not support it. For example, it can be seen that one site at Portsmouth had no invalid test results, which itself suggests that there was nothing wrong with the kits and that invalid test results were or might have been the product of human error.

Those points, and they are a summary of the detailed submissions that have been made to me, are sufficient for me to conclude that I cannot say, on a summary basis, that the defendants have no real prospect of success on this issue of robustness, despite the apparent level of agreement of the experts. I decline to grant summary judgment on this issue or this claim as a whole. It may be, at trial, that the claimant succeeds on this basis, but it would be wrong to reach that conclusion at this stage, solely on the basis of the joint statement and without fuller consideration of the defendants' case, the factual evidence, the documentary evidence and the matters that Mr. Twigger has advertised.