A strange Scottish case on evaluation of tenders -- Boston Sci. Ltd v Common Service Agency [2016] CSOH 132

I find the recent Scottish case Boston Scientific Limited v The Common Service Agency [2016] CSOH 132 most confusing. This is a case of healthcare-related procurement whereby the Scottish NHS' central purchasing body, the Common Service Agency, was tendering framework contracts for the supply of certain types of medical equipment--for simplicity, pacemakers and implantable defibrillators.

The litigation concerned the applicable award criteria and the ensuing evaluation of the tender submitted by Boston Scientific Limited. Even if the case seems to be decided mainly on procedural grounds (the claimant, or pursuer in Scottish terminology, seemed to have been time-barred in raising a challenge against the published award criteria), it raises substantive issues that, in my view, should have been dealt with differently by the Court.

The tender had been advertised and the relevant invitation to tender (ITT) had published the applicable award criteria. For each of the lots in which the framework agreement was to be divided, the tenders would be assessed against a pass/fail criterion of essential features (ie mandatory technical specifications) and then evaluated on a 60:20:20 split of the maximum score of 100. The offered price would carry a 60% weight, whereas two quality criteria would carry 20% each: (a) the inclusion of certain defined desirable features and (b) the longevity of the devices.

The challenge was based on Boston Scientific's submission that the assessment of the longevity of the pacemakers must have been wrong. In a nutshell, Boston Scientific claimed that their position as market leaders and the existence of independent tests that demonstrated that their devices had a very long individual life led them to the conclusion that 'there must have been a failure to compare like with like because if there had not been such a failure [Boston Scientific] would have had the highest longevity scores' [para 15]. In short, the tenderer was not convinced that its competitors could (truthfully) have offered devices with a superior longevity.

Boston Scientific's submission of improper technical evaluation of the tenders is complicated by two additional factors. First, that tenderers had only been asked to declare (or self-certify) the longevity of their devices without providing any supporting evidence. Second, that the criteria applicable to the evaluation of the longevity component were not all that clear.

Self-certification of verifiable technical characteristics?

On the first issue, the complaint considers that the contracting authority was not allowed to include as award criteria elements based on pure self-declaration and which it intended not to verify. Indeed, the case seems peculiar because the Common Service Agency 'had stated clearly prior to the date for submission of tenders that supporting evidence was not sought.  It had protected itself in a different way by making clear that the framework agreement would include a clawback provision if battery life fell short of the figure submitted in a tender' [para 18].

This seems to me to be a peculiar way of conducting business because the longevity of devices that need to be implanted in the human body seems a rather important technical characteristic (as submitted by Boston Scientific, but dismissed by Lord Tyre in his Opinion, despite the relevance of this issue for the purposes of EU consumer law as discussed here), and the abrogation of the power to check compliance with technical specifications in this regard seems odd, regardless of the inclusion of financial penalties in the contract. The Judgment relies on two English precedents that would support the legality of relying on self-certification of compliance with contractual terms. Most importantly, it ignores the EU precedent in EVN and Wienstrom (C-448/01, EU:C:2003:651), to which one of the English cases refers, though. A reference to EVN paras [50]-[51] would have sufficed to quash the award procedure (I am thankful to Karen Wontner and Erik Plas for having raised this point in private correspondence).

First, Lord Tyre relies on Public Interest Lawyers v Legal Services Commission [2012] EWHC 3277 (Admin), Cranston J at para [64] to justify the acceptability of self-certification. However, in my view, this precedent is inapplicable here. First, because it concerned an on-going requirement to be discharged during the execution of the contract (ie an element closer to a contract performance clause than a technical requirement) but, most importantly, because in the previous paragraph of that speech Cranston J stressed that 

... the principle behind its decision was the need to ensure the equal treatment of tenderers through the objective and uniform application of the criteria in their assessment. The principle applies whether or not the public authority is able to verify the criteria. If it is able but omits to do so, that is as much a breach of the duty as if it sets criteria which cannot be verified. That is because the outcome may be an inequality of treatment of tenderers through the equal treatment of unequals, i.e. the equal treatment of those meeting and those failing to meet the tender requirements. After all, it is trite law that equality of treatment means not only treating like cases alike but unlike cases differently [at 63].

And this led Cranston J [at para 65] to insist on the need for robust verification where the contracting authority relies on self-certification by the tenderers. This is important in the context of the Boston Scientific v Common Service Agency dispute because, this case, 'Although it was accepted that in some cases a contracting authority might have a duty to validate information provided by a tenderer, this was not such a case. The defender did not have the means to verify independently the figures for longevity provided by tenderers' [para 18]. The issue here would have been whether this inability of independent verification (a) covered a complete lack of engagement with existing technical information and (b) was not attributable to the contracting authority itself and its decisions on how to organise the procurement procedure. Generally, one would expect that the entity running framework contracts for medical supplies has (or has access to) necessary technical knowledge in any case. Thus, this point of the case remains obscure and, in my opinion, shows excessive deference to the contracting authority.

Second, Lord Tyre relies on Parker Rhodes Hickmotts Solicitors v Legal Services Commission [2011] EWHC 1323 (Admin), McCombe J at paras [35]-[40], which in turn refers back to Public Interest Lawyers v Legal Services Commission. The difficulty with this second case is that its ratio rests on the construction or interpretation of the tender documentation, rather than an assessment of the requirements of the principle of non-discrimination of tenderers--which was the legal basis for the challenge in Boston Scientific. Importantly, in Parker Rhodes, the relevant part of the Judgment focuses on the fact that the Information for Applicants (IFA) document had not indicated how the contracting authority would proceed to verifying specific aspects of the offers, which the Court considered to cover the possibility of relying on self-certification.

To me, this makes both precedents irrelevant for (if not contradictory to) the assessment of the claims raised by Boston Scientific, which aimed to strike down the procurement process on the basis that the contracting authority had appended a significant weight to a criterion it actually decided not to verify at all. In my view, there are good arguments under the principle of good administration (Art 41 CFR) to demand that contracting authorities only evaluate what they can assess and, even more, that they do not claim not to be in a position to assess technical characteristics of the products they are buying--if nothing else, by reliance on the rules on test reports, certification and other means of proof (now under Art 44 Dir 2014/24/EU). 

Longevity, price, both or none of the above?

Additionally, and focusing on the point of the need to construct or interpret the tender documents as published, the second argument raised by Boston Scientific deserves attention as well because, indeed, the criteria applicable to the evaluation of the longevity component were not all that clear. In that regard, it must be noted that the ITT had established that:

In relation to longevity, the tender receiving the highest total longevity score would receive 20 points.  Each other tender would receive “20‑X points where X = 0.2 x the percentage by which each price in each tender exceeded the lowest price tender achieving the lowest total price score” (Boston Scientific v Common Service Agency, para [5], emphasis added).

This seems odd because the criterion that is aimed at scoring longevity is (or, at least, seems to be) referential to the price of all tenders except that of the tender with (self-certified) longer individual device life. In my view, this is a breach of the general scoring rule included in the ITT, according to which price would carry a weight of 60%. This would not be true except for the tender self-certifying highest longevity, and all other offers' price would be taken into account twice (once for the price component itself, and a second time for the scoring of longevity). This is, simply, technically incorrect and, in my view, should have sufficed to cancel the tender.

However, this does not seem to be the whole story and a mistake must have happened in the preparation of the ITT (there seems to be an obvious explanation if one thinks in terms of copy and paste ...) because, in a debriefing letter, the contracting authority had indicated to Boston Scientific that:

The weighting for Longevity was 20% therefore in each lot the longest longevity submitted received 20 points. The scoring guidance in section 3.3 clearly identifies the points allocated to longevity and how the tender would be scored ... (i.e. if one product had longevity or 100 months (longest) it would score 20 points and if a different product submitted had a longevity of 50 months it would score 10 points)  (Boston Scientific v Common Service Agency, para [10], emphasis added).

Now, this is the natural understanding of a relative scoring for longevity, but it happens not to be the scoring rule disclosed in the ITT, which made reference to relative prices rather than relative longevity. Such a substantial deviation between disclosed scoring rule (even if absurd) and its application seems to run against the basic requirements of the principles of transparency and equal treatment, as recently recast by the Court of Justice of the European Union in TNS Dimarso (for a comment, see here).

In my view, this should also have been taken into account by the Court and, rather than dismissing the challenge, Lord Tyre should have sought to understand better whether the longevity criterion had been assessed as the debriefing letter said, or rather as the ITT established (which could have led to abnormal results ultimately preventing Boston Scientific from making much sense of the scores obtained). Most likely, a divergence between the published scoring rules and the actual evaluation of the tender should have led to a cancellation of the award in any case.

Overall, I think that there are two main problems with the Judgment in Boston Scientific v Common Service Agency, and both of them seem to me to result from a lack of engagement with the case law of the Court of Justice of the European Union by the Scottish court. First, because it is truly abnormal to allow for self-certification of a technical requirement that can be assessed and verified by the contracting authority--at least, by reference to technical documents. Second, because it is also truly remarkable that a contracting authority can evaluate tenders in a way that deviates from the published criteria without the reviewing court picking up on this important aspect (or anomaly) of the process. Ultimately, in my opinion, this is a strange case. But also a very technically deficient Judgment and an incorrect decision.

Don't skip a beat: CJEU intends to strengthen consumer protection of medical devices, but does it? (C-503/13)

In the interesting Judgment in Boston Scientific Medizintechnik, C-503/13, EU:C:2015:148, the Court of Justice of the European Union (CJEU) has clarified the requirements for the application of the EU rules on liability for damage caused by defective products to the manufacturers of potentially defective medical devices which substitution require surgical intervention. 

In the case at hand, the issue was whether the manufacturer of potentially defective pacemakers and implantable cardioverter defibrillators was liable to cover the cost of surgery and related damages to patients that needed those potentially defective products replaced. 

In a clear and rather short Judgment, the CJEU has ruled that such situations are covered by the special liability regime. This is bound to trigger commercial adjustments in this sector, as well as in the insurance sector and I would not be surprised if the Boston Scientific Medizintechnik is strongly criticised. I can think of some reasons why, which I sketch below.

The key controversial legal issues were whether the mere fact that a specific product is potentially defective suffices to classify it as defective for the purposes of EU law and, if so, whether the surgery needed to replace (potentially) defective medical devices was within the scope of the damages imposed on the producer. The CJEU has answered both questions in the affirmative. Some of its reasoning is worth considering in detail.

Firstly, regarding the way in which potentially defective medical devices should be treated, the CJEU determined that
37 ... a product is defective when it does not provide the safety which a person is entitled to expect, taking all the circumstances into account, including the presentation of the product, the use to which it could reasonably be expected that it would be put and the time when the product was put into circulation. Moreover ... that assessment must be carried out having regard to the reasonable expectations of the public at large.
38 The safety which the public at large is entitled to expect ... must therefore be assessed by taking into account, inter alia, the intended purpose, the objective characteristics and properties of the product in question and the specific requirements of the group of users for whom the product is intended.
39 With regard to medical devices such as the pacemakers and implantable cardioverter defibrillators at issue in the main proceedings, it is clear that, in the light of their function and the particularly vulnerable situation of patients using such devices, the safety requirements for those devices which such patients are entitled to expect are particularly high.
40 Moreover, as observed, in essence, by the Advocate General at point 30 of his Opinion, the potential lack of safety which would give rise to liability on the part of the producer ... stems, for products such as those at issue in the main proceedings, from the abnormal potential for damage which those products might cause to the person concerned.
41 Accordingly, where it is found that such products belonging to the same group or forming part of the same production series have a potential defect, it is possible to classify as defective all the products in that group or series, without there being any need to show that the product in question is defective
(C-503/13, paras 37 to 41, emphasis added).
This is a very significant line of reasoning, as it clearly establishes that the potential for damage is an element to take into consideration when assessing the level of safety that users of specific products can expect. In that regard, the higher the potential for damages (in this case, possibly, death), the lower the threshold for the special liability regime to be applicable. This basically comes to create a further objectification of the test for the imposition of objective liability under the EU rules and, in my view, significantly raises the financial risks faced by producers of medical devices. 

A law and economics detailed assessment would be necessary, but this case seems like a good candidate in the list of cases where the good intentions of the CJEU may create unforeseen and undesirable effects, eg by imposing additional costs on producers of medical devices that they pass-on to consumers, ultimately pricing out those with a lower acquisition power [for general discussion, see A Sanchez Graells,  The Importance of Assessing the Economic Impact of the Case Law of the Court of Justice of the European Union: Some Exploratory Thoughts (April 18, 2013)].

An alternative approach could have been explored by focusing on the level of security that medical professionals could expect, as medical devices are clearly not products directly offered to their end users. More alternatives could have been explored in view of the fact that the claimants in the case are mandatory insurance funds and not the ultimate users of the medical devices, which could also have triggered an analysis of the justification for medical insurance itself and the eventual obligation of medical insurers to absorb some of the risks they are perceived to insure. However, none of these issues are addressed by the CJEU in its Boston Scientific Medizintechnik Judgment.

http://candorville.com/2013/08/16/hypocritical-oath/

Secondly, regarding the classification of the surgery costs and related damages as "damage caused by death or by personal injuries" for the purposes of EU law, the CJEU made a distinction based on the recommendations of the manufacturer as to how best to minimise or reduce the risk derived from the potential defect. In that regard, it is worth stressing that
49 Compensation for damage thus relates to all that is necessary to eliminate harmful consequences and to restore the level of safety which a person is entitled to expect...
50 As a consequence, in the case of medical devices, such as pacemakers and implantable cardioverter defibrillators, which are defective ... compensation for damage must cover, inter alia, the costs relating to the replacement of the defective product.
51 In the present case ...
[the manufacturer/importer] recommended to surgeons that they should consider replacing the pacemakers in question.
52 In that case, the Court finds that the costs relating to the replacement of such pacemakers, including the costs of the surgical operations, constitute damage ... for which the producer is liable...
53 That finding may be different in the case of implantable cardioverter defibrillators, as
[the manufacturer/importer] recommended ... that the magnetic switch of those medical devices should simply be deactivated.
54 In that regard, it is for the national court to determine whether, having regard to the particularly vulnerable situation of patients using an implantable cardioverter defibrillator, the deactivation of the magnetic switch is sufficient for the purpose of overcoming the defect in that product, bearing in mind the abnormal risk of damage to which it subjects the patients concerned, or whether it is necessary to replace that product in order to overcome the defect
(C-503/13, paras 49 to 54, emphasis added).
In my view, this nuanced approach of the CJEU that makes the imposition of liability dependent on the recommendation issued by the manufacturer/importer of the potentially defective medical devices is tricky. On the one hand, it shows some space for technical considerations and allows manufacturers to take responsibility in finding the best ways to correct the defect or substitute the defective product. 
 
On the other hand, however, the CJEU is not very clear on this point and hints at the fact that the "particularly vulnerable situation of patients using an implantable cardioverter defibrillator" may tilt the national court's assessment on whether the manufacturer/importer's recommendation was actually fit for purpose. Once more, the focus seems to be in the wrong place, as the technical criteria of the doctors is not being taken into consideration.

If doctors performed an operation to substitute certain medical devices despite the fact that the manufacturer/importer had recommended a less intrusive approach, the medical criterion should be taken into account and, most likely, prevail. A doctor under the Hippocratic Oath is under a duty not to impose (unnecesary) suffering or damage. In this specific context, a doctor would be liable for performing an unnecessary surgery to replace a potentially defective medical device that could be satisfactorily fixed in an alternative way.
 
Hence, determining that the intervention was not necessary (ie releasing the manufacturer/importer from liability) would almost automatically trigger liability for the doctor. This, again, would create undesirable incentives for physicians, who would abstain from replacement surgery where the manufacturer/importer recommendation was different. In that case, there would be no technical check on the manufacturer/importer's views, and users (rectius, patients) could be at a clear disadvantage.

All in all, then, I think that the CJEU's Boston Scientific Medizintechnik Judgment creates significant distortions in the incentives that all parties involved have when medical devices are potentially defective. In my view, this derives from a lack of thought on the implications derived from the fact that medical devices are not acquired freely or willingly by their users, but under a strong prescriptive supervision by the medical profession. And that, in turn, their activities are further overseen (and influenced) by medical insurers. This is something that I would like to see gain more space in future Judgments or, otherwise, the consumerization of healthcare will end up actually under-protecting patients.