1A and others v. National Blood Authorityand another QUEEN'S BENCH DIVISION [2001] 3 All ER 289, 60 BMLR 1 HEARING-DATES: 10, 11, 12, 13, 16, 17,18, 19, 20, 23, 24, 25, 26, 27, 30 October, 1,6, 7, 8, 9, 13, 15, 16, 20, 21, 27, 28, 29November, 1, 4, 5, 6, 8, 11, 12, 13 December2000, 9, 10, 11, 12, 15, 16, 17, 18, 19, 26, 29,30 January, 26 March 2001 26 March 2001 CATCHWORDS: EuropeanCommunity--Consumerprotection--Productliability--Whetherunavoidabilityofriskrelevantindeterminingwhetherproductdefective--Whetherunavoidableriskfallingwithindevelopmentrisksdefenceifproducerunabletodiscoverdefectinparticularproductbymeansofaccessible information -- Consumer ProtectionAct1987--CouncilDirective(EEC)85/374,arts 6, 7(e).HEADNOTE: TheclaimantshadbeeninfectedwithHepatitisC(thevirus)throughbloodtransfusionswhichhadusedbloodorbloodproducts obtained from infected donors.Theybroughtactionsfordamagesagainstthedefendants, the authorities responsible for theproductionofbloodandbloodproducts.During the period when most of the claimantswere infected, the risk of such infection throughbloodtransfusions,thoughknowntothemedicalprofession,wasimpossibletoavoid,either because the virus itself had not yet beendiscoveredorbecausetherewasnowayoftesting for its presence in blood.Accordingly,the claims were brought not in negligence, butunder the Consumer Protection Act 1987 whichimplemented Council Directive (EEC) 85/374(on the approximation of the laws, regulationsandadministrativeprovisionsofthememberstatesconcerningliabilityfordefectiveproducts).Under that directive, a producer wasliablefordamagecausedbyadefectinhisproduct.By virtue of art 6(1), a product wasdefectivewhenitdidnotprovidethesafetywhich a person was entitled to expect, taking allcircumstancesintoaccount,includingthepresentation of the product, the use to which itcould reasonably be expected that the productwouldbeputandthetimewhentheproductwas put into circulation.Article 7(e) providedthe producer with a defence if he could establishthatthestateofscientificandtechnicalknowledge at the time when he put the productinto circulation was not such as to enable 'theexistence of the defect' to be discovered.On thetrialofthesixleadcases,thedefendantsaccepted that a producer's liability under art 6wasirrespectiveoffault.Theyneverthelesscontendedthat,inassessingwhethertheinfected blood was defective, the unavoidabilityof the risk was a circumstance to be taken intoaccount, and that the most that the public wasentitledtoexpectwasthatallreasonablyavailable precautions had been carried out, notthatthebloodwouldbe100%clean.Insocontending,thedefendantssubmittedthattheinfectedbloodwastoberegardedasaninherently risky standard product (ie one whichperformed as the producer intended) rather thana non-standard product (ie a product which wasdeficient or inferior in terms of safety from thestandardproduct,andwhoseharmfulcharacteristic,notpresentinthestandardproduct,hadcausedthematerialinjuryordamage).They also relied on the fact that theywereobligedtoproducebloodandhadno2alternativebuttosupplyittohospitalsandpatients, as a service to society.Alternatively,thedefendantssoughttorelyontheart7(e)defence,contendingthatanunavoidableriskqualified for protection under it if the producerwas unable to discover, by means of accessibleinformation, the defect in a particular product.Held--(1)Avoidabilitywasnotoneofthecircumstancestobetakenintoaccountunderart6,eveninrespectofaharmfulcharacteristic in a standard product.In thatprovision, 'all circumstances' meant all relevantcircumstances.Avoidability was not a relevantcircumstance since it fell outside the purpose ofthe directive, which was intended to eliminateproofoffaultornegligence.Thatwasnotsimplyalegalconsequence.Itwasalsointended to make it easier for claimants to provetheir case, such that not only would a consumernothavetoprovethattheproducerhadnottaken reasonable steps, or all reasonable steps,to comply with his duty of care, but also that theproducerhadnottakenalllegitimatelyexpectable steps either.Even without the fullpanoplyofallegationsofnegligence,theadoptionoftestsofavoidabilityoroflegitimately expectable safety precautions wouldinevitably involve a substantial investigation.Ifit had been intended that avoidability would beincluded as a derogation from, or a palliation of,thedirective'spurpose,itwouldhavebeenmentioned.Itwouldhavebeenanimportantcircumstance, and it was intended that the mostsignificant circumstances were those listed.Inthecaseofanon-standardproduct,thecircumstancesspecifiedinart6mightobviouslyberelevant,aswellasthecircumstances of the supply.However, theprimary issue might be whether the public atlargeacceptedthenon-standardnatureofthe product, ie whether they accepted that aproportionoftheproductswasdefective.That was not the end of the matter, becausethequestionwasoneoflegitimateexpectation,andthecourtmightconcludethattheexpectationofthepublicwastoohigh or too low.Questionssuchaswarningsandpresentations would be in the forefront, but theavoidabilityoftheharmfulcharacteristic,theimpractability, cost or difficulty of precautionarymeasures, and the benefit to society or the utilityoftheproduct(exceptinthecontextofwhether,withfullinformationandproperknowledge,thepublichadandshouldhaveacceptedtherisk)werenotrelevant.Intheinstantcase,theinfectedbloodproductswere non-standard products since they weredifferent from the norm which the producerintendedforusebythepublic.Theyweredefective within art 6 because the public atlargewasentitledtoexpectthatthebloodtransfusedtothemwouldbefreefrominfection.There had been no warnings andno material publicity.The knowledge of themedicalprofession,notmateriallyoratallsharedwiththeconsumer,wasofnorelevance.Norwasitmaterialtoconsiderwhetheranyfurtherstepscouldhavebeentakentoavoidorpalliatetheriskthattheblood would be infected (see [57], [58], [63],[65], [66], [68], [80], [82], below); EuropeanCommission v UK Case C-300/95 [1997] AllER (EC) 481 considered.(2) The defence in art 7(e) of the directivedidnotapplywheretheexistenceofthegenericdefectwasknownorshouldhavebeenknowninthecontextofaccessibleinformation.Once the existence of the defectwasknown,therewastheriskofthatdefectmaterialisinginanyparticularproduct,anditwasimmaterialthattheknownriskwas3unavoidable in the particular product.It wouldbe inconsistent with the purpose of the directiveifaproducer,inthecaseofaknownrisk,continued to supply products simply because,anddespitethefact,thathewasunabletoidentifyinwhichofhisproductsthatdefectwould occur or recur, or, more relevantly in acase where the producer was obliged to supply,hecontinuedtosupplywithoutacceptingtheresponsibilityforanyinjuriesresulting,byinsurance or otherwise.Such a conclusion didnot mean that non-standard products wereincapableofcomingwithinart7(e).Suchproducts might qualify once-ie if the problemwhich led to an occasional defective productwas not known.However, once the problemwasknownbyvirtueofaccessibleinformation,thenon-standardproductwould no longer qualify for protection underart 7(e).Accordingly, in the instant case, art7(e)wasofnoavailtothedefendants,andtheclaimantswerethereforeentitledtorecoveragainstthem(see[74],[77],[78],[82], below).(3)If,contrarytothecourt'sprimaryconclusion,theissuesofavoidabilityordiscoverability of the defect in the particulardonation of blood had arisen, precautions toprevent or make a material reduction in thetransferoftransmittedinfectionthroughinfected blood were available and not taken.From 1 March 1989 the blood was defectivein all the circumstances and from 1 March1990thedefectinthedonationswasdiscoverable(see[106]-[107],[173],[181]-[187], below).***NOTES: For liability for defective products, see 41Halsbury'sLaws(4thednreissue)paras515-520.For the Consumer Protection Act 1987, see39 Halsbury's Statutes (4th edn) (1995 reissue)150.INTRODUCTION: ActionBywritissuedon1May1998,114claimantssoughtdamages,pursuanttotheConsumerProtectionAct1987,fromthedefendants, the National Blood Authority andVelindreNHSTrust,fordamagesufferedbythemasaresultofreceivingbloodorbloodproducts infected with the Hepatitis C virus.Byorderdated26February1999,BurtonJrequired the identification of generic issues to bedeterminedatthetrialofthesixleadcases,those of Ms T, Ms V, Mr U, Mrs X, Mr W andMr S. The facts are set out in the judgment.COUNSEL: Michael Brooke QC, Stuart Brown QC, IanForrester QC and Jalil Asif for the claimantson the generic issues; Michael Brooke QC andJalil Asif for Ms T, for Ms V, for Mr U, for MrsX and Mr W and for Mr S; Nicholas UnderhillQC, Philip Brook Smith and Louise Merrett forthe defendants.JUDGMENT-READ: Cur adv vult 26 March 2001.The followingjudgment was delivered.PANEL: BURTON J 4TABLE OF CONTENTSParagraphTHE CLAIMANTS [1]CAUSE OF ACTION [2]THE DEFENDANTS [3]THE PROCEEDINGS [4]SETTLEMENT [5]BLOOD TRANSFUSION [6]-[7]HEPATITIS [8]TESTING IN RESPECT OF NANBH/HEPATITIS C [9]-[11]Surrogate tests [9]-[11]THE CLAIMS [12]THE DIRECTIVE [13]-[16]THE CPA [17]-[23]THE STRUCTUREOF THIS JUDGMENT[24]THE SIX ISSUES [25]-[30]ARTICLE 6 [31]-[46]The common ground [31]The differences between the parties [32]All circumstances [33]-[35]Non-standard products [36]-[38]Boxes [39]-[41]The status of the defendants [42]Travaux preparatoires [43]Court decisions [44]Academic literature [45]Summary [46]ARTICLE 7(e) [47]-[54]The issues betweenthe parties[50]-[51]Travaux preparatoires [52]Court decisionH[53]Academic literature [54]CONCLUSIONS ON ARTICLE 6 [55]-[73]Non-standard products [68]-[70]Standard products [71]-[73]CONCLUSIONS ON ARTICLE 7(e) [74]-[77]THE RESULT IN LAW ON ISSUE I [78]-[84]The consequence [82]-[84]ISSUE II [85]-[107]The defendants' factual witnesses [87]-[88]The defendants' expert witnesses [89]-[92]The claimants' factual witnesses [93]-[94]The claimants' expert witnesses [95]The oral evidence [96]The literature [97]-[98]The background facts [99]The approach to be adopted [100]The proper analysis [101]-[107]SURROGATE TESTS [108]The literature [109]*The United States [110]-[113]The rest of the world [114]-[118]THE PROS AND CONS OF SURROGATE TESTING [119]-[142]The points in favour [120]-[129]The points against [130]-[140]Conclusion on surrogate testingTHE ASSAYThe chronology of the introduction of the assay in the UKThe background factsWhat had to be allowed forPractical trialsThe need for evaluation of the assayThe need for confirmationThe need to compare Ortho with AbbottImplementation in the RTCsFunding and decision-makingConclusion on routine screeningDEFECTIVE WITHIN ARTICLE 6NATURE AND MEASURE OF DAMAGESISSUE IIIaISSUE IIIb: LOSS OF A CHANCEISSUE IV: AVAILABILITY OF ARTICLE 7(e)ISSUE V: GENERIC ISSUES OF QUANTUMARISING OUT OF THE LEAD CASESEvidenceHEPATITIS C: THE DISEASE AND ITS TREATMENTClearance of the virusThe course of the diseasePrevalence of Hepatitis CTransmission of Hepatitis CPrognosisTreatmentsThe effect of Hepatitis CISSUES OF DAMAGESProvisional damagesHeads of damagePSLA'Stigma' or handicapEmployment handicapFinancial products/insurance handicapThe provision of gratuitous servicesThe claimants' submissionsThe defendants' responseDiscount rateISSUE VI: THE SIX LEAD CASESJUDGMENT* (Paragraphs [109-[140] are not included in thisreport.5THE CLAIMANTS[1] This trial has concerned the claims of114 claimants for recovery of damages arisingout of their infection with Hepatitis C fromblood and blood products through bloodtransfusions from 1 March 1988.It has beenthe first and main trial heard by me as theassigned judge within the Hepatitis Litigation,which was the subject matter of a PracticeDirection issued by the Lord Chief Justice on30 July 1998.This trial has been limited toconsideration of the case brought by thoseclaimants infected with Hepatitis C from bloodand blood products who are making claimsunder the Consumer Protection Act 1987(CPA)....The 114 claimants received bloodtransfusions or blood products usually in thecourse of undergoing surgery, whetherconsequent upon having suffered an accidentor otherwise, or immediately after childbirth orin the course of treatment for a blooddisorder.The earliest date of infection inrespect of which claimants can make suchclaims is 1 March 1988, being the date whenthe CPA was brought into effect.Most of theclaimants have been identified by thedefendants' own admirable Look-Backprogramme, which began in 1995.Therewere, fortunately, relatively few suchsufferers, and it should be said immediatelythat there is no question of their havingreceived 'contaminated' blood, that is bloodinfected by some outside agent: the blood theyreceived was 'infected' because, exceptionally,the donor's blood was infected by Hepatitis C.CAUSE OF ACTION[2] The claims the subject matter of thistrial are not in negligence, but are putagainst the defendants by way of 'strict' or'objective' liability by virtue of the CPA,which implemented in the United Kingdomthe European Union (then the EEC)Product Liability Directive of 1985:Council Directive (EEC) 85/374 (on theapproximation of the laws, regulations andadministrative provisions of the memberstates concerning liability for defectiveproducts).... Consequently both parties haveduring this trial almost exclusivelyconcentrated on the terms of the directive, onthe basis that, in so far as the wording of theCPA, in relation to matters which have beenthe subject matter of particular issue in thiscase, differs from the equivalent articles in thedirective, it should not be construed differentlyfrom the directive; and consequently thepractical course was to go straight to thefount, the directive itself.As will be seen, thearguments were directed mainly to the trueand proper construction of art 6 of thedirective (the equivalent being s 3 of the CPA)and art 7(e) (the equivalent being s 4(1)(e)),and consequently it is with those articles, andnot the relevant sections, with which thisjudgment will be primarily, if not exclusively,concerned.It is conceded for the purpose ofthese proceedings that the blood or bloodproducts by which the claimants wereinfected are products within the meaningof the CPA and the directive, and that thedefendants' production of blood was, forthe purpose of the directive, an industrialprocess.THE DEFENDANTS[3] The National Health Service bodiesresponsible for the production and supply ofblood and blood products prior to 1 April1993 in England (and also covering northernWales) were 14 regional blood transfusioncentres (RTCs), controlled and administeredby regional health authorities....I shall refer inthis judgment to 'the defendants' without6taking into account the various changes ofidentity and responsibility.THE PROCEEDINGS[4] The group action effectivelycommenced with a generic order for directionson 1 May 1998 made by Master Eyre, whowas assigned master, which set out the basicrules for the conduct of the HepatitisLitigation, gave leave to issue an omnibus writand provided for the maintenance of aHepatitis Register.The omnibus writ wasissued on 1 May 1998.I was appointed asassigned judge in February 1999, and MasterEyre and I have made a number of orderssince then, which have, with the considerableco-operation of those representing the parties,led to the identification and trial of genericissues and of six lead cases.Each claimant hasbeen entitled to have his or her own solicitor,but the generic aspects of the action have beenhandled, and the individual cases co-ordinated,on the claimants' behalf by Messrs DeasMallen, instructing Michael Brooke QC,Stuart Brown QC, Ian Forrester QC and JalilAsif.The defendants' solicitors have beenMessrs Davies Arnold Cooper, instructingNicholas Underhill QC, Philip Brook Smithand Louise Merrett.They have togetherworked extraordinarily hard in order toachieve a miracle of good order and clarity, byslimming down the issues, where at allpossible, and managing to contain a myriad ofdocumentation within a relatively smallcompass and a relatively small number offiles....The generic issues effectivelyamounted to whether the defendants areliable to the claimants under the CPA, iewhether the claimants as a whole can provethat (assuming injury, causation and losscan be proved in respect of each claimant)the defendants are liable under s 3 (art 6)and not exonerated within s 4(1)(e) (art7(e)), to which I shall refer...All theclaimants have, by an unopposed order in May1998, been entitled to remain anonymous, andthe six lead claimants have been known by thecodes of Mr S, Miss T, Mr U, Ms V, Mr Wand Mrs X.As will be seen, these six leadclaimants have been carefully chosen (theequal balance of their sex is, I believe, acoincidence) to cover and illustrate a spread ofconsequences from their Hepatitis C infection:ranging from Mr S, now 17, who was infectedby a blood transfusion after a road trafficaccident at the age of 7, but had the goodfortune that the virus spontaneously clearedhis blood and has not recurred: through toMrs X, a lady of 56, who at the age of 45 wasinfected by a blood transfusion in the course ofroutine surgery, and whose treatment forHepatitis C was not successful, such that hercondition progressed to cirrhosis of the liver(severe damage and/or scarring to liver tissue(fibrosis)), resulting in progressivedeterioration in liver function, and aconsequent liver transplant, which to date hasbeen successful, although her Hepatitis Cinfection remains.SETTLEMENT[5] After the case started, I was informedthat it had been agreed between the partiesthat the claims of almost all those claimantsalready then party to the action who wereinfected on or after 1 April 1991 would nolonger be opposed, on the basis that theywould each receive 90% of whatever sum Ishould find...***7BLOOD TRANSFUSION[6] Organised blood transfusion began inEngland and Wales in 1921.The practice(unlike in the United States, where donorswere paid until the 1970s) was of donationby unpaid volunteers......[7] Blood is traditionally donated two tothree times per year, by voluntary donors.Itis collected by encouraging the donor to bleedinto a collection bag, where the blood is mixedwith an anti-coagulant.Each donor's bloodwill be kept separate, and separatelyidentifiable, though it may be retained andused as whole blood, to be transfused to thosesuffering serious life-threateninghaemorrhages, or may be separated out intoconstituent parts, such as red cellconcentrates, white cell concentrates, plateletconcentrates, fresh frozen plasma or otherblood products.Depending on how muchblood or blood products a patientsubsequently needs, he may derive such bloodor blood products from a number of differentdonors.Blood is given to a patient in units,that is bags, each from a single donor.Rarely,a single unit is supplied to a patient, but forserious operations or illnesses many units,from different donors, may be necessary. Autologous transfusion, that is the use of apatient's own blood, which is a rare alternativemethod, though originally canvassed, did notmaterially feature in the trial.HEPATITIS[8] Hepatitis simply means 'inflammationof the liver'.It can result from a number ofdifferent causes, including self-inflictedsubstance abuse.It has been known since the1940s that hepatitis can be transmitted bytransfusions of blood and plasma.It quicklybecame apparent that there was a distinctionbetween what was then called infectioushepatitis (now known as Hepatitis A) andserum hepatitis (now known as Hepatitis B). The Hepatitis A virus was identified byFeinstone and others in 1973, and istransmitted almost entirely from the oral andfaecal routes, rather than by the transfusion ofserum and plasma.The Hepatitis B virus(found in the serum of an AustralianAboriginal and called the 'Australia antigen')was identified by Blumberg and others in1964.Tests to screen out Hepatitis B inblood were pioneered in 1971, and wereintroduced for all blood in the UnitedKingdom from December 1972.Thecombination of the exclusion of paid donorsand of blood donors tested positive forHepatitis B led in the United States to asubstantial reduction in Post-TransfusionHepatitis (PTH).However, by 1975 an agentother than Hepatitis A or B was recognisedto be causing PTH, and it was found by DrHarvey Alter (for many years the doyen ofresearch in this field, based in the UnitedStates), of the National Institutes of Health inMaryland (NIH), that by 1985 PTH stilloccurred in 7% to 12% of blood transfusionrecipients in the United States.Thecondition caused by this unknown agent was,as Dr Gunson put it, 'for the want of a betterterm', described by Dr Alter and others asNon-A Non-B Hepatitis (NANBH).The viruswhich caused NANBH was eventually firstidentified within the research department of aUS company called Chiron Corp (Chiron)by Houghton and others, in spring 1988, andwas announced by a news release by thatcompany on 10 May 1988 which stated:'Scientists at Chiron Corporation haveidentified, cloned and expressed proteinsfrom a long-sought blood-borne hepatitisnon-A, non-B virus and have developed aprototype immunoassay that may lead to a8screening test for hepatitis non-A, non-Bantibodies.'The virus was hurriedly itselfchristened, perhaps inevitably, as HepatitisC.Its convenient shortening is Hep C. However, it has also been regularly known asHCV in the medical and blood professions,and the antibody to it, and hence theimmunoassay subsequently developed, knownas anti-HCV, and indeed Hepatitis B as HBV. This shorthand seems to me to be totallyunnecessary and is responsible for a great dealof distress, embarrassment and indeedpotentially for economic loss, because of theconsequent association with the quiteunconnected condition of HIV-the humanimmunodeficiency virus related to AIDS.Theresultant confusion of sufferers themselves, oftheir relatives and friends, even of doctors anddentists, certainly of employers and insurancecompanies, has been natural and quiteunnecessary.Though it is to be hoped thatattitudes towards HIV sufferers change, andthat a treatment for HIV is developed andexpanded, nevertheless so far as Hepatitis Csufferers are concerned it is important todistinguish between the conditions.So far asconcerns the source of infection by HepatitisC, it can, on the evidence I have heard, almostnever be transmitted sexually.In so far as itsconsequences are concerned, although it is andcan be a serious condition, leading in rarecases to eventual death, many sufferers fromHepatitis C have few or no clinical symptoms,life expectancy is often unaffected and little ifany change in lifestyle results, unlike thepresent position in relation to HIV sufferers. If this case and the publication of thisjudgment do any good at all to anyone, theone achievement that can be hoped for is thetotal and permanent abandonment of theshorthand of HCV, anti-HCV and indeedHBV.TESTING IN RESPECT OFNANBH/HEPATITIS CSurrogate tests[9] As appears above, there was neitheridentification of the NANBH virus nor,consequently, development of any screeningtest or assay so as to eliminate such virus fromblood donations prior to their use, in the yearsup to 1988.There was, however, as willappear in more detail below, considerableresearch and academic discussion in themedical journals about the problem of PTH,particularly in the United States, which wasstill suffering from the aftermath of paiddonors, and at all times appears to have had amuch higher incidence of PTH than Europe. There was discussion as to whether tointroduce in the United States what becameknown as 'surrogate tests'; but after lengthyand detailed studies carried out and reportedby two prestigious groups, the TransfusionTransmitted Virus Study ('TTVS') and theNIH Study (the latter including Dr Alter),published in 1981 and subsequent years, and,after considerable discussion in committeesand in the medical journals, no surrogate testswere introduced.The two tests that werebeing looked at by the two bodies were theALT test and the anti-HBc test.These wereas follows.(i) ALT.This test measures thelevel of an enzyme, ALT (AlanineAminotransferase), in the blood.This was atest regularly used by hepatologists in thediagnosis and treatment of liver diseases.Raised ALT in the blood could suggestabnormality of liver function: it could indicatethe presence of hepatitis; it could on the otherhand, even where substantially raised, be anindicator of other liver conditions or simply of9high alcohol intake and/or obesity.An ALTtest therefore did not test for the presence ofhepatitis or the NANBH virus; and a'positive' test (about the marker for whichthere was in any event no unanimity,because different 'cut-offs' were adopted indifferent laboratories and in differentcountries) thus did not signify the presenceof hepatitis, but was only a possible indicatorof it.Hence a 'surrogate' test.(ii) Anti-HBc. A virus or antigen can have an envelopecontaining a core.Thus there is reference tosurface antigen and core antigen.A healthybody develops antibodies, which hopefullyresist the antigens, by binding on them.Sometests identify the antigen (whether the surfaceor the core) and some the antibodies.Thescreening test introduced for Hepatitis Bidentified the Hep B surface antigen (HBsAg). An additional test was also developed, but notused as the screening test for Hep B, whichcould identify, not the Hep B core antigen(HBcAg), but the antibody to the Hep B coreantigen (anti-HBc).Such a test therefore, which was onlyidentifying the antibody to Hep B, couldplainly not identify (what had in any event notbeen itself discovered) the NANBH antigen orindeed antibody.However, it was contendedthat it could provide what was called a'lifestyle marker'.Those who had had, but hadrecovered from, Hepatitis B in the past (andthus would no longer test positive for the HepB antigen) would or could retain in their bloodtraces of the Hep B antibody.It could thus be identified by the use of theanti-HBc test whether someone had hadHepatitis B, and it was suggested that a donorwith past exposure to Hepatitis B would bemore likely to have been exposed also to theNANBH agent, eg by intravenous drug use. This was the other suggested 'surrogate test'.[10] As will appear in more detail below,the United States did not introduce either ofthese surrogate tests after the detailed studiesreferred to above: ALT testing (but not anti-HBc) was introduced in Germany as early as1965 and in Italy in 1970, but neither in theUnited Kingdom nor in any other country, sofar as is known to the parties in this case, waseither test then introduced.The United States,however, introduced both tests starting fromSeptember 1986.As will appear, albeit thatdiscussion continued, those responsible forblood transfusion in the United Kingdomdid not support, and did not introduce, thesurrogate tests, notwithstanding theiradoption in the United States, and, onceChiron had pioneered the assay in respectof Hepatitis C, they concentrated uponwhether and when to introduce that test.[11] Anti-Hep C screening.After theidentification of the Hepatitis C virus,development speedily continued, as indeedwas indicated in the Chiron news release, of anassay: well in the lead was a US companycalled Ortho Diagnostic Inc (Ortho) (Chiron'slicensee) followed some time later by anotherUS company, Abbott Laboratories Inc(Abbott) and, less successfully and later still,by others.Known as anti-HCV, but, for thereasons I have given, to be resolutely called,at any rate by me, anti-Hep C, this assaydid not detect the antigen, but was a testfor the antibody to the Hepatitis C virus (atest to identify the antigen took very muchlonger to develop, by means of polymerasechain reaction (PCR)-later 'NAT' (nucleic acidtesting)-and is not relevant to the timescalewhich I am now considering).The anti-HepC assay was an enzyme-linkedimmunoabsorbent assay (ELISA).Thedetails of the Ortho Elisa were disclosed inApril 1989 and were fully canvassed at a10well-attended symposium organised byOrtho in Rome on 14-15 September 1989,when it was given backing by, among others,Dr Alter.Dr Gunson came away impressed,and reported back to the two high-poweredcommittees on which he sat, the UnitedKingdom Advisory Committee on VirologicalSafety of Blood (ACVSB), and the UnitedKingdom Advisory Committee on TransfusionTransmitted Diseases (ACTTD), of whichlatter he was the chairman.The factual historywill appear below in greater detail.At thisstage it is sufficient to set out as follows.(i)At this time the Ortho Elisa had only just beendeveloped.It was a 'first generation' testand there were concerns about itssensitivity (not catching all it should) andits specificity (catching those it should not). There was no supplementary or confirmatorytest yet developed to verify or cross-check itsfindings and increase the specificity of theprocess.(ii) No export licence was obtainedfor export of the assay from the USA untilthe end of November 1989, and the approvalby the US Food and Drugs Administration(FDA) for its use within the USA was notgranted until 2 May 1990.(iii)Recommendations to proceed with theintroduction of the anti-Hep C testing weremade by the relevant United Kingdomcommittee, the ACVSB, in July andNovember 1990, subject to the holding ofvarious trials.Ministerial approval wasgiven on 21 January 1991 and aprogramme of implementation was thencommenced for all RTCs.The tests (by nowsecond generation tests, and with asupplementary test available forconfirmatory purposes in place) wereintroduced throughout England and Waleson 1 September 1991.However, as set outabove, the defendants have accepted that therelevant date for these proceedings is 1 April1991 and most claimants who were infectedon or after that date have received anadmission of 90% liability.Since theintroduction of the tests on 1 September 1991,the problem of PTH in the United Kingdomhas been all but eliminated.THE CLAIMS[12] The claims in this trial have been that,pursuant to the CPA, those who receivedblood or blood products infected by HepatitisC subsequent to 1 March 1988, when the Actcame into effect, are entitled to recoverdamages: that is notwithstanding that: (i) theHepatitis C virus itself had not beendiscovered or identified at the date when theclaims commence on 1 March 1988; (ii) noscreening test to discover the presence of suchvirus in a donor's blood was even known of,certainly not available, until Ortho's assay, firstpublicised in spring/summer 1989; and (iii) it isnot sought to be alleged (at least not in thistrial) that the United Kingdom bloodauthorities for whom the defendants areresponsible were negligent in not introducingthe screening tests until they did on 1September 1991 (or now, as a result of theagreed concession, 1 April 1991) nor that theywere negligent in not having introducedsurrogate tests.The case which is put is thatthey are liable irrespective of the absence ofany fault, under the directive and the CPA.THE DIRECTIVE[13] The directive, resolved by the Councilon 25 July 1985, had taken a long time incoming.In the first instance this was becausediscussion of it, which had begun in1969/1970 in the light of the Thalidomidescandal, was held up largely due to theimpending arrival of a number of new11members of the Community, including theUnited Kingdom; but then because of the verylengthy processes of discussion andnegotiation, and of intergovernmental andparliamentary discussion, which then tookplace.A number of matters appear to becommon ground between the parties to theseproceedings: (i) that its purpose was toincrease consumer protection; (ii) that itintroduced an obligation on producers whichwas irrespective of fault, by way of objectiveor strict liability, but not absolute liability; (iii)that its aim was to render compensation of theinjured consumer easier, by removing theconcept of negligence as an element of liabilityand thus of the proof of liability; and (iv) thatit left an escape clause (in those Communityjurisdictions, like the United Kingdom, wheresuch provision was desired) for productsotherwise found pursuant to the directive tobe defective, if the producer could bringhimself within what was, in the course of the'travaux preparatoires', described as a'development risks' defence.[14] The parties before me agreed tonumber what are in the published directive anotherwise unnumbered set of 19 recitals.Thesignificant ones for the purpose of theseproceedings have been as follows:'[1] Whereas approximation of the laws ofthe Member States concerning the liability ofthe producer for damage caused by thedefectiveness of his products is necessarybecause the existing divergences may distortcompetition and affect the movement of goodswithin the common market and entail adiffering degree of protection of the consumeragainst damage caused by a defective productto his health or property;[2] Whereas liability without fault on thepart of the producer is the sole means ofadequately solving the problem, peculiar toour age of increasing technicality, of a fairapportionment of the risks inherent in moderntechnological production;[3] Whereas liability without fault shouldapply only to movables which have beenindustrially produced; whereas, as a result, it isappropriate to exclude liability for agriculturalproducts and game, except where they haveundergone a processing of an industrial naturewhich could cause a defect in these products :[6] Whereas, to protect the physical well-being and property of the consumer, thedefectiveness of the product should bedetermined by reference not to its fitness foruse but to the lack of the safety which thepublic at large is entitled to expect; whereasthe safety is assessed by excluding any misuseof the product not reasonable under thecircumstances;[7] Whereas a fair apportionment of riskbetween the injured person and the producerimplies that the producer should be able tofree himself from liability if he furnishes proofas to the existence of certain exoneratingcircumstances . . .[11] Whereas products age in the courseof time, higher safety standards are developedand the state of science and technologyprogresses; whereas, therefore, it would notbe reasonable to make the producer liable foran unlimited period for the effectiveness of hisproduct; whereas, therefore, liability shouldexpire after a reasonable length of time,without prejudice to claims pending at law :[13] Whereas under the legal systems ofthe Member States an injured party may havea claim for damages based on grounds ofcontractual liability or on grounds of non-contractual liability other than that providedfor in this Directive; in so far as theseprovisions also serve to attain the objective of12effective protection of consumers, they shouldremain unaffected by this Directive; whereas,in so far as effective protection of consumersin the sector of pharmaceutical products isalready also attained in a Member State undera special liability system, claims based on thissystem should similarly remain possible :[16] Whereas, for similar reasons, thepossibility offered to a producer to freehimself from liability if he proves that the stateof scientific and technical knowledge at thetime when he put the product into circulationwas not such as to enable the existence of adefect to be discovered may be felt in certainMember States to restrict unduly theprotection of the consumer; whereas it shouldtherefore be possible for a Member State tomaintain in its legislation or to provide by newlegislation that this exonerating circumstanceis not admitted; whereas, in the case of newlegislation, making use of this derogationshould, however, be subject to a Communitystand-still procedure, in order to raise, ifpossible, the level of protection in a uniformmanner throughout the Community.'[15] It is not in dispute between the partiesthat the directive can and must be construedby reference to its recitals and indeed to itslegislative purpose, insofar as it can be gleanedotherwise than from the recitals.Thefollowing points are also not in dispute and arein any event clear: (i) that it is proper to lookat travaux preparatoires to glean suchpurpose, but with caution, always chary ofearly discussions or disputations which mayhave been overtaken by later events, or ofdocuments which may always have beeninternal or confidential and not reflected in thedecisions; (ii) that it is important to bear inmind in construing a directive that there maybe an 'autonomous' or Community meaning orconstruction for legislation intending toharmonise and to be of effect in diversejurisdictions within the Community; and thatsome guidance can be obtained from otherlanguages in which the directive waspublished, all of which are of equal weight, themore so if some appear clear and congruent;and to some extent also from the way in whicha directive has been implemented or applied inother Community countries.[16] The relevant articles [of the ECProducts Liability Directive] are as follows:'Article 1The producer shall be liable for damagecaused by a defect in his product :Article 4The injured person shall be required toprove the damage, the defect and the causalrelationship between defect and damage :Article 61. A product is defective when it doesnot provide the safety which a person isentitled to expect, taking all circumstancesinto account, including: (a) thepresentation of the product; (b) the use towhich it could reasonably be expected thatthe product would be put; (c) the timewhen the product was put into circulation.2. A product shall not be considereddefective for the sole reason that a betterproduct is subsequently put intocirculation.Article 7The producer shall not be liable as aresult of this Directive if he proves: (a) thathe did not put the product into circulation;or (b) that, having regard to thecircumstances, it is probable that the defectwhich caused the damage did not exist at thetime when the product was put into13circulation by him or that this defect cameinto being afterwards; or . . . (d) that thedefect is due to compliance of the productwith mandatory regulations issued by thepublic authorities; or (e) that the state ofscientific and technical knowledge at thetime when he put the product intocirculation was not such as to enable theexistence of the defect to be discovered.Article 81. Without prejudice to the provisionsof national law concerning the right ofcontribution or recourse, the liability of theproducer shall not be reduced when thedamage is caused both by a defect inproduct and by the act or omission of athird party.2 The liability of the producer may bereduced or disallowed when, having regardto all the circumstances, the damage iscaused both by a defect in the product andby the fault of the injured person or anyperson for whom the injured person isresponsible.Article 9For the purpose of Article 1, "damage"means: (a) damage caused by death or bypersonal injury :Article 12The liability of the producer arisingfrom this Directive may not, in relation tothe injured person, be limited or excludedby a provision limiting his liability orexempting him from liability :Article 151. Each Member State may . . . (b) byway of derogation from Article 7(e)maintain or . . . provide in this legislationthat the producer shall be liable even if heproves that the state of scientific andtechnical knowledge at the time when heput the product into circulation was notsuch as to enable the existence of a defect tobe discovered.'THE CPA [Consumer Protection Act][17] When the United Kingdomimplemented the directive, it did so by way ofthe CPA, which came into force on 15 May1987, but with effect from 1 March 1988. There have been few decisions under the CPA. *** I have had the great benefit of detailedsubmissions in writing, and some ten days ofexegesis and argument orally in opening andclosing by leading counsel, just on the law,including authorities and academic writingsfrom France, Germany, Spain, Portugal,Sweden, Denmark, Belgium, Italy, Holland,Australia and the United States, as well as theUnited Kingdom and the Court of Justice.Inthe light of the concession in this case thatblood is a product within the directive, and thenature of the issues for determination and thepossible consequent knock-on effect of thisjudgment (subject always to any appeal tohigher courts in this country or on reference toEurope), I note without surprise thatProfessor Stapleton, probably the mosteminent and certainly the most prolific of thecommon law writers on the topic of productliability, refers to the fact that this case ispending in her introduction to the recentvolume in the Butterworths Common LawSeries The Law of Product Liability (2nd edn,2000) edited by Professor Howells.[18] The most authoritativeconsideration of the CPA has of coursebeen in the case of European Commission vUK, to which I have referred in [2] above, andthat was consideration in principle, not byreference to the facts of any case, and directed14specifically to art 7(e) (and s 4(1)(e)).As Ihave set out in [2], the Commission contendedthat the section did not properly or lawfullyreflect the article as it should.As will be seenbelow, it adopts different wording from thearticle, and this may result from the UnitedKingdom Government's own unilateraldeclaration that it made at the time of theadoption of the directive, namely-'this provision should be interpreted inthe sense that the producer shall not beliable if he proves that, given the state ofscientific knowledge at the time theproduct was put into circulation, noproducer of a product of that kind couldhave been expected to have perceived thatit was defective in its design.'This falls to be compared with the text ofthe article, which I have set out in [16] above. Section 4(1) of the CPA as enacted is asfollows:'In any civil proceedings . . . against anyperson . . . in respect of a defect in a productit shall be a defence for him to show . . . (e)that the state of scientific and technicalknowledge at the relevant time was not suchthat a producer of products of the samedescription as the product in question mightbe expected to have discovered the defect if ithad existed in his products while they wereunder his control . . .'[19] Whatever the content of aunilateral declaration may be, aCommunity government is obliged in lawto enact the directive, and the Commissioncontended before the Court of Justice thatthe United Kingdom Government had notdone so.The Court of Justice concludedthat, notwithstanding that there was adifference of wording, it could not besatisfied that it was intended by the UnitedKingdom to interpret its statute differentlyfrom the directive, nor was the UnitedKingdom entitled to do so.The AdvocateGeneral (Tesauro) stated in his opinion([1997] All ER (EC) 481 at 490-491 (para25)):'I consider that I am unable to share theCommission's proposition that there is anirremediable conflict between it and thenational provision at issue.Indeed, there is nodenying that the wording of s 4(1)(e) of the[CPA] contains an element of potentialambiguity: in so far as it refers to what mightbe expected of the producer, it could beinterpreted more broadly than it should. Notwithstanding this, I do not consider thatthe reference to the "ability of the producer",despite its general nature, may or even must(necessarily) authorise interpretations contraryto the rationale and the aims of the directive.'[20] After its own analysis of art 7(e), theCourt of Justice concluded (at 495-496):'32. The Commission takes the view thatinasmuch as s 4(1)(e) of the [CPA] refers towhat may be expected of a producer ofproducts of the same description as theproduct in question, its wording clearlyconflicts with art 7(e) of the directive in that itpermits account to be taken of the subjectiveknowledge of a producer taking reasonablecare, having regard to the standardprecautions taken in the industrial sector inquestion.33. That argument must be rejected in sofar as it selectively stresses particular termsused in s 4(1)(e) without demonstrating thatthe general legal context of the provision atissue fails effectively to secure full applicationof the directive.Taking that context intoaccount, the Commission has failed to makeout its claim that the result intended by art157(e) of the directive would clearly not beachieved in the domestic legal order.34. First, s 4(1)(e) . . . places the burden ofproof on the producer wishing to rely on thedefence, as art 7 of the directive requires.35. Second, s 4(1)(e) places no restrictionon the state and degree of scientific andtechnical knowledge at the material timewhich is to be taken into account.36. Third, its wording as such does notsuggest, as the Commission alleges, that theavailability of the defence depends on thesubjective knowledge of a producer takingreasonable care in the light of the standardprecautions taken in the industrial sector inquestion.37. Fourth, the court has consistently heldthat the scope of national laws . . . must beassessed in the light of the interpretation givento them by national courts . . . Yet in this casethe Commission has not referred in support ofits application to any national judicial decision,which, in its view, interprets the domesticprovision at issue inconsistent with thedirective.38. Lastly, there is nothing in the materialproduced to the court to suggest that courts inthe United Kingdom, if called upon tointerpret s 4(1)(e), would not do so in the lightof the wording and the purpose of thedirective so as to achieve the result which ithas in view and thereby comply with the thirdparagraph of art 189 of the Treaty . . .Moreover, s (1)(1) of the [CPA] expresslyimposes such an obligation on the nationalcourts.39. It follows that the Commission hasfailed to make out its allegation that, havingregard to its general legal context andespecially s 1(1) of the Act, s 4(1)(e) clearlyconflicts with art 7(e) of the directive.As aresult, the application must be dismissed.'[21] Although the United KingdomGovernment has not amended s 4(1)(e) of theCPA so as to bring it in line with the wordingof the directive, there is thus binding authorityof the Court of Justice that it must be soconstrued.Hence, although I shall in certainrespects require to consider sections of theCPA, when dealing with the issues raisedbefore me of causation and/or quantum ofloss, to which I shall refer, the majordiscussions in this case, and all the areas ofmost live dispute, have concentrated entirelyupon the wording of arts 6 and 7(e) of thedirective, and not upon the equivalent sectionsof the CPA, to which I shall make little or nofurther reference.[22] In those circumstances there is noneed for me to set out in full s 3 of the CPAwhich implements art 6, although it may beworth pointing out that the words in art6(1)(a) 'the presentation of the product' arehelpfully expanded and clarified in the CPA inthe following way-'the manner in which, andpurposes for which, the product has beenmarketed, its getup, the use of any mark inrelation to the product and any instructionsfor, or warnings with respect to, doing orrefraining from doing anything with or inrelation to the product' (s 3(2)(a); and that thewords with which s 3(2) ends are perhaps acogent way of expressing art 6(2) which Ihave set out above, and in particular thereference in the article to 'a better product[being] subsequently put into circulation'namely: 'Nothing in this section shall require adefect to be inferred from the fact alone thatthe safety of a product which is supplied afterthat time is greater than the safety of theproduct in question.'16[23] I shall set out below, when they fallfor consideration, the two other sections ofthe CPA to which reference was made in thecourse of the trial, with respect to the issuewhich I have described as causation and/orquantification of loss, namely ss 2(1) and 5(1).THE STRUCTURE OF THISJUDGMENT[24] I propose to adopt the followingstructure in this judgment.I shall begin withthe most significant legal questions, arising outof the construction of the directive.I shouldat this point make it clear that because I haveheard all the facts of the case upon whicheither side might wish to rely upon any of theissues, I shall make the necessary findings,irrespective of my conclusions in law.This isbecause both parties wish to take advantage ofthe very full consideration which there hasbeen so that, if there were appeals orreferences leading to different conclusions oflaw in due course, there would be the factualmaterial for the substitution of a differentresult.In particular, as will appear, if theclaimants be right about their construction ofthe directive, then little if any of the evidencethat I have heard relating to the factual historywith regard to Hepatitis C and screeningwould be admissible or relevant.I shall,however, resist the temptation, nor am I in anyevent permitted by the approach of the parties,if I were to resolve such point of law in favourof the claimants, not to proceed to resolve thefactual issues which would then have becomeirrelevant.Equally, at any rate until there wasthe 90% concession, which has meant thatliability to some claimants is no longer inissue, it might have been that if I had found forthe defendants on liability I would not haveneeded to go on to decide what I would haveawarded to the claimants, had they beensuccessful: but again, for similar reasons, thisis not a course that I have adopted. Accordingly, whatever my decisions on thevarious issues, I have proceeded to decide thefurther issues, whether or not they continue toarise.THE SIX ISSUES[25] [ISSUE I] This raises the questionof whether the defendants are liable to theclaimants, without consideration of thehistory of testing.The claimants allegethat, upon the basis of a proper constructionof the directive and the agreed factualcommon ground, the blood was defectiveunder art 6 and the defendants have noescape within art 7(e), without need forfurther consideration of the facts (Issue I). This was described in the course of thehearing as the 'Forrester case' or the 'Brownshort case' (which descriptions derogate fromthe role of Mr Brooke QC for the claimantswho ably married together all the claimants'arguments).[26] [(Issue II)]Factual case: legitimateexpectation .Whether or not I find thedefendants so liable, for the reasons I have setout above, I must proceed to resolve thefactual questions which the claimants assert tobe unnecessary-the 'Brown case'.Theclaimants assert, if they need to, that, in thelight of the factual history relied upon by thedefendants, the blood was defective withinart 6.I shall also make sufficient findings toresolve any factual issues under art 7(e), as towhich see [28] below.[27] I must then resolve the issue of thenature and measure of damages under art6.***[28] I must decide whether the defendantsescape any such liability under art 7(e): (i) in17the light of my conclusions on the constructionof art 7(e) on Issue I (Issue IVa) and/or (ii) inthe light of my conclusions on Issue II (IssueIVb).[29] I shall turn then to the six lead cases. Subject always to the outcome of Issue I, Imay have made, in my consideration in respectof Issue II, findings as to the date when testscould legitimately have been expected to beimplemented which might mean that,depending upon their date of infection, onlycertain claimants succeed, ie those infectedafter such and such a date, while others donot.That apart, I have heard a good deal ofevidence about Hepatitis C and its prognosisand consequences generally, and in addition allthe evidence relating to the individualcircumstances of the six lead claimants (two ofwhom, as previously discussed, will in anyevent receive compensation in accordancewith my conclusions on quantum, by virtue ofthe 90% concession agreement).[30] I shall, again even if I shall havefound that some or all of the claimants fail(apart from those covered by the concession):(i) make findings on the generic issues raisedrelating to quantum arising out of and byreference to the particular circumstances ofthe six lead claimants, including such mattersas recoverability or otherwise of damages inrespect of alleged social or insurance oremployment stigma resulting from theirHepatitis condition, past or present (Issue V);and (ii) assess damages, in the case of five ofthe lead claimants by way of provisionaldamages, on the basis of what have now, afterconsiderable discussion and argument, becomeagreed triggers for any potential futureentitlement to additional damages pursuant tos 32A of the Supreme Court Act 1981, and inthe case of one of them, Mr W, at his request,final damages (Issue VI).ARTICLE 6The common ground[31] I turn then to consideration of art 6. There is a foundation of common ground.(i) Article 6 defines 'defective', andhence a defect.A harmful characteristic ina product, which has led to injury ordamage, may or may not be a defect as sodefined, and thus within the meaning of thedirective.It is common ground that theliability is 'defect-based' and not 'fault-based', ie that a producer's liability isirrespective of fault (Recitals 2, 6).(ii) The purpose of the directive is toachieve a higher and consistent level ofconsumer protection throughout theCommunity and render recovery ofcompensation easier, and uncomplicated bythe need for proof of negligence.Both thesepropositions are expressed by ChristopherNewdick in two published articles, first in theLaw Quarterly Review 'The Future ofNegligence in Product Liability' [1987] 103LQR 288:'. . . liability for defective products is nolonger to be dependent on fault, but rather onthe mere fact of defectiveness.The broadreasons of policy for the change continue to bearticulated by the injuries suffered by thethalidomide children.By the attention itdevotes to consideration of the alleged fault ofthe defendant, the law of Negligence is unableto consider the interests of the person forwhom the action has been brought.'and also in 'The Development RiskDefence of the Consumer Protection Act1987' [1988] CLJ 455 where, before going on18to deal with art 7(e) as a possible exception,he states:'The . . . Directive . . . introduces a newregime of strict product liability to the memberstates of the Community.Those injured byproducts may recover by showing that theproduct is "defective", i.e., that it "does notprovide the safety which a person is entitled toexpect . . ." The advantage of this approachfor the individual is that liability turns on theexistence of a defect alone.Unlike the law ofNegligence, no question of foresight of thedanger, or of the precautions taken to avoid it,arises for consideration.Strict productliability depends on the condition of theproduct, not the fault of its maker or supplier.'(iii) The onus of proof is upon theclaimants to prove the product to bedefective.(iv) The question to be resolved is thesafety or the degree or level of safety orsafeness which persons generally areentitled to expect.The test is not that of anabsolute level of safety, nor an absoluteliability for any injury caused by the harmfulcharacteristic.(v) In the assessment of that questionthe expectation is that of persons generally,or the public at large.(vi) The safety is not what is actuallyexpected by the public at large, but whatthey are entitled to expect.At one stage MrForrester QC contended that the process wasto discover what the expectation was, andthen see if it was legitimate; but, not least forthe reasons set out in the next followingsubparagraph, he no longer actively pursuedthat contention.The common ground is thatthe question is what the legitimateexpectation is of persons generally, ie whatis legitimately to be expected, arrived atobjectively.'Legitimate expectation',rather than 'entitled expectation', appearedto all of us to be a more happy formulation(and is analogous to the formulation in otherlanguages in which the directive is published);the use of that expression is not intended toimport any administrative law concepts.(vii) The court decides what the publicis entitled to expect: Dr Harald Bartl inProdukthaftung nach neuem EG-Recht (1989)described the judge (as translated from theGerman) as 'an informed representative of thepublic at large'.Mr Brown did not like this,and preferred to suggest simply that the judgeis determining what level of safety the public isentitled to expect, but I do not consider thetwo descriptions inconsistent.Suchobjectively assessed legitimate expectationmay accord with actual expectation; but it maybe more than the public actually expects, thusimposing a higher standard of safety, or it maybe less than the public actually expects. Alternatively the public may have no actualexpectation-eg in relation to a new product-the word coined in argument for such animaginary product was a 'scrid'.(viii) There are some products, whichhave harmful characteristics in whole or inpart, about which no complaint can bemade.The examples that were used ofproducts which have obviously dangerouscharacteristics by virtue of their very nature orintended use, were, on the one hand knives,guns and poisons and on the other handalcohol, tobacco, perhaps foie gras.Theexistence of such products was recognised inan exchange of question and answer by MrsFlesch MEP to the European Commission,answered by Viscount Davignon on behalf of19the Commission in June 1980.The questionread in material part as follows:'This provision ought apparently to beinterpreted in the sense that nobody canlegitimately expect from a product which byits very nature carries a risk and which hasbeen presented as such (instructions for use,labelling, publicity, etc.) a degree of safetywhich this product does not and cannotpossess, with the result that this productwould not therefore be defective within themeaning of the future directive.'The answer was:'The Commission agreed with theHonourable Member that nobody canexpect from a product a degree of safetyfrom risks which are, because of itsparticular nature, inherent in that productand generally known, e.g., the risk ofdamage to health caused by alcoholicbeverages.Such a product is not defectivewithin the meaning of . . . the . . . Directive.'This does not of course amount to anexemption for such a product from the article,but simply an explanation of how the articleoperates.Such obvious danger or risk ofinjury is, not very felicitously, described by aDanish writer, Borge Dahl, as 'system'damage.Professor Howells in The Law of ProductLiability at para 1.19 refers to this as adescription of:'The risks which are inherent within aproduct which it is nevertheless consideredjustifiable to market.Examples include therisk of being cut by a sharp knife and the riskof illness associated with such otherwisepleasure giving products [as] alcohol andtobacco . . . The emphasis on the autonomy ofthe individual and his free choice to exposehimself to risks has generally relieved theproducer of . . . liability.However this freechoice must be an informed choice and sothere has been a need to define which types ofsystem damage users can be expected to beaware of from their general life experience(i.e., that knives can be sharp) and those thatthey have to be warned about (i.e., risksassociated with drinking and smoking).'Drugs with advertised side-effects may fallwithin this category.The defendants point outthat, with other such products also, the knowndangerous characteristics need not be thedesired ones-eg carcinogenicity in tobacco.(ix) Article 6(2) means that such testmust be applied as at the date when theproduct is put into circulation, ie testedagainst the safety then to be expected.It isapparent that a product may be compared withother products said to be safer, but will not becondemned simply because another saferproduct is subsequently put into circulation.(x) There is also important factualcommon ground.It has, as set out in [8]above, been known, at least since the 1970s,by blood producers and the medicalprofession, primarily blood specialists,hepatologists and epidemiologists, that therewas a problem of infection by Hep C (formerlyNANBH) in transfused blood, and that apercentage of such blood-in the UnitedKingdom thought to be between 1% and 3%-was infected with NANBH/Hep C.The claimants say that such knowledgeby the medical profession and bloodproducers is on the one hand irrelevant toart 6, and to the public's expectation, andlegitimate expectation, and on the other20rules out the producers from the protectionof art 7(e).The defendants say that such risks soknown, which they allege to be impossibleto avoid or prevent, affect the legitimateexpectation of the public, such as toexclude art 6, and, because they wereunavoidable, qualify them, if necessary, forart 7(e).THE DIFFERENCES BETWEEN THEPARTIES[32] Having set out what is commonground, I now summarise briefly the differencebetween the two parties, some of which isalready apparent from my setting in context ofthe factual common ground. (i) As to art 6, the claimants assertthat, with the need for proof of negligenceeliminated, consideration of the conduct ofthe producer, or of a reasonable orlegitimately expectable producer, isinadmissible or irrelevant.Thereforequestions of avoidability cannot and do notarise: what the defendants could or shouldhave done differently; whether there were anysteps or precautions reasonably available; andwhether it was impossible to take any steps byway of prevention or avoidance, orimpracticable or economically unreasonable. Such are not 'circumstances' falling to beconsidered within art 6.In so far as the riskwas known to blood producers and themedical profession, it was not known to thepublic at large (save for those few patientswho might ask their doctor, or read theoccasional article about blood in a newspaper)and no risk that any percentage of transfusedblood would be infected was accepted bythem.(ii) The defendants assert that the riskwas known to those who mattered, namelythe medical profession, through whomblood was supplied.Avoiding the risk wasimpossible and unattainable, and it is notand cannot be legitimate to expect theunattainable.Avoidability or unavoidabilityis a circumstance to be taken into accountwithin art 6.The public did not and/or wasnot entitled to expect 100% clean blood.Themost they could legitimately expect was thatall legitimately expectable (reasonablyavailable) precautions-or in this case tests-hadbeen taken or carried out.The claimants musttherefore prove that they were legitimatelyentitled to expect more, and/or must disprovethe unavoidability of the harmfulcharacteristic.There would need to be an investigation asto whether it was impossible to avoid the riskand/or whether the producers had taken alllegitimately expectable steps.In so far asthere was thus an investigation analogous to,or involving similar facts to, an investigationinto negligence, it was not an investigation ofnegligence by the individual producer and wasnecessary and, because it was not aninvestigation of fault, permissible.If,notwithstanding the known and unavoidablerisk, the blood was nevertheless defectivewithin art 6, then it is all the more necessary toconstrue art 7(e) so as to avail those whocould not, in the then state of scientific andtechnical knowledge, identify the defect in aparticular product so as to prevent its supply.(iii) The claimants respond that art 7(e)does not apply to risks which are knownbefore the supply of the product, whetheror not the defect can be identified in theparticular product; and there are a number21of other issues between the parties in respectof art 7(e) to which I shall return later.ALL CIRCUMSTANCES[33] Article 6 must then be consideredagainst the background of this summary of theissues.In the establishment of the level ofsafety, art 6 provides that the court (onbehalf of the public at large) takes intoaccount all circumstances, including thefollowing: (i) Presentation, ie the way in which theproduct is presented, eg warnings and price. As set out above, the expanded wording of s3(2)(a) of the CPA is helpful.(ii) The use to which the product couldreasonably be expected to be put, eg: (a) ifthe product is not a familiar or usual one, suchas a scrid, it will be necessary to find out whatits expected or foreseeable use is; (b) if it isexpected and required to be dangerous inrespect of its expected use, eg a gun, thencomplaint cannot be made of thatdangerousness; but complaint could still bemade of a different dangerousness, such as if itexploded on the trigger being pulled; and (c) ifit is not expected to be dangerous in respect ofits expected use, but the use to which it is putis unexpected, then it may not be defective.(iii) The time when the product iscirculated, for example when the product isout of date or stale.***[35] The dispute therefore is as towhat further, if anything, falls to beconsidered within 'all circumstances'. There is no dispute between the parties, as setout in para 31(i) and (ii) above, thatconsideration of the fault of the producer isexcluded; but does consideration of 'allcircumstances' include consideration of theconduct to be expected from the producer,the level of safety to be expected from aproducer of that product?The parties agree that the starting point isthe particular product with the harmfulcharacteristic, and if its inherent nature andintended use (eg poison) are dangerous, thenthere may not need to be any furtherconsideration, provided that the injury resultedfrom that known danger.However, if theproduct was not intended to be dangerous,that is the harmful characteristic was notintended, by virtue of the intended use of theproduct, then there must be consideration ofwhether it was safe and the level of safety tobe legitimately expected.At this stage, the defendants assert thatpart of the investigation consists of what stepscould have been taken by a producer to avoidthat harmful characteristic. The defendantsassert that conduct is to be considered not byreference to identifying the individualproducer's negligence, but by identifying andspecifying the safety precautions that thepublic would or could reasonably expect froma producer of the product.The exercise isreferred to as a balancing act; the moredifficult it is to make safe, and the morebeneficial the product, the less is expected andvice versa, an issue being whether a producerhas complied with the safety precautionsreasonably to be expected. This is contendedby the defendants to be appropriatelyanalogous to the 'risk/utility' considerationfamiliar from United States law, particularly assummarised in the US Second Restatement onTorts (1965).However-(i) the claimants point outthat, although the Advocate General in22European Commission v UK Case C-300/95 [1997] All ER (EC) 481 at 488 (para17) records that the Commission's originalproposal in 1976 drew its inspiration fromthe US model, it is clear from the travauxpreparatoires that when submissions weremade that a United States style formulationshould be adopted, it was not: the rejectedsuggestions including (from a body calledUNICE in 1980) that 'the fact that a productconforms with generally accepted standardsshould be prima facie evidence that theproduct is not defective' and, from theAmerican Chamber of Commerce in Belgiumin the same year, that the proposed article'should be amended to include specificlanguage concerning unavoidably unsafe butuseful products . . . In drafting this amendmentregard should be paid to the wording ofComment K to Section 402a of [the SecondRestatement]'.(ii) Although the concept of'unavoidably unsafe' has meant that producershave been found not liable in many states ofthe United States in respect of infected blood(see eg Brody v Overlook Hospital (1974) 317A (2d) 392 (subsequently affirmed by theSupreme Court of New Jersey (1975) 332 A(2d) 596), the US Second Restatement has ledto, or allowed for, a result, at least in Illinois,whereby there was strict liability imposed onthe supplier of blood unavoidably infectedwith hepatitis (Cunningham v McNealMemorial Hospital (1970) 47 Ill (2d) 443,Supreme Court of Illinois): which decisionwas dealt with statutorily, as a matter ofpublic policy, by the giving of immunity toblood banks-a so-called 'blood-shieldstatute', passed in most states of the UnitedStates.(iii) The defendants themselves acceptthat the risk/utility model adopted in theUnited States cannot be applied in itsentirety, because of the express exclusion,so far as the directive is concerned, of anyquestion of liability for negligence.Nevertheless the defendants assert thatthere is a 'basket' of considerations: thelikelihood of injury resulting and theseriousness of it if it results, the cost and thequality of the product, the efficacy of theproduct (with and without safety precautions),none of which would necessarily becontentious from the claimants' point of view. For if it were to be asserted by a producer thata product was very cheap, and thus mighthave been expected to have been less safe, thatmight, on the claimants' case, be part of thepresentation, if it were simply a question of analleged lowering of expectations by virtue ofthe cheapness; while on the defendants' casethe questions would arise in their own right asto what could have been practicable (or not)by way of safety precautions, and/or thenperhaps as to the cost of such precautions, andperhaps the effect on the profitability of aproducer.What would, on any basis, be contentiouswould be the further contents of thedefendants' basket, namely the avoidability orunavoidability of the danger, and theavailability or unavailability of alternatives. The contentions proceed as follows.Thedefendants assert that, in looking at theproduct, it is essential to consider, in decidingwhat level of safety could reasonably havebeen expected, what more if anything couldhave been done: what precautions or testscould be used/should have been used/wereavailable to be used/can legitimately beexpected to have been used.If, the defendantscontend, the producer did not use obviouslyavailable safety processes or precautions, thenthat itself must be a factor to be taken into23account against him, just as it would be in hisfavour if all available safety precautions wereadopted.They accept that the investigation of whatlevel of safety the public is entitled to expectmay involve consideration of factual issueswhich would also be relevant in a negligenceinquiry, but they say that this would be amatter of overlap rather than duplication, andinevitable and acceptable.The claimants,however, assert that, given that it is commonground that the article imposes liabilityirrespective of fault, the exercise ofconsidering what could or should have beendone by the producer is an impermissible andirrelevant exercise, which lets questions offault back in by the back door.They say thatthe consideration of what safety precautionsshould have been expected to have beenadopted simply amounts to the introduction ofa standard of legitimate expectability, ratherthan a standard of reasonableness, againstwhich the conduct of a producer must be set:while the defendants may be asserting thatthey accept that the consideration of theconduct of the individual producer is notrelevant, nevertheless by the veryconsideration of what steps could legitimatelyhave been expected to have been taken(against which what did occur inevitably hasto be set) the same result is achieved. Theclaimants contend that any consideration ofthe method or processes of production,including the safety precautions taken or nottaken, is irrelevant. They assert that it isnecessary only to look at the product itself(including comparison with similar or identicalproducts on the market), which would involveits expected or intended use, withoutconsidering what more could have been done(and how easy or difficult or cheap orexpensive it would have been to have done it). The safeness even of a scrid must beconsidered by reference to examination ofsuch a product and its intended or foreseeableuse, not its method of manufacture.The defendants counter that it would beimpossible to carry out any comparativeexercise without understanding what stepswere taken, and why certain steps could orcould not have been taken.If suchcomparison is with a later and safer product,the producer would then rely on art 6(2), toassert that the greater safety offered by asubsequent model was not to be held againsthim, pursuant to art 6(2): to which a claimantcould inevitably seek to respond that, althoughthe safer product was five years later, theproducer could have taken the same steps fiveyears earlier.Non-standard products[36] In any event, however, the claimantsmake a separate case in relation to theblood products here in issue: namely thatthey are what is called in the United States'rogue products' or 'lemons', and inGermany 'Ausreisser'-escapees or 'off the road'products.These are products which areisolated or rare specimens which are differentfrom the other products of a similar series,different from the products as intended ordesired by the producer.In the course of MrForrester's submissions, other more attractiveor suitable descriptions were canvassed, and Ihave firmly settled on what I clearly prefer,namely the 'non-standard' product.Thus astandard product is one which is and performsas the producer intends.A non-standardproduct is one which is different, obviouslybecause it is deficient or inferior in terms ofsafety, from the standard product: and where24it is the harmful characteristic orcharacteristics present in the non-standardproduct, but not in the standard product,which has or have caused the material injuryor damage.Some Community jurisdictions inimplementing the directive have specificallyprovided that there will be liability for 'non-standard' products, ie that such willautomatically be defective within art 6: Italyand Spain have done so by express legislation,and Dr Weber, in Produkthaftung imBelgischen Recht (1988) at pp 219-220,considers that that is now the position inBelgium also as a result of the implementationof the directive.[37] Were the infected bags of blood inthis case non-standard products?Theclaimants say Yes-99 out of 100 are safeand uninfected as intended. Thedefendants say No-all blood, derived as it isfrom a natural raw material, albeit thenprocessed, is inherently risky. But the claimants assert that personsgenerally are entitled to expect that all bloodand blood products used for medical treatmentare safe, and that they will not receive theunsafe one in 100.The claimants say that thiswill only not be the case if the public doesknow and expect that blood, like cigarettes oralcohol, is or may be defective, not becausethe public's expectation is limited to anexpectation that legitimately expectable safetyprecautions will have been taken.[38] In a jurisdiction where, unlike Spainand Italy, and perhaps Belgium, no legislativedistinction has been drawn between standardand non-standard products, the distinction,even if I were to conclude that the blood bagsin this case are non-standard products, wouldnot be absolute.Non-standard productswould not be automatically defective.Aproduct may be unsafe because it differs fromthe standard product, or because the standardproduct itself is unsafe, or at risk of beingunsafe.It may, however, be easier to provedefectiveness if the product differs from thestandard product.BOXES[39] United States tort law hasdeveloped a difference betweenmanufacturing defects, design defects andinstruction defects (the last category beingirrelevant for our purposes).This wasworked through in case law, though it didnot appear in the Second Restatement,published in 1965, but it has been expresslyincorporated into the Third Restatement,published in 1998 (s 2(a)(b)(c): Categoriesof Product Defects).There is almost a separate jurisprudencefor manufacturing defects as opposed todesign defects.A manufacturing defect isdefined as being 'when the product departsfrom its intended design even though allpossible care was exercised in the preparationand marketing of the product' and a designdefect as-'when the foreseeable risks of harmimposed by the product could have beenreduced or avoided by the adoption of areasonable alternative design by the seller orother distributor, or a predecessor in thecommercial chain of distribution, and theomission of the alternative design renders theproduct not reasonably safe.'25The claimants say that, in terms of thatdichotomy, the infected blood here is amanufacturing defect-an error inproduction has led to a one-off. The defendants say that, if a defect atall, it is a design defect, because the processas designed leads inevitably to theoccasional failure as a result of an inherentdefect in the raw material.In this context, so far as the academicsare concerned, the claimants appear tohave the better of it.Professor Sole Feliu inhis book El Concepto de Defecto delProducto en la Responsabilidad Civil delFabricante (1997) p 525, when addressing thequestion of whether blood with hepatitis is tobe considered a design or manufacturingdefect, following the view of AmericanProfessors Phillips and Pryor (ProductsLiability (1993) vol 1, p 392), concludes (astranslated from the Spanish) 'since the defectsoccur only occasionally and since there is nodesign whatsoever, and since the blood assuch is processed and used for the transfusion,these are rather manufacturing defects'.Professor Howells (The Law of ProductLiability, para 1.14) considers that'manufacturing defects are caused by an errorin the production process or by the use ofdefective raw materials'. However,notwithstanding that there was some use ofthese American terms in the travauxpreparatoires, there is no place for them in thedirective.After some discussion in the course of thehearing, I am satisfied, and indeed neithercounsel contended to the contrary, that noassistance can be gained from what MrUnderhill called the 'boxing', orcategorisation, of defects in this regard forthe purpose of construction of the directive,or the determination of any of the issuesbefore me, for the following reasons amongothers: (i) as referred to above, there are no suchboxes or categories in the directive, unlike theThird Restatement; (ii) in order to define whether the defectsare manufacturing or design defects, in mostcases it would be inevitable that there wouldrequire to be consideration of the preciseprocesses adopted in production, which bothsides accept to be inappropriate; and (iii) consequently, whatever may be theposition in US jurisprudence, art 6 directsconsideration of whether the product isdefective, and as to what legitimateexpectation is as to the safeness of theproduct.Whether it is appropriate to definethe one infected bag of blood in 100 as amanufacturing defect, or as an inevitable resultof a chosen design process which cannotguarantee uniformity of product, the issue isstill the same, namely whether the safety wasprovided which the public was entitled toexpect in respect of that product.[40] The significance to my mind onlyarose at all in our discussions because, byvirtue of the fact that many Europeanexperts in product liability, both academicsand practitioners, have been steeped in theUS jurisprudence, 'rogue products', orrather what I now call 'non-standardproducts', have been almost automaticallydefined by them as manufacturing defects.26Given that there is a dispute between theparties in this case as to what is meant by amanufacturing defect, it seems to me sensibleto concentrate simply on the concept of astandard or non-standard product.As willappear, this does appear to me to make easierthe understanding of those few Europeandecisions which there have been arising out ofthe directive.In the criminal field, the UnitedKingdom courts have responded stringently tomanufacturing errors: this appears clearly fromthe House of Lords decision in Smedleys Ltdv Breed [1974] 2 All ER 21, [1974] AC 839,where, notwithstanding non-negligent qualitycontrol, there was strict liability at criminallaw where a caterpillar identical in colour,size, density and weight to the peas in a tinsurvived the process in one out of threemillion tins: but that too would be a non-standard product.[41] If the distinction is between astandard and non-standard product, thecritique of a non-standard product will be thesame, namely by virtue of its difference from astandard product, whether it is treated as aone-off manufacturing defect or as a designdefect resulting from a way in which theproducer's system was designed, which led toall the producer's product being subject to thesame risk.The approach to whether non-standard and standard products aredefective may, however, be different,primarily because non-standard productsfall to be compared principally with thestandard product, while standard products,if compared at all, will be compared withother products on the market.THE STATUS OF THEDEFENDANTS[42] One final point with which I shoulddeal is the fact that the defendants arerequired to produce the product, in this caseblood, pursuant to the obligations of theNBTS, and thus, it is said, had noalternative but to supply it to hospitals andpatients, as a service to society. *** Furtherthere is, in any event, no necessary reasonwhy a public authority or a non-profitmaking organisation should be in anydifferent position if the product is unsafe(which proposition accords with the opinionof the Advocate General (Colomer) inHenning Veedfald v Arhus AmstkommuneCase C-203/99 (14 December 2000,unreported) at para 27 (the 'Danish Kidneycase'), which has not yet been considered bythe Court of Justice (Editor's note: the Courtof Justice delivered judgment in this case on10 May 2001.)).There is of course no 'blood-shield' statute in the United Kingdom.Travaux preparatoires[43] There is nothing much to assist in thetravaux preparatoires, save for: (i) the rejection of the express USapproach and risk-utility analysis (see [35]above); (ii) the fact that the strength of thecontentions in support of a defence of state ofthe art, and of protection for producers in thecontext of inevitable risks, was directed first tothe introduction into the drafts, and then theexpansion and exposition, of art 7(e).It mightwell be said that if those lobbying for extraprotection for the producer had consideredthat there was already substantial protectionunder art 6 itself (which is not mentioned inthis context in the documents in evidence)27they might not have needed to fight so hard tointroduce and retain art 7(e).This probably inadmissible approach isbetter expressed simply as the fact that in thedocuments before me (and that in itself is animportant caveat) there is no discussion ofwhether the availability (or not) or adoption(or not) of safety precautions by a producer isrelevant, or a circumstance, in the context ofart 6 (nor of course is such listed at any timeamong the circumstances which are set out inthe article, 'notamment' or otherwise).COURT DECISIONS[44] I turn to consider the few courtdecisions in Europe in which the directive, orthese issues under the directive, have beenconsidered or touched upon.As indicatedabove, these have not been many,***(i) United Kingdom.On the art 6 issueswhich I have to decide, Richardson's case isunclear.Ian Kennedy J concluded in relationto a condom, the teat end of which becamedetached during sexual intercourse, resultingin the pregnancy of the claimant, that 'naturallyenough the users' expectation is that a condomwill not fail'.But he does not then appear tohave gone on to consider the actual question,being whether they were entitled so to expect. He appears to have concluded that he couldnot identify a harmful characteristic, eitheroccurring in the factory (art 7(b)) or at all.Whether that resulted from too muchconcentration during the trial by both partieson the method of manufacture, or whetherthere was an implicit finding that the fracturewas caused by misuse by the claimants, is notclear, but in any event he concluded, withoutconsideration of the issue of legitimateexpectation, that the claimants' claim failed.In the 'Cosytoes case', the claimant wassuccessful, where an elastic strap for attachinga buckle to a baby's sleeping bag sprang back,causing the buckle to hit the baby's brother inthe eye.So far as concerns the claim underthe CPA, and hence for our purposes under art6, the claim succeeded.Chadwick LJ (at para44) emphasised that fault of the producer isirrelevant:'It is irrelevant whether the hazard whichcauses the damage has come, or oughtreasonably to have come, to the attention ofthe producer before the accident occurs.Tohold otherwise is to my mind to seek toreintroduce concepts familiar in the concept ofa claim in negligence at common law into astatutory regime which has been enacted inorder to give effect to the . . . directive.'But he does not appear to address in termswhether the conduct of any producer would berelevant.Pill LJ left the position unclear (atpara 27) when he concluded 'Members of thepublic were entitled to expect better from theappellant': but Chadwick LJ (at para 45) doesaddress himself towards the level of safety tobe expected 'in relation to child care products'. In neither of these two cases, however, does itappear that there was any or any full argumenton the points now in issue.(ii) Germany.In what has been called the'German Bottle case' (9 May 1995) NJW1995, 2162), the Bundesgerichtshof (BGH),the German Federal Supreme Court, gavejudgment on 9 May 1995, allowing an appealby a claimant injured as a result of anexploding mineral water bottle, resulting froma very fine hairline crack, not discoverednotwithstanding what was found to be atechnical and supervisory procedure in thedefendant's factory in accordance with the28very latest state of technology (includingseven different inspections).***Thedefendants accept that the crack in thatcase was plainly a manufacturing defect,capable of being described, as the BGHexpressly did, as a rogue product('Ausreisser') and do not contend that thedecision of the BGH was wrong.Theysubmit, however, that this logic does notapply to a bag of blood, which they submitto share the same characteristics as allblood, namely in that all blood bears-orbore-the 1% risk of being infected.(TheBGH also rejected the producer's argumentsunder art 7(e), to which I shall return.)(iii) Holland.The County Court ofAmsterdam (not an appellate court) gave ajudgment on 3 February 1999 in the case ofScholten v Foundation Sanquin of BloodSupply (unreported).In this case theclaimant received blood infected with HIV,after the introduction of HIV screeningtests in that country, because of the(infinitesimal) risk in that case from bloodwhich had been so screened but must havebeen given by a donor who had only justcontracted HIV, such that his infectioncould not be detected by a test during whathas been called 'the window period'.The court appears to have looked at thefacts in that case with some care:The claimant was pointing out that thefoundation's leaflet suggested that the chanceof being infected with HIV was so small thatone should consider that one would not beinfected.The defendants pointed out that the mediahad paid a great deal of attention to the factthat blood products always carried a risk oftransmitting infections, and the defendantscontended that (para 6, as translated from theDutch)-'the foundation carefully carried outinvestigations of the blood and followed thecorrect and relevant guidance, so that one isnot able to expect a greater safety of the bloodproduct than that which can be offered by theproper compliance with the relevantregulations.'The court concluded, in finding for theclaimant in respect of art 6 (or the Dutchimplementing equivalent), as follows:'The court agreed with Scholten that,taking into account the vital importance ofblood products and that in principle there is noalternative, the general public expects and isentitled to expect that blood products in theNetherlands have been 100% HIV free forsome time.The fact that there is a smallchance that HIV could be transmitted via ablood transfusion, which the foundationestimates at one in a million, is in the opinionof the court not general knowledge.It cannottherefore be said that the public does not orcannot be expected to have this expectation. The fact that the foundation acted inaccordance with the relevant guidance, andthat the use of an HIV-1 RNA test at the timecould not have detected the HIV virus doesnot have any bearing on this.'The defendants contend that this decisionof the County Court of Amsterdam, which isobviously not in any way binding upon me,was wrong: but further or in the alternativethey contend that the decision which the courtthen went on to make which resulted inScholten's claim failing by reference to art 7(e)(to which I shall return below) was right.29(iv) France.There are no decisionsdirectly under the directive in France***Academic literature***SUMMARY[46] I summarise the position.(i) The firstquestion of law which I have to resolve in thelight of my construction of arts 6 and 7(e) iswhether I need to consider and determine theissues raised by the evidence, which I have infact heard over more than 20 days (includingconsideration of documents), from theclaimants and the defendants, at thedefendants' instance, on the 'Brown case';namely as to whether in fact the defendantsdid everything that could be legitimatelyexpected of them (what might be called their'Zumutbarkeit' evidence).If I consider that Ido not in law need to do so, then I resolve thequestion of defectiveness without suchevidence (the 'Forrester case').If I concludethat in law the evidence is admissible (but, as ithappens, in any event, for the reason set out in[24] above, of possible appeals or references)then I must proceed to decide whether theclaimants have shown that the defendantsfailed to do what was legitimately e