Input:
The claimant, Declan OByrne, was vaccinated on 3 November 1992 with an HIB vaccine (the Product).
He alleges that the Product was defective and that it caused him brain damage.
The vaccine in question was manufactured in France by a French company, now known as Aventis Pasteur SA (APSA).
On 18 September 1992 APSA sent a consignment of the vaccine, including the Product, to a company, now known as Aventis Pasteur MSD Ltd (APMSD), in England.
At all relevant times in 1992 APMSD was a wholly owned subsidiary of APSA and acted as a United Kingdom distributor for APSAs products.
APMSD received the consignment on 22 September.
On an unknown date, probably in late September or early October, APMSD sold part of the consignment, including the Product, to the Department of Health, which in turn supplied it to the medical practice which used it to vaccinate the claimant.
On 1 August 2001 the claimant began proceedings for damages against APMSD, alleging that he had suffered damage caused by a defect in the Product which APMSD had manufactured and/or produced and so it was liable under section 2 of the Consumer Protection Act 1987.
In its defence, served in November 2001, APMSD pointed out that it was not the manufacturer, but merely the distributor, of the Product.
In response to a further request, in April 2002 APMSD identified APSA as the manufacturer of the Product.
On 16 October 2002 the claimant issued separate proceedings against APSA, also under section 2 of the Consumer Protection Act, alleging that APSA was the producer of the Product and claiming damages against it.
APSA defended the action on the basis, inter alia, that it had put the Product into circulation either on 18 September 1992, when it sent the Product to APMSD, or on 22 September 1992 when APMSD received it.
APSA contended that, in these circumstances, the claimants action against it was time barred since it had been raised more than 10 years after APSA had put the Product into circulation.
In advancing this defence, APSA relied on section 11A(3) of the Limitation Act 1980 and Article 11 of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ 1985 L210, p 29) (the Directive), which provides: Member States shall provide in their legislation that the rights conferred upon the injured person pursuant to this Directive shall be extinguished upon the expiry of a period of ten years from the date on which the producer put into circulation the actual product which caused the damage, unless the injured person has in the meantime instituted proceedings against the producer.
Faced with this defence in his action against APSA, in his action against APMSD with which this appeal is concerned the claimant applied on 10 March 2003 for an order that APSA be substituted as defendant in place of APMSD.
The application was based on section 35(5)(b) and (6)(a) of the Limitation Act 1980 and rule 19.5(3)(a) of the CPR.
It is, of course, common ground that the application was made after the expiry of the ten year time limit under Article 11 for initiating proceedings against the producer of the Product.
In these circumstances APSA contended that, in so far as English law might permit APSA to be substituted after the expiry of the time limit, it was inconsistent with Article 11.
By contrast, the claimant contended that provisions of domestic law permitting this substitution would not be inconsistent with Article 11.
In November 2003, at the request of both parties, the High Court made a preliminary reference to the European Court of Justice.
The European Court answered three questions: OByrne v Sanofi Pasteur MSD Ltd (formerly Aventis Pasteur MSD Ltd) (Case C 127/04) [2006] 1 WLR 1606.
One of the questions concerned the point in time at which a product was put into circulation for purposes of Article 11 in a situation where the producer which manufactured it then transferred it to a distribution subsidiary.
I quote and discuss the European Courts ruling on this point at paras 20 23 below.
concerned, the European Court held, [2006] 1 WLR 1606, 1622: So far as the power to substitute one producer for another as defendant was When an action is brought against a company mistakenly considered to be the producer of a product whereas, in reality, it was manufactured by another company, it is as a rule for national law to determine the conditions in accordance with which one party may be substituted for another in the context of such an action.
A national court examining the conditions governing such a substitution must, however, ensure that due regard is had to the personal scope of Directive 85/374, as established by Articles 1 and 3 thereof.
In the light of this answer, Teare J allowed the claimants application for substitution of APSA in place of APSMD, pursuant to section 35(5)(b) and (6)(a) of the Limitation Act 1980 and rule 19.5(3)(a) of the CPR, on the ground that the claimant had named APMSD as the defendant in mistake for APSA: OByrne v Aventis Pasteur MSD Ltd [2007] 1 WLR 757.
APSA appealed, but the Court of Appeal (Sir Anthony Clarke MR, Arden and Moore Bick LJJ) [2008] 1 WLR 1188 dismissed its appeal.
The House of Lords granted APSA leave to appeal.
At the hearing of the appeal a majority of the appellate committee considered that it was clear that the European Court was saying that, in some circumstances, proceedings, which are obviously intended to be proceedings against the producer but which use the wrong name, can properly be treated by national procedural law as having been proceedings against the producer.
The majority considered that this would have been the proper approach in the circumstances in the present case and so they would have dismissed APSAs appeal.
But, because this was not the unanimous view of the appellate committee as to the effect of the judgment of the European Court, the House of Lords referred the case to Luxembourg for a second time: [2008] 4 All ER 881.
The decision on this reference was given by the Grand Chamber: Aventis Pasteur SA v OB (Case C 358/08) (unreported) given 2 December 2009.
The answer returned by the European Court in response to the second reference is not in line with either of the interpretations of its judgment on the first reference which had been advanced before the appellate committee.
Happily, however, this time the core answer could not be clearer: Article 11 of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products must be interpreted as precluding national legislation, which allows the substitution of one defendant for another during proceedings, from being applied in a way which permits a producer, within the meaning of Article 3 of that directive, to be sued, after the expiry of the period prescribed by that article, as defendant in proceedings brought within that period against another person.
Putting the point shortly and subject to the important qualification which I must address in a moment the Court of Justice holds that, once ten years have passed since a producer put a product into circulation, that producer cannot be sued, unless proceedings have been taken against it within the ten year period.
As the Court explains, at para 38 of its judgment, Article 11: provides for a uniform 10 year period after which those rights are extinguished.
It fixes, in a binding manner, the starting point of that period as the date on which the producer put into circulation the product which caused the damage.
It specifies the institution of proceedings against that producer as the only reason for that period to be interrupted.
It follows, as the Court says at para 44, that a rule of national law which allows the substitution of one defendant for another during proceedings cannot, under Directive 85/374, be applied in a way which permits such a producer to be sued, after the expiry of that period, as defendant in proceedings brought within that period against another person.
As it explained in paras 41 43 of its judgment, the Court adopted this approach because, in its view, it gave effect to the balance which the Community legislator had intended to achieve between the interests of consumers and producers: 41.
Pursuant to the 11th recital in the preamble to Directive 85/374, the latter seeks, second, to limit, at Community level, the liability of the producer to a reasonable length of time, having regard to the gradual ageing of products, the increasing strictness of safety standards and the constant progressions in the state of science and technology. 42.
As is stated by the Advocate General in points 49 and 50 of her Opinion, the Community legislatures intention to limit in time the no fault liability established by Directive 85/374 is also intended to take account of the fact that that liability represents, for the producer, a greater burden than under a traditional system of liability, so as not to restrict technical progress and to maintain the possibility of insuring against risks connected with that specific liability (see, to that effect, paragraph 3.2.4 of the Report from the Commission of 31 January 2001 on the Application of Directive 85/374 on Liability for Defective Products, COM (2000) 893 final). 43.
It follows that, without prejudice to the possible application of the rules on contractual or non contractual liability or a special liability system existing at the moment when Directive 85/374 was notified, the application of which is not prejudiced by the latter, as is apparent from Article 13 thereof and the 13th recital in the preamble thereto, the producer, as defined in Article 3 of that directive, is, under Article 11 of that directive, relieved of his liability under that article upon the expiry of a period of 10 years from the putting into circulation of the product in question, unless, in the meantime, proceedings have been instituted against him.
The European Court also went out of its way, at para 48, to emphasise that it made no difference if the failure to sue a particular producer within the relevant ten year period had been due to some mistake on the claimants part.
Even in that event what mattered was that the ten years had expired without that producer having been sued.
So it could not be substituted as defendant after the ten years were up: 48.
It should also be added that subjective elements deriving, for example, from the wrongful attribution, by the injured person, of the status of manufacturer of the allegedly defective product to a company which is not the manufacturer, or from the injured persons genuine intention to proceed against that manufacturer by way of its action against such other company, cannot, without infringing the objective dimension of the harmonisation rules laid down by Directive 85/374, justify the substitution, after the expiry of the 10 year period set out in Article 11 thereof, of that manufacturer in proceedings initiated during that period against another person (see, to that effect, OByrne, paragraph 26 and, by analogy, Case C 51/05 P Commission v Cantina sociale di Dolianova and Others [2008] ECR I 5341, paragraphs 59 to 63).
In these circumstances the claimant now accepts that he cannot use section 35 of the Limitation Act 1980 as a basis for substituting APSA for APMSD as the defendant in the present proceedings.
The claimant submits, however, that, even though he cannot make the substitution on the basis of his mistake, the European Court indicated in its judgment a different basis on which he can actually make the desired substitution.
For this purpose he relies on the second answer which the Court of Justice gave on the second reference: However, first, Article 11 must be interpreted as not precluding a national court from holding that, in the proceedings instituted within the period prescribed by that article against the wholly owned subsidiary of the producer, within the meaning of Article 3(1) of Directive 85/374, that producer can be substituted for that subsidiary if that court finds that the putting into circulation of the product in question was, in fact, determined by that producer.
In short, the claimant submits that the position falls within the terms of this qualification to the European Courts core answer on the effect of Article 11 and so there is nothing to prevent him from substituting APSA for APMSD on this basis.
APSA contends, however, that this passage in the Courts judgment has to be interpreted in the context of the judgment as a whole and in the light of the Opinion of Advocate General Trstenjak, 8 September 2009, unreported, which preceded it.
When that is done, APSA says, it can be seen that the qualification should be given a narrower interpretation, which would not allow substitution in this case.
As will become apparent, in a case like the present, the possibility of substitution depends, to some extent, on various matters of fact concerning the relationship between the two entities.
At the hearing before this Court, however, on the basis of what he now knows about the facts, the claimants counsel, Mr Maskrey QC, accepted that, if the Court were to conclude that APSAs interpretation of the European Courts judgment was correct, then its appeal against its substitution for APMSD should be allowed.
The dispute between the parties turns, therefore, on the interpretation of paras 49 53 of the judgment of the European Court on the second reference: 49.
In light of the foregoing, Article 11 of Directive 85/374 must be interpreted as precluding national legislation which allows the substitution of one defendant for another during proceedings from being applied in a way which permits a producer, within the meaning of Article 3 of that directive, to be sued, after the expiry of the period prescribed by that article, as defendant in proceedings brought within that period against another person. 50.
However, the Court, giving a preliminary ruling on a reference, has jurisdiction, in the light of the information in the case file, to give clarifications to guide the referring court in giving judgment in the main proceedings (see, to that effect, Case C 366/98 Geffroy [2000] ECR I 6579, paragraph 20, and Case C 446/07 Severi [2009] ECR I 0000, paragraph 60). 51.
It should be noted in that regard, first, that it is apparent from the reference for a preliminary ruling that APMSD (formerly Mrieux UK), which in 1992 supplied the vaccine which was administered to OB to the United Kingdom Department of Health, was, at that time, a wholly owned subsidiary of APSA (formerly Pasteur Mrieux). 52.
In such a context, it is for the national court, in accordance with the applicable rules of national law on matters of proof, to assess whether the putting into circulation of the product in question was, in fact, determined by the parent company which manufactured it. 53.
Where the national court notes that fact, Article 11 of Directive 85/374 does not preclude that court from holding that, in the proceedings instigated within the period prescribed by that article against the subsidiary under the system of liability laid down by that directive, the parent company, producer within the meaning of Article 3(1) of that directive, can be substituted for that subsidiary.
Under reference to its reasoning in paras 34 48, in para 49 the European Court gave its core ruling on the construction of Article 11, which I have already discussed.
The Court then went on, in the subsequent paragraphs, to give some additional guidance which it considered might be helpful to any domestic judges who were going to be dealing with this particular case.
There is nothing, however, to suggest that, in these paragraphs, the Court was intending to depart from the principled approach which it had just been at such pains to develop and finally to formulate in para 49.
What the Court says in paras 50 54 must therefore be read in the light of that core decision.
In other words, the Court is explaining how that decision may fall to be applied, depending on the domestic courts assessment of the practical relationship between the manufacturer, APSA, and the distributor, APMSD.
In venturing to give this additional assistance the European Court was following the lead of the Advocate General.
Although the structure of her Opinion makes for repetition, it is clear that she, too, had concluded that only the bringing of proceedings against the particular producer could stop the Article 11 time bar from taking effect ten years after the producer had put the relevant product into circulation.
See, in particular, paras 61 and 69 78 of her Opinion.
So, in reaching its conclusion in para 49 of its judgment, the Court was following this aspect of the Advocate Generals reasoning.
The Advocate General went on to hold, at para 68, that a substitution of the producer as a defendant when he has been released by the expiry of the ten year limitation period is equally incompatible with the Directive.
She gave her reasoning for this conclusion at para 79, where she said that to allow the substitution of a producer against which proceedings had not been taken within the ten year period in place of a producer against which they had been taken would de facto be capable of also interrupting the limitation period in relation to producers.
The upper temporal limit of liability for producers in Article 11 would thereby be broken through, and that is excluded in the light of the complete harmonisation of the field which is the aim of Directive 85/374.
So, when reaching the comparable conclusion at paras 44 47 of its judgment, the European Court was, again, following the Advocate Generals approach.
The Advocate General also gave some thought to how Article 11, thus interpreted, should be applied in a case, like the present, where the parent manufacturing producer (APSA) transferred the Product to a distributor (APMSD) which was its wholly owned subsidiary.
In this connexion the Advocate General referred back to the judgment of the European Court on the first reference: OByrne v Sanofi Pasteur MSD Ltd (formerly Aventis Pasteur MSD Ltd) [2006] 1 WLR 1606.
The first ruling in that judgment, at p 1622, had been in these terms: Article 11 of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products is to be interpreted as meaning that a product is put into circulation when it is taken out of the manufacturing process operated by the producer and enters a marketing process in the form in which it is offered to the public in order to be used or consumed.
This conclusion reflects what the Court says in para 27 of its judgment, which is, in turn, based on its reasoning in the preceding paras 20 26.
Paragraphs 27 32, [2006] 1 WLR 1606, 1620 1621, are of importance in the present context: 27.
In light of those considerations, a product must be considered as having been put into circulation, within the meaning of Article 11 of the Directive, when it leaves the production process operated by the producer and enters a marketing process in the form in which it is offered to the public in order to be used or consumed. 28.
Generally, it is not important in that regard that the product is sold directly by the producer to the user or to the consumer or that that sale is carried out as part of a distribution process involving one or more operators, such as that envisaged in Article 3(3) of the Directive. 29.
When one of the links in the distribution chain is closely connected to the producer, for example, in the case of a wholly owned subsidiary of the latter, it is necessary to establish whether it is a consequence of that link that that entity is in reality involved in the manufacturing process of the product concerned. 30.
The examination of such a close relationship must not be influenced by the question whether or not distinct legal persons are involved.
On the other hand it is of relevance whether those are companies carrying out different production activities or are, on the contrary, companies one of which, ie the subsidiary company, acts simply as a distributor or depository for the product manufactured by the parent company.
It is for the national courts to establish, having regard to the circumstances of each case and the factual situation of the matter before them, whether the links between the producer and another entity are so close that the concept of producer within the meaning of Articles 7 and 11 of the Directive also includes that latter entity and that the transfer of the product from one to the other of those entities does not amount to putting it into circulation within the meaning of those provisions. 31.
In any case, contrary to what is maintained by the defendants, the fact that the products are invoiced to a subsidiary company and that the latter, like any purchaser, pays the price, is not conclusive.
The same applies to the question of knowing which entity is to be considered as owner of the products. 32.
Therefore the reply to the first question must be that Article 11 of the Directive is to be interpreted as meaning that a product is put into circulation when it is taken out of the manufacturing process operated by the producer and enters a marketing process in the form in which it is offered to the public in order to be used or consumed.
As can be seen from para 31 of the European Courts judgment, in the first reference APSA which naturally wanted to push the starting date for the ten year period back as far as possible was arguing that it had put the Product into circulation when it transferred the consignment containing the Product to APMSD in the period of 18 to 22 September 1992.
In support of that argument APSA was pointing to the fact that APMSD had been invoiced for the consignment and had paid for it.
The claimants counsel, who was, of course, contending for as late a date as possible for the Product being put into circulation, was contending that this had not happened until APMSD supplied it to the Department of Health.
The European Court rejected any approach that was based on the formal legal relationship between the parent manufacturing producer and the subsidiary distributor.
In particular, the Court emphasised, at para 30, that the fact that the manufacturer and the distributor were distinct legal entities was irrelevant.
The national court had to look at all the links between the two entities and decide on that basis whether they were so close that, for the purposes of Article 11, the concept of the manufacturing producer (which would apply to APSA) really included the distributor (in this case, APMSD).
In that event, even if the Product were transferred from one to the other, this would not mean that it had been taken out of the manufacturing process operated by the producer.
So, applying the test in para 27 of that judgment, for the purposes of Article 11 the Product would not have been put into circulation by the manufacturing producer when it transferred it to the distributor.
Obviously, the Courts concern was that, unless this were indeed the position, at least in the case of products with a long shelf life, by the time they were eventually put on the market by the distributor, a significant part of the ten year period for proceedings against the manufacturing producer might have elapsed.
This would upset the balance which the Directive sought to maintain between the interests of the consumer and the producer.
In paras 83 90 of her Opinion on the second reference, the Advocate General did indeed make use of this part of the Courts analysis in the first reference when considering how the domestic court might determine the date at which the Product was put into circulation.
But she also used it for the rather different purpose of showing when a distribution subsidiary could be so closely involved with the parent producer that they could, in effect, be regarded as one for the purposes of Article 11.
In that event, suing the subsidiary would be tantamount to suing the parent.
In concrete terms, if that were the position in this case, by suing APMSD within the ten year period, the claimant would also have sued APSA within that period.
So the Article 11 time bar would not bite and the claimant could, if he wished, substitute APSA for APMSD as defendant in the present action or, indeed, simply proceed with his (second) action against APSA.
The Advocate Generals reasoning and conclusions on these matters are to be found in paras 109 113 of her Opinion: 109.
If, by contrast, the national courts were to reach the conclusion in the main proceedings that a supplier such as APMSD was, because of its involvement in the manufacturing process operated by APSA, to be regarded together with APSA as a producer within the meaning of the first half of Article 3(1) of Directive 85/374, the bringing of proceedings in due time against APMSD would indeed have the effect of interrupting the limitation period in relation to APSA. 110.
The decisive point here is the fact that a supplier who is sufficiently closely involved in the manufacturing process operated by the producer is to be classified together with the producer as a producer within the meaning of the first half of Article 3(1) of the directive.
Because those two entities are to be regarded, in the light of the functional interpretation of the concept of producer, as one producer within the meaning of the first half of Article 3(1), the limitation period must also run in the same way for both entities. 111.
In this connection the Court in OByrne, after carefully weighing up the interests of consumers and producers, synchronised the starting point of the 10 year limitation period under Article 11 of Directive 85/374 for the producer stricto sensu and the supplier who forms part of the manufacturing process by reference to the date on which the supplier puts the product into circulation.
In the context of the same balancing of interests, the running of the limitation period must also be uniform. 112.
Since the running of the limitation period under Article 11 of the directive is interrupted only by the bringing of proceedings, a uniform limitation period for the producer and supplier who are to be regarded together as a producer within the meaning of the first half of Article 3(1) presupposes that the bringing of proceedings against the supplier interrupts the running of the 10 year limitation period not only in relation to that supplier but also in relation to the producer in whose manufacturing process the supplier is involved. 113.
Accordingly, my conclusion is that classification to be assessed by the national courts of the supplier of a product as its producer has the consequence that that supplier is liable under Article 1 of the directive for the damage caused by a defect in the product, regardless of whether he is classified as a producer within the meaning of Article 3(1) or a producer within the meaning of Article 3(3) of the directive.
Classification of a supplier as a producer within the meaning of the first half of Article 3(1) of the directive has the further consequence that the 10 year limitation period for the producer in whose manufacturing process the supplier is involved does not start to run until the time when the supplier puts the product into circulation.
At the same time, proceedings brought against that supplier will in that case interrupt the running of the limitation period under Article 11 of the directive in relation also to the producer in whose manufacturing process the supplier is involved.
In the summary which she gives in para 115, the Advocate General repeats the conclusion which she reaches in para 113.
Two points stand out.
First, the Advocate Generals conclusion in paras 113 and 115 involves no departure from the principle that the Article 11 time bar can only be interrupted by bringing proceedings against the producer concerned.
Secondly, when she contemplates the domestic court classifying a supplier as a producer within the meaning of Article 3(1), she contemplates the domestic court applying the approach of the European Court in its judgment on the first reference: OByrne v Sanofi Pasteur MSD Ltd (formerly Aventis Pasteur MSD Ltd) [2006] 1 WLR 1606.
And as the Advocate General recalls at paras 111 and 113 according to that judgment, where the supplier forms part of the manufacturing process, the starting point of the ten year limitation period under Article 11 is fixed by reference to the date on which the supplier puts the product into circulation.
Indeed, in the proceedings on the first reference, the claimant fought successfully to establish exactly that point.
With this background in mind, it is appropriate to return to paras 51 and 52 of the European Courts judgment on the second reference: 51.
It should be noted in that regard, first, that it is apparent from the reference for a preliminary ruling that APMSD (formerly Mrieux UK), which in 1992 supplied the vaccine which was administered to OB to the United Kingdom Department of Health, was, at that time, a wholly owned subsidiary of APSA (formerly Pasteur Mrieux). 52.
In such a context, it is for the national court, in accordance with the applicable rules of national law on matters of proof, to assess whether the putting into circulation of the product in question was, in fact, determined by the parent company which manufactured it.
It is correct to say that, unlike the Advocate General, the European Court does not actually refer to its answer to the first question on the first reference.
But there is nothing whatever to suggest that it intended to depart in any way from that analysis.
The assumption must therefore be that it falls to be applied where appropriate.
Certainly, the Court supplies no alternative or additional theoretical analysis which could displace or supplement it.
The European Court is concerned to show how the principle which it has just laid down would apply in relation to the substitution of APSA for APMSD.
Certainly, to judge by the Advocate Generals analysis and there is no rival the only way in which that principle could be maintained and yet APSA could be substituted for APMSD, would be if, by suing APMSD, the claimant had, in effect, sued APSA.
So the Court must be pointing the domestic court to the way in which it should approach that issue.
Mr Maskrey argued, however, that the position was really much simpler.
As the European Court noted, at para 51, APMSD was a wholly owned subsidiary of APSA.
Secondly, APSA had determined that the Product should be put into circulation by transferring it to its wholly owned subsidiary, APMSD, and it had then in fact transferred the product to the subsidiary.
So the requirements of paras 51 and 52 were fulfilled and the substitution could be made.
I would reject that argument.
As counsel freely admitted, this argument runs completely counter to the one which the claimant advanced on the first reference.
That is, of course, merely a forensic point.
More significantly, the argument is internally incoherent as well as being inconsistent with the reasoning of the Court of Justice.
If, as counsel now contends, APSA put the Product into circulation when it supplied it to APMSD, then, consistently with the Courts ruling on the first reference, this can only be because the two companies are to be regarded as having operated quite distinctly so that the Product was taken out of the manufacturing process operated by APSA when it was transferred to APMSD.
But the fact that APMSD was a wholly owned subsidiary of APSA, which the Court began by noting in para 51, could not be a pointer towards that conclusion.
If anything, it would point against it.
So, on this interpretation, the European Court could have had no reason to draw attention to the status of APMSD.
Yet it did.
Mr Maskrey criticised APSAs interpretation of para 52 on the specific ground that it involved reading in three words: whether the putting into circulation of the product in question by the supplier, was, in fact, determined by the parent company which manufactured it.
Mr Leggatt QC accepted that this was, in effect, how he contended that the sentence should be interpreted.
In my view, that is indeed the correct interpretation.
The European Courts reference to APMSD being a wholly owned subsidiary of APSA is only consistent with it directing attention to factors which may point to a close connexion between the two companies.
Given the context of the discussion (seeing whether proceedings against APMSD count as proceedings against APSA), that is precisely what we would expect.
For the reasons already given, we should also expect the focus to be on the time when the Product was supplied by APMSD to the Department of Health, since, if APMSD was, in effect, tied into the manufacturing process of APSA, the Product would only be put into circulation when it was supplied by APMSD.
And that is what we find in para 51 where the European Court refers to APMSDs status as a wholly owned subsidiary at the time when it supplied the Product to the Department of Health.
Therefore, in para 52 the Court must indeed be referring to the Product being put into circulation by the supplier at the behest of its parent.
That interpretation is also consistent, of course, with what the Advocate General says in paras 111 and 113 of her Opinion on the second reference (quoted at para 24 above).
This interpretation of para 52 is also consistent with its language, both in the English version and in the original French (si la mise en circulation du produit concern a t dtermine en fait par la socit mre qui la fabriqu).
The European Court is plainly contemplating a situation where, to all outward appearances, a supplier has decided to put a product into circulation.
The domestic court must look at the circumstances to see whether, despite appearances, in fact, it was the manufacturing parent company which had determined that the product should be put into circulation.
If, by contrast, the European Court had meant what Mr Maskrey suggested, it would have had no reason to use this language: all it would have required to say was that the national court was to assess whether the parent company, which manufactured the product, transferred it to its wholly owned subsidiary, the distributor.
The further difficulty with that interpretation is, of course, that everyone agrees that APSA sent the consignment containing the Product to APMSD on 18 September and that APMSD received it on 22 September.
There would therefore be nothing for the domestic court to assess.
The European Court was therefore indicating, in para 52, that the domestic court was to consider, in accordance with domestic rules of proof, whether the manufacturer, APSA, was in fact controlling APMSD and determining when it put the Product into circulation.
There is nothing in the judgment of the European Court on either reference to suggest that the fact that APMSD was a wholly owned subsidiary of APSA could somehow, of itself, be a reason for allowing APSA to be substituted after the expiry of the ten year period.
Indeed, that would be inconsistent with the two companies being distinct entities.
Rather, the fact that APMSD was a wholly owned subsidiary was simply one by no means decisive factor to be taken into account by the domestic court when assessing how closely the subsidiary was involved with its parents business as an Article 3(1) producer.
All the circumstances would have to be taken into account.
If APSA was indeed in a position to decide when the Product was to be distributed, then APMSD would be integrated into the manufacturing process and so tightly controlled by APSA that proceedings against APMSD could properly be regarded as proceedings against the parent company, APSA.
Hence, as the European Court goes on to hold in para 53, the manufacturing parent company could be substituted for the subsidiary APSA for APMSD.
Mr Maskrey submitted that, if the European Courts judgment were interpreted in this way, then it would allow substitution of the parent producer only where the supplier could, in any event, itself be sued as a producer falling within the definition in Article 3(1).
But that is, of course, precisely what the Advocate General does say in paras 113 and 115 of her Opinion.
Moreover, the criticism seems a little ungenerous.
It is, after all, the claimant who, for what must presumably appear to him to be good reasons, wishes to substitute APSA for APMSD as the defendant.
The Advocate General and the Court are merely responding to that situation by pointing to circumstances where it might indeed be possible for the claimant to do so.
It is, of course, the case that, in any such circumstances, the claimant will also be able to sue the supplier as a producer within the terms of Article 3(1).
But that is not a criticism of the approach taken by the Advocate General or the Court.
If a claimant will gain nothing by suing the manufacturer in substitution for the supplier, he will presumably not try to do so.
But such a course might have advantages if, say, the supplier were insolvent.
The Advocate General and the European Court were entitled to assume that, in this case, the claimant had what he regarded as good reasons for wishing to make the substitution.
For these reasons, I would allow the appeal and set aside paragraph 1 of the order of Teare J dated 20 October 2006 substituting Aventis Pasteur SA for Aventis Pasteur MSD in the present action, HQ02X00848.

Output:
The Respondent was vaccinated on 3 November 1992 with a vaccine (the Product) manufactured in France by a French company, now known as Aventis Pasteur SA (APSA).
On 18 September 1992 APSA sent a consignment of the vaccine, including the Product, to its then wholly owned subsidiary, Aventis Pasteur MSD Ltd (APMSD), in England.
APMSD acted as a United Kingdom distributor for APSAs products.
APMSD received the consignment on 22 September 1992 and sold part of it, including the Product, on an unknown date.
The Product was eventually used to vaccinate the Respondent.
On 1 August 2001 the Respondent began proceedings under section 2 of the Consumer Protection Act 1987 (CPA) against APMSD, alleging that the Product was defective and had caused him brain damage.
On 16 October 2002 the Respondent issued separate proceedings against APSA also under section 2 of the CPA.
Relying on section 11(3) of the Limitation Act 1980 (the LA) and Article 11 of Council Directive 85/374/EEC of 25 July 1985 (the Directive), APSA defended this action on the basis that it had been raised more than ten years after APSA had put the Product into circulation, which APSA alleged was 22 September 1992 at the latest.
Broadly, Article 11 provides that there is a ten year time limit for initiating proceedings against the producer (as defined in the Directive) of a product.
Faced with this defence, the Respondent sought an order that APSA be substituted as a defendant in place of APMSD in the proceedings against APMSD, relying on section 35(5)(b) and (6)(a) of the LA.
These provisions allow a new party to be substituted for a party whose name was given in any claim made in the original action in mistake.
APSA contended that, in so far as English law permitted such substitution after the expiry of the time limit, it was inconsistent with Article 11.
The High Court made a preliminary reference to the European Court of Justice (ECJ).
So far as the power to substitute one producer for another as defendant was concerned, the House of Lords (to which the case eventually came) could not reach a unanimous view as to the effect of the ECJs judgment.
The House of Lords therefore referred the question back to the ECJ.
The answer returned by the ECJ is now clear: once ten years have passed since a producer put a product into circulation, that producer cannot be sued unless proceedings have been taken against it within the ten year period.
The Respondent now accepts that he cannot use section 35 of the LA as a basis for substituting APSA for APMSD as the defendant in the present proceedings.
The Respondent submits, however, that in its judgment the ECJ indicated a different basis on which he can actually make the desired substitution, namely, that in proceedings instituted within the ten year period against the wholly owned subsidiary of the producer, that producer can be substituted for that subsidiary if the domestic court finds that the putting into circulation of the product in question was,
in fact, determined by that producer.
The dispute between the parties therefore turns on the interpretation of that part of the ECJs judgment.
The Supreme Court unanimously allowed the appeal and set aside paragraph 1 of the order of Teare J dated 20 October 2006 substituting APSA for APMSD in the present action.
Lord Rodger gave the judgment of the Court.
There is nothing to suggest that, when providing the additional guidance which is the subject of the dispute in the present case, the ECJ was intending to depart from the principled approach which it had formulated earlier in its judgment, namely, that Article 11 precluded national legislation being applied in a way which permitted a producer to be sued after the expiry of the ten year limitation period as defendant in proceedings brought within that period against another person (para 17).
In venturing to give the additional guidance, the ECJ was following the lead of the Advocate General.
The Advocate General had given some thought to how Article 11 should be applied in a case like the present, where APSA transferred the Product to a distributor, APMSD, which was its wholly owned subsidiary.
In doing so, the Advocate General had referred back to the ECJs judgment on the first reference where the ECJ had held that a product is put into circulation when it is taken out of the manufacturing process operated by the producer and enters a marketing process in the form in which it is offered to the public in order to be used or consumed (paras 18 20).
The ECJ, in its judgment following the first reference, had rejected an approach that was based on the formal legal relationship between the parent manufacturing producer and the subsidiary distributor.
The national court had to look at all the links between the two entities and decide on that basis whether they were so close that, for the purposes of Article 11, the concept of the manufacturing producer (which would apply to APSA) really included the distributor (in this case, APMSD).
In that event, even if the Product were transferred from one to the other, this would not mean that it had been taken out of the manufacturing process operated by the producer (para 22).
The Advocate General made use of that part of the ECJs analysis from the first reference to show when a distribution subsidiary could be so closely involved with the parent producer that they could, in effect, be regarded as one for the purposes of Article 11 (so that suing the subsidiary would be tantamount to suing the parent).
In concrete terms, if that were the position in this case, by suing APMSD within the ten year period, the Respondent would also have sued APSA within that period.
So the Article 11 time bar would not bite and the Respondent could, if he wished, substitute APSA for APMSD as defendant in the present action (para 23).
It is with this background in mind that the ECJ gave its additional guidance in the second reference.
There is nothing to suggest that, in giving that guidance, it was intending to depart in any way from the analysis in its first reference (para 27).
Certainly, to judge from the Advocate Generals analysis, the only way in which the principle that had just been laid down in relation to the substitution of APSA for APMSD could be maintained and yet APSA could be substituted for APMSD would be if, by suing APMSD, the Respondent had in effect sued APSA (para 28).
The ECJ was therefore indicating, in giving its guidance, that the domestic court was to consider, in accordance with domestic rules of proof, whether the manufacturer, APSA, was in fact controlling APMSD and determining when it put the Product into circulation.
The fact that APSA was a wholly owned subsidiary was simply one by no means decisive factor to be taken into
account by the domestic court when assessing how closely the subsidiary was involved with its parents business as a producer.
All the circumstances would have to be taken into account.
If APSA was indeed in a position to decide when the Product was distributed, then APMSD would be integrated into the manufacturing process and would be so tightly controlled by APSA that proceedings against APMSD could properly be regarded as proceedings against the parent company, APSA.
Hence, the manufacturing company could be substituted for the subsidiary (para 34).


Input:
The issue in this case is the proper approach of the immigration appellate authorities where the Secretary of State has decided that a national of the European Economic Area who is lawfully living in the United Kingdom should be removed on the ground of abuse of the right to reside here.
The abuse in question happened to be an alleged attempt to enter into a marriage of convenience but the issue would arise in respect of any abuse which would justify removal under article 35 of Directive 2004/38/EC on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States (the Directive).
The facts
Ms Sadovska is a citizen of Lithuania.
She came to this country lawfully in February 2007 and has since been living and working here lawfully, exercising her rights under the Directive.
She lives in Edinburgh, where her sisters also live, and works as a cleaner.
Mr Malik is a citizen of Pakistan who came to this country lawfully with a Tier 4 student visa in May 2011.
His visa expired on 15 April 2013 and he has been here unlawfully ever since.
He too lives and worked in Edinburgh until 17 April 2014.
They say that they met at a disco, El Barrio in Edinburgh, in October 2012.
They spent that night together and saw one another from time to time afterwards, meeting members of one anothers families, but the relationship did not become a steady one until Valentines Day 2013.
Thereafter, they say, they saw one another as boyfriend and girlfriend.
It is common ground (and there is photographic evidence) that in December 2013, Mr Malik attended the wedding of Ms Sadovskas sister and that they were on the streets of Edinburgh together during the celebrations at Hogmanay 2013.
It is also common ground that Mr Malik booked a double room for two adults at a London hotel for four nights in January 2014 and that they were both in London at that time.
They say that they were on holiday together and that was when they decided to get married.
On 25 March 2014, they published notice of their intention to marry on 17 April 2014 at Leith Registry Office.
On 28 March 2014, they signed a one page statement about their relationship which included the following puzzling sentence: We have discussed the idea of living together in depth and also have touched upon the subject of marriage, but as of yet, none of these discussions have manifested into action.
That statement was enclosed in a letter dated 11 April 2014, sent by solicitors acting for Mr Malik (and, it would appear, also for Ms Sadovska) to the Home Office in Glasgow.
This explained that their client was an over stayer, but that he intended to marry an EEA national on 17 April 2014 and would be applying for recognition that he was exercising Treaty rights as a family member of an EEA national, so it was hoped that no enforcement action would be taken against him.
The letter recognised that officials might wish to interview their clients but hoped that this could be done before their wedding on 17 April.
It also stated that: We would like you to take this letter as a human rights allegation that both the applicant and the EEA national have established a family life in the United Kingdom and any decision to attempt to remove the applicant from the United Kingdom would be challenged on article 8 grounds and also on the grounds that the applicant [sci: attempt?] breaches our clients right to marry under article 12 of the ECHR.
Enclosed were copies of Mr Maliks passport, of Ms Sadovskas identity card, birth certificate and most recent payslip, a receipt from the Property Management Company in respect of a flat in Edinburgh for which they had signed a lease on 6 April 2014, three statements from two people who knew them, and their statement of 28 March.
Mr Malik and Ms Sadovska had indeed signed a lease for a flat in Edinburgh on 6 April 2014 and each gave this as their home address when interviewed on 17 April. (We are told that they still live together but at a different address.) On 16 April 2016 they bought wedding rings.
The solicitors letter was faxed to the Home Office on Friday 11 April.
The wedding was due to take place on the afternoon of the following Thursday.
Before that could happen, however, immigration officers arrived at the Registrars Office and asked to interview them.
They agreed.
Each was cautioned and agreed to be interviewed in English.
They were interviewed separately, Mr Malik from 14.55 to 16.20 and Ms Sadovska from 14.54 to 16.50, according to the immigration officers records.
After the interviews they were detained and thus unable to marry.
Ms Sadovska was released soon afterwards, but Mr Malik was detained until 11 June.
On the same day as the interviews, each was issued with a two part decision notice.
Mr Malik was issued with a notice that he was a person liable to removal as an over stayer, who had not applied for further leave to remain after his visa had expired and was thus liable to be detained pending a decision whether or not to give directions for his removal from the United Kingdom.
The notice explained that he had breached section 10(1)(a) of the Immigration and Asylum Act 1999, which provides that a person who is not a British citizen may be removed from the United Kingdom, in accordance with directions given by an immigration officer, if (a) having only a limited leave to enter or remain, he . remains beyond the time limited by the leave, and had therefore committed an offence under section 24(1)(b)(i) of the Immigration Act 1971.
Ms Sadovska was issued with a notice that she was a person liable to removal because her removal was justified on grounds of abuse of rights, specifically that she had attempted to enter into a marriage of convenience with Mr Malik.
The notice referred to regulation 19(3)(c), without explaining that this was contained in the Immigration (European Economic Area) Regulations 2006.
At the time, this provided that an EEA national who has entered the United Kingdom . may be removed if (c) the Secretary of State has decided that the persons removal is justified on grounds of abuse of rights in accordance with regulation 21B(2).
Regulation 21B(1) provided that The abuse of a right to reside includes (c) entering, attempting to enter or assisting another person to enter or attempt to enter, a marriage or civil partnership of convenience.
Regulation 21B(2) provided that The Secretary of State may take an EEA decision on the grounds of abuse of rights where there are reasonable grounds to suspect the abuse of a right to reside and it is proportionate to do so.
Regulation 24(2) provided that where a decision to remove was taken under regulation 19(3)(c), the person was to be treated as someone to whom section 10(1)(a) of the 1999 Act applied.
In each case, the notice was accompanied with notice of a decision to remove.
Both appealed to the First tier Tribunal which heard their appeals together on 4 August 2014 and promulgated a determination refusing them both on 19 August 2014.
Their appeals to the Upper Tribunal were heard on 5 February 2015 and a determination refusing them was promulgated on 9 February 2015.
Their appeals to the First Division of the Inner House of the Court of Session were refused on 17 June 2016: [2016] CSIH 51.
They now appeal to this court.
They make two complaints about the decisions of the tribunals and court below.
The first, and most important, relates to the burden of proof in a case such as this.
Under the heading Applicable law, the First tier Tribunal judge said this, at para 7: In immigration appeals, the burden of proof is on the appellant and the standard of proof required is a balance of probabilities.
In human rights appeals, it is for the appellant to show that there has been an interference with his or her human rights.
If that is established, and the relevant article permits, it is then for the respondent to establish that the interference was justified.
The appropriate standard of proof is whether there are substantial grounds for believing the evidence.
It is apparent from his determination that his whole approach was to require Ms Sadovska and Mr Malik to prove that their proposed marriage was not a marriage of convenience, rather than to require the Home Office to prove that it was.
Before the Upper Tribunal the appellants complaint was that the First tier Tribunal judge had taken the interviews as his starting point and given too much weight to the inconsistencies between them and had not considered them in the context of the totality of the evidence, as required by the decision of the Upper Tribunal in Papajorgji v Entry Clearance Officer, Nicosia [2012] UKUT 38, [2012] Imm AR 3 (at para 39).
Papajorgji was an extraordinary case in which an Albanian woman who had been married to and living with a Greek man for 12 years and had two children with him was refused a visa to accompany him on a visit to this country on the ground that theirs was a marriage of convenience, a belief which, as the Upper Tribunal said, was on the information supplied with the application simply ludicrous (para 32).
There was no burden on the claimant in an application for a family permit to establish that she was not party to a marriage of convenience unless the circumstances known to the decision maker gave reasonable ground for suspecting that that was the case.
Where there was such a suspicion the matter required further investigation and the claimant should be invited to respond to by producing evidential material to dispel it (para 27).
But suspicion was not enough.
The claimant was only disqualified if it was established that the marriage was one of convenience (para 37).
The question for the judge was in the light of the totality of the information before me, including the assessment of the claimants answers and any information provided, am I satisfied that it is more probable than not this is a marriage of convenience? (para 39)
Before the First Division, the appellants did complain that the tribunal had adopted the wrong approach to the burden of proof and that the respondent had failed to prove to the requisite high degree that the appellants were guilty of fraud.
The court dealt with the matter in this way, at para 20: However, as has often been said, once the evidence has been heard, questions of onus usually cease to be important (Sanderson v McManus 1997 SC (HL) 55, Lord Hope at 62).
The view of the UT in Papajorgji (at para 39) that the question, in the Tribunal context, was whether it is more probable than not that the marriage is one of convenience in [the] light of the totality of the information, accords with that dictum.
The court went on to say that the First tier Tribunal had considered all the information and reached a decision based upon it.
That decision did not depend upon onus but upon weighing the various factors in the balance.
In that context, there was only one standard of proof, that being the balance of probabilities (Scottish Ministers v Stirton 2014 SC 218, the Lord Justice Clerk (Lord Carloway) at paras 117 119).
It is perhaps worth noting that Lord Hopes observation in Sanderson v McManus, that questions of onus usually cease to be important once the evidence is before the court was in the context of a dispute between unmarried parents about a fathers contact with his child, when, as Lord Hope observed the matter then becomes one of overall impression, balancing one consideration against another and having regard always to the consideration which has been stated to be paramount (that is, the welfare of the child).
Even then, the court had to be able to come to the conclusion that making an order would be in the childs best interests.
This demonstrates that, when considering the burden of proof, it is necessary to understand what the issues are and what has to be established.
The appellants also complain that their interviews were unfair, oppressive and repugnant to public law standards.
The circumstances of being approached on their wedding day by uniformed immigration officers carrying batons and handcuffs meant that they were frightened.
They agreed to be interviewed in English but neither is fluent in English.
They had no time to contact their solicitor for advice, to obtain an interpreter, to produce evidence and contact witnesses.
They complain that both the First tier and the Upper Tribunal had thought the interviews were of central importance, yet they gave no weight to the circumstances in which they had taken place.
The law
It is of central importance in this case to consider the substantive law governing the respondents decisions and what had therefore to be established in each case.
It differs significantly as between the two appellants.
Ms Sadovska is an EEA national.
Her rights are therefore governed by the Directive, which the 2006 Regulations were designed to implement in UK law.
To the extent, if any, that the 2006 Regulations do not accurately transpose the requirements of the Directive, we have to give effect to the Directive rather than the Regulations and so it is appropriate to focus on the provisions of the Directive.
She has been living lawfully in the United Kingdom for a continuous period of more than five years.
This means that, under article 16 of the Directive, she has the right of permanent residence here.
None of the conditions attached to the right of residence of people who have been here for more than three months but less than five years, provided for in article 8 of the Directive, applies.
Article 28.2 lays down the general rule that a host member state may not take an expulsion decision against a Union citizen who has the right of permanent residence except on serious grounds of public policy or public security.
However, Recital 28 to the Directive states that: To guard against abuse of rights or fraud, notably marriages of convenience or any other form of relationships contracted for the sole purpose of enjoying the right of free movement and residence, member states should have the possibility to adopt the necessary measures.
This is therefore provided for in article 35, which is the crucial article in this case: Member states may adopt the necessary measures to refuse, terminate or withdraw any right conferred by this Directive in the case of abuse of rights or fraud, such as marriages of convenience.
Any such measure shall be proportionate and subject to the procedural safeguards provided for in articles 30 and 31.
Article 30 requires that the person concerned be notified in writing of the decision and informed precisely and in full of the reason for it and where and within what time that person may lodge an appeal.
Article 31 requires that the person have access to judicial and, where appropriate, administrative redress procedures to appeal against or seek review of any decision taken against them.
These shall allow for an examination of the legality of the decision, as well as of the facts and circumstances on which [it] is based.
They shall ensure that the decision is not
disproportionate
A Communication from the Commission to the European Parliament and the Council on guidance for the better transposition and application of Directive 2004/38/EC, dated 2 July 2009, has this to say about marriages of convenience, at para 4.2: Recital 28 defines marriages of convenience for the purposes of the Directive as marriages contracted for the sole purpose of enjoying the right of free movement and residence under the Directive that someone would not have otherwise.
A marriage cannot be considered as a marriage of convenience simply because it brings an immigration advantage, or indeed any other advantage.
The quality of the relationship is immaterial to the application of Article 35.
The definition in the first sentence is repeated in the Commissions more recent Handbook on addressing the issues of alleged marriages of convenience between EU citizens and non EU nationals in the context of EU law on free movement of EU citizens, dated 26 September 2014.
However, this goes on to explain that: the notion of sole purpose should not be interpreted literally (as being the unique or exclusive purpose) but rather as meaning that the objective to obtain the right of entry and residence must be the predominant purpose of the abusive conduct.
But it repeats that: On the other hand, a marriage cannot be considered as a marriage of convenience simply because it brings an immigration advantage, or indeed any other advantage (for example the right to a particular surname, location related allowances, tax advantages or entitlement to social housing for married couples).
Mr Malik is in a different position from Ms Sadovska.
As an over stayer he is, as noted above, liable to be removed under section 10(1)(a) of the 1999 Act.
However, had he succeeded in marrying Ms Sadovska, he would have become a family member within the meaning of article 2.2 of the Directive.
Under article 7.2, this would bring with it the right of residence for more than three months, provided that Ms Sadovska satisfied one of the conditions in article 7.1(a), (b) or (c).
As a worker she would satisfy condition (a).
Once he had been living here lawfully for five years, he too would acquire a right of permanent residence under article 16.2.
As with Ms Sadovska, of course, he would be liable to removal under article 35 if their marriage was one of convenience.
As they have not succeeded in marrying, Mr Malik is not a family member of an EU citizen.
However, article 3.2 requires Member States to facilitate the entry and residence of certain other persons, who include (b) the partner with whom the Union citizen has a durable relationship, duly attested.
Article 3.2 also requires that The host member state shall undertake an extensive examination of the personal circumstances and shall justify any denial of entry or residence to these people.
Finally, of course, both Ms Sadovska and Mr Malik have rights under the European Convention on Human Rights.
Article 8.1 guarantees the right to respect for private and family life, although under article 8.2 interference is justified if it is in accordance with the law and necessary in a democratic society to achieve a legitimate aim.
Article 12 guarantees the right of men and women of marriageable age to marry and to found a family, according to the national laws governing the exercise of [the] right.
Analysis
It is clear from the provisions of the Directive quoted above that Ms Sadovska has a right of permanent residence in the United Kingdom.
As an EU citizen, under article 27.1, her freedom of movement can only be restricted on grounds of public policy, public security or public health.
As a permanent resident, under article 28 she could only be removed if those grounds are serious.
It is not suggested that she can be removed under article 28 on any of those grounds.
She can therefore only be removed, under article 35, if it is established that she has entered, or attempted to enter, into a marriage of convenience.
Furthermore, although the Regulations permit the respondent to take steps on the basis of reasonable grounds to suspect that that is the case, Ms Sadovska is entitled to an appeal where the facts and circumstances must be fully investigated.
That must mean, as held in Papajorgji, that the tribunal has to form its own view of the facts from the evidence presented.
The respondent is seeking to take away established rights.
One of the most basic rules of litigation is that he who asserts must prove.
It was not for Ms Sadovska to establish that the relationship was a genuine and lasting one.
It was for the respondent to establish that it was indeed a marriage of convenience.
For this purpose, marriage of convenience is a term of article Although it is defined in the Directive and the 2009 Communication as a marriage the sole purpose of which is to gain rights of entry to and residence in the European Union, the 2014 Handbook suggests a more flexible approach, in which this must be the predominant purpose.
It is not enough that the marriage may bring incidental immigration and other benefits if this is not its predominant purpose.
Furthermore, except in cases of deceit by the non EU national, this must be the purpose of them both.
Clearly, a non EU national may be guilty of abuse when the EU national is not, because she believes that it is a genuine relationship.
In the case of a person exercising EU law rights, the tribunal must also be satisfied that the removal would be a proportionate response to the abuse of rights established.
So it would be one thing to find that the proposed marriage had been shown to be one of convenience, and therefore that it was right to prevent it, but quite another thing to find that expelling Ms Sadovska from the country where she had lived and worked for so long and had other family members living was a proportionate response to that.
The First tier Tribunal did not analyse her rights in this way.
It was quite simply incorrect to deploy the statement that in immigration appeals the burden of proof is on the appellant, correct though it is in the generality of non EU cases, in her case.
She had established rights and it was for the respondent to prove that the quite narrow grounds existed for taking them away.
Nor did the determination address the issue of proportionality.
It is impossible for this court to conclude that, had the matter been approached in the right way, the decision would inevitably have been the same.
The position of Mr Malik is different, for he has no established rights, either in EU law or in non EU immigration law.
In order to benefit from the Directive, he would have to show that he has a durable relationship with Ms Sadovska.
However, article 3.2 requires the respondent to justify any refusal of entry or residence in such cases.
So if he can produce evidence of a durable relationship (a term which is not defined in the Directive), it would be for the respondent to show that it was not or that there were other good reasons to deny him entry.
It is not impossible that a tribunal, properly directing itself, would reach different conclusions in the case of these two appellants.
But it is impossible for this court to conclude that, had the matter been approached in the right way, the decision relating to Mr Malik would inevitably have been the same.
It follows that the appeal must be allowed and the case remitted for a full re hearing by the First tier Tribunal.
In seeking to establish its case, the respondent will no doubt concentrate on the interviews, the discrepancies between the appellants accounts, and the gaps in Ms Sadovskas knowledge of Mr Maliks family, together with the sentence in their statement of 28 March that their thoughts of living together and marriage had not yet manifested into action (which on 28 March was strictly true in that they were not yet living together or married but they had given notice of intention to marry).
But in considering those discrepancies, the circumstances in which the interviews took place and the statement was made must be borne fully in mind.
Furthermore, there were many matters on which their accounts were consistent.
It turns out, for example, that Ms Sadovskas mother does indeed live in Lithuania, as Mr Malik said in explaining why she was not there.
There is also a considerable body of evidence which supports their claim to have been in a genuine relationship, dating back some time before they gave notice of intention to marry.
Should the tribunal conclude that Mr Malik was delighted to find an EU national with whom he could form a relationship and who was willing to marry him, that does not necessarily mean that their marriage was a marriage of convenience, still less that Ms Sadovska was abusing her rights in entering into it.
Their legal and their factual cases must be considered separately.
Having reached the firm conclusion that the case must be remitted to the First tier Tribunal to be heard afresh, because a wrong approach was taken to the requirements of EU law in this case, it is unnecessary to consider whether the appellants Convention rights add anything further to their claims.
But for my part I would not accept their argument that, because their marriage was frustrated by the respondents actions, their case should be approached as if they were married, which would, of course, enhance Mr Maliks claims.
It must be permissible for the state to take steps to prevent sham marriages, although it is also incumbent on the state to show that the marriage would indeed be a sham.

Output:
An EU citizen with a permanent right of residence in a host member state may have that right removed in the case of abuse of rights or fraud, such as marriages of convenience.
The issue in this appeal is which party bears the burden of proof of establishing that a proposed marriage is one of convenience.
Ms Sadovska is a citizen of Lithuania.
She moved to the United Kingdom in 2007 and has lived and worked here lawfully since, acquiring a right of permanent residence as an EU citizen pursuant to Directive 2004/38/EC (the Directive).
Mr Malik is a citizen of Pakistan who entered the UK with a student visa in May 2011 and has remained here unlawfully after his visas expiry in April 2013, in breach of section 10(1)(a) Immigration and Asylum Act 1999.
Ms Sadovska and Mr Malik (the appellants) maintain that they have been in a relationship with each other since February 2013, and decided to marry in January 2014.
On 11 April 2014, the appellants solicitors notified the Home Office in Glasgow that they intended to marry on 17 April 2014 at Leith Registry Office and invited officials to interview them before the wedding.
Immigration officers arrived at the Registrars Office, interviewed the appellants separately, and then detained them before they were able to marry.
Both were then served with notice that they were persons liable to removal from the UK: Mr Malik by having stayed after the expiry of his visa and Ms Sadovska by giving the Secretary of State reasonable grounds to suspect the abuse of her EU right of residence by attempting to enter into a marriage of convenience, contrary to regulation 19(3)(c) Immigration (European Economic Area) Regulations 2006.
The appellants appealed to the First tier Tribunal.
The judge held that the burden of proof was on the appellants to establish that their proposed marriage was not a marriage of convenience, and that they had failed to do this, having regard to the inconsistencies in their accounts at interview.
The appellants appealed unsuccessfully to the Upper Tribunal and to the First Division of the Inner House, arguing that the tribunal had adopted the wrong approach to the burden of proof, and that the Secretary of State had failed to prove that the appellants were guilty of fraud, when the totality of the evidence relating to their relationship and the circumstances in which the interviews had taken place was taken into account.
The Supreme Court unanimously allows the appeal and remits the case for a full re hearing by the First tier Tribunal.
Lady Hale gives the only substantive judgment.
It was important to identify the different rights the appellants individually enjoyed, and thus what the Secretary of State needed to establish in order to remove them: Ms Sadovska had a right of permanent residence in the UK and could not be expelled unless she had abused her rights within the meaning of article 35 of the Directive.
A Communication in 2014 from the European Commission giving guidance on the Directive explained that a marriage of convenience was a marriage contracted with the predominant purpose of enjoying the right of free movement.
It was not enough that the marriage might bring incidental immigration and other benefits, and the predominant purpose must be the purpose of both parties [21 24, 29].
Mr Malik was liable to be removed as an over stayer.
Had he succeeded in marrying Ms Sadovska he would have acquired a right of residence in the UK under the Directive as a family member of an EU national working here.
The Directive also required member states to facilitate the entry and residence of the partner of an EU citizen if it was a durable relationship, duly attested [25 26].
Both appellants enjoyed rights under articles 8 and 12 of the European Convention on Human Rights to a private and family life, and to marry and found a family [27].
The 2006 Regulations permitted the Secretary of State to take steps to remove Ms Sadovska on the basis of reasonable grounds to suspect that she had entered or attempted to enter a marriage of convenience, but she was entitled to an appeal where the facts and circumstances were fully investigated.
The tribunal had to form its own view of the facts from the evidence presented.
It was not for her to establish that her relationship with Mr Malik was a genuine and lasting one, but for the Secretary of State to establish that it fell within the definition of a marriage of convenience [28].
The tribunal had also to be satisfied that the removal of Ms Sadovska from the country where she had lived and worked for so long with other family members would be a proportionate response to the abuse of rights, rather than merely the prevention of the marriage [30].
As the tribunal had not analysed Ms Sadovskas rights this way, it was not possible for the Supreme Court to conclude that the Secretary of State had proved that the narrow grounds for taking away her established rights existed [31].
Mr Malik had no established rights but if he could produce evidence of a durable relationship with Ms Sadovska, it would be for the Secretary of State to show that it was not, or that there were other good reasons to deny him entry.
Again, the Supreme Court could not conclude that, had his case been approached in the right way, the outcome would have inevitably been the same [32 33].
Accordingly, the burden of proof of establishing that the proposed marriage is one of convenience falls on the Secretary of State.
The appeal is allowed and the case remitted for a full rehearing by the First tier Tribunal, at which the inconsistencies in the appellants interviews will be considered along with their evidence supportive of a genuine relationship dating back several months, and the circumstances in which the interviews took place will also be taken into account [34].
The appellants ECHR rights did not add anything further to their claims in the light of this conclusion.
Such rights would not in any event prevent a state from taking steps to prevent sham marriages, if it could show that the marriage would indeed be a sham [35].