Scottish Court of Session Decisions

The regulatory framework

"Any substance or combination of substances presented as having properties for treating or preventing disease in human beings;

Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis."

It should be noted for the sake of completeness that from 31 October 2005 that definition replaced an earlier definition in the following terms, to which reference is made in the provisional determination notice (No. 6/5 of process):

"Any substance or combination of substances presented for treating or preventing disease in human beings.

Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product."

"'medical device' means an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which -

(a) is intended by the manufacturer to be used for human beings for the purpose of -

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

(iii) investigation, replacement or modification of the anatomy or a physiological process, or

(iv) control of conception; and

(b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,

and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device."

"2. For the purposes of this Directive, the following definitions shall apply:

(a) 'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

- diagnosis, prevention, monitoring, treatment or alleviation of disease,

- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

- investigation, replacement or modification of the anatomy or of a physiological process,

- control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

[. . . ]

4. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 65/65/EC and which is liable to act upon the body with action ancillary to that of the device, that device must be assessed and authorized in accordance with this Directive."

"'intended purpose' means -

(a) in relation to an active implantable medical device [not relevant]

[. . . ]

(b) in relation to any other medical device, the use to which the device is intended according to the data supplied by the manufacturer on the labelling, the instructions for use and/or the promotional materials."

"(1) Where the licensing authority are of the opinion that a product without a marketing authorization [. . . ] is a relevant medicinal product, they may, by a notice in writing (referred to in this regulation as a 'provisional determination notice') served on any person who has placed or who in the opinion of the authority may place the product on the market -

(a) inform him that they are minded to determine that the product is a relevant medicinal product (referred to in this regulation as 'the provisional determination') and of the reasons why they are so minded; and

(b) advise him that if he disagrees with the provisional determination, he may request that the licensing authority review their provisional determination, provided that within four weeks of the date on which the provisional determination notice was served on him (referred to in this regulation as 'the date of the provisional determination') he makes that request, and

[. . . ]

(ii) within four weeks of the date of the provisional determination, he informs the licensing authority in writing that he wishes to make oral representations to a review panel, appointed by the licensing authority, explaining why he considers that the product is not a relevant medicinal product.

(2) Where the licensing authority have been informed, pursuant to paragraph (1)(b)(ii), that a person wishes to make oral representations to a review panel, they shall, after consultation with that person, set a date for the oral hearing (at which the licensing authority may also make oral representations to the panel) and [. . . ] that date shall be the date fixed for the oral hearing.

[. . . ]

(5) If a person on whom a provisional determination notice was served -

[. . . ]

(b) has made oral representations to a review panel at an oral hearing arranged pursuant to paragraph (2), [. . . ] the licensing authority shall, after further consideration of the matter and in particular after having considered the advice of the review panel arising out of -

(i) the oral representations made and any other evidence submitted to the panel at the hearing by that person;

(ii) any oral representations made and any other evidence submitted to the panel at the hearing by the licensing authority, and

(iii) any other evidence considered by the review panel,

determine whether or not the product is a relevant medicinal product,

and shall inform that person in writing of their determination and their reasons for it, and if the licensing authority make a determination which is contrary to the advice of the review panel, they shall also give their reasons for disagreeing with the advice of the review panel.

(6) In respect of any product which the licensing authority determine, in accordance with paragraph [. . . ] (5), to be a relevant medicinal product, the licensing authority may, by a notice in writing served on any person who has placed or who in the opinion of the licensing authority may place the product on the market, require that he shall -

(a) stop marketing the product from a date specified in the notice; or

(b) not place the product on the market,

unless or until a marketing authorization [. . . ] is granted in respect of that product."

"The present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical devices. They are legally not binding. The Guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (Competent Authorities, Commission services, industries and other interested parties in both the medical devices and the medicinal products sectors) during which intermediate drafts were circulated and comments were taken up in the document. Therefore this document reflects positions taken in particular by the aforementioned interested parties.

Due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that these guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions."

"It was recognised that the subject needs to be further explained and illustrated by practical guidance and examples. The present document has no legal force. It has nevertheless been elaborated by an expert group including experts from Member States' competent authorities for both medical devices and medicinal products, the European Commission, as well as industry trade associations. It is therefore intended that the document will provide useful guidance which should assist common positions to be taken throughout the European Union."

Section A goes on to state general principles, give examples of medical devices and medicinal products, and discuss medical devices incorporating a medicinal substance with ancillary action. I shall refer to the contents of MEDDEV in more detail later in this Opinion.

Procedure

"(1) The respondent's decision to make the final determination being unsupported by proper reasons in terms of regulation 3A(5) of the 1994 Regulations, decree of declarator and reduction should be pronounced."

The petition was disposed of on 14 July 2005 by the Court's pronouncing an interlocutor (No. 6/8 of process) interponing authority to a joint minute (No. 6/9 of process), sustaining the petitioners' first plea-in-law and reducing the first final determination.

"3.1 Declarator that the respondent made the decision to make the final determination without having proper advice from the Review Panel in terms of the 1994 Regulations, in an unfair manner and in a manner which was contrary to the petitioners' legitimate expectations;

3.2 Declarator that the final determination is ultra vires;

3.3 Reduction of the final determination;

3.4 Suspension of the purported notice under regulation 3A(6) of the 1994 Regulations given in the notice of final determination requiring that the petitioners cease the sale and supply of the topical components in the products VisThesia and VisThesia Light with immediate effect and interim suspension;

3.5 A finding of expenses against the respondent."

At the first hearing the solicitor advocate for the petitioners explained that interim suspension was not sought because an undertaking had been given.

VisThesia

The initial dispute

"Whilst the product has two separate functions, lubrication and anaesthesia, these are two separate and independent actions. As anaesthesia is essential prior to surgery the Agency does not agree that the action of the lidocaine is ancillary."

The Review Panel

"Hyaltech Ltd.

Visthesia & Visthesia Light

FINDINGS

The Panel considered the oral and written representations of the MHRA (Borderline Section) and Hyaltech Ltd. In light of the fact that there was no dispute in relation to whether Visthesia and Visthesia Light bore any medicinal claims, the Panel did not consider whether the first limb of the definition of 'medicinal product' ('Any substance or combination of substances presented for treating or preventing disease in human beings or animals') as per Article 1 of Directive 2001/83/EC was satisfied. The Panel, therefore, only had to consider whether the second limb of the definition of 'medicinal product' ('Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological function in human beings or in animals is likewise considered a medicinal product') was satisfied. The Panel found that Visthesia and Visthesia Light fell within the second limb of the definition of a medicinal product.

ADVICE

The Panel advised that Visthesia and Visthesia Light are relevant medicinal products and subject to the provisions of The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144) as amended by The Medicines for Human Use (Marketing Authorisations Etc.) (Amendment) Regulations 2000 (S.I. 2000/292).

REASONS FOR ADVICE

The products Visthesia and Visthesia Light are presented as kits comprising an intracameral, a viscoelastic cannula and two topical ampoules containing sodium hyaluronate (3mg/ml) and lidocaine hydrochloride (20mg/ml). The topical ampoules are the components under review.

The definition of medical device in Regulation 2(1) of the Medical Devices Regulations 2002 includes devices incorporating a medicinal product 'which is liable to act upon the body with action ancillary to that of the device'. By definition, therefore, a product cannot be classified as a device if the medicinal component is more than merely ancillary.

It is well documented that lidocaine is an established medicinal substance with a local anaesthetic action i.e. its effects will modify physiological functions in human beings. Anaesthesia is an essential part of surgery and lidocaine is commonly used by surgeons at the start of a cataract operation. Lidocaine has no effect on the action of the hyaluronate, whereas the hyaluronate has a synergistic effect on the lidocaine.

After having considered all the information available, including the witness statements and evidence, the patent, the claims of the manufacturer (both original and current), other literature and the presentations made by both parties, the Panel held that the anaesthetic element in the products Visthesia and Visthesia Light is not an ancillary medicinal product, but has a separate and substantial action of its own. The lidocaine is not liable to act on the body with action ancillary to that of the device itself. Accordingly, neither Visthesia nor Visthesia Light can be considered as a medical device for the purposes of the Medical Devices Regulations 2002.

The Panel, therefore, considered that Visthesia and Visthesia Light fall within the second limb of the definition of a medicinal product as stated in Article 1 of Directive 2001/83/EEC."

First ground for review: the advice of the Review Panel

"1. The respondent having made the decision to make said final determination without having proper advice from the Review Panel et separatim in an unfair manner et separatim in a manner which was contrary to the petitioner's legitimate expectations, decree of declarator and reduction should be pronounced as craved."

"36 The reasons for a decision must be intelligible and they must be adequate. They must enable the reader to understand why the matter was decided as it was and what conclusions were reached on the 'principal important controversial issues', disclosing how any issue of law or fact was resolved. Reasons can be briefly stated, the degree of particularity required depending entirely on the nature of the issues falling for decision. The reasoning must not give rise to a substantial doubt as to whether the decision-maker erred in law, for example by misunderstanding some relevant policy or some other important matter or by failing to reach a rational decision on relevant grounds. But such adverse inferences will not readily be drawn. The reasons need refer only to the main issues in the dispute, not to every material consideration. [. . . ] Decision letters must be read in a straightforward manner, recognising that they are addressed to parties well aware of the issues involved and the arguments advanced. A reasons challenge will only succeed if the party aggrieved can satisfy the court that he has genuinely been substantially prejudiced by the failure to provide an adequately reasoned decision."

"the consequences of a failure to comply with a statutory duty to give reasons depend, like those of other failures to comply with procedural requirements imposed by statute, upon the terms of the relevant provision and upon the context."

In the present case it is accepted that the Review Panel had an obligation, albeit not a statutory duty, to give reasons. On the assumption that they failed to do so, the consequences were not, in my view, prejudicial to the petitioners. The MHRA were fully aware of the petitioners' evidence and arguments, and took them into account in reaching their own view as to what their second final determination should be. Viewed in that context, the presumed inadequacy of the Panel's reasons cannot be said to have vitiated the determination. To say that the outcome could have been different if the Panel had acted otherwise must be no more than speculation.

Second ground for review: the second final determination

"2. The respondent having acted ultra vires in deciding to make said final determination, decree of declarator and reduction should be pronounced as craved."

The petitioners, having stated on averment their criticisms of the reasoning of the Review Panel go on to say, "Alternatively, in any event," if the second final determination does not fall to be reduced on that basis, "it should be reduced as it was based upon material errors of law going to the root of the questions for determination and is accordingly ultra vires." It is said, first, that the MHRA made material errors of law. Secondly, they took into account irrelevant considerations. Thirdly, they failed to take account of relevant and material considerations which ought to have been taken into account. I shall consider each of these criticisms in turn.

The definition of "medical device"

"'medical device' means an [. . . ] article [. . . ] which -

(a) is intended by the manufacturer to be used for human beings for the purpose of -

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

(iii) investigation, replacement or modification of the anatomy or a physiological process, or

(iv) control of conception; and

(b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,

and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device."

Regulation 2(1) also provides the following definition of "intended purpose", read short:

"'intended purpose' means -

[. . . ]

(b) in relation to any other medical device [that is, one other than 'an active implantable medical device] the use to which the device is intended according to the data supplied by the manufacturer on the labelling, the instructions for use and/or the promotional materials."

"In order to decide which regime applies, the following criteria should be examined:

Step 1 The intended purpose of the product taking into account the way the product is presented (this is likely to establish if either the MDD or the MPD apply, rather than distinguish between the two regimes),

Step 2 The method by which the principal intended action is achieved.

The latter criterion, based on the 'principal intended action' is crucial in the definition of a medical device. Typically the medical device function is fulfilled by physical means (including mechanical action, physical barrier, replacement of or support to organs or body functions, . . .). The action of a medicinal product is generally achieved by pharmacological, immunological means or by metabolism.

The principal intended action of a product may be deduced from:

-                     the manufacturer's labelling and claims,

-                     scientific data regarding mechanism of action.

Although the manufacturer's claims are important, it is not possible to place the product in one or other category in contradiction with current scientific data. Manufactures may be required to justify scientifically their rationale for classification of borderline products."

"It follows from the definition of a medical device that devices may incorporate substances as an integral part which, if used separately, may be considered to be a medicinal product. This is specifically addressed in article 1(4) MDD which makes it clear that such products are devices, provided that the action of the medicinal substance is ancillary to that of the device, as reflected in the product claim and as supported by the scientific data provided by the manufacturer of the devices."

The underlining is in the original.

"In making this determination it is necessary to consider the meaning of 'intended purpose', 'principal intended action' and 'ancillary'. The definition in Directive 93/42/EC ('the Directive') and the Medical Devices Regulations [the 2002 Regulations] is supplemented by Guidance issued by the European Commission: the Medical Devices Guidance Document, or MEDDEV. The Guidance is authoritative but not legally binding. The MHRA accepts the relevance of these matters, although it notes that they are not exhaustive of the material which may be considered; nor are they set out in either the Directive or the Medical Devices Regulations.

Under the Directive:

Intended purpose relates to the question of whether the product has, overall one of the four purposes set out in categories I to IV [(i) to (iv)] above. This is determined by having regard to the data supplied by the manufacturer in the labelling, instructions for use and promotional materials. Insofar as the Guidance makes reference to manufacturers' claims, where the product remains unchanged, this is not limited to current claims. The issue of manufacturer's intent is determinative only at the initial stage of deciding whether a product has, overall, one of the four purposes which would suffice to make it a device (e.g. the purpose of investigation, replacement or modification of the anatomy or of a physiological process).

The principal intended action of the product is to be determined objectively. Although the Guidance (p3) states that the principal intended action may be deduced from manufacturer's claims and scientific data, it notes that it is not possible to categorise a produce in contradiction with current scientific data and that manufacturers may be required to justify scientifically their classification rationale. The question of whether or not such action is achieved by pharmacological, immunological or metabolic means can only be addressed by scientific evidence.

Taking into account the examples given in the Guidance, MHRA is of the view that:

Ancillary action, in relation to the principal intended action, is an action which is insignificant or of little importance; or an action which is subsidiary or auxiliary, or which supplements or provides support, to the principal intended action.

Because the definition of medical device includes devices incorporating a medicinal product 'which is liable to act upon the body with action ancillary to that of the device' it does not include devices incorporating medicinal products whose action is more than 'ancillary'. Such devices do not come within the scope of the Medical Devices Regulations and are to be regulated as medicines. The question of whether a medicinal component of a device has an ancillary action is to be determined according to whether it is 'liable' to have ancillary action, not whether it is intended by the manufacturer to have an ancillary action. If an action is more than ancillary, this does not necessarily mean that it must be a principal intended action.

The Guidance states that the issue of whether the action of a medicinal component is ancillary is to be decided in the light of 'the product claim' and 'the scientific data provided by the manufacturer of the devices' (para A.5). It is important to note that manufacturers' claims cannot prevail over scientific data (para A.2)."

"The issue of manufacturer's intent is determinative only at the initial stage of deciding whether a product has, overall, one of the four purposes which would suffice to make it a device."

I shall deal later with their observation that in so far as the Guidance makes reference to manufacturers' claims, "where the product remains unchanged, this is not limited to current claims."

"The latter criterion, based on the 'principal intended action' is crucial in the definition of a medical device. Typically the medical device function is fulfilled by physical means (including mechanical action, physical barrier, replacement of or support to organs or body functions, . . .). The action of a medicinal product is generally achieved by pharmacological, immunological means or by metabolism.

The principal intended action of a product may be deduced from:

-                     the manufacturer's labelling and claims,

-                     scientific data regarding mechanism of action.

Although the manufacturer's claims are important, it is not possible to place the product in one or other category in contradiction with current scientific data. Manufactures may be required to justify scientifically their rationale for classification of borderline products."

"Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive; [. . . ]"

Similarly, Recital 2 to the Medicinal Products Directive states:

"The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health."

Accordingly the manufacturer's claims are not simply to be accepted, but are to be tested, and cannot prevail against scientific data. I am therefore of opinion that the MHRA's understanding of the expression "principal intended action" in the paragraph of the determination beginning "The principal intended action" is entirely correct.

"Taking into account the examples given in the Guidance, MHRA is of the view that:

Ancillary action, in relation to the principal intended action, is an action which is insignificant or of little importance; or an action which is subsidiary or auxiliary, or which supplements or provides support, to the principal intended action."

The petitioners argued that ancillary meant "subordinate", while the respondent argued that it meant "insignificant" or "of little importance", or an action which was "subsidiary" or "auxiliary" to the principal intended action.

"The courts have repeatedly warned against the dangers of taking an inherently imprecise word, and by redefining it thrusting on it a spurious degree of precision."

In the present case, suffice it to say that in my opinion the MHRA directed themselves correctly as to the meanings of "ancillary". They took account of both groups of meanings when they said that "ancillary" action, in relation to the principal intended action, "is an action which is insignificant or of little importance [the first group]; or an action which is subsidiary or auxiliary, or which supplements or provides support, to the principal intended action [the second group]." If the analysis of the meanings of "ancillary" which has been attempted above is correct, the MHRA's interpretation of it cannot be held to be an error in law.

"It is therefore for the Agency to determine whether the action of the lidocaine in the topical component is ancillary to the purpose of the topical component as a whole. Whether or not such action is ancillary is a question of fact."

That appears to me to be unassailable. They went on to express the following view:

"In the present case, MHRA is of the view that the lidocaine component is liable to have an effect on the body which is more than ancillary because:

1) The evidence suggests that the anaesthetic function of VisThesia Topical is of greater, or at least equal, importance relative to the wetting function served by the sodium hyaluronate.

2) Even if that is not the case, it is the Agency's view that the anaesthetic function of VisThesia Topical is at least a significant, independent function of the product and cannot properly be regarded as ancillary."

Accordingly, the product did not satisfy either group of definitions of "ancillary". First, its anaesthetic action was not insignificant or of little importance: thus, it did not satisfy the first group. Secondly, it was not auxiliary to the wetting function of the solution because the anaesthetic function was independent of the wetting function and did not serve to make the wetting function more effective: thus, it did not satisfy the second group.

Relevant material

"A new composition set and a kit for use by intraocular operations, preferably cataract operations. The composition set comprises a first and a second viscoelastic agent, e.g. [read 'i.e.'] sodium hyaluronate, containing an anaesthetic, e.g. [read 'i.e.'] lidocaine hydrochloride. Hereby a simplified operation and anaesthesia is achieved while at the same time the risk of complications and discomfort on the patient are reduced."

The petitioners aver that they "materially developed" VisThesia "specifically as a device from an original concept of Dr Per Julius Nielsen" (statement 7). In a statement provided to the Review Panel (No. 6/16 of process) Dr Nielsen said, "VisThesia is effectively my invention." There is no indication that there has been any material change to the product since the publication of the US patent.

"The anaesthetic ingredient of both VisThesia topical and VisThesia intracameral is lidocaine which stabilises the neuronal membrane and prevents the initiation and conduction of nerve impulses thereby effecting local anaesthetic action."

The April 2002 IFU leaflet also contained the following passage. The words omitted from the July 2003 leaflet are printed in italics:

"VisThesia topical hydrates and lubricates the surface of the eye in preparation for intraocular surgery, with analgesia.

Application 5 minutes before intraocular surgery enables hydration of the surface tissue and diffusion of the analgesic through the viscous solution to be absorbed directly into the cornea.

A second application immediately before surgery supplements the initial application to provide hydration, lubrication and analgesia of the cornea for the early stages of the surgical procedure.

The viscous solution brings the anaesthetic into intimate contact with the corneal epithelium through which it is absorbed. Anaesthesia occurs rapidly usually within 5 minutes. The duration of effect is normally 20 to 30 minutes."

The July 2003 leaflet contains the following words, which do not appear in the April 2002 leaflet:

"[Application before intraocular surgery] ensures that the cornea stays clear and hydrated throughout the surgery and is not compromised. The lubricating properties ensure that a clean small incision can be made with minimal damage.

A second, supplementary, application is used only if needed.

Lidocaine is incorporated in the topical viscoelastic as an ancillary anaesthetic agent. It should be included in the ophthalmic surgeon's routine anaesthetic regimen."

"There was [in the April 2002 leaflet] no suggestion in the dosage regime that additional anaesthesia from another product would be needed during the procedure, implying that the manufacturer's intention was that the product provided all of the anaesthesia necessary during surgery."

Under the heading "Changes to the Information for Use leaflet" they said:

"During our investigation, the Information for Use leaflet was significantly amended in 07/2003 in order to place less emphasis on the role of the anaesthetic claims relating to lidocaine. However, the product formulation has not altered in any way and the action of the lidocaine in the topical ampoules remains to provide anaesthesia for cataract surgery. The change in the manufacturer's claim does not reflect any change in the scientific evidence of the anaesthetic effect of lidocaine at the concentration contained in the product or as to how the product is used."

"CIBA Vision will begin offering an entirely new produce for cataract surgery called VisThesia - a combination [of] viscoelastic and aesthetic to be used for the new procedure of 'viscoanesthesia'. By combining viscoelastic and anaesthesia, VisThesia may help surgeons shorten the time needed for cataract surgery and help increase patient comfort.

VisThesia is packaged with both topical and intracameral components with separate percentages of sodium hyaluronate and lidocaine hydrochloride. Surgeons have the advantage of no longer needing to choose between a topical or an intracameral anaesthetic. In addition, they can save time by eliminating separate injections of viscoelastic and anaesthetic. Procedures previously requiring two injections now require only one.

Patients also benefit from these same advantages. VisThesia is designed to help patients by reducing time in surgery and by avoiding separate injections of anaesthetic and viscoelastic."

Onus

Relevant considerations

"The experts disagreed over the function of the topical sodium hyaluronate. Mr Singh noted that it had an important role as a wetting agent, but was not needed for lubrication because the eye does not blink during surgery. Mr Mackintosh described its function both in terms of wetting and lubrication. Whether or not sodium hyaluronate is a more novel or interesting compound than lidocaine, as suggested by Mr Mackintosh, is not relevant to this determination. The legal test is whether the action is ancillary. Mr Mackintosh does not suggest that the topical anaesthetic in VisThesia is unimportant.

Expert evidence shows that the product is intended to facilitate surgery in two ways, by providing anaesthesia and acting as a wetting agent. Both experts agree that wetting and anaesthesia are essential for surgery. The fact that two substances with two different objectives are used in combination does not, of itself, reduce either objective to an ancillary role."

"From the expert evidence, it can be deduced that:

Topical anaesthetic is routinely used in cataract surgery in the UK. Both Mr Singh and Mr Mackintosh agree that it is necessary for usual surgical practice. It is not in dispute that VisThesia provides topical anaesthesia. Some surgeons also provide anaesthesia by injection; some do not. There is therefore no dispute that topical anaesthesia plays an essential role.

Even where anaesthesia is given by injection subsequent to topical anaesthesia, topical anaesthesia clearly plays an important role in anaesthetizing the eye. The opinion of Mr Mackintosh indicates that an injection would not normally be given without prior local anaesthesia. Although Mr Mackintosh states that he would add additional topical anaesthetic, he notes that VisThesia can fulfil that function:

'A fault in the descriptive use of this product in Hyaltech's literature is that it emphasises using it preoperatively, but does not stress that it should be used during the operation . . .'"

"I accept all the properties of Viscoelastic as claimed by the company. My contention is that the addition of lidocaine is done with the sole purpose of its local anaesthetic effect hence it is a medicine.

Two substances in combination where each on its own has a different primary action cannot be portrayed as one having a primary action and the other a secondary role. In this case the primary action of Viscoelastic is wetting and of lidocaine is as a topical anaesthetic.

[. . . ]

Viscoelastic is primarily a wetting agent and lidocaine is primarily a local anaesthetic agent. The combination of these two does not reduce either of them to an ancillary role."

Mr Singh went on to say that Dr Nielsen did not claim that lidocaine had any role in the wetting of the cornea and maintaining its clarity during cataract surgery. He pointed to an article by Dr Nielsen in the May 2003 issue of Eurotimes in which he had said, "VisThesia provides a good introduction to topical anaesthesia and brings comfort to both patient and surgeon." Dr Nielsen detailed in the article 160 cataract operations performed using only VisThesia as a local anaesthetic agent.

"The experts [Mr Singh and Mr Mackintosh] disagreed over the function of the topical sodium hyaluronate. Mr Singh noted that it had an important role as a wetting agent, but was not needed for lubrication because the eyelid does not blink during surgery. Mr Mackintosh described its function both in terms of wetting and lubrication. Whether or not sodium hyaluronate is a more novel or interesting compound than lidocaine, as suggested by Mr Mackintosh, is not relevant to this determination. The legal test is whether the action is ancillary. Mr Mackintosh does not suggest that the topical anaesthetic in VisThesia is unimportant.

Expert evidence shows that the product is intended to facilitate surgery in two ways, by providing anaesthesia and acting as a wetting agent. Both experts agree that wetting and anaesthesia are essential for surgery. The fact that two substances with two different objectives are used in combination does not, of itself, reduce either objective to an ancillary role."

Decision wholly unreasonable

Result