Janssen-Cilag Pty Ltd v Pfizer Pty Ltd

Re: JANSSEN-CILAG PTY LIMITED
And: PFIZER PTY LIMITED
No. G340 of 1990
FED No. 581
Trade Practices

COURT

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY
GENERAL DIVISION
Lockhart J.(1)

CATCHWORDS

Trade Practices - Misleading or deceptive conduct - statements made in advertising material - advertisements on television and in journals and pamphlets distributed to pharmacists concerning treatment of worms in humans by Combantrin and Vermox - scientific evidence - relevance of earlier judgment on similar issues between the same parties - s. 52 Trade Practices Act 1974.

Trade Practices Act 1974: s. 52.

HEARING

SYDNEY

#DATE 24:9:1991

Counsel for the Applicants : Mr S. Robb, Ms K. Howard

Solicitors for the Applicants : Michell Sillar McPhee Meyer

Counsel for the Respondent : Mr J. Allsop, Mr P. Whitford (4 days)

Solicitors for the Respondent : Clayton Utz

ORDER

The matter be adjourned to a date to be fixed.

On the adjourned date, the applicant bring in short minutes of order to give effect to these reasons for judgment.

NOTE: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

JUDGE1

This case is about worms of the kind that infest humans. The applicant and the respondent each sells in Australia a product as a medication for persons suffering from worms. The applicant's product is Vermox and the respondent's product is Combantrin. Each product is capable of treating more than one kind of worm; however Vermox may require multiple doses whilst Combantrin only requires a single dose.

In January 1990 the respondent commenced a vigorous advertising campaign for Combantrin including advertisements on television and in magazines, brochures and other material distributed to pharmacists and members of the public and displays to pharmacists for the information of the public. The campaign has been very successful and has contributed (the degree of such contribution is difficult to assess) to an increased market share of Combantrin.
Combantrin and Vermox are the principal products in the anthelmintic market in Australia. Combantrin is the market leader with sales over $6 million per annum. Market share of Combantrin is about 60 percent whilst market share of Vermox is about 35 percent, leaving about 5 percent for other products. These figures are round figures and are approximations which vary from year to year, but they are sufficiently accurate for present purposes to give an idea of the success and importance of each of the two rival products in this market for products to treat intestinal worms in human beings.
The applicant complains that the respondent's advertising contains representations which are misleading or deceptive, contrary to the provisions of s. 52 and s. 53(f) of the Trade Practices Act 1974. The applicant seeks injunctive relief against the respondent and damages. By consent of the parties the question of damages, if it arises, is to be heard later as a separate issue.
The respondent cross-claims against the applicant asserting that the applicant has engaged in misleading and deceptive conduct in contravention of ss. 52, 53(c) and 53(f) of the Trade Practices Act in certain of its advertising of its product Vermox, and it too seeks injunctive relief and damages.
The core of the dispute is whether certain of the claims by each party in its advertising material are scientifically valid in the field of parasitology. The primary dispute concerns the advertising of Combantrin. The cross-claim did not occupy a great deal of time either by way of evidence or submissions at the trial.
The case is an interesting example of the application of Part V of the Trade Practices Act because that Part is essentially a public interest provision, not primarily a tool to protect private interests. It is the vehicle in this case for two commercial rivals in the anthelmintic market in Australia (each seeking to increase its market share) to ventilate issues concerning public health and to test the validity of scientific claims. Most of the evidence, both oral and documentary, relates to these public interest issues. So the advancement of private interests and the protection of the public have coalesced in this case.
Each of the products Combantrin and Vermox is available for sale to members of the public in pharmacies throughout Australia. Neither is a prescription drug. Hence the battle for market share is fought out in pharmacies rather than doctors' surgeries.
The first question to which I shall turn is whether the advertising material issued by the respondent for Combantrin makes the representations which the applicant asserts are made by it. This involves an examination of each of the particular forms of advertising in issue, though certain of the alleged representations of which complaint is made by the applicant are common to more than one of the advertisements.
The form of advertising principally attacked by the applicant is the video commercial played on television stations and in doctors' surgeries throughout Australia since about May 1990 known as the Combantrin commercial. It appears to have been a very successful commercial, though fortunately my only association with it has been when it was screened in court, alas more than once.
The Combantrin Commercial
The script for the Combantrin commercial reads as follows:

"FIRST LADY: 'I'd like a worm treatment for my family please.' VOICEOVER: 'What worm?'

SECOND LADY: 'My boy has worms.'

VOICEOVER: 'What worm?'

SECOND LADY: 'What do you mean what worm. I don't know what worm. Julius what sort of worm have you got? He doesn't know what sort of worm he's got. How do you expect me to know what he's got? Do you know what sort of worm he's got? What worms are there? Fat worms, skinny worms, worms with glasses, worms that go bump in the night.'

VOICEOVER: 'There's one family worm treatment that gets rid of a variety of worms in a single dose.' THIRD LADY: 'I want some Combantrin please.' VOICEOVER: 'What worm treatment gets rid of a variety of worms in a single dose, Combantrin.'

A Combantrin packet is shown during the last voiceover. Above the packet the words 'Use only as directed' appear; below the packet the words 'from your pharmacy' appear.

On the packet appears the following:-

"Caution S2

Combantrin 1 dose treatment economy pack For threadworm, roundworm and hookworm"

This packet does not contain the balance of the information on the economy packet of Combantrin.

SECOND LADY: 'For crying out loud you'd think you had a worm farm down there.'"

The applicant claims that the Combantrin commercial makes two representations. As these representations (and others to which reference will be made later) are said to be common to more than one of the forms of advertising adopted by the respondent for Combantrin, I shall for ease of reference number each of them. I shall number the two representations said to have been made with respect to the Combantrin commercial 1 and 2 respectively.
Representation 1
The first representation alleged in the statement of claim is that roundworm and hookworm are types of human infesting worms which are reasonably likely to infect persons living under ordinary Australian standards of accommodation, hygiene and other aspects of Australian life.
Representation 2
Representation number 2 is said to be that roundworm and hookworm have a prevalence throughout Australia that warrants the public in believing that it is medically appropriate to treat a person suspected of being infected by a human infesting worm with a patent medicine which treats roundworm and hookworm as well as threadworm in a single dose.
In my opinion, the Combantrin commercial suggests that threadworm, roundworm and hookworm are three varieties of worms reasonably likely to infest persons living in Australia. The commercial is plainly directed to ordinary people, not a narrow class of persons. The viewer would be likely to regard the commercial as applying generally to ordinary Australian families in Australia. The commercial suggests that threadworm, roundworm and hookworm are reasonably likely to infect persons living under ordinary Australian standards of hygiene and accommodation. The activity in the commercial takes place in a pharmacy where the women are plainly concerned with the health of their children. The viewer would gain the impression that the activity applies to the ordinary type of pharmacy found in Australian cities and towns. The viewer would assume that a variety of worms may infest ordinary Australian families and these are reasonably likely to be threadworm, roundworm or hookworm.
The question "What worm?" is heard three times in the commercial, twice by itself and the third time as part of a longer sentence. Also the reference to the words "What worms" occurs a number of times throughout the commercial. This all suggests that there is a real possibility that viewers or their families may suffer now or in the future from worms of one kind or another and that it is medically appropriate to treat a person suspected of being infested by worms with a patent medicine which treats three different kinds of worms.
In my opinion both representations 1 and 2 which are said to be made in this advertisement are in fact made.
The commercial also asserts that Combantrin cures threadworm, roundworm and hookworm in a single dose. However, it was submitted by counsel for the applicant that the advertisement went further and conveyed the impression to the viewer that Combantrin, and Combantrin alone, has the capacity to get "rid of a variety of worms in a single dose". I reject that submission.
The Combantrin Brochure
Since March 1990 the respondent has distributed a brochure relating to Combantrin to pharmacists within Australia to be used by them and given to members of the public. The respondent has made efforts to retrieve this brochure from pharmacies, but acknowledges that despite its efforts some pharmacists may still have them.
The Combantrin brochure consists of a single sheet with writing and pictures in various colours on both front and back and folded over into three. A copy is annexure "B" to the statement of claim. The centre of the three panels on the front of the brochure depicts a mother and her two children all looking rather unhealthy and in a state of dejection. The words in large print "WHAT WORM?" appear above the picture and below it is a depiction of packets of Combantrin stating that it is for "threadworm, roundworm and hookworm" "one dose treatment" under which appear the words in print "A single dose of Combantrin can get rid of Threadworm, Roundworm or Hookworm". To the right of the centre panel is a depiction of three wormlike creatures in an exaggerated, elongated form, singing or crooning together in visible harmony with life and each other, replete with health and vigour as they engage in gentle dancing presumably within the intestines of the mother and two children depicted in a nearby advertisement who convey the impression of poor health and general disenchantment with life. The beginning of new life to humanity and the end of the good life of the worms resides in the taking of a single dose of Combantrin. The three creatures are all saying "Worms", above which appear the words "The Combantrin Guide to". Under the picture of the worms appears the statement "Everything you'll ever need to know about what worms are, how you catch them, and how to get rid of them." The left hand panel has a picture of part of a green and blue worm in a basically horizontal position with the words underneath "How do you know when someone has Threadworms?" with a number of statements made to answer that question and bearing the handdrawn picture of a rather dejected child. Under that appear the words "Other worms: Less common but more dangerous" in bold print and underneath those words appear the following:

"Although much less common than Threadworms, a few other types of worms are found in Australia:

They include Roundworms and Hookworms. Both of these are potentially more dangerous than Threadworms. Roundworms and Hookworms were once thought to be confined to warmer areas, but recent research indicates that they are regularly being diagnosed all over Australia. The research also indicated that the number of diagnosed Hookworm cases had increased by 30% over the 3 year period.1"

The reference to footnote 1 is to the footnote on the centre of the back page of the brochure which says:

"1: Pharmacy Roundtable with Professor John Welch, John Bell, Dr John Stuart: New Study on Roundworm and Hookworm infestations. Special Feature, Australian Journal of Pharmacy, July 1989."

On the back of the brochure on the left hand side is a heading "What Are Worms?" and inside it is a description of worms concluding with the words "There are several types of worms in Australia, but the most easily caught worms are Threadworms." Underneath that there is a heading "Threadworms: The most common worms" with a description of threadworms. In the centre panel is a column at the top headed "Facts About Roundworms ..." then follows a description of roundworms. And below that the heading "... and Hookworms" with a description following of hookworms. Under that appears the heading "How to get rid of worms". There follows: "Just ask your pharmacy for Combantrin. One dose of Combantrin can get rid of Threadworm, Roundworm or Hookworm 2. The dose of Combantrin is tailored to suit individuals of varying sizes. Only Combantrin is approved for treating the whole family, even children as young as six months. Be sure to treat your whole family at the same time, to reduce the risk of reinfection from one member of your family to another. If you're pregnant or if you have liver disease, you should ask your doctor before treating yourself for worms".

The reference to footnote 2 is to the following:

"2. If Roundworm or Hookworm is suspected seek medical attention."

The final section is headed "How To prevent Threadworm reinfection" with a statement of how this is to be done. The brochure concludes with the words, placed below the handdrawn picture of a seemingly happy child, "One dose of Combantrin can treat not just Threadworm, but Roundworm or Hookworm as well. If you would like more information or advice about the treatment of worms, please contact your local pharmacist, or your doctor."
Four representations are said to have been made in this brochure. The first two representations are those numbered 1 and 2 already dealt with in relation to the Combantrin commercial, so I shall now determine whether those representations or either of them are made in the Combantrin brochure. In my opinion each of these representations is made in the Combantrin brochure. The most striking features of the brochure which support this conclusion consist of the photograph of the mother and two children preceded by the question "What worm?"; the drawing of the three worms each of which is saying "WORMS"; the depicted packets of Combantrin referring to threadworm, roundworm and hookworm; the statement underneath the depiction of the packets "A single dose of Combantrin can get rid of Threadworm, Roundworm or Hookworm"; the statement on the right panel of the back page "One dose of Combantrin can treat not just Threadworm, but Roundworm or Hookworm as well"; and the statement that follows the drawing of the three worms "Everything you'll ever need to know about what worms are, how you catch them, and how to get rid of them."
Under the heading "Other Worms: Less common but more dangerous" appear the words mentioned earlier. In my opinion, they convey the message that, although roundworm and hookworm are much less common than threadworm, they are nevertheless potentially more dangerous than threadworm and that roundworm and hookworm are no longer confined to warmer areas in Australia but are regularly being diagnosed all over Australia. The word "regularly" in the context of the brochure conveys the meaning of constantly, not its primary meaning of "at the proper time; at fixed times or intervals". Reference to roundworm and hookworm being regularly diagnosed all over Australia is a reference to diagnosed in the sense of identified and recognised. No doubt to some readers it would convey the impression that roundworm or hookworm are being contracted all over Australia but I think the better view is that most people would gain the impression that roundworm and hookworm are being regularly found by diagnostic analysis conducted all over Australia, wherever the disease was contracted.
On the back page of the brochure under the heading "Facts About Roundworms" appears the statement "Roundworms are caught by swallowing eggs which may be present in soil or on vegetables". This would convey to the ordinary reader that roundworm eggs may be present in the soil or on vegetables with which the average Australian comes into daily contact, so that they are present generally in Australian soil or on vegetables purchased from the greengrocer or vegetable markets or any other source of supply. There are other statements appearing on the back of the brochure which I do not find it necessary to deal with because it is plain to my mind that representations 1 and 2 are made by this brochure.
Representation 3
Representation 3 is said to be that scientifically reliable recent research in Australia justifies the statement that roundworm and hookworm are regularly infecting Australians throughout Australia.
Representation 4
Representation 4 is said to be that recent scientific research indicates that the number of diagnosed hookworm cases has increased by 30 percent over a three year period and that this is reliable research and is medically significant and justifies an increase in concern that members of the public in Australia might be infected by hookworm.
On page 1 of the brochure express reference is made to recent research indicating that threadworm, roundworm and hookworm are regularly being diagnosed all over Australia and that the number of diagnosed hookworm cases has increased by 30 percent over the three year period. Footnote 1 refers to the Pharmacy Roundtable with Professor John Welch and others and a new study published in the Australian Journal of Pharmacy of July 1989.
In my opinion, the material which I have referred in relation to representations 1 and 2 coupled with the material just mentioned indicates plainly that representations 3 and 4 are made by the brochure.
The Combantrin Pharmacy Product Reference
This document has been supplied by or on behalf of the respondent to pharmacists since about March 1990 for their use and is entitled "Pfizer Pharmacy Product Reference" and relates to Combantrin and other products of the respondent. It contains seventeen pages. The first reference to Combantrin is on page 2 where packets of Combantrin are depicted, but nothing turns on that. Four pages of the document deal specifically with Combantrin. The first statement is "ANYONE CAN CATCH WORMS" followed by the words "There are many types of worms in Australia - including threadworm, roundworm and hookworm." Then follows a description of threadworm and its treatment which in turn is followed by a description of roundworm and hookworm. There appears the heading "ROUNDWORM AND HOOKWORM" under which are the words:

"Roundworm and hookworm are much less common in Australia. However, a recent 3 year study (the first in 65 years) conducted by Professor John Welch at the Queensland University of Technology highlighted a number of interesting facts.

1. Hookworm incidence has increased 33% over the 3 year study

2. Whilst it was earlier believed both hookworm and roundworm only occurred in tropical areas, Professor Welch's study revealed - 810 cases (68%) of hookworm cases occurred in cool temperature zones

- 699 cases (96%) of roundworm cases occurred in Southern areas of Australia

The incidence of these worms now is about one case per day in Australia. As these are only reported cases through Pathology laboratories, Dr Welch feels 'there is no reason for complacency*' with regards to these worms.

Roundworm and hookworm can be very difficult to diagnose, and if not properly treated can cause serious health problems. Customers who are concerned about either of these worms should seek medical advice.

* Round Table Article AJP July 1989"

Then there is a reference to the symptoms of roundworm and hookworm and their treatment and the treatment of threadworm in a single dose by Combantrin, followed by the drawing of the three worms which appeared on the Combantrin brochure. The third page dealing with the treatment by Combantrin is headed "EFFECTIVE AGAINST" "Threadworm, and also roundworm and hookworm in a single dose." A similar message is conveyed under the heading "WHY RECOMMEND COMBANTRIN?"

The applicant asserts that representations 1, 2, 3 and 4 are made with respect to this document and I am satisfied that that assertion is correct. In relation to representations 1 and 2, I rely particularly on the statement that "anyone can catch worms" followed by the words "There are many types of worms in Australia - including threadworm, roundworm and hookworm." I also rely on the description of the study and the general setting out of the information. The statement that roundworm and hookworm are much less common in Australia is effectively nullified by the comments immediately following it. The reliance on the study clearly establishes that representations 3 and 4 are made.
Representations 5, 6, 7 and 8 are said to be as follows:

5. That a finding that hookworm incidence has increased by 33% over the period of a recent three year study referred to in a Round Table Article in Australian Journal of Pharmacy in July 1989 is scientifically reliable and medically significant.

6. That the result of Professor Welch's study scientifically justified the statement that 810 of the cases (68%) of hookworm diagnosed in Australia occurred in the temperate to cool temperature zones.

7. That the results of Professor Welch's studies scientifically justified the statement that 699 (96%) of roundworm cases diagnosed in Australia occurred in southern areas of Australia.

8. That the results of Professor Welch's study scientifically justified the assertion that the risk of Australians being infected with roundworm and hookworm throughout Australia is such that there is no reason for complacency."

With one exception, it is plain that each of these representations is made in this document, a copy of which is annexure "C" to the statement of claim. By referring to the study, the respondent is implyingly representing that the findings in it are scientifically reliable and by highlighting the findings to pharmacists, they must be taken to have represented that the findings are medically significant. The one exception is representation 6. In fact, the respondent only makes, in my opinion, a representation that the result of the study scientifically justified the statement that 810 of the cases (68%) of hookworm diagnosed occurred in cool temperature zones, not "temperate to cool temperature zones".
The Combantrin Display Document
A copy of this document is annexure "D" to the statement of claim. The respondent has since January 1990 caused to be displayed in pharmacies throughout Australia a poster and cardboard display known as the Combantrin display. This consists of a single page display. The page is headed by the words "What worm?" appearing in large print, underneath which is the photograph of a mother and her two children, being the same photograph as previously mentioned, showing them not looking very healthy and in a state of dejection. Underneath that are the words "One dose of Combantrin gets rid of threadworm, roundworm and hookworm."
The representation said to have been made in this document are those numbered 1 and 2. The document conveys to my mind the representation that the average person looking at the document in the local pharmacy would probably interpret it as saying that if she or one of her children has a worm problem, then the worm could be either threadworm, roundworm or hookworm. It suggests in unequivocal language that, if worms are suspected, threadworm, roundworm and hookworm are possible sources of infection. There is nothing to indicate that roundworm and hookworm are less common than threadworm in Australia. In my opinion both representations 1 and 2 are made in this document.
The First Combantrin Advertisement
This advertisement was caused by the respondent to be published in the March 1990 issue of the Australian Journal of Pharmacy. It is a one page advertisement which is in the form of a partial extract from a telex reading:

"IT IS IMPORTANT FOR THE PHARMACIST, PHARMACY ASSISTANT AND GENERAL PRACTITIONER TO BE AWARE THAT A ROUNDWORM AND HOOKWORM INFECTION WERE RECORDED IN EVERY CAPITAL CITY 1"

The footnote reference states at the bottom:

"1. Reference: Pharmacy Roundtable with Professor John Welch, John Bell, Dr John Stuart: New study of Roundworm and Hookworm Infestations, Special Feature, Australian Journal of Pharmacy, July 1989"

Underneath the telex in large bold print appears "WHAT WORM?"

The applicant has submitted that representations 1 and 2 are made in this advertisement. Plainly representation 1 is made by this advertisement. However, in my view, representation 2 is not made out as there is no reference to the fact that Combantrin treats the three worms with a single dose. Indeed there is no reference to Combantrin at all although it may be arguable that some readers of the advertisement would see the word Pfizer and associate it with Combantrin.
Representation 9
Representation 9 is said to be made, namely, that the number of cases of roundworm and hookworm recorded in every capital city has been sufficiently high and of a medical significance to make it important for pharmacists to consider which worm, including roundworm and hookworm, might have infected members of the public who might be infected with a human infecting worm of some kind. In my opinion this representation is plainly conveyed by the advertisement.
The Second Combantrin Advertisement
The respondent caused this advertisement to be published in the January 1990 issue of Pharmacy Trade. The advertisement takes the form of an interview with the product manager of Combantrin. It contains the statement attributed to the product manager:

"Unfortunately, the consumer generally thinks a worm is a worm and they're all the same ... Now, although threadworm is the most common type in Australia, other worms do exist, the campaign addresses this ... Combantrin is the only leading treatment that can get ride of threadworm, roundworm or hookworm in a single dose."

It is asserted that representations 1 and 2 are made in this advertisement.
In my opinion these two representations are made in the advertisement.
The Third Combantrin Advertisement
The respondent caused this advertisement (annexure "G" to the statement of claim) to be published in the May 1990 issue of the Australian Journal of Pharmacy. Like the first Combantrin advertisement this advertisement takes the form of an extract from a telex but it has different content. The words in very bold large print "What worm?" appear but above them in the form of an extract from a telex appears the following:

"However, the finding that the vast majority (78.6%) of confirmed hookworm and roundworm infections occurred in residents from cold, dry and developed urban areas of southern Australia (including N.S.W., Vic. and S.A.) is alarming1."

There then follows the reference in footnote 1 as follows:

"1. Reference. John S. Welch, Intestinal parasitic infections in Australia: an overview. Proceedings of the 25th Silver Jubilee Annual Scientific Seminar of the Malaysian Society of Parasitology and Tropical Medicine. 1989, pp 122-133."

The applicant asserts that representations 1 and 2 are made by this advertisement. Representation 1 is made by this advertisement. However representation 2 is not made as there is no reference to Combantrin treating the three worms with a single dose.

Two other representations are said to be made by the advertisement.
Representation 10
Representation 10 is that it had been found that the vast majority (78.6%) of confirmed hookworm and roundworm infections occurred in residents from cold, dry and developed urban areas of southern Australia (including New South Wales, Victoria and South Australia) and that that finding is alarming.
Representation 11
Representation 11 is that the results of scientific findings suggest Australian pharmacists should, when giving advice to the public about human worm infestations, take into consideration the likely infestation of persons living in cold, dry and developed urban areas of southern Australian by hookworm and roundworm.
Representation 10 is plainly made by the advertisement. Representation 11 is also made by the text of the advertisement itself and the reference to the footnote which is clearly intended to convey to pharmacists that they should take into account the information referred to in the telex supported by the John S. Welch paper when advising their customers.
Other Documents
The applicant asserts that nine other documents have at various times since January 1990 been published and distributed by the respondent.
(a) Poster entitled "What worm?"
This poster is 70cm high and 40cm across and contains the words "What worms?" in large and bold print with the picture below it of the mother and two children already mentioned and at the bottom of which appears "One dose of Combantrin gets rid of threadworm, roundworm and hookworm." This poster is the same as the Combantrin display and is said to convey representations 1 and 2 which I have already found that it does convey with reference to the Combantrin display; and I make the same finding with respect to this poster.
(b) Circular Trade Presenter headed "What worm?"
This document is in circular form and though not as large as the poster mentioned above contains the same material. Representations are said to be the same, that is 1 and 2, and I make the same findings as I have earlier with respect to them so far as this document is concerned.
(c) Rectangular free standing trade presenter headed "What worm?"
This contains the same material as the Circular Trade Presenter, although in rectangular, not circular form, and the representations are the same as those made by the Circular Trade Presenter.
(d) Brochure Headed "TV News all through 1990"
Representations 1 and 2 are said to be made by this document. Although displayed in a different form it conveys the same information as does for example the Circular Trade Presenter. The representations are said to be the same as made by that circular trade presenter and my findings are the same.
(e) Selling Sheet Headed "Worms, Worms, Worms"
This is a two-page document which contains the familiar drawing of the three worms each saying the word "Worms" and it gives five reasons on the first page as to why Combantrin is the recommended brand. The first reason is because Combantrin is said to be able to be used by children from six months of age whereas other leading brands can only be given to children from two years (this includes Vermox). The second reason is said to be that Combantrin treats threadworm, roundworm and hookworm in a single dose and goes on to say:

"A recent 3 year study has indicated that about one case of roundworm and one case of hookworm is diagnosed somewhere in Australia everyday.

The study also indicates hookworm is being diagnosed more often and that the majority of cases of roundworm and hookworm diagnosed occurred outside the tropical north*."

The asterisk appears at the bottom of the page and attributes the material to "Study conducted by Professor J. Welch, Qld University of Technology".

The third reason is said to be that Combantrin is the brand mothers have trusted for nearly twenty years and it states that:

"Combantrin is very effective; studies on threadworm indicate that Combantrin in a single dose has an average cure rate of 95%**."

There is a double asterisk also with a source reference. The second sheet offers "125 double movie passes" and contains a questionnaire, which if answered correctly would give the entrant the chance of winning one of the movie passes. Only pharmacy sales assistants were entitled to enter the competition. One of the questions is:

"2. What types of worms do Combantrin and Vermox treat with a single dose?

Combantrin Vermox hookworm ( ) ( ) threadworm ( ) ( ) roundworm ( ) ( )"

Representations relied on are numbers 1, 2, 3 and 9. In my opinion all four representations are made by the document.
(f) Advertisement in "Your Pharmacy" (Volume 3 No. 1 June 1989 entitled "Second Glance."
This document is titled "A Closer Look at Your Sales - Understanding the Worm Market". It contains a number of sections covering some four pages. The second page is the critical page for present purposes though not the only relevant page. The principal portion of the second page reads as follows:

"REPORTED CASES OF HOOKWORM ON THE INCREASE

Apart from the common threadworms a number of cases of hookworm and roundworm infections are recorded in the resident population in Australia every year.

Threadworm infestation is known to be common in Australia and infections occur in a significant proportion of children in their preschool and school years. Such infections are usually uncomplicated and respond well to medication. These worms are easily transmitted between individuals and once infection is detected, consideration should be given to treatment of all family members to prevent reinfection.

Information on the current prevalence of hookworm and roundworm infections in Australians has recently been documented by my team at the Queensland University of Technology.

Pathology Laboratories in all capital cities and major towns throughout Australia were surveyed. The results of the study conducted over three years 1985-1987 showed both of these potentially dangerous parasites were regularly recorded about two cases for each day of the year.

An important survey finding was that both hookworm and roundworm infections were recorded in each Australian state and not only in the tropical north.

Perhaps the most alarming finding was that records of hookworm infection increased each year of the study.

This new information demands an increased awareness among health workers and practitioners to ensure that these infections are correctly diagnosed and treated.

Dr John Welch,

Head of Department

Medical Science

Queensland University of Technology"

On the same page appear the words:

"Take advantage of the Pfizer in-store Training Program and product information to learn all you can about threadworm, hookworm and roundworm. Combantrin is the only product approved for treatment of these three worms in a single dose."

Representations which are said to have been made in this advertisement are numbers 1, 2, 3 and 9. All these representations are made by this document.
(g) Advertisements in the Australia Journal of Pharmacy, Volume 71, January 1990 entitled "Big Combantrin Spending"
This advertisement contains a picture showing boxes of Combantrin each stating that it is for threadworm, roundworm and hookworm but emphasising threadworm more than roundworm or hookworm. Underneath the pictures appear various statements attributed to the respondent's product manager including the following:

"He said Combantrin was the only leading brand that could treat threadworms, roundworm or hookworm in a single dose. 'Considering the findings of the three year survey conducted by Professor John Welch of the Queensland University of Technology, it is important that everyone is aware that although threadworm is the most common worm, others do exist in Australia', Mr Templeman said. 'Most consumers think 'a worm is a worm' and that they are all the same, and a our new campaign addresses this misconception'."

This advertisement is thus similar but not the same as the second Combantrin advertisement.
The representations said to be made in this advertisement are 1 and 2 and I agree that they are made.
(h) Advertisement in "Your Pharmacy" (Issue unknown) entitled "Great reaction to 'What Worm' campaign"
This advertisement contains a picture of three packets of Combantrin each in the same form as mentioned with respect to other advertisements and again records what the product manager of the respondent is alleged to have said, namely, that, amongst other things:

"Combantrin's active ingredient ... shows single dose cure rates of 95% to 100% for threadworm, similar rates for roundworm and slightly less for hookworm.

'There is no more effective drug in a single dose for threadworm, roundworm or hookworm, than Combantrin.'

Given the results of the study conducted by Professor Welch of the Queensland University of Technology, pharmacy staff cannot ignore the fact that roundworm and hookworm do exist and that they were diagnosed in every capital city in the country', Mr Templeman said referring to the pharmacy paper published in July 1989. The 'What Worm?' TV commercial is due to go to air a number of times through the year and will be supported by the new point of sale material and in-store promotions. Concluding, Mr Templeman said pharmacy will need to ensure stock weight is up because consumer demand is sure to be high."

Representations said to be made by this advertisement are those numbered 1, 2, 3 and 9. In my opinion each of those representations is made by the advertisement.

(i) Advertisement in Pharmacy Trade, June 1990 entitled "Combantrin Sales Break New Records"

This document again records statements made by the marketing manager of the respondent and among other things contains the following statements:

"(3) Increased professional and consumer awareness about roundworm and hookworm infestations due to the study conducted over the last four years by Professor John Welch. This study indicates that roundworm and hookworm occur in every state of Australia, not just the tropical north.

Combantrin is the only leading brand that can treat threadworm, roundworm and hookworm in a single dose. 'There is no more convenient broad spectrum treatment on the market.' ... 'It's obvious from the early months of 1990, many consumers who tried Vermox last year are moving back to Combantrin, the brand they've known and trusted for many years'."

Again this advertisement depicts two packages of Combantrin in the same form as those mentioned earlier. All statements are made in the context of reasons given by the respondent for the success of its advertising campaign so as to increase its market share as at 4 March 1990 to 62%, with Vermox having a market share of 33%.

This advertisement is said to make representations 1, 2 and 3. In my opinion it makes each of these representations.
This completes the list of representations which the applicant asserts have been made by the respondent.
Section 52
I now turn to the question whether the representations are misleading or deceptive and thus contravene s. 52 or s. 53(f) of the Trade Practices Act. No separate case was made out with respect to s. 53(f), so I shall confine my findings to s. 52.
The accuracy of each of the eleven representations which have been made depends largely on the scientific evidence both oral and documentary. The witnesses who gave evidence on behalf of the applicant were the following:

. Dr J.R.L. Forsyth - the Director of the Microbiological Diagnostic Unit at the University of Melbourne;

. Dr Paul Prociv - Senior Lecturer in Medical Parasitology at the University of Queensland and Associate Senior Research Fellow with the Queensland Institute of Medical Research; . Dr Alexander Henderson - the Chief Microbiologist for the Health Department of Western Australia;

. Dr Norbert Ryan - a hospital scientist in the Clinical Pathology Department of the Fairfield Hospital (Queens Memorial Infectious Diseases Hospital), Victoria;

. Professor David Ian Grove - the Senior Director of the Departmen of Clinical Microbiology and Infectious Diseases at the Queen Elizabet Hospital, Adelaide;

. Dr Terrance Grimmond, the Chief Microbiologist for the Flinders Medical Centre, Department of Microbiology and Infectious Diseases in Bedford Park, South Australia;

. Dr John Charles Walker, a Senior Lecturer in Medical Parasitology in the Department of Medicine at the University of Sydney.

The expert witnesses called on behalf of the respondent were:

. Dr John Edwin Stuart, a practising paediatrician, also a Senior Lecturer in Community Medicine and Paediatrics at the University of Newcastle, New South Wales; Visiting Medical Officer (Paediatrics) at the Mater Misericordiae Hospital, Waratah, New South Wales and Honorar Associate Physician, Royal Alexandra Hospital for Children, Camperdown New South Wales.

. Dr John Marsden Goldsmid, Reader in Medical Microbiology, Department of Pathology, University of Tasmania; . Associate Professor John Sinclair Welch, a Parasitologist and Head of the Department of Medical Laboratory Science, Queensland University

of Technology, Brisbane and an Associate Professor in Medical Science.
70. My description of the position held by each of the witnesses is not exhaustive. All witnesses were well qualified, some highly qualified and of world renown in the field of parasitology.
71. The witnesses who were cross examined were:

. Dr Forsyth

. Dr Walker

. Dr Prociv

. Professor Grove

. Professor Welch

. Dr Goldsmid

There was not a great deal of divergence of opinion between the experts and such differences as did exist were primarily in emphasis; although there was a degree of divergence of opinion between some of the witnesses, in particular Drs Forsyth, Walker and Prociv on the one hand and Professor Welch on the other hand. I have assessed the evidence of each witness, considered the probability and accuracy of it and balanced the evidence of each witness against the evidence of other witnesses by assessing them in the witness box. The firm impression I formed is that Professor Welch was to a degree embarrassed by the emphasis placed in certain of the impugned documents published by the respondent and said to constitute the representations in this case, attributing scientific statements or statements of scientific accuracy to Professor Welch and his published works. I shall return to this question later. It is unnecessary to refer to or summarise the evidence of each of the expert witnesses; what I propose to do is to make my findings, having considered all the evidence.
Threadworm is the most common worm that infests humans in Australia. The eggs from which they hatch can enter the body by physical contact such as licking fingers and eating infected food or sucking something which has been touched by an infected person. Children whose hygiene is not as disciplined as that of adults regularly catch threadworms and because of the ease of transmission they are frequently communicated to their parents and other adults with whom they come in contact. The eggs hatch into worms in the stomach. They grow to about half an inch in length.
A human parasite is endemic in a country if all of the conditions necessary for the transmission of it to human beings are present and the parasite is in fact constantly being transmitted to humans within that country. Threadworm is endemic within the community. Children are mainly affected, but the worm is present in adults also. It is difficult to assess the incidence of threadworm in the Australian community, but studies have shown that, for example, the highest prevalence of threadworm infection is in children aged 3 to 9 years and a figure of about 30% represents the approximate prevalence of threadworm in children with the overall prevalence in adults of about 20% at some stage or stages in their lives. High rates of threadworm are usually discovered in institutions either because of inadequate sanitation, poor hygiene or overcrowding. Some studies indicate that in boarding schools, hostels and dormitories the prevalence rates for threadworm have ranged between 70% to 90%.
Threadworm is treated by drugs. Combantrin can get rid of it with one dose as can Vermox.
Threadworm is fundamentally different from roundworm, hookworm and whipworm in the means of transmission. Threadworms are transmitted from person to person and by bodily contact. An essential condition for the transmission of both roundworms and hookworms is that worm eggs are deposited in the soil in faeces and have an opportunity to develop into a state capable of infecting humans. It is for this reason that both worms are called geohelminths. For either roundworm or hookworm to be endemic in any country it is necessary that the culture and sanitation systems of the country are such as to lead to substantial and regular indiscriminate defecation on the soil surrounding the communities in which people live or systematic use of nightsoil as a fertiliser. The sanitation practices adopted in virtually all places in Australia are such that the essential link in the chain of transmission of roundworms and hookworms, being the seeding of the soil with eggs, is missing. In fact, soil contamination has largely been eradicated as over 85% of Australians live in cities and towns with good sewerage systems. Contact with infected soil is uncommon for populations living in cities and large towns. Exceptions occur in some Aboriginal communities and some closed communities and institutions including psychiatric hospitals, but this is because in such places standard Australian sanitation practices break down.
Other factors also inhibit or tend to inhibit the transmission of roundworm and hookworm. For example, climate and soil conditions in much of Australia. The usual conditions for the transmission of hookworm and roundworm are only found in limited regions of Australia, in particular the coastal areas of northern New South Wales and Queensland. Areas inland tend to be too dry to sustain these worms in the soil.
In summary, the requirements for transmission include the following:

(a) infected individuals;

(b) contamination of the soil by defecation on it by infected individuals or the systematic use of nightsoil which contains faeces from infected individuals;

(c) suitable soils and climates; and

(d) contact with infective soil by uninfected individuals.

Roundworm and hookworm are only endemic in Australia where the climatic and sanitary situations are such as to cause those helminths regularly to be transmitted to humans. They are therefore not endemic throughout most of Australia because the conditions are not suitable either because the standards of hygiene are too high or because the climate is unfavourable. The likelihood of most Australians (excluding special groups such as certain classes of tribal Aboriginals and inmates in mental institutions) contracting roundworm or hookworm in Australia is so small as to be virtually negligible.
Interestingly, most infections with roundworm and hookworm are diagnosed in the southern states, and in cities such as Sydney, Melbourne, Adelaide, Perth and Hobart. This is related to the fact that concentration of the population is greatest in these places. However, in light of the requirements for transmission, they represent little if any threat for the transmission of those worms to the rest of the general public.
Roundworm and hookworm are endemic in many parts of the world. A small proportion of migrants or refugees from countries where roundworm and hookworm are endemic such as South-East Asian countries arrive in this country infected by roundworm or hookworm. The care with which migrants and refugees are screened to detect these problems varies from State to State, but I accept the evidence that few only of the people who arrive here as migrants or refugees are infected with hookworm or roundworm or even whipworm and most of those are treated before they arrive here or upon arrival.
Persons who usually live in Australia but travel abroad and return here may become infected with roundworm or hookworm when staying in endemic areas particularly if they travel for extensive periods or work in endemic areas overseas, for example, troops previously serving in Malaya or Vietnam. Small or light infestations of roundworm or hookworm and other rare worms have sometimes been detected in returning travellers and treated but these infestations are rare.
Roundworm and hookworm are regularly (in the sense of "at fixed times or intervals") diagnosed in Australia but in some Aboriginal settlements, persons in certain institutions, migrants or refugees from endemic areas and some returning travellers. However it seems clear that roundworms and hookworms are rare infestations in Australia. Neither is prevalent or has any real significance in Australia for most Australians.
Other types of worms, namely, whipworm and strongyloides stercoralis are more prevalent in Australia than hookworm or roundworm, though the degree of their prevalence is slight. Strongyloides is the most dangerous of the nematode worms in Australia. Some former prisoners of war who were imprisoned in camps in South East Asia during the Second World War still suffer from it. Strongyloides is also found in mental institutions because it has the capacity to infect human beings from faeces to the mouth without requiring a seeding in soil. Whipworm is more common in Australia than infections from hookworm or roundworm. Although the ecology and mechanisms of transmission of whipworm and roundworm are very similar, whipworm appears in surveys far more frequently.
Combantrin is effective to combat threadworm, roundworm and hookworm, but it does not combat (nor does the respondent claim it combats) whipworm or strongyloides and they are at least as significant in this country as roundworm and hookworm, though none of them (excluding threadworm) have any real significance here.
I note that although Combantrin correctly claims that it can combat threadworm, roundworm and hookworm it does so in its advertising material on the basis that they are the three kinds of worms most likely to infect Australians; whereas the scientific evidence satisfies me that roundworm and hookworm are slightly less likely to infest humans in this country than whipworm and strongyloides. Whipworm and strongyloides are both cured by the applicant's drug Vermox.
Roundworm and hookworm infections are not generally considered life threatening diseases. Roundworm can cause fatal respiratory obstruction but this is extremely rare.
The symptoms of hookworm and strongyloides significantly overlap in many instances and it is difficult on the basis of symptoms alone to determine whether or not a human has either of those worm infections. Also where the presence of intestinal worm infection is suspected it is reasonable to suspect, in addition to hookworm or roundworm, whipworm, strongyloides or tapeworm as possible sources of infection. So the symptoms which a person may explain to a doctor or pharmacist of a gastrointestinal nature may indicate any number of illnesses which have serious medical consequences and which have no relationship whatever to the existence of any human parasite whether roundworm, hookworm or other kind of worm. The presence of symptoms of roundworm and hookworm are not specific and may be consistent with more serious conditions. For example, symptoms of hookworm infection may resemble those of duodenal ulcer or bowel cancer or bone marrow disorders.
Even with hookworm and roundworm in refugees and migrants the worms found are comparatively short lived and most infections are asymptomatic.
Many thousands of stool samples are examined in laboratories every day throughout Australia and worms are rarely detected. High levels of transmission can be seen in closed communities in cities, for example, mental hospitals when hygiene standards deteriorate. Except for threadworm, worm infections are relatively rare in Australia. Where soil-born worms have been prevalent, control using a broad spectrum anthelmintic has reduced levels significantly especially for hookworm and roundworm. Refugees and immigrants entering Australia may be infected with various helminths but these are usually detected and treated. The small number of infections entering the community in this way is not public health risk. Strongyloides may present a problem for immigrants and for the Aboriginal population. Although threadworm is common in children in Australia transmission of soil transmitted worms is unlikely but there is no evidence of an increase in the prevalence of these latter parasites in Australia and recent claims to this effect are not supported by the data.
The conclusions in the above paragraph are taken from a publication of a Round Table meeting being an academic discussion with all guests making contributions on the subject of Human Helminthic Infections in Australia. It was held in Sydney on 23 February 1990 and was sponsored by the applicant. The meeting was attended by a number of highly qualified experts including some of those who gave evidence here, namely, Drs Forsyth, Walker and Prociv and Professor Grove. See Dr Forsyth's affidavit, annexure "A".
Evidence was given by Professor Welch that it is conceivable that local transmission of hookworm could occur in temperate areas whenever a micro-environment is created which is suitable for the embryonation of hookworm eggs and reinfection of human beings. Examples given by him included indoor heated swimming pools and spas, children's play areas and covered market and flower gardens or green houses. Two French scientists, Jacqueimin and Flohican, have published research showing that the intestinal strongyloidaisis parasite can be transmitted from person to person in indoor swimming pools in France ("Role Des Piscines Publiques Daus La Transmission de l'Anguillusose Intestinal" Nouv Presse Med 1975; 4: 2271)." I am satisfied, having considered all the evidence from the experts including oral evidence of Professor Welch himself, that at its highest this evidence could only indicate that there was a logically conceivable possibility of the events occurring to which this evidence relates, and to which he deposed in paragraph 24 of his affidavit of 7 November 1990, and that there is no probability of these events occurring. Some of the examples of the micro-environment such as swimming pools and spas and covered market and flower gardens and greenhouses are highly improbable and at the highest only logically conceivable possible sources given a reasonable number of other assumptions which would together constitute an unlikely set of circumstances in Australia. Professor Welch conceded in cross-examination +hat the word "conceivable" was used by him not to convey any probability that it would happen but that logic prevents it from being excluded and that as a scientist he would not rule out the possibility.
The source of much of the controversy in this case is a three year study undertaken by Professor Welch between 1985 and 1987 in which he surveyed private and public pathology laboratories to determine the incidence of roundworm and hookworm infestations in Australia.
In 1985 Professor Welch was asked by Mr K. Verghese of the respondent whether he would be willing to give expert evidence of his opinion on, amongst other things, the prevalence of hookworm and roundworm in Australia in earlier proceedings in this Court which had been brought by the applicant against the respondent. I shall be referring to these proceedings later, but it is sufficient for present purposes to say that the applicants sued the respondent in this Court claiming that certain advertising material then distributed by the respondent (including a video film, a television advertisement, radio advertisements and brochure) contained representations which were misleading and deceptive and thus contravened s. 52 and s. 53(f) of the Trade Practices Act. Again the rival products were Combantrin and Vermox. The applicant succeeded in the proceedings which were heard by Burchett J. who gave judgment on 7 November 1985 and which is reported in 1986 ATPR 40-654. Professor Welch agreed to give evidence in those proceedings and attended court, but was not required as a witness.
In late 1985 Mr Verghese and Professor Welch had two conversations, the first brief and the second longer. In the second conversation, which occurred after the litigation to which I have just referred, Mr Verghese asked the Professor whether his Department would be willing to undertake research on the prevalence of hookworm and roundworm in Australia. Professor Welch said that there would need to be a survey of a large number of people chosen at random over several years; that you would need to interview each individual about racial background, normal place of residence, overseas travel and so on; that it might be necessary to look at as many as 100,000 participants and require a large team of researchers and other sources. He said to Mr Verghese that a much more modest survey could be undertaken by surveying the pathology laboratories and, although it probably would not reveal precise information about patients, an idea of prevalence would be obtained. He said it would be a relatively simple and cheap study to undertake and that his Department could do it. Mr Verghese asked the Professor to prepare a proposal and budget for the survey and said that the respondent would leave the design and conduct of the survey entirely in the Department's hands, but would expect Professor Welch personally to supervise it. The Department, which is the Department of Medical Laboratory Science at the Queensland University of Technology of which the Professor is the head, received from the respondent $21,000 to cover the cost of conducting the survey and received certain additional grants from the respondent. One grant was an air ticket and hotel accommodation to allow the professor to travel to Sydney in April 1989 to attend a Pharmacy Round Table organised by the Pharmaceutical Society of Australia (N.S.W. Branch) as part of its Self Care programme. The Round Table was chaired by Mr John Bell, Principal Adviser to the P.S.A. Self Care Programme. The third participant was Dr John Stuart, Senior Lecturer in Community Medicine, Faculty of Medicine, Newcastle University. The purpose of the Round Table was to discuss the results of the survey and its public health implications. A summary of the Round Table was written by a journalist and published in the Australian Journal of Pharmacy as a special feature in July 1989. It is this publication that is described as the source of certain of the statements under challenge in this case in the footnote and elsewhere to the Combantrin brochure, the Combantrin pharmacy product reference and the first Combantrin advertisement.

The third Combantrin advertisement, after stating certain alleged facts and figures with reference to hookworm and roundworm, refers to a footnote which is a paper by Professor Welch on Intestinal Parasitic Infections in Australia: An Overview, Proceedings of the 25th Silver Jubilee Annual Scientific Seminar of the Malaysian Society of Parasitology and Tropical Medicine 1989 pp 122-133. This paper, like the article in the Australian Journal of Pharmacy of July 1989, mentioned above, has as its source the study conducted by Professor Welch.
It is this study which is the source of the statements said to be based on scientific research that is the genesis of much of the dispute between the parties. After the discussion in late 1985 with Mr Verghese, Professor Welch proceeded to prepare an appropriate questionnaire to be sent to pathology laboratories. In 1986 450 laboratories were contacted by the Professor's Department by letters which enclosed a questionnaire sheet concerning the number of hookworm and roundworm infections recorded by the relevant laboratory in 1985. All of the laboratories were at the time of the survey accredited by the Department of Health. Similar questionnaires were sent in 1987 and 1988 concerning, respectively, the years 1986 and 1987.
The Professor prepared an unpublished manuscript which is presently under consideration for publication by the Australian Journal of Medical Laboratory Sciences. Until the manuscript is fully considered the Professor is obliged to ensure that the manuscript is not published elsewhere, and he said in evidence that the papers he has given to date concerning the results of the survey have been "overview" papers which do not set out the methodology or the results of the survey in detail.
The study of Professor Welch was severely criticised by the expert witnesses called by the applicant. It must be said in fairness to Professor Welch that he has regarded the study from the outset as a provisional or preliminary one. He said that it was designed to determine whether the data revealed that the prevalence of roundworm and hookworm in Australia was sufficient to justify the expense of a proper study.
The data returned to Professor Welch's Department by the pathology laboratories did not distinguish special groups (such as Aboriginals, migrants, refugees and travellers returning from overseas) from the population as a whole. The questionnaire was not designed to differentiate between special groups and the rest of the community. Indeed, the questionnaire was not sent by Professor Welch to selected specialists laboratories which he knew regularly examined people from places which have an environment particularly conducive to parasitic infections such Aboriginal communities or institutions including mental homes, dormitories, orphanages or prisons. They were deliberately excluded because they were specialist laboratories and only dealt with specimens from those particular groups. Professor Welch said that this is explicable on the basis that his study was a provisional one.
Some of the laboratories were excluded because they would have examined a large proportion of Aboriginal specimens. The Professor said he knew that not all Aboriginal specimens went to those specialist laboratories. Because the study did not differentiate between special groups such as Aboriginal communities and certain institutions and because the specimens received by the laboratories which were the subject of their reports to the Professor's Department may be from the special groups, the data would be unreliable. For instance, a number of laboratories in South Australia and Western Australia regularly examine specimens from immigrants and Aboriginal populations which clearly bias the study and make the data unreliable. It is unreliable because it is not known what population subgroup was the source of the sample taken and therefore it cannot be said whether the result of the sample is representative of the whole population. In the result the data was highly skewed.
Also the questionnaire sent to the laboratories which participated in the study asked only for the total number of diagnoses per year of that study, it did not ask for the total number of specimens examined in each laboratory in each year. Thus the study did not determine prevalence of hookworm or roundworm, as a survey attempting to determine the number of cases proportionate to the population would require inclusion of both positive and negative results of the samples and the study did not do that. It is not possible to tell from the data the number of specimens or the number of patients actually tested. The population which the figures represent in the study is totally unknown as Dr Goldsmid, one of the witnesses for the respondent recognised in his affidavit of 13 November 1990, in paragraph 44:

"the survey did not elicit information about the total number of faecal specimens examined by the laboratories in each year. In other words, the study does not show in which proportion of faecal specimens examined hookworm and roundworm ova were ultimately found."

A further criticism of the survey is that it was conducted on the basis of the locations of the laboratories without any means of identifying the geographical origins of the specimens. The analysed specimens were assumed to have originated from the same postal district as the laboratories and were then analysed as part of that district's population and extrapolated to the rest of Australia. The results are inaccurate as the locality of the laboratories does not necessarily correlate to the locality of the specimens. Most major reference laboratories are located in capital cities and many of them receive samples from far and wide. There is evidence that one laboratory (the Flinders Medical Centre, Department of Microbiology and Infectious Diseases in Bedford Park, South Australia) occasionally receives samples from northern regions of South Australian and the Northern Territory. The relevant parasitology laboratory at Westmead Hospital, Sydney is a reference laboratory and receives samples even from New Zealand. Professor Welch himself agreed that the residential status of individuals in his study was not recorded and that the data recorded describes the actual records of hookworm and roundworm diagnosed within the survey location. He also agreed that the evaluation and conclusions from the accumulated parasitological data should be interpreted with caution for it is known that individuals from country areas may be referred to capital and provincial laboratories pathological testing.
Another problem with the study is that it is not possible to tell from the data how many of the specimens sent to pathology laboratories were "double counted" owing to the same specimen being examined more than once. Medical personnel frequently ask for a repeat test on a sample in order to confirm a positive result. Unless the number of the test is identified on the one sample there is a serious risk of "double counting" which would prejudice the validity of the results obtained. There are at least two possible sources of double counting; first, more than one test may be made of the same patient to check an earlier diagnosis or later to check that the treatment has been successful; and second, the referral of patients from one laboratory to another. In other words, is impossible to tell from the data how many of the specimens sent to pathology laboratories have been "double counted" owing to repeated specimens being examined, which may often happen and this can lead to "double counting" of positive results which would seriously prejudice and undermine the results obtained.
A further imperfection in the study which expert witnesses said existed was that there was no information provided in the study about egg count which indicates worm burden and thus the likelihood of hookworm disease. It is from a calculation of egg count that there may be derived an estimate of the number of worms of a given species infecting the patient. Manifestations of hookworm disease as distinct from the fact of individual infection are heavily dependent on the worm burden and the nutritional state of the patient. Dr Forsyth gave evidence that his experience in the case of Indo-Asian migrants or refugees indicated that heavy concentrations of eggs in the stools of patients are rare and are influenced by anthelmintics given to the patients in camps before they migrated to Australia. He said it was the scale of the worm burden which determines the risk of hookworm disease and that the study could not provide evidence concerning the likelihood of hookworm disease because it gave no information about the egg count which indicates the worm burden and thus the likelihood of the disease.
Professor Welch also undertook a limited study in 1988 but the manuscript does not indicate how the study was limited and why it was so limited. The study did not identify whether the individual shown to be infected by the 1988 data was also included in the data collected from the previous years 1985 to 1987. The questionnaire used in relation to the 1988 data in the study asked for the total number of positive diagnoses of hookworm and roundworm to be categorised as one of "Australian residents", "Australian travellers", "Other travellers" and "Migrant groups". There was no separate category for Aboriginals so it must be that the Aboriginal data was included under one of the other headings, thereby making the results unreliable. Further the laboratories which responded to the questionnaire in 1988 were not asked to explain how they determined the racial origin of the population. In busy diagnostic laboratories the technicians have little or no time to obtain such specific information and quite often the specimens arrive only with a laboratory's number and even if they did have names on them, that would not be an indication of racial origin. The inclusion of results from Aboriginals in communities, who are often not detectable by name and who represent heavily infected subgroups in many parts of Australia, would greatly bias the result.
Without going into the details of Professor Welch's awareness of some of the limitations of his study, it is fair to say that he frankly conceded in the witness box a number of the limitations. He said that he was aware of some of the limitations at the inception of the survey and some became apparent as the survey progressed.
Dr Forsyth concluded that the study was "unsound and scientifically unreliable". He said "any suggestion that the concept of prevalence in Australia of hookworm and roundworm disease can be measured from the figures set out in the study is erroneous in the absence of denominators. The design of the study was inadequate and its execution inherently unlikely to provide useful data".
Dr Forsyth also said:

"At the moment the only information which can be deduced from the Manuscript is that laboratories in Australia are able to identify diagnostic forms of hookworm and roundworm and that most patients found in the Southern metropolitan cities to have these can be identified as coming from known endemic areas. ... In my opinion the results of the study ... do not confirm that there is an increase in the prevalence of roundworm and hookworm in Australia."

Dr Walker said:

"In my opinion, the study is so defective in its method and application that it cannot support the proposition that there has been any increase in the cases of roundworm or hookworm either generally or in the southern States of Australia."

Dr Goldsmid who was called for the respondent criticised the study, though not as trenchantly as did Dr Forsyth and Dr Walker, but he plainly had considerable reservations about it. He said, for example, that he did not agree that the data "strongly suggests" (the words of the manuscript) that roundworm and hookworm are endemic throughout Australia and have a much wider distribution and range and prevalence rate than has been previously reported. Dr Goldsmid said that "the prevalence of hookworm and roundworm infections in Australia (as they appear from Dr (sic) Welch's data) are not alarming".
I accept the criticisms of the study to which I have referred and which are to be found principally in the evidence of Dr Forsyth, Dr Prociv and Dr Walker. Certain of the material which underlies the criticism is to be found from the evidence of Dr Henderson and Dr Ryan. However, in fairness to Professor Welch it must be remembered that he was preparing only a provisional study, so that whether a full and proper epidemiological study would be justified would depend on the results of the provisional study. He was aware of a number of the deficiencies in the study and frankly accepted them. Indeed, some of them are referred to in his own manuscript.
Professor Welch gave evidence that from his discussions with Mr Verghese of the respondent he believed that he would have suggested that there were limitations in the accurate determination of prevalence in his study and that Mr Verghese would have known from the discussion that it was a "descriptive" study in the sense of the first step in analysing the data. He said that the basis of his arrangements with Mr Verghese was a study to be relatively inexpensive and which could yield results of at least sufficient scientific validity to determine whether a proper definitive study was warranted. When asked in cross-examination examination by counsel for the applicant if he suggested to Mr Verghese that the results of the study could be treated as if they were definitive and scientifically accurate, he said "I don't believe I made that comment". Professor Welch said that he had discussions with Mr Verghese subsequent to the initial discussion in relation to the caution with which the results must be used and that he probably raised the issue of migrants as being a very relevant source so that Mr Verghese or the respondent had been aware of some of the reservations which he held but not all of them. Mr Verghese did not give evidence in the case.
In my opinion the respondent must have been aware that the study which it had commissioned from Professor Welch's Department was a preliminary one from which it would be determined whether the data was such that the prevalence of roundworm and hookworm in Australia was sufficient to justify the expense of a fuller and proper study. The respondent knew that it could not regard the study as being definitive and scientifically accurate although it no doubt was entitled to believe from the discussions between Professor Welch and Mr Verghese that the results which the study yielded did produce sufficient material to justify a fuller and definitive study.
Professor Welch was aware that the respondent had in its possession the Round Table Publication which appeared in the Australian Journal of Pharmacy in 1989. Professor Welch provided the respondent with a copy of the overview in 1989 and he assumed that the respondent would be using the Round Table publication for part of its advertising campaign.
The question now arises whether the representations which I have held to have been made in the various advertising material of the respondent were misleading or deceptive within the meaning of s. 52. I shall consider this question using the same numbers as I have used to identify each representation.
Representation 1
It is plain, in my opinion, that this representation is inaccurate and that it constitutes misleading conduct within the meaning of s. 52 of the Trade Practices Act. Scientific evidence before the Court, which I accept, establishes that roundworm and hookworm are only of minor significance in Australia and that they are not reasonably likely to infect persons living under ordinary Australian standards of accommodation, hygiene, sanitation and enjoying other aspects of Australian life. I need not elaborate on this finding further because it follows from my earlier findings with respect to the scientific evidence.
Representation 2
It is misleading to say that roundworm and hookworm are prevalent throughout Australia and that the public is warranted in believing that it is appropriate to treat persons suspected of being infected by a human infesting worm with Combantrin which treats roundworm and hookworm as well as threadworm in a single dose. My earlier findings on the scientific evidence was that the prevalence of these worms was small and confined to certain groups. Also two other types of worms, as to which no claims are made by the respondent for Combantrin, would have to be included in any truthful statement about prevalence of worms presenting a health risk in Australia, namely, whipworm and strongyloides. Yet Combantrin does not treat these two varieties of worm.
Representation 3
This is plainly misleading. The statement in this representation that scientifically reliable recent research in Australia justifies the statement that roundworm and hookworm are regularly infecting Australians throughout Australia is of course a reference to Professor Welch's study. That study is not scientifically reliable and it does not justify the statement that roundworm and hookworm are regularly infesting Australians throughout Australia. As I said earlier it is a provisional study which is not a reliable scientific basis for conclusions to be drawn. Indeed, Professor Welch himself fairly recognises this in substance.
Representations 4, 5, 6, 7 and 8
The accuracy of these representations turns on the reliability of the Welch study and what I have said above applies to them also, and I draw the same conclusions, namely, that contraventions of s. 52 have occurred upon the making of each of these representations.
Representation 9
This representation is also misleading for substantially the same reasons as I have already given in the case of the other representations. It is inaccurate to make the claim involved in this representation.
Representations 10 and 11
For the same reasons these representations are misleading and constitute contraventions of s. 52. They too are based on the Welch study.
A great deal of evidence was adduced in this case that was critical of Professor Welch's study. I concluded earlier that the study is unsound and scientifically unreliable. I need not elaborate on that finding further. It is supported by the highly qualified experts called by the applicant and indeed by some of the evidence called by the experts on behalf of the respondent. Much of it is conceded by Professor Welch himself because the study was, as he told the respondent and as the respondent knew at all times, a provisional one. The respondent should not have made the representations which I have held it did make on such a scientifically unreliable base. It made assertions with respect to matters of public health for the purpose of improving the market share of Combantrin as against Vermox and it must have known that the base for its greater market share was a statement suggesting that worms of one kind or another were prevalent in the Australian community, in particular threadworm, roundworm and hookworm; and that its single dose product could cure those three diseases whereas Vermox required multiple treatments in the case of roundworm, whipworm and hookworm and was only effective in a single dose with respect to threadworm. The respondent was faced with the strong findings against it made by Burchett J. in 1985 in a case which was substantially the same as the present case. It then put in train the events that led to Professor Welch's study. The respondent then used this, a flimsy reed indeed, to improve Combantrin's share of the market (which has been very successful) against the market share of Vermox. All that can be said in favour of the respondent's conduct is that at least it made the representations encouraged by the finding of Professor Welch in his study, but it well knew that it was only a provisional study. In the field of public health when dealing with people's fears and care for their health, the respondent should not have engaged in the conduct which is central to this case.
Relief

This is a strong case for appropriate relief. Prima facie the applicant is entitled to the injunctive relief for both negative and mandatory injunctions, mentioned in paragraphs 1 to 10 inclusive, 13, 14 and 15 of the application. As to the power of the Court to make mandatory orders requiring publication of corrective advertisements, I adopt the statements made by Burchett J. in the early Janssen case at 47-295 which supports the making of such orders. I say that these are my prima facie views as to the appropriate injunctive relief to be granted because at a directions hearing on 20 June 1991 (11 days before the hearing) the respondent by its counsel proffered undertakings to the Court without admissions in the following terms:

"Without admissions Pfizer Pty Limited undertakes to this Honourable Court that it will not in trade or commerce, make any of the following representations or any representation to the same effect:

(a) That the number of diagnosed Hookworm cases in Australia increased by 30% between 1985 and 1987.

(b) That Hookworm incidence in Australia increased by 33% between 1985 and 1987.

(c) That between 1985 and 1987 810 cases (68%) of hookworm cases occurred in cool temperature zones.

(d) That between 1985 and 1987 699 cases (96%) of roundworm cases occurred in Southern areas of Australia.

(e) That the vast majority (78.6%) of confirmed hookworm and roundworm infections between 1985 and 1987 occurred in residents from cold, dry and developed urban areas of Southern Australia (including NSW, Vic and SA)."

The undertakings relate to the representations numbered 4, 5, 6, 7 and 10 and they concern such parts of those representations as relate to percentages of cases of roundworm or hookworm in Australia which were diagnosed, occurred or were confirmed, as the case may be. The essence of the representations remains unaffected by the concessions inherent in the undertakings, so the only relevance they could have, if any, is as to costs. In my opinion they have no bearing on the question of costs because if one excises from the representations the elements covered by the proffered undertakings one is still left with the essence of the applicant's case. It was not unreasonable for the applicant to have continued with the prosecution of its case after the proffering of the undertakings.
In my opinion the respondent should pay the costs of the applicant of this proceeding. That order should not be diminished by the fact that the undertakings were proffered on behalf of the respondent.
Counsel for the applicant placed considerable reliance upon the judgment of Burchett J. in the earlier Janssen Case. He did not suggest that it gave rise to the application of the doctrine of issue estoppel but submitted that it should be taken as the starting point for this case and in particular for the Court's findings. I reject that submission. I do not know what evidence was before Burchett J. in 1985 except the evidence to which his Honour referred in his reasons for judgment. All I know about the earlier case is what is recorded in those reasons. They are of interest historically and as a judgment of another Judge of this Court to be read and treated with interest and respect. I note however that many of the findings made by his Honour are echoed in my findings but I do not think that the judgment can be put to any other use in the present case than as of historical interest.
The orders of the Court will make provision for directions with respect to the remaining issues in the case which will predominantly be questions of damages, if any.
Cross Claim
That leaves the respondent's cross-claim. The respondent cross-claims against the applicant to restrain it from engaging in conduct which is said to be misleading and deceptive and to constitute contraventions of ss. 52, 53(c) and 53(f) of the Trade Practices Act arising from the following:-

. the distribution to pharmacists in Australia of a pamphlet entitled "Vermox for Worms. Nothing Could Be Simpler" (the "Vermox pamphlet").

. publishing and inserting in Your Pharmacy magazine for distribution to pharmacists a supplement entitled "Across the Counter" (the "Vermox Supplement");

. publication by the applicant as an insert in Family Circle magazine and also distributed to pharmacists for on-distribution in turn to consumers of a pamphlet entitled the "The Volley Vermox Growth Chart and School Holiday Planner" ("the Volley Vermox pamphlet"); . publication by the applicant in the Australian Journal of Pharmacy, volume 71, January 1990, of certain representations about Vermox and the same representations in an insert in the journal "Your Pharmacy", July 1990 edition and on page 13 of "Your Pharmacy Magazine", January 1990 edition.

. the distribution to pharmacists in August 1989 of a sales promotional brochure entitled "Theory No. 2: Television makes parents smarter about treating worms" (the "Vermox Sales Brochure"). . the distribution since about 1989 to pharmacists for distribution to the public of a production information leaflet ("the Vermox production information leaflet") with its product known as Vermox.

Each of these documents is said to contain misleading or deceptive information.
The Vermox Pamphlet
The respondent asserts that various representations have been made in this pamphlet. It is asserted that it represents that:

"(i) As many as one in three children between the ages of three and twelve years, and one in five adults could be infected with threadworm ('representation (i)').

(ii) The estimate referred to above is based upon scientifically reliable data which is statistically significant. ('representation (ii)')

The Vermox pamphlet states on its second page:

"HOW COMMON ARE THREADWORMS?

As many as 1 in 3 children between the ages of 3 and 12 years, and 1 in 5 adults, could be infected with threadworms.1"

The footnote reads:

"Data on file."

The representation in (i) above is clearly made by the Vermox pamphlet; however it is a statement as to what the possible prevalence of threadworm may be, not a statement as to its actual or general prevalence. In relation to the representation which was said to be made in (ii) above, the Vermox pamphlet certainly conveys to the reader by reference to the footnote that the applicant is in possession of scientific data which makes it reasonable to assert that statement (i) is correct. There is no evidence before the Court bearing upon the correctness of the assertion made in representation (i) save what can be gleaned from certain portions of the evidence of experts which does not touch it directly but none of it seems to me to be inconsistent with the assertion in (i). Whether or not the applicant does in fact have in its possession scientific data bearing upon the correctness or otherwise of the statement in (ii) is not the subject of any evidence before me. It follows that the respondent's case with respect to these representations has not been established.
(iii) It is further alleged by the respondent that the Vermox pamphlet represents that "It is an advantage to the ordinary consumer that Vermox is effective against whipworm" ("representation (iii)"). On page 2 of the pamphlet the statement appears:

"Vermox is effective against all these worms - unlike pyrantel (Combantrin) which is not effective against whipworm."

The context in which this statement appears in the Vermox pamphlet is fundamentally different from the context in which the various claims are made by the respondent in the Combantrin documents the subject of the statement of claim. The Vermox packets depicted on the first page of the pamphlet state that it is to control threadworm and makes no reference to whipworm. At page 2 of the pamphlet it is stated that because of Australia's high living standards threadworm is the only type of worm commonly appearing in Australia. The particular part of page 2 in which the statement complained of in this representation is made is headed "Why Australians are protected from other types of worms". The pamphlet then states:

"Unlike threadworms, rare worms such as roundworm, hookworm and whipworm depend on poor sewerage systems and warm, moist soil. Australia has a dry climate and the majority of Australians (87%) live in cities and large towns with efficient sewerage systems. These factors help protect us against rare worms. Isolated cases of rare worms can still occasionally be found in Aboriginal communities and in tropical areas. They are rarely seen in urban Australia, unless imported by unsuspecting tourists returning from some overseas countries. Even in this circumstance, rare worms cannot be transfered from person to person in Australia without poor sewerage.

In Australia, only a few cases of rare worm are reported each year in a population of around 16,000,000.

Infections with rare worms can be serious and medical advice should always be sought."

That section concludes with the passage the subject of the alleged representation (iii). In my opinion, the impression to the reader would be that rare worms including whipworms are most unlikely to be present in Australia, but that to the extent that they may be found, Vermox, unlike Combantrin, is effective against whipworm.
In my opinion this representation is not made because the alleged representation suggests that there is a real possibility that the ordinary consumer (whoever he or she might be) may suffer from whipworm. This implication cannot fairly be gleaned from the document.
(iv) The next representation claimed to be made is that "Vermox is more effective against threadworm than Combantrin" ("representation (iv)"). This representation is not made in terms in the pamphlet. So far as I can see the only relevant part of the pamphlet (and the part relied on by counsel for the respondent) that could bear on the representation is on page 1, under the heading "How Does Vermox Work?", where the following appears:

"Unlike pyrantel (Combantrin) which paralyses the worms, Vermox works by killing the worms which live in the bowel."

In my opinion this statement cannot be interpreted reasonably as making the representations which is alleged in (iv). It simply states the facts, namely, that Combantrin paralyses worms whereas Vermox kills them and both those are scientifically correct statements. I do not think the reader could reasonably imply that the pamphlet is saying that Combantrin only temporarily paralyses worms whereas Vermox kills them.

(v) The representation that Vermox is effective against threadworm, roundworm, hookworm and whipworm ("representation (v)") and (vi) that it is an advantage to the ordinary Australian consumer that Vermox is effective against roundworm, hookworm and whipworm ("representation (vi)") are the next representations claimed. Complaint is not made as to the accuracy of representation (v). It is made in the Vermox pamphlet and is not alleged to be false.

In my opinion, representation (vi) is not made in the Vermox pamphlet. The material relied upon to found the alleged falsity of representation (vi) is the same as is relied upon with respect to representation (iii) and I rely upon what I said there to support my finding that this representation has not been made.
(vii) The next representation is that as a consequence of the fact that Vermox is administered in the same single dose quantity, irrespective of the consumer's weight, nothing could be simpler for the treatment of worms than Vermox ("representation (vii)"). The dosage instructions for the use of Vermox is given on the second page in a dosage chart under the heading "Compared with other treatments, nothing could be simpler than Vermox". Above that are five paragraphs with the heading "Treating your family with Vermox Tablets or Suspension". Immediately following that heading the words appear:

"Unlike other threadworm treatments, Vermox provides a simple treatment for the family ...

Because of the ease with which threadworms spread, it is advisable to treat all members of the family.

The simple dosage of Vermox makes it easier to treat those family

members without symptoms, who may not want to swallow a handful of tablets." The complaint is that the alleged representation is false because a single dose of Vermox is only effective against threadworm and that multiple doses are required to treat hookworm, roundworm and whipworm.
135. When the statement complained of in (vii) is read in the context of the Vermox pamphlet as a whole it is I think correct, as counsel for the applicant submitted, that it is dealing only with the dosage of Vermox in the treatment of threadworm. The complaint is not established.

The Vermox Supplement

Representation (i) and representation (ii) are also said to be made in the Vermox supplement. The statement mentioned in the Vermox pamphlet is also mentioned in the Vermox supplement on page 1 under the heading "Threadworm". The difference here is that there is no footnote referring to "data on file" but the applicant accepts that the making of a statement such as that involved in this alleged representation implies that there is some scientific basis for it, an acceptance with which I agree. I make the same findings as I made earlier with respect to representation (i) and representation (ii).
It is next said that representations (v) and (vi) are made in the Vermox supplement. The introduction to this document states:

"Threadworm is the most common worm infection in Australia. Other worm species such as roundworm, whipworm and hookworm occur only very rarely in Australia and so are not really a problem here."

On page 3 it is further stated that:

"While they (mebendazole and pyrantel) are equally effective in getting rid of threadworm, Vermox is the only one which is effective in the treatment of roundworm, hookworm and whipworm also".

Again it is not suggested that representation (v) is false.

Reading the whole of the document, and in particular column 3 on the front page, I am satisfied that the reader would form the view that there is little risk of an ordinary Australian contracting roundworm, hookworm or whipworm. The document gives a substantially balanced account of why soil transmitted worms are rare in this country. The representation that is being made, in my opinion, is that it is most unlikely that an Australian will contract roundworm, hookworm or whipworm, but if he or she does, Vermox is the only treatment that is effective against all three worms. It is not a fair reading of the document to conclude that the applicant is suggesting that a member of the public should purchase Vermox for the purpose of curing worms other than threadworm. Representation (vi) is not made in the Vermox supplement.
Representation (viii) is that Vermox is the only treatment that is effective against threadworm, roundworm, hookworm and whipworm by taking one tablet ("representation (viii)"). Page 3 of the document contains a statement:

"While they are equally effective in getting rid of threadworm, Vermox is the only one which is effective in the treatment of roundworm, hookworm and whipworm also.

In addition, Vermox is the only treatment that requires taking one tablet once as opposed to pyrantel dosage which depends on patient weight calculations."

The question of dosage is dealt with also on page 3 and it states:

"Usually a single dose of Vermox (tablet or suspension form) or other worm medication is an effective way to get rid of most worm infections in the household.

However, unlike other threadworm treatments, Vermox provides a simple treatment.

One tablet or one 5 ml dose of suspension, once only, is all that is needed for each member of the family.

There are no weight calculations; no dosage calculations and no chance of taking the wrong dose."

Although the essence of the document is with respect to threadworm, the particular part of it mentioned above commencing with the words "In addition ..." does on a fair reading amount to the making of this representation.
In my opinion representation (viii) is made in the Vermox Supplement and it is false. Prima facie the applicant should be restrained from making this representation which in my opinion is misleading conduct under s. 52. However, whether the injunction should be granted or an undertaking accepted is a matter which can be considered when short minutes of order are brought in by the parties.
Representation (ix) is that for the average Australian family the only possible form of contact with roundworm, hookworm and whipworm is in Aboriginal communities, isolated tropical areas and travelling in third world countries ("representation (ix)"). This representation is made in a section of the document headed "Questions and Answers"; but it must be read in the context of the whole of the document including the giving of scientific information under the heading "Other Types of Worms", the further heading "Dr Walker's Comments" and a map on page 2 which depicts areas which "Represents areas where threadworm is the only common human infecting nematode worm, and soil-borne worms have always been rare or virtually been eliminated". In my view, it has not been shown that, representation (ix) is false, misleading or deceptive.
Volley Vermox Pamphlet
It is claimed that representations (i) and (ii) are made in the Volley Vermox Pamphlet as well. Although the wording of the Volley Vermox Pamphlet is different in certain respects to that used in the Vermox pamphlet, there is no material difference and my conclusion is the same.
It is also claimed that representation (iv) is made, namely, that Vermox is more effective against threadworm than Combantrin. The matter complained of is on page 3 of the Volley Vermox pamphlet which states:

"Vermox containing mebendazole passes through the body into the bowel where the worms live, blocks the processes which keep the worm alive in the intestine and causes them to die. Other worming treatments (which use pyrantel), such as Combantrin, merely paralyse the worms."

Counsel for the applicant submitted that, read in context, this statement should not be construed as an assertion that Combantrin is less effective than Vermox because of the different effect that each drug has on threadworms, that is, paralysis as compared to death. He submitted that the Volley Vermox pamphlet is prepared in simpler language than is the Vermox pamphlet or the Vermox supplement and that the Volley Vermox pamphlet does not purport to deal fully with the mechanism by which each drug acts. I do not accept this submission. I think the reader would assume from reading this particular part of the pamphlet (and I see nothing in the context in which it appears to lead to a different conclusion) that Vermox is represented as having an advantage over Combantrin in that Vermox kills the worms but Combantrin merely paralyses them, that is Combantrin does something which is less effective than killing worms and which may keep them alive in some way inside one's body. The respondent is entitled to relief in relation to this representation and my earlier comments made in relation to the Vermox Supplement and representation (viii) apply here.

Representation (vii) is also claimed to have been made, namely that as a consequence of the fact that Vermox is administered in the same single dose quantity, irrespective of the consumer's weight, nothing could be simpler for the treatment of worms than Vermox. This representation is not in fact made in this document. Read fairly the pamphlet deals only with the dosage given to cure threadworm. I do not think it can be reasonably inferred that what is said about dosage means that a single dosage is effective in relation to any other kinds of worm than threadworm. In fact, with the exception of a paragraph on pet's worms, other worms are not discussed in the pamphlet except in the context of some children's riddles, for example, "What kind of worm would you use to measure a ball? A roundworm."
Australian Journal of Pharmacy Vol 71

It is claimed that this "article" represents that Vermox is a broad spectrum anthelmintic and is effective against threadworm, roundworm, hookworm and whipworm ("representation (x)") and that it is an advantage to the ordinary Australian consumer that Vermox is effective against roundworm, hookworm and whipworm (representation (xi)").
It is true that representation (x) is made, but it is not asserted that this representation is false, misleading or deceptive.
The article is headed "Big Vermox sales rise" and contains the statement:

"A broad-spectrum anthelmintic, Vermox also treated roundworm, hookworm and whipworm, a company spokesman said."

I think the average reader would assume on reading this part of the article, not that hookworm, roundworm and whipworm are particularly prevalent, but that to the extent that they are in the Australian community Vermox can combat them. Further, while the article does suggest that the big sales rise was due primarily to the "simplicity of the product" in relation to threadworm, the statement quoted above appears next and suggests that the increase in sales was also partly due to the fact that it treated roundworm, hookworm and whipworm as well. This implies that Vermox had an advantage in this area over other products. However, it must be remembered that the article is directed to pharmacists, not the public generally.
In my view, representation (xi) has been made out. In light of my earlier findings in relation to the scientific evidence and the absence of other explanation (as in the Vermox Pamphlet with respect to representations (iii) and (vi) and the Vermox Supplement with respect to representation (vi)), representation (xi) is misleading. Prima facie the applicant should be restrained from making this representation. However my comments regarding relief with respect to representation (viii) and the Vermox Supplement apply equally here.
Your Pharmacy (July 1990 Edition)
Representations (x) and (xi) are said to be made here. Again representation (x) is made but this is not challenged. However, in my view, representation (xi) is not made in this document. On page one there is a statement "These have reduced the prevalence of worms, including whipworm ..." but this is made in relation to Queensland Aboriginal population ("these" is a reference to "effective anthelmintics, especially those with a broad spectrum of activity such as mebendazole"). There are references to "rare worms" and there is a statement under the heading "Prevalence of Threadworm in the Australian Community" in relation to roundworm, whipworm and hookworm that:

"Unlike roundworm, whipworm and hookworm, threadworm (pinworm) is not a soil-transmitted worm, according to Dr Paul Prociv ..."

The section then proceeds to deal only with threadworm. On page 2 there are separate discussions on "Queensland Aboriginal Communities" and "Refugee Populations in Australia" which would bear no relationship to the "ordinary Australian consumer". On page 3 there is a discussion about the "Environmental Determinants of Soil Borne Worm Transmission", which I referred to earlier in my reasons with respect to the scientific evidence as correctly summarising the scientific evidence. Lastly, on page 4 there appears the following:

"... (Vermox) is extremely safe and effective against most parasites including whipworm, roundworm, threadworm and hookworm."

And later on in page four, under the "Conclusion" heading appear:

". Except for threadworm, worm infections are relatively rare in Australia.

. Where soil borne worms have been prevalent, control using a broad spectrum anthelmintic has reduced levels significantly, especially for hookworm and roundworm."

If the first statement I have quoted from page four was given alone, my comments regarding the last article would be applicable. However they appear in a context where it is made clear that representation (xi) is not made.

Your Pharmacy (January 1990)

Representations (x) and (xi) are also alleged to be made here.
Representation (x) is made but again no complaint is made of this. As to the representation (xi) the article states:

"The spokesperson also emphasised that convenience was not the only Vermox advantage. 'Although threadworm is the most likely worm for which customers seek treatment, it's comforting to know that Vermox is a broad spectrum anthelmintic which treats threadworm, roundworm, hookworm and whipworm (unlike Pyrantel based brands which are ineffective against whipworm)'."

That paragraph is one of a number of paragraphs which seek to explain why sales of Vermox "flourished". This article is similar to the Australian Journal of Pharmacy article. It clearly asserts that the ability to treat those three worms is regarded as an advantage by the applicant, resulting in increased sales, and, in the context in which it appears, it suggests that this is an advantage to ordinary Australian consumers (who must be presumed to be the purchasers increasing Vermox's sales). The representation in this context is false, misleading and deceptive conduct in breach of s. 52. Again, my earlier comments regarding relief apply in this respect.
Representation (iii) is also claimed to have been made here, namely, that it is an advantage to the ordinary Australian consumer that Vermox is effective against whipworm. This is essentially the same representation as is alleged in (xi) and it has the same answer.
Vermox Sales Brochure
Representation (xii) is that mebendazole, the active ingredient of Vermox, is the only preparation that treats threadworm, roundworm, hookworm and whipworm ("representation (xii)").
Representation (xi) is also claimed to have been made, that it is an advantage to the ordinary Australian consumer that Vermox is effective against roundworm, hookworm and whipworm.
Representation (xii) is made in this document but there is nothing to suggest that it is false and nor it is pleaded that it is false. As to representation (xi) there is a statement in the brochure under the heading:

"Theory No. 6: It's Better to be Safe Than Sorry. Vermox treats all known worms. Threadworm is probably the only worm which your customers are ever likely to need treatment. However, it is comforting to know that mebendazole, the active ingredient of Vermox, is the only preparation that treats threadworm, roundworm, hookworm and whipworm".

As the brochure does not suggest that there is any real likelihood that ordinary Australians will suffer from worms other than threadworm, representation (xi) is not made out. The third sentence distinguishes this article from the Australian Journal of Pharmacy article and the Your Pharmacy article.

Representation (xiii) is that Vermox treats all known worms ("representation (xiii)"). This is a reference to the words which I have just quoted under Theory No. 6. The representation has been made and it is plainly inaccurate as the applicant concedes. The applicant proffers an undertaking to the Court that it will not in the promotion of Vermox make that statement or any statement to that effect. When short minutes of order are brought in that undertaking should be incorporated in them.
Vermox Product Information Leaflet
Representation (xiv) is that Vermox is effective against whipworm, large roundworm, hookworm and strongyloides ("representation (xiv)").
Representation (xv) is that it is an advantage to the ordinary Australian consumer that Vermox will cure most of roundworm, hookworm, whipworm and strongyloides infections ("representation (xv)") and representation (xvi) is that it is an advantage to the ordinary Australian consumer that Vermox is effective against whipworm, large roundworm, hookworm and strongyloides ("representation (xvi)").
The representation alleged in (xiv) is made in this document but it is not claimed that it is false. In my view, representations (xv) and (xvi) are not made.
Under a heading "RARE WORM TYPES SYMPTOMS" the following is stated:

"Infections with soil-borne worms such as whipworm, large roundworm, hookworm and strongyloides are extremely rare in Australia, as they are associated with poor disposal of human waste matter. If infection with one of these rare worms is suspected, for example after an overseas trip to an endemic country, you should consult your doctor for positive worm identification. ... these types of symptoms should be referred immediately to a doctor."

Under the heading "TREATMENT OF RARE WORM TYPES" the following appears:

"Whipworm, large roundworm, hookworm and strongyloides are extremely rare in Australia - should infection occur then a doctor should be consulted.

One Vermox tablet twice daily for three days will cure most of the above infections. Pyrantel (Combantrin) ... is not effective against whipworm or strongyloides infections."

The document makes it clear that worms are rare and are associated with "poor disposal of human waste matter". I do not think it is reasonable to infer that an ordinary Australian consumer would infer that he or she is at risk in Australia of contracting any of these rare conditions so that it would appear to be an advantage to such a consumer to buy Vermox. Indeed, the document does recognise the possibility that Australians might contract the rare worms "after an overseas trip to an endemic country". This is true. The document then states that where this is suspected a doctor should be consulted for positive worm identification. This also tends to negate any advantage to "ordinary Australian consumers" argument. There is therefore nothing incorrect about stating in the document that Vermox is effective in treating these rare worms.

So much for the cross-claim. I have dealt with most of the alleged representations in the cross-claim briefly because there are many of them and they inter-relate with each other to a fair degree. They are also essentially matters of impression gained upon reading the relevant documents and where appropriate with the background of scientific knowledge afforded by the evidence in the case.
The applicant proffers an undertaking to the Court that it shall not in the promotion of Vermox make the statement "Vermox treats all known worms" or any statement to that effect, as mentioned by me earlier, or represent that Vermox should be selected as a form of treatment for threadworm, whipworm, hookworm and roundworm on the ground that it is better to be safe than sorry and treat all of these worms (if present) where the presence of any worms is suspected. These can be embodied in short minutes when brought in. If either party wishes to proffer undertakings rather than suffer injunctive relief I will hear counsel on that question when the short minutes are brought in.
I turn to the costs of the proceeding. The applicant has succeeded on its claim and is therefore entitled to its costs from the respondent. The respondent has been partly successful on its cross claim, but largely unsuccessful. Most of the proceeding, including the final hearing, was devoted to the applicant's claim, not the cross claim of the respondent. Rather than make separate orders for costs of the claim and cross claim, which would create considerable difficulties on taxation, the fair and proper order for costs will be that the respondent pay three-quarters of the costs of the applicant of the proceeding (the proceeding being both the applicant's claim and the respondent's cross claim).
Before I part from the case I wish to say that it is a case that was presented on both sides by counsel and solicitors with considerable ability and efficiency.

[1991] FCA 581

24 SEPTEMBER 1991