Merial Australia Pty Limited v Fort Dodge Australia Pty Limited
[2001] FCA 1796
•14 DECEMBER 2001
FEDERAL COURT OF AUSTRALIA
Merial Australia Pty Limited v Fort Dodge Australia Pty Limited
[2001] FCA 1796AGRICULTURAL AND VETERINARY CHEMICALS – LABEL APPROVED FOR REGISTERED PRODUCT – INJECTABLE CHEMICAL FOR PREVENTION OF HEARTWORM IN DOGS – APPLICATION FOR INJUNCTION TO RESTRAIN MAKING OF CLAIMS INCONSISTENT WITH APPROVED LABEL – WHETHER ADVICE ON CD-ROM DISTRIBUTED BY RESPONDENT TO VETERINARIANS IS INCONSISTENT WITH INSTRUCTIONS ON APPROVED LABEL – WHETHER RESPONDENT HAS REASONABLE EXCUSE FOR MAKING THE CLAIM.
Agricultural and Veterinary Chemicals Code Act 1994, Schedule ss 10, 14, 84, 130
MERIAL AUSTRALIA PTY LIMITED v FORT DODGE AUSTRALIA PTY LIMITED
N 1408 of 2001
WILCOX J
SYDNEY
14 DECEMBER 2001
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
N1408 of 2001
BETWEEN:
MERIAL AUSTRALIA PTY LIMITED
APPLICANTAND:
FORT DODGE AUSTRALIA PTY LIMITED
RESPONDENTJUDGE:
WILCOX J
DATE OF ORDER:
14 DECEMBER 2001
WHERE MADE:
SYDNEY
THE COURT ORDERS THAT:
1.The respondent, Fort Dodge Australia Pty Limited, by itself, its servants and agents, be restrained from:
(a)making any claim in respect of the chemical product ProHeart SR-12 Injection that is inconsistent with the terms of the label for such product approved from time to time by National Registration Authority for Agricultural and Veterinary Chemicals (“the NRA”); and
(b)in particular, unless and until such a claim is accepted by the NRA in connection with an application for variation of the approved label for the said product, making any claim that suggests the product provides heartworm protection for a dog later than the expiration of seven days after the first anniversary of the previous injection of the product into the dog.
2.Not later than 31 January 2002 and at its own expense, the said respondent publish a notice, in the form set out in the schedule hereto:
(a)as an advertisement in The Veterinarian magazine; and
(b)by posting a copy of the notice to all persons to whom the respondent supplied a copy of its CD-ROM relating to the said product.
3.Liberty to apply be reserved in relation to orders 1 and 2.
4.The said respondent pay to the applicant, Merial Australia Pty Limited, its costs of the proceeding.
THE SCHEDULE
In October 2000 Fort Dodge Australia Pty Limited released to veterinarians a CD-ROM concerning ProHeart SR-12 Injection. One section of the CD-ROM was headed “Frequently Asked Questions”. It contained the question “What if a dog is not presented for retreatment with ProHeart SR-12 Injection within a week of the due date?” The stated answer to this question included claims that, when moxidectin (the active constituent of the product) is injected into dogs with tissue stages of Dirofilaria immitis, “it can ‘reach back’ to inactivate L3, L4 and early L5 stages as old as 60-70 days” and “dogs may be confidently retreated (with ProHeart SR-12 Injection) up to 2 months after the due date”.
The Federal Court of Australia has held these claims are inconsistent with the terms of the label for ProHeart SR-12 Injection approved by the National Registration Authority for Agricultural and Veterinary Chemicals and the claims were published without reasonable excuse. The approved label advises that a repeat dose of ProHeart SR-12 Injection should be given within seven days of the anniversary of the dog’s previous treatment with the product.
The Court has ordered that, unless and until such a claim is accepted by the National Registration Authority in connection with an application for variation of the approved label of ProHeart SR-12 Injection, Fort Dodge Australia Pty Limited be restrained from making any claim that suggests the product provides heartworm protection in a dog later than the expiration of 7 days after the first anniversary of the previous injection of the product into the dog.
Fort Dodge Australia Pty Limited has made application to the National Registration Authority for variation of the approved label. That application is not yet resolved. In the meantime, this notice is published, by order of the Court, for general information.
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Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
N1408 of 2001
BETWEEN:
MERIAL AUSTRALIA PTY LIMITED
APPLICANTAND:
FORT DODGE AUSTRALIA PTY LIMITED
RESPONDENT
JUDGE:
WILCOX J
DATE:
14 DECEMBER 2001
PLACE:
SYDNEY
REASONS FOR JUDGMENT
WILCOX J:
This proceeding is brought to restrain an alleged breach of s 84 of the Agricultural and Veterinary Chemicals Code (“the Code”), to which effect is given by the Agriculture and Veterinary Chemicals Code Act 1994 and associated State statutes.
THE FACTS
The applicant, Merial Australia Pty Limited (“Merial”), and the respondent, Fort Dodge Pty Limited (“Fort Dodge”), both market products designed to prevent canine heartworm disease. In order to explain some aspects of their arguments, it is necessary for me to summarise the evidence concerning that disease.
Heartworm disease is a parasitic disease of dogs transmitted by mosquitoes. Adult heartworms breed in the tissues (generally the heart) of dogs and their offspring, called microfilariae, start their life cycle there. This stage of their life is often called “L1”. However, microfilariae quickly enter the dog’s bloodstream where they may be ingested by a mosquito. A microfilaria metamorphoses within the mosquito to a second-stage larva (“L2”). It then develops into a third-stage larva (“L3”) resident in the proboscis of the mosquito, from whence it may pass to the skin of a dog from which the mosquito seeks blood. This larva enters the dog’s subcutaneous tissue. After about a week, it moults into a fourth-stage larva (“L4”) and migrates through the tissues into the bloodstream in the dog’s thoracic area. It resides in that area for approximately two months before turning into an immature worm (“L5”) and migrating to the pulmonary arteries. Approximately one month later, the worm moves to the dog’s heart where it breeds. Mature heartworms can reach a length of up to 26cm.
Heartworm disease has no adverse effect on the dog until at least the fourth stage. During the fourth and fifth stage, there are two possible adverse effects: interference with the dog’s immune system and clogging of an artery. This can be fatal.
It is not possible to ascertain whether a dog is carrying L3 or L4 larvae. Blood tests can show whether a dog has L5 worms. However, there is a risk in attempting to cure that condition. The accepted treatment is to kill the heartworm with poisons, such as arsenic and levamisole. If the dog is heavily infected, the treatment may cause all the worms to die at once, thereby clogging the heart and causing the dog’s death. Earlier preventative treatment is preferable.
Since 1988 Merial has imported, and sold in Australia, a product called Heartguard-30, the active constituent of which is ivermectin. This product is effective in the prevention of canine heartworm disease. It is sold in packs of six “chewables” (tablets palatable to dogs), one to be consumed each month. Merial claims on its packet that this “prevents heartworm disease by eliminating the tissue stage of larvae (Dirofilaria immitis) that infected the dog in the month (30 days) before treatment”.
On 25 September 2000 the National Registration Authority for Agricultural and Veterinary Chemicals (“the NRA”) granted registration under s 14 of the Code of a chemical product called “ProHeart SR-12 Injection”. This product is made and distributed by Fort Dodge. Its active constituent is moxidectin. The product is designed as a subcutaneous injection involving microspheres from which the active constituent is released over a 12 month period.
The NRA also approved a label for use in containers of the product: see s 10(c) and s 14(1) of the Code. The label included the description “ProHeart SR-12 Injection. Once-a-Year Heartworm Preventative for Dogs”. Under the heading “Dosage & Administration”, were the words: “To maintain full protection, repeat the treatment every 12 months.” The “General Directions” included item 3:
“3.A repeat annual dose of ProHeart SR-12 Injection should be given within 7 days of the anniversary of the dog’s previous treatment with the product.”
Fort Dodge launched Pro-Heart SR-12 Injection onto the market on 16 October 2000. Thereafter the company’s sales representatives visited veterinarians (veterinary surgeons) throughout Australia in order to acquaint them with the product. They provided the veterinarians with documents and a CD-ROM. The CD-ROM included a section headed “Frequently Asked Questions”. One of the questions posed in this section was: “What if a dog is not presented for retreatment with ProHeart SR-12 Injection within a week of the due date?” That question was answered in the following way:
“The product is designed to give 12 months heartworm protection in dogs of all conformations and metabolic states. In most cases protection will continue beyond the 12 month period but this will vary between individual dogs and is not predicable or to be relied on. We also know that when moxidectin is administered in these doses to dogs with tissue stages of D immitis, it can ‘reach back’ to inactive L3, L4 and early L5 stages as old as 60-70 days. Our advice therefore is that dogs may be confidently retreated up to 2 months after the due date. Dogs presented beyond that 2 month period may be treated, but we strongly recommend that they be antigen tested for heartworm at least 5 months later to ensure that there was no infection during a possible window of susceptibility.”
The CD-ROM came to the attention of Mark Morrison, a Division Director of Merial. He thought the statement “dogs may be confidently retreated up to 2 months after the due date” was inconsistent with the terms of the label approved by the NRA. On 27 June 2001, Mr Morrison wrote to Fort Dodge requesting withdrawal of the claim and publication of corrective advertising. Fort Dodge rejected that request. Further correspondence ensued but no agreement was reached.
THE PROCEEDING
On 9 October 2001 Merial filed an Application instituting this proceeding. The Application was based on s 130 of the Code and sought the following relief:
“1.An order that the Respondent, by itself, its servants or agents be restrained permanently from:
(a)making any claim which is contrary to the National Registration Authority for Agricultural and Veterinary Chemicals (the ‘NRA’) approved label no 51805/0900 or such other label for the product known as ProHeart SR-12 Injection (‘ProHeart’) as may be approved by the NRA from time to time;
(b)making any claim that ProHeart provides heartworm protection in dogs for in excess of 12 months;
(c)making any claim that the repeat annual dosage of ProHeart can take place later than seven days after the anniversary of the previous dosing;
(d)making any claim that dogs can be retreated with ProHeart up to 2 months after the anniversary of the previous dosing;
(e)publishing or distributing any material, including material contained on any CD-ROM, which includes claims contrary to subparagraphs (a), (b), (c) or (d) above.
2.an order that the Respondent take all reasonable steps to recall all copies of the CD-ROM entitled ‘ProHeart SR-12 Injection’ distributed by the Respondent;
3.an order that the Respondent publish a corrective article, in a form to be approved by the Court, such article to be:
(a)published prominently in The Veterinarian Magazine; and
(b)mailed directly to veterinarians to whom the Respondent had previously sent copies of the CD-ROM entitled ‘ProHeart SR-12 Injection’.
4.such further orders as the court deems fit;
5.costs.”
Pleadings and affidavits were subsequently filed and the matter came before me for hearing on 6 December 2001. There was some cross-examination of deponents to affidavits. Three important new facts emerged.
First, it became clear that owners often fail to comply strictly with veterinarians’ recommendations as to the date when they should return their dogs for further treatment. Consequently, the requirement for retreatment with ProHeart SR-12 Injection within seven days of the anniversary of the previous injection causes practical difficulties; dog owners often present their dogs after that deadline. The question on the CD-ROM raised a significant practical problem.
Second, it was conceded by Merete Holm-Martin, Veterinary Programs Manager (Pharmaceuticals) of Fort Dodge, that no empirical research verified the CD-ROM claim that “dogs may be confidently retreated up to 2 months after the due date”. Dr Holm-Martin sought to justify this claim on a theoretical basis. She said tests had established that moxidectin administered in tablet form had a two month reach-back effect and a recent study of the blood profile of moxidectin suggested subcutaneously injected moxidectin would have a similar effect. If it did, she said, any injection administered within two months of the anniversary of the previous injection would inactivate any larvae that had been introduced into the dog’s bloodstream since the previous injection ceased to have effect. However, Dr Holm-Martin conceded that, in the absence of empirical tests, it was impossible to be certain the analogy applied.
Elizabeth Ann Evans, Merial’s Technical Services Veterinarian, Companion Animal Business, said it was “likely” that injected moxidectin would have a two-month reach-back effect. But she commented that “biological systems don’t always conform to the way we like them to”; analogies sometimes proved to be wrong. She said different formulations of a chemical sometimes produced similar blood levels but different effects. Ms Evans thought empirical tests were necessary in order to establish the reach-back claim. She said a testing program would take about six months.
Third, counsel for Merial (Mr Peter McEwen SC and Mr Paul McGuire) tendered a letter to their instructing solicitors from Fort Dodge’s solicitors in which the following formal admissions were made:
“1.Fort Dodge Australia Pty Limited has not until 10 October 2001 applied to the National Registration Authority for approval of a label for containers for ProHeart SR12 injection which contains a direction or recommendation that a repeat annual dose of ProHeart SR12 injection should be given within any period other than within seven days of the anniversary of the dog’s previous treatment with the product.
2.On 10 October 2001 Fort Dodge Australia Pty Limited applied to the National Registration Authority for a technical label change under ‘General Instructions’ on the insert to the product packet, in order to provide veterinary practitioners with additional information to use when clients present their dogs ‘late’ for treatment or re-treatment. The changes sought for the inset are as follows:
From:
•A repeat annual dose of ProHeart SR12 Injection should be given within 7 days of the anniversary of the dog’s previous treatment with the product.
To:
•A repeat annual dose of ProHeart SR12 Injection should ideally be given within 7 days of the anniversary of the dog’s previous treatment with the product. If more than 60 days have elapsed since the anniversary of the previous treatment, ProHeart SR12 Injection can be administered, but it is recommend that the dog be tested for the presence of adult heartworms 6 months later.”
WAS THERE AN INCONSISTENT CLAIM?
The applicant relies on s 84 of the Code. That section relevantly provides:
“(1)A person must not make any claim, or cause or permit any claim to be made, in respect of:
(a)a registered chemical product; or
(b)a chemical product that contains a registered chemical product;
that is inconsistent with any of the instructions on any approved label for containers for the registered chemical product.
Penalty: 300 penalty units.
(2)…
(3)…
(4)Subsection (1) does not apply if the person has a reasonable excuse.”
Counsel argue that, since October 2000, Fort Dodge has made, and continues to make, representations in its CD-ROM that are inconsistent with instructions on the approved label.
Counsel point out that, by s 3 of the Code, “approved label” means “a label approved under Part 2 of the Code” (that is, under s 14), “label” includes “tag, leaflet, brand, stamp, mark, stencil or written statement” and “instruction” includes “direction, caution, warning or recommendation”. They say the ProHeart SR-12 Injection approved label contained the following instructions:
“(a) A once-a-year heartworm preventative for dogs;
(b) For the 12 month prevention of heartworm;
(c ) To maintain full protection, repeat the treatment every 12 months;(d)A repeat annual dose should be given within 7 days of the anniversary of the dog’s previous treatment with the product.”
However, the CD-ROM makes three claims that are inconsistent with those instructions:
“(a)ProHeart provides heartworm protection in dogs which will continue beyond the 12 month period;
(b)When moxidectin is administered in these doses to dogs with tissue stages of D.immitis, it can ‘reach-back’ to inactivate L3, L4 and early L5 stages as old as 60-70 days;
(c)Dogs may be confidently retreated with ProHeart up to 2 months after the anniversary of the previous dosing.”
This means, say counsel, that the “label representation of the need for repeat dosage within 7 days of the anniversary of the previous treatment is inconsistent with and is confused by a purported extension of the period for re-treatment to 60 days”.
It seems to me this argument is correct. The approved label describes ProHeart SR-12 injection as being intended for “12 month prevention of heartworms … in dogs”. It advises users: “To maintain full protection, repeat the treatment every 12 months”. So it is clear the product was authorised to be promoted as one that gave protection for 12 months, and only 12 months. The point was further emphasised by item 3 of the General Directions: “A repeat annual dose of ProHeart SR-12 Injection should be given within 7 days of the anniversary of the dog’s previous treatment with the product”. The approved label makes no recommendation for a repeat dose after that date, the implication being that a later repeat dose would not be useful.
In contrast, the CD-ROM claims utility for an injection administered up to two months after the due date (“dogs may confidently be retreated up to 2 months after the due date”). This claim is based upon a claimed reach-back effect, something not mentioned on the approved label.
Counsel for Fort Dodge (Mr Timothy Hancock) sought to justify this departure from the approved label. He pointed out the answer was only one item in a CD-ROM that contained much other material, including repetition of the label statements, and it was supplied only to qualified veterinarians. He suggested veterinarians would be capable of evaluating the position and making an informed decision as to the utility of the product; accordingly, there would be no possibility of people being misled.
Counsel’s statements are factually correct. But they do not negative inconsistency. The fact that the approved label statements also appear on the CD-ROM means that a person, who reads all the material on the CD-ROM, will be presented with conflicting information. The person may become confused; nonetheless, he or she may be influenced by the question and answer section to inject the product outside the period (12 months plus seven days) recommended on the label. No doubt this was the reason why Fort Dodge included the reach-back claim on the CD-ROM.
It is not an answer to say the contentious material was sent only to veterinarians. Section 84 makes no distinction between claims addressed to informed audiences and claims addressed to the general public. Anyway, it is unrealistic to think practising veterinarians are equipped to form a judgment about the reach-back effect of ProHeart SR‑12. Fort Dodge did not feel able to make a claim about the existence of that effect when it made its initial registration application to the NRA. It has felt able to make that claim only recently, in the light of blood profile data not provided on the CD-ROM.
During the course of the hearing, reference was made to “off-label” use of a product. I understood counsel and the witnesses to be referring to use of a registered product for a purpose other than the purpose or purposes disclosed in the application for registration of the product. Curiously, there is nothing in the Code inhibiting such use or the promotion of product for such use. I use the word “curiously” because one of the matters about which the NRA is required to be satisfied, before granting registration of a chemical product, is “that the use of the product in accordance with the recommendations for its use that the NRA proposes to approve would be effective according to criteria determined by the NRA for the product”: see s 14(3)(f) of the Act. In satisfying itself about that matter, the NRA must have regard to “whether any trials or laboratory experiments have been carried out to determine the efficacy of the product and, if so, the results of those trials or experiments”: see s 14(6). Given that effectiveness for a particular purpose is relevant to the decision to grant or refuse registration, it seems odd that, once registration is granted, the product may be used, and promoted for use, for a different purpose, in relation to which it may not be effective.
However, promotion of the product for use for a different purpose does not entitle the promoter to make a claim that is inconsistent with the approved label. Section 84 makes that clear. Perhaps s 84 imposes a practical limitation on promotion of off label uses.
The references in this case to off-label use arose out of the fact that counsel for Fort Dodge suggested that use of ProHeart SR-12 Injection, after the expiration of 12 months and seven days from the previous injection, was a use for a purpose (a “therapeutic purpose”) different from the purpose of use (a “prophylactic purpose”) within that period. Any such dichotomy does not make a difference to the question whether s 84 is infringed. However, there is no dichotomy. Regardless of when it is injected, ProHeart SR-12 Injection does not prevent invasion of the dog’s body tissues by L3 larvae. During the period of 12 months and seven days from the previous injection, it works by promptly destroying L3 larvae; thereby preventing them mutating into L4 larvae and, eventually, adult worms that threaten the dog’s well-being. If the product has a reach-back effect during the period of two months after the anniversary of the previous injection, this is because, during that time, it destroys L3 and L4 larvae in the dog’s body. The larvae may be more advanced than larvae destroyed during the earlier period, but the product’s function is identical. As larvae at L3-L4 stage are harmless, the function is probably more accurately described as prophylactic, rather than therapeutic. But the label does not matter; in either case there is the same purpose of use.
I resolve the first issue adversely to Fort Dodge; its claim respecting the efficacy of ProHeart SR-12 after the expiration of 12 months and seven days is inconsistent with the approved label for the product.
WAS THERE A REASONABLE EXCUSE FOR THE CLAIM?
Counsel for Merial point out that, if inconsistency is shown, it is for Fort Dodge to establish the existence of a “reasonable excuse” for making the claim. They are not aware of any authority as to the meaning of “reasonable excuse” in this context but cite a comment by Brennan CJ, Toohey, McHugh and Gummow JJ in Taikato v The Queen (1996) 186 CLR 454 at 464:
“The term ‘reasonable excuse’ has been used in many statutes and is the subject of many reported decisions. But decisions on other statutes provide no guidance because what is a reasonable excuse depends not only on the circumstances of the individual case but also on the purpose of the provision to which the defence of ‘reasonable excuse’ is an exception.”
Counsel also refer to discussion by Hely J, in Bank of Valletta PLC v National Crime Authority (1999) 164 ALR 45, of the use of the term “without reasonable excuse” in s 29(3) of the National Crime Authority Act 1984. His Honour’s judgment was approved by a Full Court: see Bank of Valletta PLC v National Crime Authority (1999) 165 ALR 60 at para 14. After referring to a number of cases in which “reasonable excuse” was considered, Hely J said at para 42:
“Thus while a reasonable excuse would include any current legal right to resist the compulsory production of documents, it is not confined to cases in which the resistance is on the basis of some right, privilege or immunity recognised by the general law. Nor is it necessarily confined to physical or practical difficulties in complying with the notice. It includes any excuse which would be accepted by a reasonable person as sufficient to justify non-compliance with a notice lawfully issued by NCA, but bearing in mind the central role that such Notices play in the discharge by NCA of its statutory functions.”
Hely J held (at para 47) this involves the Court making “an objective determination as to the existence or otherwise of a reasonable excuse”.
Counsel argue this approach ought to be adopted in the present case; Fort Dodge’s conduct must be objectively determined in light of the purpose of s 84 and the Code: “to ensure compliance with the scheme for the approval, registration and control of veterinary chemicals and to ensure adherence to approved labels.” In particular, counsel mention the central role of the NRA in determining what claims may be made about registered products.
Counsel submit:
“… it cannot be a reasonable excuse to make claims on the basis of evidence which has not be [sic] presented to the NRA either for initial approval or as part of an amendment to the approved label. To allow such conduct as a reasonable excuse would permit suppliers of veterinary chemicals to circumvent the operation of the Code.”
I agree that the question whether Fort Dodge had reasonable excuse for making the claim is to be determined objectively and in light of the purpose of the Code, including s 84.
ProHeart SR-12 Injection may have a reach-back effect, so as to be efficacious against heartworm larvae until the expiration of 14 months from the date of the previous injection. Ms Evans thought this “likely” to be the case. But she pointed out her view was based on theoretical considerations, not empirical data from trials, and trials sometimes confound theory.
If it was relevant for me to make a finding on the subject, I would find it is probable, but not certain, that ProHeart SR-12 Injection has a reach-back effect giving protection for dogs for 14 months after the previous injection. Even so, I do not think Fort Dodge had reasonable excuse for its CD-ROM claim.
The Code provides a statutory regime in respect of labels. It is an offence for a person to supply, or cause or permit to be supplied, a chemical product in a container that does not have an approved label attached to it: see s 80. It is also an offence if the label is not identical to the approved label, except for particulars relating to the batch number, date of manufacture or expiry date of the product: see s 81. The obvious purpose of these provisions is consumer protection. The idea is that people who purchase or use the product will have information that has been approved by the NRA as containing adequate instructions relating to the use of the product: see s 14(3)(g) of the Code. The NRA is to come between the supplier of the product and the consumer, ensuring the information is adequate and accurate. It is inconsistent with this statutory scheme to excuse a supplier of a chemical product, who publishes material that contradicts the approved instructions, simply on the basis that the contradictory material is probably scientifically correct. For the supplier to take this course is to subject the recipient of the information to contradictory messages, that the recipient may not be equipped to resolve, and to transfer to the Court the evaluating function intended by the Code to be performed by the NRA.
The Code does not require an approved label to be immutable. On the contrary, it makes provision for applications for variation of NRA approvals, including in respect of the label: see ss 27 to 29. Fort Dodge has now taken advantage of these provisions. The application for variation of the approved label may prove successful; possibly only after empirical trials, possibly without that necessity. If the application is successful, Fort Dodge will no doubt take advantage of its success by promoting the reach-back qualities of ProHeart SR-12 Injection. At that stage, it will be justified in doing so. It was not justified in doing that, in contradiction of the label, before obtaining NRA approval.
The defence of reasonable excuse fails.
DISPOSITION
It follows that Merial is entitled to succeed. It is appropriate to restrain Fort Dodge from making any claim in respect of ProHeart SR-12 Injection that is inconsistent with the terms of label, as approved from time to time by the NRA, and, in particular, any claim that suggests the product provides heartworm protection in dogs if injected later than 12 months and seven days after the previous injection, unless and until such a claim is accepted by the NRA in connection with an application for variation of the approved label for the product.
I do not think it is necessary to order recall of the CD-ROMs provided to veterinarians. However, it is appropriate that a notice explaining the position be published, at the expense of Fort Dodge, as an advertisement in The Veterinarian magazine and by posting a copy thereof to all persons to whom the CD-ROM was supplied. This must be done by 31 January 2002.
Fort Dodge must pay Merial’s costs of the proceeding.
I certify that the preceding forty-two (42) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Wilcox. Associate:
Dated: 14 December 2001
Counsel for the Applicant: P J McEwen SC and P R McGuire Solicitor for the Applicant: Cropper Parkhill Counsel for the Respondent: T J Hancock Solicitor for the Respondent: Dibbs Barker Gosling Date of Hearing: 6 December 2001
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