Abbott v Zoetis Australia Pty Ltd

Case [2022] FCA 1390

Federal Court of Australia

Abbott v Zoetis Australia Pty Ltd [2022] FCA 1390

File number(s): NSD 406 of 2018
Judgment of: RARES J
Date of judgment: 23 November 2022
Catchwords:

CONSUMER LAW – whether manufacturer engaged in misleading or deceptive conduct in contravention of s 18 of Australian Consumer Law in promotion of equine Hendra virus vaccine – whether manufacturer’s publications conveyed representations as to the necessity for, or side effects of, vaccination – whether representor had reasonable grounds for making alleged representations as to future matters in compliance with s 4(1) of ACL

EVIDENCE – proof on balance of probabilities under s 140(2) of Evidence Act 1995 (Cth) of causation of adverse reaction from administration of vaccine – whether sufficient for applicant to prove clinical sign is side effect caused by vaccine if its contemporaneous presentation is biologically plausible – proof of causation as matter of fact – degree of satisfaction on balance of probabilities

CONSUMER LAW – whether manufacturer of equine vaccine contravened consumer guarantee of acceptable quality under s 54(1) and (2) of Australian Consumer Law ­– whether vaccine was of acceptable quality – where vaccine did not cause serious side effects – whether vaccine supplied to consumers – where manufacturer supplied to veterinarians for resupply to horse owner – held: application dismissed

Legislation:

Agricultural and Veterinary Chemicals Code Act 1994 (Cth) Sch 1 (Agricultural and Veterinary Chemicals Code) ss 20(2), 112(1)

Competition and Consumer Act 2010 (Cth) Sch 2 (Australian Consumer Law) ss 4(1), 18(1), 54(1), (2), 236

Evidence Act 1995 (Cth) ss 69, 136, 140(2)

Federal Court of Australia Act 1976 (Cth) Pt IVA

Cases cited:

Adelaide Stevedoring Co Ltd v Forst (1940) 64 CLR 538

Amaca Pty Limited v Booth (2011) 246 CLR 36

Briginshaw v Briginshaw (1938) 60 CLR 336

Butcher v Lachlan Elder Realty Pty Ltd (2004) 218 CLR 592

Campomar Sociedad, Limitada v Nike International Ltd (2000) 202 CLR 45

Commonwealth of Australia v McLean (1996) 41 NSWLR 389

Elbourne v Gibbs [2006] NSWCA 127

Ethicon Sarl v Gill (2021) 288 FCR 338

Fairfax Media Publications Pty Ltd v Voller (2021) 392 ALR 540

Gould v Vaggelas (1984) 157 CLR 215

H Lundbeck A/S v Sandoz Pty Ltd (2022) 399 ALR 184

Merck Sharp & Dohme (Australia) Pty Ltd v Peterson (2011) 196 FCR 145

Murray v Murray (1960) 33 ALJR 521

North East Equity Pty Ltd v Proud Nominees Pty Ltd (2012) 285 ALR 217

Parkdale Custom Built Furniture Pty Ltd v Puxu Pty Ltd (1982) 149 CLR 191

RAIA Insurance Brokers Ltd v FAI General Insurance Co Ltd (1993) 41 FCR 164

Sellars v Adelaide Petroleum NL (1994) 179 CLR 332

Smith v Chadwick (1884) 9 App Cas 187

Tubemakers of Australia Ltd v Fernandez (1976) 50 ALJR 720

Webb v Bloch (1928) 41 CLR 331

Wyong Shire Council v Shirt (1980) 146 CLR 40

Yorke v Lucas (1985) 158 CLR 661

Division: General Division
Registry: New South Wales
National Practice Area: Commercial and Corporations

Continue reading Abbott v Zoetis Australia Pty Ltd

Sign in free to access the full text

Details
AGLC
Abbott v Zoetis Australia Pty Ltd [2022] FCA 1390
Case
[2022] FCA 1390
Decision Date

CaseChat Overview and Summary

Abbott initiated legal proceedings against Zoetis Australia Pty Ltd in the Federal Court of Australia, challenging Zoetis' conduct in promoting its equine Hendra virus vaccine, Equivac HeV. Abbott claimed that Zoetis had engaged in misleading or deceptive conduct under section 18 of the Australian Consumer Law (ACL) through its publications, which allegedly represented that vaccination against Hendra virus was necessary and that the vaccine had no serious side effects. Abbott also contended that Zoetis breached the consumer guarantee of acceptable quality under sections 54(1) and 54(2) of the ACL by supplying a vaccine that did not cause serious side effects.

The court had to determine whether Zoetis' publications conveyed misleading representations regarding the necessity for vaccination and the side effects of the vaccine. It also needed to establish whether Zoetis had reasonable grounds for making these representations under section 4(1) of the ACL. Additionally, the court had to assess whether the vaccine met the consumer guarantee of acceptable quality. The proof of causation of adverse reactions from the vaccine administration had to be established on the balance of probabilities under section 140(2) of the Evidence Act 1995 (Cth).

The court found that Zoetis' publications did not convey misleading representations regarding the necessity for vaccination or the side effects of the vaccine. It held that Zoetis had reasonable grounds for making the representations, as they were based on research studies and testing. The court also determined that the vaccine met the consumer guarantee of acceptable quality, as it did not cause serious side effects. Consequently, the court dismissed Abbott's application.

The parties were ordered to confer and file draft orders reflecting the court's reasons for judgment by 7 December 2022, with any disagreements to be marked up. The proceeding was to stand over to 9 December 2022 for the making of final orders.

Orders

Orders of the court

1. The parties confer and on or before 7 December 2022 file draft orders to give effect to the Court’s reasons for judgment delivered today and in default of agreement draft orders marked up to show any disagreements and written submissions limited to 3 pages.

2. The proceeding stand over to 9 December 2022 for the making of final orders.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Background

Background to the litigation

In about December 2014, Zoetis published as part of its Health4Horses series a two page pamphlet headed: “Facts About: The Hendra vaccine” (the facts about HeV pamphlet). The applicant relies on this pamphlet as conveying the no serious side effects representation. The pamphlet outlined on the left hand side of the front page the research studies and testing of Equivac HeV that provided the basis of the Authority’s grant of the permit for its use. It told the reader that in the field studies, “the only reactions seen were temporary injection site swellings in some horses”. The front page then stated on its right hand side: Across the foot of its front page, the pamphlet stated the following:“The Hendra vaccine has been subject to the same level of rigorous safety and efficacy testing as other vaccines on the equine market.”Dr Deborah Middleton: Research Team Leader and Senior Veterinary Pathologist, CSIRO On the reverse page of the pamphlet, Zoetis explained that it had an obligation to report suspected reactions to the Authority and it advised horse owners to report to their vet, Zoetis or the Authority any suspected reaction to the Equivac HeV. The reverse page had quotes attributed to, first, Dr Padraig Kelly, the resident veterinarian of Coolmore stud in the Hunter Valley in New South Wales and, secondly, Megan Jones, an Olympic silver medal winner, who operated a stud farm in the Adelaide Hills. Both recommended vaccinating horses with Equivac HeV. In his quote, Dr Kelly expressly acknowledged that the Hunter Valley “is not located in a high-risk area, [but] we deem it prudent to be proactive in terms of protecting against the risks posed by the disease”. The quote did not refer to any reaction of a horse at Coolmore stud. Ms Jones stated that in the Adelaide Hills, “there is a risk of Hendra virus from fruit bats. In addition, a number of our horses and our clients’ horses travel interstate for competitions, which also poses a risk”. She said that her stud was not prepared to take a risk of contracting HeV and that they had “seen only one minor site reaction, which was temporary and not threatening to the horse’s health”. A summary at the foot of the reverse page of the facts about HeV pamphlet stated: 5.11 The third permit disclosure The third permit again continued the restrictions on the administration and use of Equivac HeV as well as the requirements for Zoetis to report and investigate fully all adverse reactions that the first and second permits had imposed. The description of side effects that had to be stated in the leaflet was slightly, but not materially, different to that required in the second permit. I have highlighted the changes below, namely from “Rarely reported symptoms” to “Additional reported clinical signs”, “Symptoms” to “Clinical signs” and, where the ellipsis is in the last paragraph, the deletion from the side effects stated in the second permit leaflet in [67] above of “are thought to occur rarely with all vaccines and”): Side EffectsTransient swelling may develop at the site of vaccination in some horses but should resolve within one week without treatment. In some horses transient post-vaccination reactions including injection site reaction, pain, increase in body temperature, lethargy, inappetence, and muscle stiffness have also been observed. Additional reported clinical signs have included urticaria, sweating, mild peripheral oedema and mild transient colic. Clinical signs may vary in severity and occasionally may require veterinary intervention. Systemic allergic reactions such as anaphylaxis […] may require parenteral treatment with adrenaline, corticosteroid and antihistamine as appropriate and should be followed with appropriate supportive therapy. (emphasis added)5.12 The Equestrian Life letter

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

Full text does not contain this section.

Ratio Decidendi

Legal Principle Established

After about May 2013, and over 25,000 doses in the first six months of use, Zoetis issued an online module to already accredited vets entitled “NEW Hendra virus e-learning module: An update on Equivac HeV vaccine” (the registration module). The registration module stated that: ·the module was designed to bring addressees up to date with recent developments on the duration of immunity, the safety, as well as the administration protocol, of Equivac HeV and an update on HeV itself; ·Hendra Virus UpdateAs of 28th April 2013 there have been two confirmed cases of Hendra virus in 2013.One horse was infected near Mackay, in January 2013.One horse was infected in the Tablelands area of North Queensland in February 2013.A Hendra-positive bat was discovered in Adelaide in January 2013, meaning Hendra positive bats are now known to be in six states or territories around Australia.·because clients heavily relied on a vet’s recommendation, vets should recommend vaccination to their clients by saying, among other things, that:·it was “the safest thing for your family and your horses”; and·“[t]he consequences of a Hendra virus outbreak are so severe, it isn’t worth taking the risk. Vaccination is a low cost for the security it provides”; ·the AVA’s recommendation was to vaccinate all horses against HeV to protect them and humans from its potentially fatal outcome. The registration module included multiple choice questions based on the information it contained, including about the adverse reaction rate from the first 25,000 doses. 5.6 The September 2013 seminar In September 2013, Dr L’Estrange approved the 30 slides entitled “Hendra virus and the Hendra virus vaccine” for Zoetis staff to use in the September 2013 seminar, which included: The applicant relied on the statement in the slide above, that the antibody had been detected in all four species of flying fox, as conveying the geographic spread representation. The next slide was interactive and set out a timeline from the discovery of HeV in 1994 to 2013, which had details of occurrences of HeV including each location, the numbers of deaths and infected humans and horses in each occurrence and observations of symptoms. The following slide was as below: Other slides described the research from which Equivac HeV resulted, the protocol for administering it, including reference to the first permit, Zoetis’ Health4Horses webpage, that enabled veterinarians to register and check vaccination of a horse using its microchip number, a summary of the results of clinical studies, details of the numbers of vets accredited to administer the vaccine and numbers of vaccinated horses. Zoetis presented the reader with further slides that recorded “current stakeholder positions”, including statements: ·“The AVA believes that all horses should be vaccinated against the Hendra virus” under the heading “Reducing Hendra risk”,·recommending vaccination of horses by then Queensland Minister for Agriculture, Fisheries and Forestry, the Hon John McVeigh MLA, Racing Queensland, and the New South Wales and Queensland Governments’ biosecurity agencies, and·Equestrian New South Wales’ mandate that any horse attending any event in that State had to be vaccinated with Equivac HeV as of 1 January 2014. 5.7 The Health4Horses website information