Markethaven Pty Ltd (subject to Deed of Company Arrangement) v Commonwealth of Australia
[2009] FCA 694
At a glance
Source factsCourt
Federal Court of Australia
Decision date
2009-06-29
Before
Besanko J
Source
Original judgment source is linked above.
Judgment (20 paragraphs)
REASONS FOR JUDGMENT 1 This is an application by the Commonwealth of Australia for an order pursuant to s 48 of the Federal Court of Australia Act 1976 (Cth) and O 10 r 1(2)(f) of the Federal Court Rules that the proceeding between Markethaven Pty Ltd (subject to Deed of Company Arrangement) ("Markethaven") and the Commonwealth of Australia ("the Commonwealth") and Rita Maclachlan, Pio Cesarin, Terry Slater, Robert Tribe and Noel Fraser ("the personal respondents") (SAD 130 of 2008) be conducted and continued in the New South Wales District Registry of this Court. The application is opposed by Markethaven but is supported by the personal respondents.
The nature of Markethaven's claim 2 Markethaven claims damages from the Commonwealth of Australia and the personal respondents. The following allegations appear in the Amended Statement of Claim ("ASOC") filed by Markethaven on 19 December 2008. 3 Markethaven is subject to a deed of company arrangement. It is a body corporate which was registered in the State of Queensland on 22 March 1989. 4 The Commonwealth by and through the Minister of the Department of Health and Ageing is responsible for the administration of the Therapeutic Goods Act 1989 (Cth) ("Therapeutic Goods Act"). 5 The complementary health care industry in Australia is governed by the Therapeutic Goods Act, which is an Act of the Commonwealth providing for a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods in Australia. The Department of Health and Ageing ("the Department") is a department of the Commonwealth of Australia. The Therapeutic Goods Administration ("the TGA") is a division of the Department and it has day to day responsibility for administering the Therapeutic Goods Act. At all material times, Mr Terry Slater (the fourth respondent) was the National Manager of the TGA. Ms Rita Maclachlan (the second respondent) was a delegate of the Secretary of the Department and the Director of the Office of Devices, Blood and Tissue. That office was a branch of the TGA which was responsible for licensing of participants within the therapeutic products industry and administered the application of the Goods Manufacturing Principles ("GMP") to manufacturers of such products. Mr Robert Tribe (the fifth respondent) was Chief GMP Auditor of the GMP Audit and Licensing Section, Conformity Assessment Branch, of the TGA. Mr Noel Fraser (the sixth respondent) was Lead Auditor of the GMP Audit and Licensing Section, Conformity Assessment Branch of the TGA. Mr Pio Cesarin (the third respondent) was an officer of the TGA and a delegate of the Secretary of the Department. 6 Pan Pharmaceuticals Ltd ("Pan") was the holder of a licence issued under Pt 3-3 of the Therapeutic Goods Act to carry out steps in the manufacture of therapeutic goods and it manufactured therapeutic goods for supply to distributors of such products. The distributors of such products are referred to in the ASOC as "sponsors". Prior to 28 April 2003, Pan was the dominant manufacturer and supplier to distributors of approximately 70 per cent of therapeutic products known as complementary medicines sold in Australia. 7 Markethaven was a sponsor in respect of therapeutic goods supplied to it by Pan listed on the register and until about 28 April 2003 distributed complementary medicines supplied by Pan as its principal business. 8 The Minister of Health and Ageing was the Minister of the Department and the Minister responsible for the administration of the Therapeutic Goods Act. Ms Jane Halton was the Executive Secretary of the Department and was the Secretary for the purposes of the Therapeutic Goods Act. 9 Prior to 28 November 2008, Markethaven traded in the complementary health care industry in Australia under the name "Vita Gold Products" and purchased vitamins and complementary medicines from suppliers, repackaged them under the Vita Gold label and sold those products on a wholesale basis. Prior to 28 April 2003, Markethaven's primary supplier of vitamins and complementary medicines was Pan, and in the period immediately prior to April 2003, Pan supplied in excess of half of Markethaven's products. Therapeutic products manufactured and supplied by Pan to Markethaven were listed on the register as required by the Therapeutic Goods Act. 10 On 30 and 31 January 2003, staff of the TGA conducted an audit of Pan's premises to investigate possible causes of a consumer level recall of five batches of two formulations of the over-the-counter motion sickness tablets known as "Travacalm" (a micro-dose product) manufactured by Pan. This audit is referred to in the ASOC as "the January Audit". The January audit reported that test data relating to Travacalm had been manipulated at Pan. After the January audit, Pan's licence was amended to prohibit it from manufacturing micro-dose products and Pan ceased to manufacture micro-dose products. 11 On 24 and 25 February 2003, staff of the TGA conducted another audit of Pan's premises. This audit is referred to in the ASOC as "the February Audit". The TGA prepared a detailed written report of the February audit. The February report was prepared at some point between 25 February 2003 and 21 March 2003, and it identified five deficiencies which were reported as critical. The February audit was never provided to Pan and it did not conclude or provide evidence of any imminent risk of death, serious illness or serious injury. 12 It is alleged by Markethaven that, between 26 March 2003 and 7 April 2003, the TGA formulated a strategy whereby the February report would not be provided to Pan, Pan's licence should be suspended or revoked, Pan would not be given 28 days' notice of the Secretary's intention to suspend or cancel its licence and an unannounced audit of Pan would be conducted with the intention of finding evidence so as to enable the Secretary to suspend or cancel Pan's licence immediately and without notice and require a recall of all Pan products. This strategy is referred to in the ASOC as "the Pan Strategy". 13 It is alleged by Markethaven that, at all material times, the TGA knew that: the effect of not providing the February report to Pan denied Pan the opportunity to correct any deficiencies identified in the report; the effect of not providing the February report to Pan denied Pan the opportunity to make submissions to the TGA about the inaccuracy or non-existence of any deficiencies reported in the report; and that for the TGA to identify critical deficiencies in a person's operations and withhold those deficiencies from that person would be a reckless exercise of the TGA's responsibilities under the Therapeutic Goods Act. 14 It is alleged by Markethaven that the TGA's standard operating procedure required that when it identified deficiencies it was to bring those deficiencies to the prompt attention of the relevant person. 15 It is alleged by Markethaven that the TGA, in formulating the Pan strategy, took into account the fact that, if given notice of the findings and conclusions of the February report or an intention to suspend or revoke its licence, Pan would have the opportunity to commence legal proceedings seeking an injunction preventing the TGA from suspending or revoking Pan's licence. The TGA wanted to deny Pan the opportunity to commence proceedings seeking an order restraining the suspension or revocation of Pan's licence. 16 Between 7 and 14 April 2003, and in furtherance of the Pan strategy, staff of the TGA conducted an audit of Pan's premises. This audit is referred to in the ASOC as "the April Audit". On 15 April 2003, the TGA decided to convene an expert committee to advise the TGA whether Pan's manufacturing operation represented an imminent risk of death, serious illness or serious injury. 17 On 23 April 2003, the TGA convened a meeting of an expert advisory group, which meeting was referred to by the TGA as an emergency meeting. The expert advisory group was provided with information regarding Travacalm and the findings of the January audit, the manipulation of test data in relation to Travacalm, and a product associated with Pan in which shark cartilage had been substituted for bovine cartilage. It was also provided with a document which was purportedly a copy of the TGA auditor's report concerning audits of Pan. 18 Markethaven alleges that there were serious deficiencies in relation to the deliberations of the expert advisory group. I will not set out those alleged deficiencies. They involve the expert advisory group not being provided with certain information, the meeting of the expert advisory group being conducted in an environment created by the TGA in which the group was pressured to reach an immediate conclusion and the expert advisory group not being properly informed by the TGA as to the correct applicable GMP code under the Therapeutic Goods Act. 19 Markethaven alleges that, prior to the meeting of the expert advisory group, the TGA had formulated a plan for the recall of the entire Pan product range, including the suspension of Pan's licence without notice, the removal of Pan's products from the register manufactured after a certain date without notice, the requirement that Pan recall all of its products manufactured after a certain date, the imposition of a condition on sponsors without notice preventing them from supplying products manufactured by Pan after a certain date, and strongly encouraging sponsors to participate in a voluntary product recall. 20 Markethaven alleges that, when the expert advisory group met on 23 April 2003, the TGA knew that, unless there was a conclusion of imminent risk as required by s 41(2) of the Therapeutic Goods Act, the Act required notice to be given to Pan of the suspension of its licence. Markethaven alleges that the expert advisory group did not find that there was an imminent risk of death, serious illness or serious injury, and did not recommend a product recall of products manufactured and/or supplied by Pan. 21 Markethaven alleges that, on 23 April 2003, the TGA issued a written report which purported to be a report on the outcomes of the February audit and the April audit and that that audit report was not provided to the expert advisory group and did not identify any non-compliance which was materially worse than the February report and did not conclude or provide credible evidence of an imminent risk of death, serious injury or serious illness. 22 Markethaven alleges that, as at 28 April 2003, the TGA had no reliable evidence from appropriately qualified persons that there was an imminent risk of death, serious illness or serious injury in relation to all or any of Pan's products or the products supplied by Pan to Markethaven. 23 On 28 April 2003, Ms Maclachlan gave notice to Pan that she had suspended Pan's licence to manufacture therapeutic goods for six months with immediate effect pursuant to s 41 of the Therapeutic Goods Act. This notice is referred to in the ASOC as "the suspension notice". On the same day, Mr Cesarin, on the basis of information provided by, and at the request of, Ms Maclachlan, gave notice to Pan that he had cancelled the listing of all products manufactured by Pan and listed in Attachment 1 to the Notice from the Register pursuant to s 30(1)(a) of the Therapeutic Goods Act and required Pan to take steps to recover immediately all goods listed in the attachment and manufactured and supplied by Pan since 1 May 2002. This notice is referred to in the ASOC as "the Recall Notice". Also on 28 April 2003, Mr Cesarin, on the basis of information provided by, and at the request of, Ms Maclachlan, gave Markethaven a notice under s 28 and s 31 of the Therapeutic Goods Act. This notice is referred to in the ASOC as "the Markethaven Sponsor Notice". 24 In paragraph 42 of the ASOC, Markethaven alleges the following: "The Markethaven Sponsor Notice: 1. advised that Pan's licence had been suspended to 'avoid imminent risk of death, serious illness or serious injury', and that Markethaven was therefore unable to use Pan to manufacture products; 2. pursuant to section 28(3) of the Act, imposed a condition of a product's listing or registration on the Register that '[a]ny further supply of products manufactured by Pan Pharmaceuticals Ltd since 1 May 2002 must cease … to prevent imminent risk of death, serious illness or serious injury'; 3. pursuant to section 31 of the Act, required Markethaven to provide information to the TGA about all of its products listed on the Register which were manufactured by Pan; 4. strongly encouraged Markethaven to initiate a voluntary safety related consumer level recall of all batches of product manufactured by Pan Pharmaceuticals since 1 May 2002; 5. set out the consequences of a failure to comply with the condition imposed on the listing of Markethaven's products on the Register. 6. represented (the Safety Representation) that: 6.1 the basis for the need for the voluntary recall were [sic] serious safety concerns held by the TGA about products manufactured by Pan; 6.2 any further supply of Pan products would result in an imminent risk of death, serious illness or serious injury." 25 On 28 April 2003, a notice in materially the same terms as the Markethaven Sponsor Notice was given to all sponsors of Pan products. This notice is referred to in the ASOC as "the other Sponsors' Notice". 26 Markethaven alleges that, as at 28 April 2003, the TGA, Ms Maclachlan and Mr Cesarin, knew that a probable outcome of the Suspension Notice, the Recall Notice, the Markethaven Sponsor Notice and the Other Sponsors' Notices, was that Pan's business would be seriously and irreparably damaged and that it would be placed into liquidation and that the business of sponsors including Markethaven would suffer serious loss and damage. Markethaven alleges that the TGA did not test any products manufactured by Pan after 1 May 2002 prior to issuing the Markethaven Sponsor Notice, and any of Pan's products prior to issuing the Suspension Notice and the Recall Notice to determine which product should be the subject of the Recall Notice. 27 On 30 April 2003, Markethaven agreed to participate in the voluntary product recall and Markethaven participated in the voluntary product recall, inter alia, as a result of the Safety Representation (see paragraph 42 of the ASOC set out in [24] above). Markethaven alleges that, as a result of its participation in the voluntary recall, it was unable to sell stock on hand and was required to make refunds to retailers and purchasers of Markethaven's products. Markethaven alleges that, by reason of the foregoing, it was unable from 28 April 2003 to obtain supply of, and therefore distribute, Pan's products, and consequently suffered a catastrophic loss of business and revenue. By reason of its financial position, on 28 November 2003, Mr Sid Sarantis, the sole director and shareholder of Markethaven, resolved to appoint administrators to Markethaven pursuant to s 436A of the Corporations Act 2001 (Cth). 28 Markethaven makes a series of allegations to the effect that the Commonwealth had control over it, knew of Markethaven's reliance on representations made by the TGA and knew that Markethaven was unable to protect itself from the consequences of the acts of the Secretary or the TGA. Markethaven alleges that, by reason of the allegations relating to these matters, the Commonwealth, acting by and through the TGA, owed the following duties to Markethaven: (1) a duty to act with reasonable care when exercising its statutory powers and functions under the Therapeutic Goods Act; (2) a duty to exercise its statutory powers and functions under the Therapeutic Goods Act in accordance with the requirements of the Act; and (3) a duty to act with reasonable care in making representations to Markethaven in connection with the exercise of statutory powers and functions in the Therapeutic Goods Act. Markethaven alleges that the Commonwealth, acting by and through the TGA, breached each of these duties. 29 Markethaven also alleges that the personal respondents were public officers who committed the tort of misfeasance in public office. It is unnecessary for me to set out the particular allegations made against the personal respondents. 30 Markethaven alleges that, by reason of the breaches of duty or misfeasance or both, it suffered loss and damage in an amount of at least $3,317,746.88. The major component of Markethaven's claim for loss and damage is loss of future profits of $2 million.