Presence of unreacted formaldehyde
30 The primary judge accepted (at [98] and [113]) that if methylene glycol is present, unreacted formaldehyde molecules would inevitably be present as well, whether in a simple or a more complex solution, such as Keratin Complex.
31 The experts agreed, as outlined in the overview of conclusions reached from the Experts' Conclave, that while they understood the nature of many of the chemical species comprising the formulation, "after these species are mixed, there is considerable uncertainty regarding the specific composition of the product" and that "[w]hile the nature of some species is known, many other components of the formulation are not known precisely." While this was an opinion stated in the most general terms it was, nonetheless, a crucial issue.
32 Mr Taylor, in his written statement dated 28 June 2013 stated that the company had since mid-2010 had its products, including Keratin Complex reviewed by a technical consulting organisation for the pharmaceutical and cosmetic industries which conducted reviews of the "lists of ingredients … and Material Safety Data Sheets (MSDS)" for regulatory compliance purposes. He annexed an MSDS relating to Keratin Complex which disclosed a number of discrete ingredients.
33 The primary judge summed up his conclusion in this respect at [113] finding the NMR tests to be both valid and reliable, disclosing the presence in Keratin Complex of a significant quantity of methylene glycol and, as a matter of necessary inference, inseparable unreacted molecules of formaldehyde.
34 To the extent that his Honour here identified a difference between the presence of methylene glycol and associated unreacted formaldehyde molecules in Keratin Complex on the one hand and in a simple aqueous solution on the other, it was merely to observe that the "equilibrium constant" may change in a complex solution. His Honour also found, as we have found, that in an aqueous solution methylene glycol is inseparable from unreacted molecules of formaldehyde.
35 Dateline, in its Notice of Contention (grounds 1 and 2), challenges the primary judge's conclusion that the presence of methylene glycol in the test sample demonstrated inferentially that unreacted formaldehyde molecules, although undetected, nonetheless must necessarily have been present.
36 If that challenge fails it puts to rest Dateline's "de minimis" submission concerning the presence, if any, of unreacted formaldehyde molecules. That submission did not engage with the ACCC's case, in any event.
37 Dateline submits that the primary judge at [90] was correct to find that the ACCC was required to and had failed to prove that such a complex mixture would be regarded as formaldehyde or would have any of the properties which allow the solution to still be called formaldehyde. This submission misconceives both the nature of the ACCC's case and the primary judge's reasons. It was never contended by it that the Keratin Complex was formaldehyde, only that it contained formaldehyde. The language of the formaldehyde representation makes this quite clear.
38 Dateline also relied on the fact that the February 2012 NMR test did not detect formaldehyde but only methylene glycol. Dateline submits that there was the following expert evidence that methylene glycol could exist without the presence of formaldehyde molecules and that there would or may be no equilibrium in solutions as complex as Keratin Complex:
(a) the Joint Experts Report acknowledged that an equilibrium situation involving formaldehyde being present was only a possibility, not a certainty: "While some dynamic equilibria may exist between chemical component species of Keratin Complex, it is impossible to specify all these equilibria, their equilibrium constants, or their equilibrium concentrations" [this statement, in fact, appears in the Experts' Conclave Overview].
(b) Professor Haddad and Dr Rowe said at sec 3.1 of the Experts' Conclave Overview that "[T]hey consider that the simple aqueous dynamic equilibrium between aqueous formaldehyde and methylene glycol cannot be considered to apply unchanged in a complex sample such as Keratin Complex."
(c) Dr Rowe said: "The pure compound [methylene glycol] has no formaldehyde at all."
(d) Dr Rowe's evidence concerning a complex solution such as Keratin Complex: "I have formulated with most of the incipients that are present in that formulation over the years, and knowing formaldehyde very well, I would suspect that that would react fairly rapidly with many of those incipients. So the equilibrium constant would be even lower [than in a simple aqueous solution]."
(e) Dr Rowe said that in Keratin Complex "[t]here may be no equilibrium at all. Who knows?", noting that formaldehyde is a very reactive compound that may react with some of the gums or other excipients which are present in the formulation;
(f) Professor Haddad's response to a question from his Honour about the dynamic equilibrium in Keratin Complex "there would be far less formaldehyde present, if any";
(g) Mr Anthony's evidence that there was a large amount of many proteins, gums and oils in Keratin Complex that "will absolutely wipe out any formaldehyde that's in that bottle" and "consume every grain of formaldehyde". Mr Anthony also said "the gums [in Keratin Complex] are highly reactive to formaldehyde and actually form complexes with formaldehyde."
39 Dateline submits that the error made by the primary judge was his apparent assumption that the proposition set out at [98], [113] and [221] (that formaldehyde molecules must necessarily exist when methylene glycol molecules are present in a solution containing water) was not in issue such that he could "infer" that that would apply. It submits that while his Honour noted that there was evidence to that effect, he did not advert to or deal with the evidence to the opposite effect this being an understandable oversight in a case as large and complex as the present. In short, the submission is that there was therefore very much a contest on the expert evidence whether there could or would be even a notional amount of formaldehyde molecules when methylene glycol was present in a complex aqueous solution and that the primary judge did not resolve this contest.
40 Dateline submits that had his Honour considered this issue, he could not have been satisfied to the level required by s 140 of the Evidence Act 1995 (Cth) (Evidence Act) that the conflict should be resolved in favour of that finding.
41 For the following reasons, we disagree.
42 First, it is overstating the passage cited from the Experts' Conclave Overview to say that the experts agreed that an equilibrium involving formaldehyde (in water) was a mere possibility. The passage was a statement concerning equilibria generally. So far as it concerned the particular equilibrium constant between methylene glycol and unreacted formaldehyde in a complex solution, such as Keratin Complex, Dateline's own experts Professor Haddad and Dr Rowe merely opined, that in a complex solution such as Keratin Complex the ratio of unreacted formaldehyde to methylene glycol would be lower than in a simple aqueous solution.
43 The primary judge accepted this evidence. To that extent it was said that the "numbers", as described by Professor Haddad at the Experts' Conclave, cannot be translated from a simple to a complex aqueous solution. Dateline's experts did not positively assert that there would be no equilibrium. It was never put to the experts called by the ACCC that there was no dynamic equilibrium between methylene glycol and unreacted formaldehyde in Keratin Complex.
44 Turning to the evidence of Mr Michael Anthony, who is the principal of Keratronics Inc (Keratronics), the manufacturer of Keratin Complex. He has a degree in Mechanical and Industrial Engineering. Whilst this discipline included, to some unspecified extent, study of organic chemistry and chemical dynamics, he was not called as an expert witness, and certainly not an expert witness in the field of chemistry. He acknowledged in his written statement that he is not a chemist and for that reason offered no response to the views of the ACCC experts on chemistry. He was, for good reason, clearly not treated as an expert witness on this issue by the primary judge.
45 Dr Rowe's evidence as to pure methylene glycol did not advance matters. He was speaking in this context of "pure" methylene glycol where there was no water present. Professor McGeary gave contrary evidence that when a molecule of methylene glycol "dehydrates, it gives up a molecule of water in forming a molecule of formaldehyde", such that it was not possible to produce a bottle of pure methylene glycol. It was unnecessary for the primary judge to resolve this question. It is a false issue. The issue in the case concerned methylene glycol in an aqueous solution. Where the primary judge found (at [72]) that methylene glycol cannot be isolated from unreacted molecules of formaldehyde he was referring to methylene glycol in a solution including water.
46 Finally, as to the failure of the NMR test to detect unreacted formaldehyde, Dateline's case involved further, rather complex, submissions based on the evidence of Dr Kling.
47 Dr Kling's oral evidence revealed that he was told that Chemical Analysis was measuring to see whether they could see, relevantly, formaldehyde in the sample. He acquired all of the spectra in Chemical Analysis' report. He carried out two sets of NMR experiments: one used carbon-13 ("13C" or "carbon") NMR testing (Carbon NMR), and the other hydrogen ("1H" or "proton") NMR testing (Proton NMR). Proton NMR was the more sensitive test. Dr Kling agreed that if any formaldehyde molecules were present in the sample being tested then:
(a) he would have seen their resonance peak at about the location of 197 on the 13C spectrum, but no such peak was observed;
(b) he would have seen a resonance peak for them in the 1H spectrum at a location of about 9.7 but he did not see such a peak in any of the many 1H spectra that he ran on the sample. Indeed, he ran a number of NMR scans, changing a number of parameters to try to detect something at 9.7, but did not see any peaks corresponding to formaldehyde molecules in any of them.
48 In response to the proposition that that region revealed there was no formaldehyde present in the sample, Dr Kling said that none could be detected. He agreed that no solvated formaldehyde molecules were observed.
49 The ACCC in its submissions relies upon the opinion given by Dr Cook, which concerned a reference spectrum as printed in a physical document provided by Chemical Analysis to the ACCC. It had been "scaled" (expanded) to make smaller peaks visible. Dr Cook and Dr Kling reviewed the spectra for the sample they tested on a computer screen. Dr Cook said he saw nothing useful in the proton spectra that he viewed on screen but doubted that he expanded the spectra around the area of 9.7 to see whether there was a peak there.
50 Although the Proton NMR testing did not show a peak for formaldehyde at the point on the NMR spectra where Dateline posited it should appear if it were present, Dr Cook explained that on the scale at which the NMR spectra were printed he would not have expected to see unreacted formaldehyde molecules at that point.
51 Dateline submits that the spectra were in a computer form and were printed out by Chemical Analysis for the purposes of the proceeding. None of the more sensitive proton spectra were included in Dr Cook's original report at all and were only produced on request by Dateline's solicitors. Dateline submits that there is a strong inference that, were it possible to detect any formaldehyde in the spectra by scaling them up, then the spectra taken by Dr Kling would have been scaled up and the peaks found and that the failure by the ACCC to adduce any such evidence gives the strongest possible inference that expanding any of the spectra would not have assisted the ACCC.
52 Dateline then submits that the only conclusion open on the evidence was that, despite very careful and extensive analysis using the most sensitive and sophisticated, non-invasive method of Proton NMR and Carbon NMR, which was the best method to use, the ACCC's own independent experts could not detect formaldehyde molecules in the sample they tested. This, it contends is "proof positive" that it is possible to have methylene glycol in a complex solution but not to have any formaldehyde molecules at the same time and that it is also proof that it is possible to have a situation where there is no equilibrium between methylene glycol and formaldehyde at all in a complex solution such as the sample they tested.
53 The ACCC submits, in answer, that the conduct of the NMR testing, upon which Dateline relies on as "proof positive" that it was possible to have methylene glycol in a complex solution without formaldehyde molecules, needs to be properly understood. The quote that Dr Cook provided was to conduct "method development and specific groundwork to determine whether the carbon-13 NMR method can reliably quantify free formaldehyde (as methylene glycol and other oligomers if present)" (emphasis in original), for reasons he explained earlier in the quote. The Validation Report prepared by Dr Cook and Dr Kling stated that it defined processes and procedures for the analysis of the following analytes: "Methylene glycol, methylene glycol dimer and monomethyl methylene glycol". Methylene glycol was described in the Validation Report as "the only detectable adduct at that low concentration".
54 Accordingly, the ACCC submits correctly that it is erroneous to describe Dr Kling as having analysed Keratin Complex for formaldehyde in solvated form as that term is used by Dateline. Importantly, again as the ACCC correctly notes, at the conclusion of his oral evidence, upon which Dateline relies, Dr Kling stood by the accuracy of the Validation Report. As the primary judge observed, the opinions of Dr Kling and Dr Cook were not contradicted by any evidence called by Dateline. His Honour found that the results of the NMR testing recorded in the Validation Report were "valid and sufficiently reliable to accept". We accept the ACCC's submission that the adverse inference that Dateline seeks to draw from Dr Cook's evidence, on the basis of a comparison between his evidence and the oral evidence of Dr Kling, is unwarranted, particularly in circumstances where, as his Honour observed, "it was not put to him that his opinion was invalidated by the discrepancies identified by Dateline's counsel".
55 The respondents did not point to any expert evidence that the failure of the NMR test to detect unreacted formaldehyde was a matter which supported a conclusion that there was no unreacted formaldehyde present in the test sample. In those circumstances, the judge was not required to consider whether such a conclusion ought to have been drawn.
56 We also do not accept the respondents' written submission that the failure to detect formaldehyde molecules was "proof positive" either that it is possible to have methylene glycol in a complex solution but not to have any formaldehyde molecules at the same time, or that it is possible to have a situation where there is no equilibrium between methylene glycol and formaldehyde at all in a complex solution such as the sample they tested. The respondents would have required expert evidence to support conclusions to that effect.
57 However, the central issue at trial was whether or not Keratin Complex could be said to contain formaldehyde, by reason of the presence of methylene glycol. There was a dispute between the experts on that point. The evidence was that methylene glycol and unreacted formaldehyde molecules in dynamic equilibrium in a simple aqueous solution was commonly referred to as formaldehyde. The experts disagreed as to whether a complex solution must be said to contain formaldehyde when it contains methylene glycol and an unknown and undetected quantity of unreacted formaldehyde.
58 Exhibit A2 contained this crucial question for answer by the experts as follows:
Question:
16. Was formaldehyde found to be present in Keratin Complex and if so what were the reported concentrations?
Answer:
The HPLC [High-performance liquid chromatography] testing did not show the presence of free formaldehyde alone, but rather showed the total of free formaldehyde, methylene glycol, and potential contributions of formaldehyde from formaldehyde oligomers, timonacic acid, and other formaldehyde producers. NMR showed the presence of methylene glycol but did not detect formaldehyde. HPLC cannot differentiate between free formaldehyde and formaldehyde produced from the species listed above and it also suffers from the "observer effect", where the process of measurement changes the sample so that the result obtained does not reflect the composition of the sample prior to the measurement. NMR is able to differentiate between formaldehyde (as methanal), methylene glycol, formaldehyde oligomers, timonacic acid, and other formaldehyde producers, and does not suffer from the observer effect.
59 It may be seen that the response to the question was neither direct nor particularly enlightening. It should have been capable of a clear unequivocal answer. That it was not is rather telling against the ACCC's case. The submissions put on behalf of the ACCC as to this question and the answer to it did not provide any further illumination.
60 There was evidence supporting the conclusion that the dynamic equilibrium ratio was lower in such a complex solution than it was in a simple aqueous solution. The conclusion that the presence of methylene glycol in dynamic equilibrium, at a lower ratio, with unreacted formaldehyde molecules in Keratin Complex is properly called "formaldehyde" would require reasoning that would require the Court to make assumptions as to what effect the lower equilibrium ratio may or may not have upon the chemical nature of methylene glycol and unreacted formaldehyde molecules subject to that lower equilibrium ratio. It may have had no effect. Conversely, it may have altered the chemical nature of the two in combination. In those circumstances, the primary judge was entitled not to accept the ACCC's experts' evidence on this point. We consider that the primary judge was correct in his analysis. No appealable error has been demonstrated.
61 It was for the ACCC to make out that critical part of its case. In our opinion, it failed to do so.
62 We would for the above reasons, reject ground 1 of the Notice of Appeal as well as grounds 1 and 2 in the Notice of Contention.
63 It follows, consequentially, that grounds 7 and 8 have not been made out.