Vioxx Decision from Trial Judge in Australia
The news is everywhere regarding the Australian trial court opinion in a Vioxx case. The trial judge’s opinion is here. The court included a summary of its full opinion. The summary is pasted after the "jump" to the extended portion of this post.
(Side note – One has to love the Australian federal court opinions for the way that internally cited materials are hyperlinked.)
In accordance with the practice of the Federal Court in some cases of public interest, I propose to summarise the reasons for judgment which I am about to publish in this proceeding. The summary is intended to convey only a very broad understanding of the decision of the court. It is not a complete statement of the conclusions reached by the court or the reasons for those conclusions. The only authoritative statement of the court’s reasons is that contained in the published reasons for judgment.
This is a representative proceeding under Pt IVA of the Federal Court of Australia Act 1976 (Cth) in which the applicant, Graeme Robert Peterson, alleges that the consumption, by him and the other group members, of a medication for the relief of arthritic pain called Vioxx contributed to the onset of various kinds of cardiovascular disease. Vioxx was the commercial embodiment of the rofecoxib molecule, which was developed by the second respondent, Merck & Co, Inc., in the 1990s. Rofecoxib was a member of a new class of drugs for the relief of arthritic pain, the advantage of which was supposed to be the absence of gastrointenstinal side-effects. Vioxx was marketed and sold in Australia by the first respondent, Merck Sharpe & Dohme (Australia) Pty Ltd, between late 2000 and September 2004, when it was withdrawn from the market internationally by the second respondent.
The existence of a relationship between the consumption of Vioxx and cardiovascular disease was, for the whole of the period that Vioxx was on the market, an unsettled question. The second respondent’s task of investigating that question was complicated by ethical considerations which made it inappropriate to conduct a lengthy placebo-controlled trial which involved persons enduring arthritic pain. It did, however, conduct a major placebo-controlled clinical trial of Vioxx amongst patients with a history of colorectal adenomas. This trial, which commenced in early 2000, was terminated by the second respondent in September 2004 on the recommendation of the independent External Safety Monitoring Board, when it became apparent to that board that the occurrence of certain cardiovascular adverse events amongst patients in the Vioxx arm of the trial was about twice that of those in the placebo arm, and the difference was statistically significant. It was this disclosure which led the second respondent to withdraw Vioxx from the market.
In my reasons to be published today, I have concluded that, across a population, the consumption of Vioxx about doubled the risk of heart attack. I am not satisfied that the consumption of Vioxx contributed to the occurrence of any of the other cardiovascular conditions referred to by the applicant, namely thrombotic stroke, unstable angina, transient ischaemic attack and peripheral vascular disease. In relation to heart attack, the applicant based his case primarily upon the results of the major clinical trial to which I have referred, and my conclusion is likewise based primarily upon those results.
It was an important element of the applicant’s case that, well before September 2004, the respondents knew, or ought to have known, that the consumption of Vioxx increased the risk of cardiovascular disease. In my reasons to be published today, I have rejected that allegation. I have held that it was not until September 2004 that the respondents ought to have reached the conclusion about the risk of heart attack which I have myself reached in this case.
By way of alternative, the applicant alleged that, at least since March 2000, the respondents ought to have been conscious of the realistic prospect that, in a world in which the science was not settled, it might well be that the consumption of Vioxx increased the risk of cardiovascular disease. For that allegation, the applicant relied principally upon the release, in that month, of the results of a major clinical trial which compared Vioxx to a traditional anti-inflammatory drug, naproxen, amongst patients with rheumatoid arthritis. Although the results of that trial showed that there were, at a statistically significant level, more cardiovascular thrombotic events in patients in the Vioxx arm than in the naproxen arm, there was, and there remains, a valid scientific basis to suppose that naproxen, if taken conscientiously, was protective against such events to an extent about equivalent to the effect of aspirin. Notwithstanding that circumstance, I have accepted the evidence given by all the expert cardiologists called in the present case that the results of this trial stood as a worrisome and important signal of potential cardiovascular risk. In my reasons to be published today, I have found that the second respondent did view the matter this way. I have rejected the applicant’s allegation that it turned a blind eye to these results. The first respondent, as was appropriate, relied upon the research and investigations of the second respondent in relevant respects.
The applicant himself commenced to take Vioxx in May 2001, and thereafter did so, more or less continuously, until it was withdrawn from the market. He had a heart attack in December 2003, to the occurrence of which he alleges Vioxx made a contribution. In my reasons to be published today, I have upheld that allegation. Having regard to what is now known about the relationship between the consumption of Vioxx and cardiovascular disease, and to the applicant’s own condition at the time, I am satisfied that Vioxx contributed to his heart attack.
The applicant seeks compensation from the respondents both at common law and under the Trade Practices Act 1974 (Cth). He proceeds at common law against the second respondent in negligence. I accept that the second respondent had a duty of care towards the consumers of Vioxx, including the applicant. I have rejected the applicant’s case that it fell short in the discharge of that duty by failing to carry out sufficient research and investigation in response to the results of the trial released in March 2000 to which I have referred. I have also rejected so much of the applicant’s case as proposed that the only reasonable response to the signal of potential cardiovascular risk given by those results was to have withdrawn Vioxx from the market. In the circumstances, I propose to dismiss the applicant’s case in negligence against the second respondent. To the extent that his case against the first respondent is based upon similar allegations, I shall dismiss that also.
The applicant also makes claims against the first respondent in relation to the ways in which Vioxx was promoted, predominantly to doctors who would prescribe it, in Australia. In these respects, his case is based both on common law negligence and on the Trade Practices Act. As to the negligence aspect, I have found that there are two respects in which the first respondent fell short of what was required in the reasonable discharge of its duty of care: its failure to warn the applicant’s doctor of the signal of potential cardiovascular risk which arose in March 2000, and the emphasis given by its sales representatives to the safety of Vioxx in their discussions with the doctor. Each of these aspects relates to the axis of communication as between the first respondent and the applicant’s doctor, and, save in certain particular respects indicated in my reasons, I am not in a position to make any such findings, at this stage, in relation to other group members. With respect to the applicant, I have held that the first respondent, under its common law duty of care, ought to have warned his doctor of the cardiovascular signal to which I have referred, and ought not to have emphasised the safety of Vioxx. However, I have not been satisfied that, had a sufficient warning been given, or had the safety of Vioxx not been emphasised, the applicant would not have taken Vioxx exactly as he did. That is to say, the first respondent’s failure to discharge its duty of care did not contribute to the applicant’s heart attack. Thus I have rejected this aspect of the applicant’s negligence case as against the first respondent.
Turning to the applicant’s claims under the Trade Practices Act, I have held under s 52 thereof that the first respondent’s failure to warn, and its emphasis on safety, amounted to misleading conduct in trade or commerce. However, for the same reasons as mentioned in relation to the applicant’s negligence case, I have not been satisfied that the applicant’s heart attack occurred by reason of this misleading conduct.
The applicant alleges also that Vioxx had a defect within the meaning of s 75AD of the Trade Practices Act. In my reasons to be published today, I have held that Vioxx did have such a defect, in the sense that the safety of Vioxx was not such as persons generally were entitled to expect. However, I have upheld the first respondent’s defence under s 75AK(c) of that Act, namely, its claim that the state of scientific or technical knowledge at the time when Vioxx was supplied to the applicant was not such as would enable the defect to be discovered. Thus I have rejected the applicant’s claim under s 75AD of the Trade Practices Act.
The applicant alleges that Vioxx was not reasonably fit for the purpose implicitly made known by him to the first respondent, and that Vioxx was not of merchantable quality. These claims arise under ss 74B and 74D of the Trade Practices Act respectively. I have upheld these claims. I have held that, because Vioxx involved about a doubling of the risk of heart attack, it was not reasonably fit for the purpose of being used for the relief of arthritic pain, which was the purpose implicitly made known by the applicant as required by s 74B and which was the purpose for which goods of the relevant kind were commonly bought as required by s 74D. I have reached the conclusion that the applicant is entitled to compensation under these sections. I have determined a number of matters which were at issue as between the parties in relation to the quantification of the compensation which should be awarded to the applicant, and the details of those determinations are set out in my reasons.
In a number of important respects, my determination of the applicant’s claim in this proceeding will have consequences for the claims of the other group members. There are, however, many respects in which it will not. Appended to my reasons is a list of questions, or issues, which I was required to address in this part of the case. As proposed by the parties during the hearing of the proceeding, I have left the answers to those questions to be the subject of consideration by them and, if necessary, of further submissions before the court. Those answers should, to some extent at least, bear upon the way in which the claims of the other group members are to be dealt with in this proceeding.
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