Full Text Findings Of The Australian Trial Court -- In Merck Vioxx® Peterson Case

Robyn Clothier (in my comment-box, below, and affliated with Healthy Skepticism) has graciously provided this link to the Australian findings in Peterson v. MSD Australia (a Merck & Co. subsidiary). A very voluminous set of Vioxx^® findings, but the able judge's reasoning is highly illuminating -- and very carefully laid out.

I am still digesting the well-over 100 pages, when printed -- but these two sections -- 903 and 904 (about 9/10ths of the way though the decision), lept out at me:

. . . .903. At all times until November 2001, the Vioxx Product Information lacked any warning which conveyed the results of the VIGOR trial. Was this misleading conduct by silence? I think it was. A practitioner reading the Product Information would, in my view, reasonably have assumed that what was said about the cardiovascular side-effects was what MSDA knew on the subject. It was said, for instance, that myocardial infarction had been observed in less that 0.1% of patients taking Vioxx in osteoarthritis studies. That was literally true, but in mid-2000 and thereafter it was misleading since MSDA was then in possession of the VIGOR results which contained a figure of 0.5% based on patient-years. There were, of course, all manner of qualifications that could, and perhaps should, have been made with respect to a direct comparison between the osteoarthritis studies data and the VIGOR data (e.g., different patient population, different dose), but these would have been understood by practitioners and given such weight as was appropriate in the making of their professional judgments. As the respondents stressed, the Product Information was written for a professional readership. I also note that, from very soon after the release of the VIGOR results, MSDA took the view that some amendments were required thereby, notwithstanding that Vioxx was then registered in relation to osteoarthritis only (and notwithstanding also that MSDA itself initially proposed that the gastrointestinal results only be the subject of an amendment to the Product Information). However the matter is looked at, to have given medical practitioners no advice of the results of the VIGOR trial when the unamended Product Information was at large amounted to misleading conduct.

904. I stress that it is no part of my reasoning to hold that the Product Information was itself misleading. The applicant did not so contend. Rather, the misleading conduct was constituted by the failure to draw to the attention of doctors and other health care professionals the cardiovascular risk message that emerged from VIGOR. The respondents criticised the applicant for not having articulated the terms that any such advice would embody. Not having done anything, however, they are in no position to make that criticism. Ultimately, they did come up with a form of advice which I have held to be sufficient for the purposes of the applicant’s negligence case. But before that occurred, MSDA’s failure to provide any qualification to what was then contained in the Product Information did, for the reasons I have given, amount to misleading conduct. . . .

Will try to offer more analysis -- after Sunday morning's breakfast -- and obviously, some morning coffee.

[Overnight, though, do keep in mind that Australian law may differ in significant respects from United States law, and thus the judge's conclusions above may differ from those which would properly result under applicable United States law.]

"In questions of science then, the authority of a thousand is not worth the humble reasoning of a single individual."

-- Galileo Galilei

N'maste, and G'night.