Vioxx withdrawal: making sense of the fight for compensation in Australia

Vioxx was withdrawn from the Australian market in October 2004 and there’s an ongoing compensation case. DaGoaty/Flickr

The enormous medical impact of modern pharmaceuticals has on occasion been matched by some large-scale litigation regarding adverse events. The Vioxx litigation in Australia and elsewhere is one such recent example.

The Federal Court last week overturned a ruling that could have seen up to 1500 former Vioxx users who suffered heart attacks or other forms of cardiovascular disease claim compensation from Vioxx’s manufacturer Merck.

In Australia, Merck Sharp & Dohme (Australia) Pty Limited recalled Vioxx in October 2004; it was reported as the biggest drug recall in history.

The Therapeutic Goods Administration (TGA) notice indicates the decision followed a then-recent clinical study showing increased risk of cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment (on the 25mg dose).

The withdrawal raised many questions – was the manufacturer of Vioxx negligent? Was Vioxx defective? Is compliance with the TGA regime a sufficient defence to claims by consumers?

Local litigation

The Australian litigation began in 2006. Mr Peterson was the applicant in a representative proceeding alleging the use, by him and others, of Vioxx contributed to various kinds of cardiovascular disease.

His claim, heard before Justice Jessup, succeeded in 2006, although various aspects of that decision were the subject of an appeal by Merck and cross appeal by Mr Peterson.

Earlier this month, the Full Court of the Federal Court of Australia considered & reversed a number of crucial findings made against Merck in the 2010 decision, where Mr Peterson had succeeded.

Why the different outcome?

The main issue regarded cause – was the evidence enough to meet the legal test for causation, such that Mr Peterson could show Vioxx caused his myocardial infarction.

The trial judge said yes, but all three members of the Full Court took the opposite view.

Tort lawyers will focus in particular on the court’s acceptance of the principle that in common law, negligently increasing the risk of harm is, alone, insufficient for a conclusion of causation by material contribution to that harm.

This issue isn’t limited to litigation about medicines – judgments from the High Court of Australia are expected soon on similar problems in cases regarding asbestos exposure and the development of ill health.

The court appears to have accepted that the use of Vioxx doubled the risk of myocardial infarction. But a small, absolute risk may be doubled without making it a likely source of injury.

While it was possible that Vioxx consumption was a cause of Mr Peterson’s infarction, he was, by reason of his age, gender, medical issues and history of smoking, within a cohort of which 25% was expected to suffer a heart attack within five years.

Mr Peterson may simply have been the unlucky one.

Some caveats

The court was careful to point out that there may be other people who used Vioxx, in a different position to Mr Peterson, who would perhaps be able to prove Vioxx was the probable cause of their condition.

Notwithstanding the causation finding against Mr Peterson, the court held that Vioxx had a defect within the meaning of s 75AC Trade Practices Act.

The defect was one which affected some people, not all. It said, in some people, by a mechanism not known, Vioxx increased the risk of myocardial infarction and the product provided no information, advice or warning about this effect.

But the state of scientific or technical knowledge at the time when the goods were supplied by Merck, was not such as to enable that defect to be discovered.

The court was unwilling to assume from the wording of the Therapeutic Goods Act that the company had the intention to abrogate the common law rights of individual consumers.

Mere compliance with the TGA system wasn’t enough to exhaust the manufacturer’s obligation to exercise reasonable care.

The Vioxx story in Australia may well have a third chapter to be written, as Mr Peterson may choose to seek leave to appeal to the High Court of Australia.

Other consumers of the medication who are in a different position to Mr Peterson may wish to pursue their claims.