Monday 22.08.2005

Vioxx Trial

1.        BACKGROUND

The US Pharmaceutical firm Merck developed and sold a type of painkiller, mainly for arthritis suffers, under the trade name Vioxx, and commenced circulation worldwide in the late 1990s.

Prior to sale in any country, Vioxx would have undergone vigorous testing by drug regulators. In the US this will have fallen upon the Food and Drug Administration (FDA. All drugs are the subject of constant research and testing, principally to look for any long term adverse side effects that were not apparent at their launch. In September 2004 Merck (and also the FDA), were sufficiently concerned, following a long-term study, that Vioxx increased the risk of heart attacks and strokes and, therefore, the drug was withdrawn.

On Friday, 19 August 2005, a widow in Texas was awarded $253.4m (£141.07m) damages after a jury accepted that her husband had been killed by Vioxx. Merck continues to deny liability and has stated that it will appeal.

2.        THE LEGAL ISSUES

There are two principle legal issues at the heart of this Vioxx trial, namely:-

(a)        Causation

Says Chris Phillips, head of dispute resolution at Halliwells:

"The Claimant in the US case has to prove not that Vioxx was the cause of her husband's death, but that it was a cause which was a material contribution to the premature death of the deceased.

"Given that the Claimant's husband had already suffered from an irregular heart beat and clogged arteries, it was always going to be a difficult question facing the medical experts in this case whether Vioxx was a causative factor in the death of the Claimant's husband.

"The Appeal Court will have to carefully analyse the medical evidence not only to consider whether Vioxx was a causative factor, but also whether other similar painkillers would have given rise to a similar risk for a person with a pre-existing heart condition."

(b)        Foreseeability

Says Chris Phillips, head of dispute resolution at Halliwells:

"Merck, the Defendant in this case, claim that it withdrew Vioxx immediately their long term study was completed (alongside a separate independent study by the FDA.

"If this is the correct position, then Merck will have a good defence on grounds of foreseeability. However, in an article that appeared in the Lancet on 5 November 2004 - only 2 months after Merck withdrew Vioxx - argued that an increased risk for cardiovascular events with the use of Vioxx was apparent in the year 2000. Merck rejects this assertion.

"It is also interesting to note that neither the FDA nor any other countries drug regulators thought it was appropriate to consider a withdrawal of Vioxx before September 2004, notwithstanding the findings of the Lancet.

3.        COMMENTARY

Says Chris Phillips, head of dispute resolution at Halliwells:

"The forthcoming Appeal in the US will be required to determine very complex issues of causation and foreseeability in this drug litigation.

"As in many of these types of cases, public policy will undoubtedly be the guiding principle. Media reports have thus far seized upon the public policy principle that it is irresponsible for a major US pharmaceuticals company to sell a drug which (allegedly) caused the premature death of so many members of the public, solely for the purpose of making profit.

"The US Appeal Court should, however, seek to balance this public policy point of view with the fact that this type of litigation against pharmaceutical companies could not only do irreparable damage to the Defendant, or even put them out of business, but it may inhibit other pharmaceutical industries from the research and development of this much needed painkiller for arthritis."

About Halliwells

Halliwells is one of the UK's leading multi-disciplinary law firms with over 1000 people and offices in Manchester, Liverpool, London and Sheffield



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