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Vioxx: Merck may settle

Merck will appeal against the verdict of the Vioxx court case on the grounds that it did not receive a fair trial

Merck may have lost the 'crucialí first court case regarding its actions in the Vioxx catastrophe, yet ñ facing the first of a potential 4,000+ bills, including many from UK patients ñ it will appeal against the verdict on the grounds that it did not receive a fair trial.

Regarding the result as merely one-nil, rather than checkmate, the disappointed company pledged fervently that it would fight each subsequent claim ìvigorously one by one over the coming yearsî in a bid to prove that it had ìacted responsiblyî.

ìWhile we are disappointed with the verdict, this decision should be put in its appropriate context. This is the first of many trials. Each case has a different set of facts,î the firm stated. Yet, this stance changed somewhat, shortly after the announcement.

Early success for the claimants ñ a Texas state jury awarded $253.4m (£141m) in damages to a widow whose husband died with alleged links to Vioxx ñ has brought about the previously feared possibility that a deluge of other claims would follow. Merck is currently understood to be facing nearly 5,000 lawsuits, worth some $18bn, and the string of claimants is growing.

Hence, despite its initial stand against the first successful case, which Merck claims was ìfundamentally flawedÖ [and] not based on reliable scienceî, on reflection the company will reportedly consider settling some lawsuits from a select, specific group of patients.

In what has been dubbed an 'about-turní, the firm might investigate a small number of patients, who took Vioxx for at least 18 months and in whom there were no other possible extenuating reasons behind their heart attacks and/or strokes, with a view to making several settlements from its $675m war chest.

However, in spite of this move, and even if the original verdict is overturned, the ongoing case has shone the spotlight on the means by which pharma firms market their products and communicate drug risks to the healthcare fraternity.

Merckís early loss in court only wiped around 8 per cent off its share value (relatively little compared with the withdrawal of Vioxx which saw the firm drop 30 per cent of its capitalisation last year) but the wider implications of this may hit every company seeking marketing approval from the US Food and Drug Administration in the future.

While the court case provides the news headlines, there is a big question mark hanging over the potential forthcoming changes to US regulation. Companies are likely to come under much fiercer scrutiny in the future, with fewer drugs being approved for marketing in the US, and more stringent rules governing risk communication, balanced marketing and safety testing.

30th September 2008

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