GSK wins legal case over withdrawal effects of Seroxat after 13 years and £9.33m in costs

I have much to say about this. For now, I'll wait.

This from the BMJ

by Clare Dyer

A group action in the High Court in London by scores of claimants over withdrawal problems with the antidepressant paroxetine has ended in a victory for the manufacturer, GlaxoSmithKline (GSK), 13 years after the case was first launched.1

A High Court trial was to start in February 2011 but the action was put on hold after legal aid was withdrawn and 369 claimants dropped their cases. In 2015 the litigation was revived when the remaining 124 claimants instructed new solicitors and found commercial funding.

In 2016 GSK asked the court to bring the case to a permanent halt, but Mr Justice Foskett said he wanted to see how the case progressed in stages before deciding if it should be stopped or go to trial.2

From the beginning, the claimants’ case had been that paroxetine, a selective serotonin reuptake inhibitor (SSRI) known in the UK as Seroxat, was a defective product because it caused worse problems than other SSRIs when patients tried to stop taking it. Later, their lawyers tried to expand the case to argue that paroxetine had no particular benefits compared with other SSRIs on a risk-benefit basis, but Foskett ruled that it was too late to change the basis of the case, and it could go ahead only on the narrow basis that paroxetine was the “worst in class” for adverse effects on discontinuance.

In 2018 a new judge, Mrs Justice Lambert, took over from Foskett. At a pre-trial hearing she ruled, “It is now far too late to expand the scope of the trial to include evidence of risks and benefits.”

When the trial opened in April 2019, Lambert ruled again that the claimants’ case could not extend to examining the relative risks and benefits and the claimants could not advance the case that paroxetine had no relative benefits compared with other drugs in the class.

The trial was adjourned so the claimants could take the matter to the Court of Appeal. The appeal court ruled in November 2019 that the claimants were not entitled to put their case on a risk-benefits basis because previous case management rulings had held that it was to be based on the “worst in class” scenario.

GSK had maintained from the outset that the claimants’ pleaded case, relating just to adverse effects on discontinuance, was the wrong approach and that a “holistic” view should be taken in determining the safety of a prescription drug.

After the appeal court ruling, GSK made an application asking the High Court to continue the trial with just one matter: whether it was appropriate in principle to assess whether paroxetine was a defective product by seeking to establish whether it caused adverse effects on discontinuance which were more frequent, more severe, and longer lasting than other SSRIs, and whether the effects made it more difficult to stop taking it.

Two working days before the hearing, the claimants’ lawyers told the court that they would not contest the company’s application and they agreed that judgment should be entered for GSK.

GSK told the court it had run up costs of nearly £9.33m since the case was revived in 2015. Lambert ruled that the claimants should pay the company’s costs. But GSK is expected to apply to the court for an order that the costs should be paid by the commercial litigation funder.

The losing party in the UK will not usually be ordered to pay the full costs incurred by the winning party, but only costs that are reasonable and proportionate to the matter. This is known as the standard basis.

Lambert ordered that part of the total costs to be paid to GSK, for the period from 21 June 2018, should be assessed on a higher than usual basis—the indemnity basis. This means that GSK is more likely to get back the actual costs the company incurred for that period.

The date chosen was 28 days after more than 300 people lost a High Court group action alleging that the DePuy metal-on-metal hip implant was defective.3 In that case the judge underscored the need for a holistic approach.

Following that decision, said Lambert, it was clear that the paroxetine claimants were “pursuing a case which was, quite simply, unarguable” and continuing the litigation was “unreasonable to a high degree.”

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