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Vioxx battle kicks off in court

A fiery quarrel has emerged from the opening sessions of the first court case involving Merck's infamous painkiller.

A fiery quarrel has emerged from the opening sessions of the first court case involving Vioxx, Merck's infamous COX-2 inhibitor withdrawn last year, in which the firm was accused of breaching laws governing patient privacy.

Plaintiff Cheryl Rogers claimed that her husband died of a heart attack that was linked to his Vioxx medication, and her lawyers requested sanctions that all Merck documents be disclosed to the public. They claim that Merck, which sought dismissal of Rogers' case on the grounds that it is falsified and without merit, had attempted to ìpoison the jury poolî by violating federal patient medical record laws with regard to deceased Howard Brad Rogers.

The company has questioned the credibility of Cheryl Rogers' claim, alleging that her testimony must be based on an untruth as the packages of Vioxx under question in the case left the factory only after the death of her husband, according to reports in the Financial Times.

It may also prove difficult for the plaintiff to prove the existence of a clear link between Vioxx and Mr Rogers' heart attack, in spite of the drug being withdrawn last year over findings that it increased the risk of heart attack and stroke in some patients after prolonged use. Merck may focus on the existence of other prevailing risk factors that may precede a heart attack.

Some analysts have speculated that the firm could be liable for more than $5bn in legal fees over the course of the Vioxx cases, which, if true, may explain the firm's dogged determination to have plaintiff Rogers' case dismissed. A victory could help it to establish a positive early foothold in the proceedings, and may even deter further plaintiffs from bringing their own cases to court.

The case continues this week.

Separately in the UK, market watchdog the Medicines and Healthcare products Regulatory Agency is investigating whether the beleaguered US company correctly reported Vioxx-related side effects to the regulator.

Merck said it was aware of an ìinvestigation by the MHRA of compliance by the company with EU reporting requirementsî, adding that it would co-operate.

The crux of the issue is understood to centre around the timing of the notification of side effects. Some believe that Merck knew years ago about the cardiovascular side effects linked to Vioxx, yet the company maintains that it was not clear on the issue until trial data was released last year.

  • The Committee for Medicinal Products for Human Use (CHMP) has, with Pfizer, reviewed the data on serious skin reactions occurring with valdecoxib (Bextra) and its parent compound (Dynastat). The European Commission has formally asked the CHMP to include the assessment of skin reactions on the ongoing review of the whole COX-2 inhibitor class. It is not expected that Bextra will re-enter the EU marketplace.

30th September 2008

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