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Same-Day Analysis

Tide Turns Back Against Merck & Co in Double Vioxx Setback

Published: 18 August 2006
The see-saw nature of U.S. pharma Merck & Co’s litigation proceedings over withdrawn arthritis drug Vioxx (rofecoxib) continued yesterday, as the company surprisingly lost a federal case, and a retrial was ordered over a previous lawsuit that Merck had won.

Global Insight Perspective

Significance

The loss in the federal trial falls in line with the only clear emerging trend in the Vioxx litigation—that while Merck is winning the majority of the trials, the damages levelled against the company when it loses are very big. It is a telling indicator of the fine line between victory and considerable defeat, and that Merck’s strategy of fighting the litigation case-by-case continues to carry significant risks.

Implications

In a conference call, Merck confirmed that if post-trial motions neither set aside the verdict nor significantly reduce the damages to the company’s satisfaction, a formal appeal will be lodged, as has been done for each loss so far. The ordering of a retrial by Judge Carol Higbee in New Jersey again reinforces our view of a pro-plaintiff judge, as well as the growing politicalisation of medical journals; an ex post facto scientific editorial led her to throw out the original verdict.

Outlook

Yesterday's double announcement reversed a trend that had seen Merck win two important cases in a row, which in itself was a reversal of several setbacks in the Vioxx litigation earlier this year. Clearly, the vagaries of the U.S. legal system, particularly with regard to cases of a complex scientific nature, are also on trial here, though the media has not picked up that aspect to the same extent.

Tide is High, but Merck is Holding On

U.S. drug giant Merck & Co yesterday confirmed in a press release that it will appeal against the verdict from a federal jury in New Orleans, which unanimously found in favour of plaintiff Gerald Barnett. The plaintiff, a former agent with the U.S. Federal Bureau of Investigation (FBI), claimed that his heart attack in 2002 was caused by regular Vioxx use, and that Merck knowingly misrepresented the drug. Separately, and at the conference call held after the verdict, Merck also commented on the decision of Judge Carol Higbee in New Jersey, who is overseeing more than 4,000 Vioxx cases, to set aside Merck's November 2005 victory in the case of Frederick "Mike" Humeston and order a retrial. She cited "new evidence"—specifically, the "expression of concern" published by the New England Journal of Medicine (NEJM) after the trial, which maintained that Merck had failed to disclose three heart attacks in its Vioxx data.

The federal jury in New Orleans awarded Barnett US$50 million in damage-related compensation, and added US$1 million in punitive damages, despite the fact that Barnett's heart attack was mild (and did not interfere with an active life) and the presence of a number of other risk factors, including high cholesterol, documented cardiac disease and family history. In a scathing assessment, the jury found that Merck "acted in wanton, malicious, wilful or reckless disregard for the plaintiff's rights". During the conference call, Merck's outside general counsel expressed the company's disappointment at the outcome, repeatedly noting the multiple risk factors that Barnett suffered, and the fact that the science simply did not add up to the verdict.

Interestingly, and somewhat confusingly, the jury gave entirely contradictory answers to the three questions that it was asked to consider in finding a verdict. On the first question, which asked if they believed that Merck failed to adequately warn Barnett, and that this failure was the legal cause of his heart attack, they answered "no". Instead, the jury found Merck guilty on the issue of negligence, and the issue of causation, which is meant to be separated from punitive assessments, was subsequently combined with the warnings issue. This will clearly form the basis of Merck's appeal.

Judge Higbee's decision falls in line with our general view that she has been pro-plaintiff in the cases that she has presided over so far—particularly with regard to the level of "junk science" that she has permitted. As we have repeatedly stressed, the NEJM "expression of concern" did not state anything that was not already known, or even anything that has not already been presented to juries in Vioxx cases, and Merck's lawyers maintained in the conference call that it was an "improper" decision. The editorial was clearly politically motivated, and was timed to coincide with jury deliberations in a separate trial that was ongoing at the time. Interestingly, plaintiff lawyers in the Barnett case did not even present the expression of concern in the case that Merck has just lost.

Merck's Vioxx Caseload

Case

Location

Outcome

Grossberg

California (Superior Court)

Merck (2 August)

Doherty vs Merck

New Jersey (Superior Court; Judge Higbee)

Merck (13 July)

Garza vs. Merck

Starr County, Texas (District Court)

Plaintiff (24 April 2006)

Cona/McDarby vs. Merck

Atlantic City, New Jersey (Superior Court; Judge Higbee)

Merck and Plaintiff (6 April 2006)

Plunkett vs. Merck 

New Orleans (federal)

Merck (17 February 2006)

Plunkett vs. Merck

New Jersey (federal)

Mistrial (13 December 2005)

Humeston vs. Merck

Atlantic City, New Jersey (Superior Court; Judge Higbee)

Merck (4 November 2005); thrown out, retrial ordered

Ernst vs. Merck 

Angleton, Texas (District Court)

Plaintiff (19 August 2005)

Source: Global Insight research

Outlook and Implications

The Barnett verdict again reinforces the view that the outcome of early Vioxx litigation remains near-impossible to forecast. Global Insight had seen a stronger likelihood of Merck losing the two previous cases, which were in pro-plaintiff jurisdictions and concerned long-term Vioxx users, yet the company emerged with two surprising—and important—victories. While the Barnett trial was finely balanced, as it involved a sympathetic victim and long-term user, the outcome is still relatively surprising, given that it was a federal trial, where the scientific bar is higher (Merck won the other multidistrict litigation federal trial that it has faced), and Barnett had a number of risk factors. In addition, the extent of the compensatory damages is again highly unusual. Despite these factors, we judge it unlikely that the verdict will be set aside on appeal, due primarily to the character of the plaintiff, although damages will almost certainly be reduced.

The next Vioxx case is another federal trial to be held on 11 September, and the case-by-case strategy has in no way been put in doubt by the Barnett verdict.

Upcoming Vioxx Trials

Case

Location

September

Smith (11 September)

Louisiana (MDL Court)

October

Crook (23 October)

Alabama (Circuit Court)

Mason (30 October)

Louisiana (MDL Court)

CA Coordinated; Plaintiff(s) unspecified (31 October)

Los Angeles, California (Superior Court)

Source: GI; the whole upcoming trial schedule is available from Merck’s Vioxx Information Centre.

Related Articles:

  • United States: 3 August 2006: Merck & Co Finds Midas Touch in Golden State Vioxx Victory
  • United States: 14 July 2006: Merck & Co Stops Vioxx Rot with Unexpected Legal Victory
  • United States: 27 June 2006: Pharma-Journal Community Polarises Further, as Merck & Co Deflects New NEJM Accusations
  • United States: 23 February 2006: Division Deepens between Merck & Co and NEJM over VIGOR
  • United States: 20 February 2006: Merck & Co Clears Another Vioxx Hurdle, with Victory in Federal Court Case
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