Merck's Alleged Manipulation of Vioxx Study Data Raises Several Serious Legal IssuesDec 12, 2005 | www.Newsinferno.com
A Possible Mistrial in Houston, a Potential Retrial in New Jersey, Possible Perjury on the Part of One or More of Merck’s Witnesses, and How the Credibility of a Key Defense Witness and the VIGOR Study Will Fare in any Future Trials Have All Emerged as Serious Considerations for Merck.
Following the rather shocking revelation by Dr. Gregory Curfman, executive editor of the New England Journal of Medicine (NEJM) that data linking Vioxx to increased cardiovascular risk was deleted (apparently by Merck researchers) from the VIGOR study two days before it was submitted to the NEJM for publication, a number of serious legal issues have been injected into the ongoing litigation.
First, however, by way of background, the situation as it stands now is that, according to Dr. Curfman: "I was somewhere between surprised and stunned. They allowed us to publish an article that was just incomplete and inaccurate in some respects and was misleading and may have contributed to the detriment to the public health."
Dr. Curfman did not find out until November 21, 2005, that by July 5, 2000, two Merck authors on the VIGOR study knew of three additional heart attacks among Vioxx patients in the study, which had not been disclosed to the NEJM. The heart attacks occurred in the final five weeks of the trial and in patients at low risk for heart problems. Curfman also learned that a prior version of the manuscript revealed more cardiovascular problems potentially connected to Vioxx than those discussed in the published study.
The editors of the NEJM had assumed that the VIGOR manuscript they were given only contained limited cardiovascular data since that was all that was available. "It turns out that they had quite a bit more already worked up,"
The Journal now contends that "at least two" of the study's three authors knew of the additional heart attacks for some 4 1/2 months prior to publication. "There was ample time to include the data on these three additional infarctions in the article."
Dr.Curfman now questions his own diligence in pursuing the obvious manipulation of the scientific data in the VIGOR study since the missing information would have dramatically changed the results.
The accusation by the NEJM that Merck knowingly withheld data on three fatal heart attacks and more, if true, significantly undermines the VIGOR study results as well as the entire premise upon which Merck has built its entire defense.
It would certainly call into question the study’s findings, which have been a central element in the three trials, as well as the testimony of one of the study's authors, Dr. Alise Reicin, Merck's vice president for clinical research, who claimed the company never misled doctors or the public about Vioxx studies.
Based upon the facts as they now stand, we asked a number of trial and appellate attorneys to offer their thoughts on what possible legal issues are raised by the NEJM’s allegations. Their responses center on four very serious problems that must now be dealt with by the courts and Merck. These include:
1. Plaintiff’s mistrial motion in the case now being deliberated by the jury in U.S. District Court in Houston has been held in abeyance for now by Judge Fallon. Although he is free to decide the motion before the verdict, courts usually reserve decision on such motions until after the verdict to avoid the necessity of a new trial if an appellate court determines the motion was decided incorrectly. Here, the missing data would have strengthened plaintiff’s case and severely damaged Merck’s defense including the testimony of its key witnesses. Thus, a verdict for Merck may have to be set aside. If the verdict is for the plaintiff, however, it would not have to be set aside although the court would then have to decide if the missing data would be admissible in the case for punitive damages. Certainly, if the verdict is in favor of Merck and the motion for a mistrial is denied, plaintiff would have the right to seek a new trial on appeal.
2. There is a serious issue of whether any of Merck’s witnesses may have committed perjury in this or either of the prior trials. Obviously, if data was deleted, someone knew about it and may have even ordered it. Since a number of key Merck employees have testified about the study, it is impossible to believe no one knew of the deletion. Moreover, Dr. Alise Reicin was one of the authors of the VIGOR study article in the NEJM and is certainly one of the people who would have had access to the data files. Even if she had no knowledge of the actual deletion of data, she may have known of the additional deaths. Thus, her testimony has become highly suspect since it is based on a study she may have known was inaccurate. In addition, after Dr. Topol and his colleagues analyzed the VIGOR study and other data, they drafted their article and sent it to Merck expecting the company might be able to reconcile several major discrepancies between its data and that kept in the FDA database. It was then that Dr. Topol got a visit from the very same Dr. Reicin, a Merck researcher and chairman of its Vioxx Commercialization Committee. At that meeting she told Dr. Topol that it was the Cleveland Clinic team that had “gotten it wrong” and would be embarrassed if we published the paper. "I thought it was harsh," he said. Obviously, if she knew about the additional deaths and/or the omission of data from the study, her meeting with Dr. Topol was disingenuous.
3. The New Jersey trial wherein Merck prevailed has also been called into question now. Since the verdict in that case was based solely on Merck’s claim that it did not know Vioxx was unsafe until September 2004, the allegations of withholding data and manipulating the central study Merck relied on in its defense would give Judge Higbee (not a big Merck fan to begin with) every reason to set aside the verdict in favor of Merck and order a new trial. In addition the same issue of possible perjury would exist. Even if Judge Higbee did not set aside the verdict, a New Jersey appellate court could.
4. The final point raised by the attorneys we spoke with had to do with the future. Clearly, if the serious allegations involving deleting data are true, Merck witnesses will be the subject of some rather intense and damaging cross-examination at any future trials, In addition, Dr. Reicin may have become a major liability to Merck instead of one of its star witnesses. She may no longer have the credibility she enjoyed in the first three trials and her involvement in the VIGOR study scandal may have made it impossible for her to hold her own on the witness stand. The value of the VIGOR study itself is also in serious doubt now. Instead of being useful in certain ways to both sides, it may have now turned into an albatross for Merck.
It would appear that as the trials have progressed, Merck has been steadily losing ground in terms of evidentiary rulings, scheduling of upcoming trials, and, most importantly, credibility. This latest fiasco has only added to Merck’s legal woes and may very well have spelled the end of the company’s brash strategy of trying each of the remaining 7,000 plus cases to verdict.