Vioxx Mistrial a Lose, Lose Situation for MerckDec 14, 2005 | www.newsinferno.com
The consequences of the mistrial in the first federal Vioxx trial may turn out to be extremely serious for Merck in terms of the embattled company’s ability to mount a credible defense in future trials.
As the trial in Houston began, Merck was regarded as the heavy favorite to win the case for a number of reasons. Among the most obvious were: (1) the trial was in the traditionally less plaintiff-friendly venue of federal court; (2) the case involved short-term Vioxx use, which is generally regarded as more defensible than long-term use cases; and (3) Merck had just won a (short-term-use) case in New Jersey state court and so “momentum” was on the drugmaker’s side.
Those clear advantages evaporated, however, when the trial judge ruled that the plaintiff could introduce expert testimony that short-term use of Vioxx carried similar cardiovascular risks to long-term use. In addition, a damaging videotaped deposition of one of Vioxx’ harshest critics, Dr. Eric Topol (renowned cardiologist from the prestigious Cleveland Clinic) was shown to the jury.
Merck, however, presented a serviceable defense that included the credible testimony of Dr. Alise Reicin, a convincing witness who has an intimate knowledge of Vioxx gained through years of working with the marketing of the drug as a high level Merck employee.
Thus, as case went to the jury for deliberation only three possibilities existed; a verdict for plaintiff, a verdict for Merck, or a mistrial. The jury would not be privy to the unexpected turn of events that was about to take place and, thus, would not be basing its verdict on the evidentiary disaster that would irreparable damage Merck’s defense and impugn the credibility of its witnesses.
What Merck needed was to win the case without the jury knowing the facts surrounding 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.
As Dr. Curfman saw it: "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."
The federal jury would never know (while deliberating, at least) that 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 or that a prior version of the manuscript revealed more cardiovascular problems potentially connected to Vioxx than those discussed in the published study.
Thus, what the jury had was defense testimony that dovetailed neatly with the published results of the VIGOR study thereby making Merck’s defense plausible and certainly able to pass the straight face test.
The deleted data, however, not only discredits the results and conclusions reached in the VIGOR study as to the safety of Vioxx, it also renders much of the testimony given by Dr. Reicin, and Merck’s other employee-witnesses highly suspect at best.
Obviously, 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.
When the NEJM revelations came to light, we asked a number of trial and appellate attorneys to offer their thoughts on what possible legal issues are raised by the Journal’s allegations. Of course, at that time, the jury was still deliberating and could have rendered a verdict despite what was taking place in the court and the media with respect to the NEJM charges.
After the mistrial was declared (based on the inability of the jury to agree on a verdict hung jury), we went back to those same attorneys to see what they thought the significance of that outcome might be in light of the Norm’s claim concerning the manipulation of the VIGOR study data.
Their responses were consistent in that they all saw the mistrial (under the particular circumstances) as being an extremely devastating blow to Merck.
Even though the mistrial was based on a “hung jury,” the attorneys we spoke with believed that Judge Fallon may have declared a mistrial on his own had there been a verdict in favor of Merck.
Plaintiff’s attorney had moved for a mistrial when the NEJM charges became public and Judge Fallon had reserved decision. Although he was 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 had to have been set aside anyway.
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 had been in favor of Merck and the motion for a mistrial was denied, plaintiff would have the right to seek a new trial on appeal to the Circuit Court of Appeals.
Merck is also faced now with the problem of maintaining its credibility since there is a serious issue of whether any of its employee-witnesses committed perjury in this or either of the prior trials.
Obviously, if Merck employees deleted critical data, someone at Merck 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. Reicin, whose entire testimony has been repeatedly based on the accuracy and reliability of the VIGOR study, happened to have been one of the authors of the article in the NEJM. She 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.
The mistrial also takes away from Merck the ability to “strike while the iron is hot” with respect to the short-term-use type of case it had prevailed upon in New Jersey and to build on its momentum.
More importantly, however, the mistrial may now jeopardize the outcome in the New Jersey trial wherein Merck prevailed. 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 a strong 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 based on the NEJM claims should they be proven to be true.
The attorneys we spoke with also believe that the failure of the federal jury to reach a quick and decisive verdict for Merck raises serious questions as to the ability of the company to overcome the mountain of evidence against it even in cases that were once thought to be eminently “winnable.”
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. This is hardly the tone Merck wanted to set after repeatedly announcing its brash strategy of trying each of the remaining 7,000 plus cases to verdict.
As a late story in the Boston Globe points out that “plaintiffs' attorneys say they will attack the credibility of Merck and its clinical trials leader, Reicin, as nearly 7,000 lawsuits are heard in federal and state courts. ‘As a general proposition, anything that smacks of manipulating studies or data is a potential bombshell,’ said Kendall Coffey, a legal analyst in Miami and a former US attorney. ‘'It's the rare case where a cover-up is of no concern to a jury. The implications range from only somewhat harmful to potentially devastating.’”
Clearly, Merck cannot point to anything positive in the mistrial. It was a missed opportunity for the company to draw a line in the sand with respect to the thousands of remaining short-term-use cases. It also represents a serious stumble for Merck’s legal team and corporate management, which have steadfastly refused to entertain the idea of settling any case or engaging in talks to resole the litigation in a global settlement.