Vioxx mistrial trips up Merck – Retrial may hear new charges

posted on:
December 13, 2005

author:
Ed Silverman and Jeff May

The nation’s first federal Vioxx trial ended yesterday with a hung jury, which couldn’t decide whether the painkiller caused a Florida man’s fatal heart attack.

The mistrial was declared after one juror refused to agree with eight other panel members, who believed Merck acted responsibly in developing and marketing the painkiller, according to published reports. A unanimous decision was required for a verdict.

Lopsided vote or not, the outcome is a setback for Merck.

The Whitehouse Station-based drugmaker now faces a retrial that likely will include sensational charges made last week by editors at the New England Journal of Medicine, who accused Merck of deliberately withholding heart-attack data from a 2000 Vioxx study.

Since withdrawing Vioxx last year over links to heart attacks and strokes, Merck has insisted the widely used painkiller was studied carefully. The company has said all pertinent data were disclosed properly and on a timely basis, especially to federal regulators.

"Those editors made very serious allegations," said Jere Beasley, one of the attorneys representing the widow of Richard "Dicky" Irvin, who suffered a heart attack after taking Vioxx for one month in 2001. "As you can imagine, we’re looking forward to the retrial."

Moreover, the outcome of this latest case – which was only the third Vioxx lawsuit to go to trial – robbed Merck of any momentum that was gained after winning a trial last month in state court in New Jersey, where about half of more than 7,000 Vioxx lawsuits are filed.

"This raises the stakes for Merck," said Chris Placitella, a plaintiffs lawyer who is involved in preparing many of the New Jersey cases. "Now Merck may have to try federal and state cases nearly simultaneously in February. There’ll be a lot more pressure on them."

Nonetheless, Merck lawyers yesterday portrayed the mistrial as something of a victory, given that the Associated Press reported eight of nine jurors believed the company’s defense. And they downplayed the fallout from charges made last Thursday by the medical journal editors, which appeared to be unrelated to the jury’s failure to reach a verdict.

"The plaintiffs weren’t successful in their objective," Kenneth Frazier, Merck’s general counsel, said in a teleconference. "And we see nothing in this result to say that we can’t defend these cases. We remain committed to addressing these one by one."

On the same call, Phil Beck, the lead attorney for Merck in the federal trial in Houston, argued that the editors at the New England Journal of Medicine always had all the pertinent heart-attack data, which also was provided promptly to the Food and Drug Administration.

"The way it was written, it’s given people a false impression" about the data that were submitted to the journal, he said. "The facts have been known to lawyers on both sides of the litigation for a long time. And all information was provided to the FDA in a timely manner."

The data were at the heart of Merck’s VIGOR study, which compared the gastrointestinal safety of Vioxx to an older painkiller. The results, published in November 2000 in the New England Journal of Medicine, reported 17 heart attacks among Vioxx users.

But there were an additional three Vioxx heart attacks that should have been included in the results, according to the journal’s editors. Those heart attacks were all in patients deemed at low risk for cardiac problems. As a result, a higher risk associated with Vioxx wasn’t published, the editors said.

The accusations hinge, in part, on timing – the study was submitted to the journal in May 2000. But last month, the editors became aware of a July 2000 Merck memo showing the higher heart-attack data were known by the authors before the study was submitted.

The episode threatens to undermine Merck’s credibility, because the drugmaker has so far repeatedly cited the VIGOR data as a linchpin in its defense. What’s more, Alice Reicin, a Merck executive who co-authorized the study, also testified about the reliability of the study.

Now plaintiffs’ attorneys are scrutinizing Reicin’s testimony for perjury, hoping to find contradictions between her previous remarks and the behind-the-scenes actions prior to publication in the medical journal.

"We believe we found one to two areas that we will take to a DA, but we are still examining the record and trying to make a decision," said Mark Lanier, a lawyer who won a $253 million verdict against Merck last summer in a state trial in Texas.

Meanwhile, Chris Seeger, who represented an Idaho man who lost the recent New Jersey case, said he expects later this week to include information about the New England Journal of Medicine in an updated motion for a retrial.

Beck, however, stood by Reicin yesterday and maintained he is "100 percent comfortable" having her testify again. He also called her a "very honest and forthright witness."

Merck lawyers also argued that the study authors, who numbered 13 scientists, followed standard procedures by not updating the journal with additional data after a specified cutoff date. In this case, that date was a few months before publication. The reason for cutoff dates, said Frazier, is "to avoid allegations that someone was manipulating the data."

Yesterday, however, a spokeswoman for the New England Journal of Medicine said that "as a regular matter, authors do update their data right up until the time of publication. In the case of the VIGOR article, the authors never told us about an early cutoff (for counting heart attacks). This was not mentioned in the article, nor was it ever mentioned to an editor."

Staff writer George E, Jordan contributed to this article.

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