A top medical journal's criticism of a study cited in Vioxx lawsuits is expected to play a part in the retrial of the first federal Vioxx lawsuit — but it's not clear if it will be a legal hand grenade or a nuclear warhead.
The disclosure that some negative data was omitted from the study could make manufacturer Merck & Co. look as if it's hiding something, legal experts say. That is what attorneys for Evelyn Irvin Plunkett, whose husband died after taking the drug for a month, say they can prove in the trial starting Monday.
The first federal trial — held in Houston in the wake of Hurricane Katrina — ended with a deadlock. Two jurors said the split was 8-1 in favor of Merck's contention that taking Vioxx had nothing to do with the death of Richard "Dickie" Irvin.
The day those deliberations began, the New England Journal of Medicine published criticism — one step short of retracting the study — accusing its authors of withholding and deleting relevant data.
The information alone is "damaging although not shattering," but its implications could be devastating, Northwestern University law professor Ronald Allen said.
Vioxx was a $2.5 billion-a-year seller when Merck pulled it from the market in September 2004 because a study found that taking it for 18 months doubled the risk of heart attacks.
An earlier study known as VIGOR, published by the journal in 2000, is being cited in allegations that Merck held back information about the risk of heart attacks.
The journal's critique noted that its editors learned that the authors had deleted information about three additional heart attacks not reported in the original study, but reported to the Food and Drug Administration. That would have changed a section about side effects, showing that Vioxx patients had five times as many attacks as those on the pain reliever naproxen, rather than four times as many — and that patients not considered high-risk were having heart attacks, it said.
"Taken together, these inaccuracies and deletions call into question the integrity of the data," the journal said.
The editors found a blank table labeled "CV events" — heart attacks and other cardiovascular side effects — on a first draft of the VIGOR study found on a computer diskette after the recall. It was deleted from later versions on the same disk.
Dr. Gregory Curfman, the journal's executive editor, confirmed through a spokeswoman that software indicated that data was deleted from the table two days before the manuscript was submitted, and identified the deleting editor as "Merck."
The company said that all that was taken from the table was data that was put into the body of the article, and it never included information about the three later heart attacks.
But, he wrote, the Journal's editors didn't realize the significance of the deletion until Nov. 21, when Curfman was questioned by Plunkett's attorneys. They produced a memo showing that at least two authors knew about the heart attacks at least two weeks before submitting the first of two revisions and 4½ months before publication.
Until then, the editors wrote, they had believed the authors didn't know about those heart attacks in time for publication. Merck says the heart attacks occurred after a reporting deadline.
The article didn't mention any such deadline, and the journal would have expected updates anyway, Curfman wrote the lead author in an e-mail released by the court.
Merck's attorneys, led by Phil Beck, plan to show that VIGOR was "done the right way," meeting all scientific standards, Beck said before the judge imposed a gag order on both sides.
The main focus of Merck's arguments, as in the first trial, is that Vioxx had nothing to do with Irvin's death. He already had clogged arteries and a blood clot, they have said in court and in interviews.
Plunkett's attorneys, led by Jere Beasley, claim Vioxx caused the clot by affecting an enzyme that thins the blood.
Allen said the editorial's precise impact will depend on just how significant the data is considered — and that, in turn, will help decide what use judges allow.
It might simply be folded into the evidence, he said. But it might also be used as a possible indication that Merck was hiding something.
"If juries get a whiff of that, it's going to be devastating," he said.
Howard Erichson, a Seton Hall Law School professor, called the editorial a stunning development. But, though he called it "terribly damaging" in a December interview, he now says it won't dramatically alter the case.
"It was about a few data points, not a fundamental rethinking of causation," Erichson said. "It's one piece of evidence that's going to undermine one of the Merck witnesses.
"It's there, it's interesting, but it doesn't fundamentally change the course of the litigation."
The case being retried starting Monday was the third among more than 9,600 state and federal lawsuits against Merck. Two state jury trials ended with a split decision: a $234 million verdict against Merck in Texas, and one clearing it of blame in New Jersey. Another trial is under way in Texas, and 10 more are scheduled in state and federal courts over the next six months.
Merck has set aside $970 million for legal costs, and said it spent $285 million of that last year. The remaining $685 million should last through 2007, it said Tuesday.