PHARMA: WSJ on how Merck lost

I know many of you don't have WSJ access, but the article this morning on how the Vioxx trial was run is really eye-opening. I'll re-quote liberally.  First off, how important was all the science? Pretty key given that Ernst did not die from a heart attack or maybe not even a clot but definitely had arrythmia.  What did the jury think? Apparently that didn't matter too much.

But the Texas verdict -- and the way the jurors reached it -- offers a worrisome harbinger. Merck argued that Vioxx couldn't have caused Mr. Ernst's death because, according to his death certificate, he died of an arrhythmia or irregular heartbeat, not a heart attack. While scientific evidence suggests Vioxx can promote blood clots leading to a heart attack, no data have linked the drug with arrhythmias.

Jurors who voted against Merck said much of the science sailed right over their heads. "Whenever Merck was up there, it was like wah, wah, wah," said juror John Ostrom, imitating the sounds Charlie Brown's teacher makes in the television cartoon. "We didn't know what the heck they were talking about."

As they assembled around a rectangular wooden table in the jury room, the question of causality -- did Vioxx kill Mr. Ernst? -- caused little trouble for the jurors. The coroner who did the autopsy of Mr. Ernst testified he could have had a blood clot that caused a heart attack but disappeared by the time of the autopsy. That would explain why the death certificate only mentioned arrhythmia.

So what is it that a jury will look at?  Perhaps it's the behavior of the company--you remember Dodgeball?

In interviews, jurors expressed anger and mistrust toward Merck. "If I could say it in one word: hiding," said Mr. Chizer, 43, who works at the Social Security Administration. "Every time a question was asked, any one of [the Merck] witnesses circumvented the questions by going somewhere else. Just give us a straight answer."

David Webb, 20, cited a letter Merck sent to doctors around the country including Mr. Ernst's doctor. Mr. Webb felt it buried information about potential cardiovascular risks. "Who knows, what if they had put the right information and Dr. Wallace had picked up the phone and called Bob Ernst and told him?" he asks.

And was the senior leadership taking the whole thing seriously enough?

Mr. Ostrom, 49, who has a business remodeling homes, was also disturbed that former Merck Chief Executive Raymond Gilmartin and another top Merck official gave videotaped testimony but weren't in the courtroom. "The big guys didn't show up," said Mr. Ostrom. "That didn't sit well with me. Most definitely an admission of guilt."

William G. Bowen, an outside director at Merck who is on the board's executive committee, said in future trials the company will seek better ways "to make basic scientific points as simple as possible." He also said the company may put different people on the witness stand although no decision has been made about Mr. Gilmartin's testimony. A spokesman for the Merck defense team said taped depositions are common in trials. Mr. Gilmartin's deposition "demonstrated that Merck's decisions with respect to Vioxx were based on the science and in the best interest of patients," the spokesman said in a statement.

And then there's the theatrics of a great trial lawyer, and Lanier appears to be very good, and also highly highly prepared (if not quite as "prepared" as Gene Hackman in The Runaway Jury)

In the Vioxx trial, Mr. Lanier paid a group of local citizens, matched to the jury's demographics, to sit in the courtroom as shadow jurors and give him feedback on the effectiveness of his arguments. The shadow jurors, who made $125 a day, weren't told who they were working for. Mr. Lanier flew in a PowerPoint expert from California to help him prepare a visual presentation for his closing argument. And he retained Lisa Blue, a psychologist and highly regarded litigator with Baron & Budd, Dallas, to watch the reactions of the real jury as the case unfolded.

From the beginning, Mr. Lanier showed his theatrical flair, speaking loudly and gesturing while roaming the courtroom as if it were a stage. PowerPoint slides in his opening statement portrayed Merck as an automated-teller machine giving cash to executives. Merck's marketing arm was depicted as a bulldozer that would push sales at any cost.

He had workers wheel 157 boxes of paper into the courtroom to show how Merck had inundated the Food and Drug Administration with documents that obscured Vioxx's problems. He finally stopped when Merck lawyer Gerry Lowry objected that the stack obstructed her view of the jury. Mr. Lanier set two trophies Mr. Ernst won for participating in marathons on the witness stand as Mrs. Ernst recounted the day he died. A huge portrait of the couple on their wedding day faced the jury on a large screen.

Mr. Lanier's shadow jury met each night at a McDonald's, providing feedback to a consultant about the progress of the trial. Last Monday, two days before closing arguments, the jurors deliberated for more than four hours and provided Mr. Lanier with an early verdict: 9 to 4 in his favor -- with $115 million in damages. That wasn't good enough. The real 12-person jury would have to vote 10 to 2 for a decision to be valid.

In a strategy meeting held the same evening, Mr. Lanier got a candid assessment from Ms. Blue, the adviser who was watching the real jury. "Four or five are really strong followers" for the plaintiff, she told Mr. Lanier, while "two or three are very bad for us."

She told him that on the issue of whether Merck failed to warn the public about the risks of Vioxx, his case was "good and tight." But that wouldn't matter if the jurors weren't convinced that Vioxx was the culprit. "You're weak on causation," Ms. Blue told him.

She advised him to press hard on "cause" in his closing statement and to stress that the jury only needed to be 51% sure Vioxx was a cause of Mr. Ernst's death. The 51% figure was a way of describing the legal requirement that there be a "preponderance of evidence" in the plaintiff's favor. "Write [51%] on the board twice: Arrhythmia is a cardiovascular event," she instructed him. "That gets you there."

She also urged him to be humble, to play up his role as a Baptist preacher and even to suggest to jurors they might get notoriety if they voted for him. One juror, Ms. Blas, had written in her questionnaire that she loves the Oprah Winfrey show and tapes it. "This jury believes they're going to get on Oprah," Ms. Blue told Mr. Lanier. "They only get on Oprah if they vote for the plaintiff."

Two days later, facing the jury with his final argument, Mr. Lanier kept to his plan. He advised jurors that 51% confidence in Vioxx as a cause of death was good enough. He sprinkled the speech with biblical references, at one point using the tale of Esther to urge the jurors to do the right thing even if they were fearful. And he hammered home the point that they would be sending a message that would be heard widely. "I can't promise Oprah," he said, but "there are going to be a lot of people who'll want to know how you had the courage to do it."

The verdict came in with punitive damages of $229m apparently estimated at the amount Merck estimated that it stood to lose "if new cardiovascular risk information on Vioxx's label were to become effective in October 2001 instead of February 2002."  Actually punitive damages aren't really allowed in Texas, but they are in plenty of other places....and jurors tend to be pissed when they're told to assess them and then find that they can't be awarded. Quite why Ernst was worth $24m I don't know and it seems to me somewhat unlikely that the Vioxx killed him, but this is clearly not over for Merck or other big pharma companies.

So here's my suggestion to big pharma.  Be open about the science and be open about the risks as well as the benefits of the products you're selling.  Think of the longer term.  I still believe that if you give consumers the full facts some people will choose a "risky" product for what they perceive to be a good shorter-term benefit. But if you're perceived as bamboozling the FDA and the public, and your marketing operation is clearly trying to hide defects, you are in the long run only hurting yourselves. And worse you're leading to a general distrust of all the science behind pharmaceuticals and medicine.  And this country already has enough people who don't believe in science.