Liability trumps science at Merck trial

BY HEATHER WON TESORIERO, ILAN BRAT AND GARY McWILLIAMS, ANGLETON, TEX.,

AND BARBARA MARTINEZ, NEW YORK WALL STREET JOURNAL STAFF

Globe and Mail

Monday, Aug 22, 2005

It was an e-mail written in February, 1997 — more than seven years before Merck & Co. Inc. withdrew its blockbuster pain­killer Vioxx over concerns it could cause heart attacks — that helped prompt a jury to deal a stunning de­feat to the giant pharmaceutical company in a courtroom here this past Friday.

In internal correspondence between researchers, Alise Reicin, a top Merck scientist, wrote that "the possibility of increased CV [cardiovascular] events is of great con­cern." She proposed that people with high heart risk be excluded from a Vioxx study so any difference in the rate of cardiovascular problems between the Vioxx patients and the others "would not be evident."

Jurors say they saw the document as part of a pattern of evidence that undermined the company's contention that it didn't know of the drug's potential for heart risk until just before it pulled it from the market last September.

"That told me they knew cardio­vascular events were possible on this drug, but they failed to tell us about it," said Lorraine Blas, a 40 year-old human-resources worker.

It is one reason the jury of seven men and five women found Merck liable for the death of Robert Ernst, a 59-year-old triathlete who took the drug for eight months before his death in 2001. The jury awarded his widow Carol Ernst a total of $253-million (U.S.) in damages.

The damage award is certain to be reduced — probably to about $26-million or even less. Jurors set $229-million of the total as punitive damages, which, in this case, lawyers from both sides said, would be reduced to less than $2-million un­der Texas law.

The verdict is nevertheless a huge blow to Merck, whose standing as one of the most respected compan­ies in the global pharmaceutical in­dustry has been tarnished by the Vioxx episode and which faces sev­eral thousand more Vioxx suits and a potential liability that analysts have estimated as high as $30-bil­lion.

But the jury's decision also underscores an erosion of trust among patients and doctors alike that is affecting the entire drug industry. Marketing practices, including ubiquitous direct-to-consumer advertising campaigns, have been criticized as overstating the benefits and minimizing the risks of medicines in the drive to boost sales. Jurors said they believed Merck failed to promptly add information on po­tential heart risk to Vioxx's product label about three years ago, and when it did, the information was difficult to understand and almost impossible to find—traits common to most product labels.

"These people are good, solid people," Mark Lanier, the plaintiff's lawyer who argued the case, declared after the verdict was read. "They know right and they know wrong. It sends the message that the drug companies must tell us the good, the bad, and the ugly"

Merck, based in Whitehouse Station, N.J., said it was "disappointed" in the jury's decision and vowed to appeal. In a statement Saturday, Kenneth Frazier, Merck's senior vice-president and general counsel, said the plaintiff's case was "fundamentally flawed" and that the company has "strong points to raise on appeal."

He also said the company was "steadfast in its legal strategy" to try each of the thousands of other cases it faces one by one.

Particularly nettlesome for Merck is that jurors paid little heed to its argument 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. The company-sponsored trial that led Merck to withdraw the drug found it was associated with an increased risk of heart attacks and strokes, and other science says Vioxx can promote formation of clots that cause such events. But no data have linked the drug with arrhythmias.

But issues of causation involve technical statistical concepts and complex biology and in this case involved differences of opinion over whether the lack of a heart-attack producing clot at autopsy ruled out the possibility that Mr. Ernst suffered a heart attack. For Merck, "the whole case was about the clot, whether there was a smoking gun," said juror Derrick Chizer, 43, but the jury essentially dispensed with the medical science — the crux of Merck's arguments — and focused on liability.

Jurors also said they thought Merck erred in not sending top executives to the trial to testify in person. Former chief executive officer Raymond Gilmartin and another high Merck official appeared in videotaped depositions but weren't in the courtroom.

Merck's legal team and even its board are weighing the implications of these responses to the company's strategy.

William Bowen, president of the Andrew W Mellon Foundation and an outside board member, 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. But no decision has been made whether Mr. Gilmartin, the former CEO, will testify in person.

Mr. Bowen said the board held a conference call that included most members late Friday, just a few hours after the jury reached its ver­dict, during which Mr. Frazier, the general counsel, gave his accounting of the verdict. "We were all ex­tremely disappointed in the court and in the handling of the case and are firmly behind Ken in his deci­sion to appeal," Mr. Bowen said. "Merck is in no way, shape or form going to stand pat."

While it didn't come up during the call, Mr. Bowen said the board is mulling whether to try to put Vioxx back on the market — partly to blunt plaintiff attorneys' legal am­munition. The possibility "has been discussed and will continue to be discussed [by management] with the board," Mr. Bowen said.

The board "is absolutely behind" the plan to defend each of the Vioxx cases one by one, he added. Still, if other losses with large damage awards follow, pressure could build for Merck to settle rather than fight. Certainly, thanks to Mr. Lanier, oth­er trial lawyers now have a how-to manual for taking the company on.

In Mr. Lanier, Merck faced a colourful and formidable adversary who had won other big decisions against corporate defendants, in­cluding a $115-million damage award — later settled for an undisclosed amount — in 1998 against an asbestos maker on behalf of 21 steel workers. That victory came in the same courthouse here in Brazoria County and before the same judge who presided over the Vioxx case. In all, Mr. Lanier says he has won 45 of the 50 cases he has tried in Texas.

As part of his strategy in this trial, he 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. He 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 jury as the case unfolded.

Merck's legal team included Ger­ry Lowry, 46, a partner at the Houston powerhouse law firm of Fulbright & Jaworski, where Mr. Lanier started his law career, and David Kiernan, 47, a lawyer with a medical degree, from Williams & Connolly, Washington. Ms. Lowry had previously been co-lead counsel when Bayer AG successfully defended the first lawsuit alleging harm from Baycol, a cholesterol fighter that the company withdrew from the mar­ket because of a rare muscle-destroying side effect.

In contrast to Mr. Lanier, the Merck lawyers were reserved in their pre­sentations, rarely leaving the podi­um from where they questioned witnesses and addressed the jury. A spokesman for Merck wouldn't say whether the company hired any shadow jurors, but it retained jury consultant Patricia Hastings, of Houston-based trial-consulting firm RandD Strategic Solutions LLC. Ms. Hastings didn't return a call seeking comment.

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 and its marketing arm 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 U.S. regulator, the Food and Drug Ad­ministration, with paper that ob­scured Vioxx's problems — finally stopping when a defence attorney seemed to support Merck's defence: while the trial leading to Vioxx's withdrawal had linked the drug to heart attacks, no study had associ­ated the painkiller with potentially fatal heartbeat irregularities. But under his questioning, Maria Ara­neta, the coroner, testified that a heart attack most likely caused the arrhythmia and that while no blood clot was present to indicate a heart attack, one could have dissolved naturally, or dislodged by cardiopulmonary resuscitation administered in an attempt to revive Mr. Ernst that was so strenuous it broke his ribs.

It was the link Mr. Lanier desper­ately needed to argue that Vioxx caused Mr. Ernst's death.

Dr. Araneta hadn't been on Mr. Lanier's witness list and Merck ob­jected to her deposition being played for the jury. It lost, but it fought back. A cardiologist and a pathologist took the witness stand to dispute the coroner's views. Merck researchers vouched for the company's stance that Vioxx was extensively tested and that there wasn't any evidence even hinting that it caused arrhythmia. Thomas Wheeler, interim chairman of pathology at Baylor College of Medicine in Houston, told the jury that Mr. Ernst's clogged arteries — not Vioxx — put him at risk of a fatal arrhythmia even though he hadn't previously showed outward symptoms of heart disease.

"I don't mean this disrespectfully: he was like a walking time bomb," Dr. Wheeler said. 'Any time it could have happened." He presented a slide of Mr. Ernst's coronary arteries to the jury, pointing out how one was as much as 75 per cent clogged with fatty deposits called plaque.

In addition to scientist Dr. Reicin's e-mail, Mr. Lanier introduced other Merck documents to build his case that the high officials had seen at least hints of Vioxx's potential heart risk even before it was ap­proved by the FDA in 1999 and had failed to pursue or disclose them.

E-mails from Edward Scolnick, Merck's research chief at the time, suggested awareness that Vioxx at least partially contributed to a find­ing of increased heart attacks and strokes. "It is a shame," Dr. Scolnick wrote in 2000, "but it is a low inci­dence and it is mechanism-based as we worried it was."

Mr. Gilmartin's taped deposition was characteristic of the company's response: The company didn't have any evidence linking Vioxx to heart and stroke risk until late September of last year, when it moved quickly and responsibly to pull the drug from the market.

In a strategy meeting held the same evening, Mr. Lanier got a can­did assessment from Ms. Blue, his jury adviser. "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 the point that they only needed to be 51-per-cent sure — reflecting a preponderance of evidence — that Vioxx was a cause of his death. "Write [51 per cent] on the board twice," she instructed him. "Arrhythmia is a cardiovascu­lar event. 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 had written in her questionnaire that she loves `Oprah',  and that she tapes it. "This jury believes they're going to get on Oprah," Ms. Blue told Mr. Lanier and that he had to make them think, "They only get on Oprah if they vote for the plaintiff."

The next day, he put on his only re­buttal witness, a professor of phar­macology from the University of Michigan who had testified earlier in the trial. He told the jury in lay­man's terms why a clot had proba­bly triggered the cardiovascular event that caused Mr. Ernst's death, and why there wasn't any evidence of a clot on the autopsy. Then on Wednesday, facing the jury with his last chance to make his argument, he followed his Monday night stra­tegy to the letter. He launched his closing argument, relying on pun­chy slides and screens with the words "denial," "deception," and "damage" to drive home his theme.

"The right decisions were not made inside that company," he told the jury. "The decisions were made on finance and not on safety"

Merck lawyers centred their clos­ing arguments on the lack of a sci­entific connection between arrhythmia and Vioxx. "Please don't believe that because we're here tell­ing you that Vioxx didn't cause Mr. Ernst's death that we don't have sympathy," Ms. Lowry said. "We put that aside and look at the evidence." She took several jabs at Mr. Lanier's presentations, telling jurors he had "put up a bunch of cartoons." She added: "The science isn't always as interesting, but that's what this case is about."

 

 

'That told me they knew cardiovascular events were possible on this drug, but they failed to tell us about it.'

n          February 1997: A top Merck researcher writes in an internal memo that "the possibility of increased CV (cardiovascular) events is of great concern."

n          May 1999: The U.S. Food and Drug Administration approves Vioxx for osteoarthritis and acute short-term pain.

n          March 2000: Merck reports the preliminary results of a large test of Vioxx in rheumatoid arthritis patients. In footnotes to the trial, the company notes that 0.5 per cent of those taking Vioxx had heart attacks, compared with 0.1 per cent who took naproxen — a statistically significant difference.

n          Sept. 17, 2001: The FDA warns Merck for improper marketing of Vioxx, saying the company had misrepresented the drug's safety profile and minimized its potential risks.

n          April 11, 2002: The FDA approves a new label for Vioxx that includes new data about heart attack risk.

n          Sept. 30, 2004: Merck pulls Vioxx off the market, sending the drug maker's share price down 27 per cent. Merck's decline knocked the company's market value down $26.8-billion (U.S.).

n          Nov. 8, 2005: Merck the U.S. Justice Department has launched a criminal investigation into the company’s handling of Vioxx

n          Nov. 9, 2005: Moody's Investors Serv­ice lowers Merck's credit rating for long-term debt two notches to Aa2 from Aaa.

n          Dec. 7, 2005: Merck appoints a special committee to "review the company's actions" before its Sept. 30 withdrawal of Vioxx.

n          Jan. 24, 2005: Study appearing in the Lancet Medical Journal says Vioxx may have caused as many as 140,000 excess cases of serious coronary heart disease in the U.S. The study's lead author, David Graham, is an FDA official and an outspoken critic of the drug.

n          July 11, 2005: The first Vioxx-related lawsuit goes to trial in south Texas. The Plaintiff is Carol Ernst, the widow of Robert Charles Ernst, a 59 year-old triathlete who suddenly died in his sleep in May, 2001.

n          Aug. 19, 2005: Jurors find Merck liable for the death of Robert Ernst and award his widow $253-million.

© 2005 Dow Jones & Co. Inc