How a Small-Firm Attorney took on Merck and Won

posted on:
August 30, 2005

author:
Staff

The dust has settled in the nation’s first Vioxx-related personal injury lawsuit—camera crews have left the Brazoria County courthouse in Angleton, Texas, jurors have returned to their lives and Wall Street has exacted its vengeance. But the question remains: How did he do it? Just how did Houston plaintiffs lawyer Mark Lanier—small firm, major talent—score such a big lick against Merck & Co. Inc. on Aug. 19 when a jury awarded his client $253.5 million?

It wasn’t supposed to be that way—this was supposed to be a winnable case for Merck. The multinational pharmaceutical company had unlimited resources, tapping the prowess of four legal giants—Fulbright & Jaworski, Baker Botts, Washington, D.C.-based Williams & Connolly and New York-based Hughes Hubbard & Reed—to defend the company against allegations it failed to warn patients of the health risks of taking Vioxx and concealed the dangers of the once-popular painkiller, even before it hit the market in 1999.

Merck had practically cherry-picked Carol A. Ernst, et al. v. Merck & Co. Inc.—or so say some plaintiffs attorneys—using it as a test case to gauge its national litigation strategy to try each of the thousands of Vioxx cases, one after the next. The plaintiff was suing for the alleged wrongful death of her 59-year-old husband Bob Ernst, a Wal-Mart produce manager (limited economic damages) who was married to the plaintiff for less than a year (limited non-economic damages, though a pre-H.B. 4 case). But the glaring weakness of the case concerned the element of causation, and on this issue, Merck rested its hopes and its defense.

“This is not a normal Vioxx case, which is about heart attacks and strokes being increased by the use of the drug,” said Hughes Hubbard & Reed outside spokesman Kent Jarrell in a July 11 article in Texas Lawyer. “We plan on making it about the specifics of causation. … This is a good case for us.”

After all, the autopsy results supported Merck’s side. The assistant medical examiner who conducted the autopsy had concluded that the cause of death was “cardiac arrhythmia secondary to coronary aterosclerosis.” According to the defendant’s Background Science Brief, aterosclerosis, hardening of the arteries, is years in the making and put Ernst at risk for cardiac arrhythmia—an irregular heartbeat—which can lead to sudden cardiac death. The science debate on Vioxx, however, has focused on its propensity to promote blood clots (cardiovascular thrombotic events), which lead to heart attacks (myocardial infarction). No reliable scientific evidence has ever demonstrated that Vioxx causes cardiac arrhythmias, contends Merck.

The same science that forced Merck to take Vioxx off the market in September 2004 was now being used by Merck to save it from liability—at least in the Ernst case. Even assuming Ernst suffered a heart attack, he had been taking Vioxx for only eight months, and Merck claimed that no “placebo-controlled study” has demonstrated a statistically significant association between Vioxx and heart attacks when it was taken for less than 18 months. Defense experts were prepared to testify that Ernst might have presented like a healthy man who ran marathons and lived a full life, but he was a walking time bomb.

The autopsy report became the centerpiece of Merck’s case. Merck was so protective of these findings, it even filed a pretrial Motion to Exclude Expert Testimony Criticizing Autopsy Findings, hoping to exclude three plaintiff’s experts from offering contrary opinions.

Lanier and his associates battled through Robinson-Havner motions, in which the defense sought to exclude plaintiff’s experts on causation because their opinions were unreliable. “The judge certainly didn’t give us everything we wanted,” Lanier says. “But we got our case before the jury.”

Merck declines to participate in any trial post-mortem, fearful that disclosure of its internal trial tactics might impact future litigation. In a post-verdict press release, Merck says it will appeal: It expects to argue that Ben Hardin, the 23rd District Court judge who presided over the suit, allowed the jury to consider unreliable scientific evidence, unqualified experts and a surprise witness—all of which conspired to deny Merck a fair trial.

Lanier holds no similar compunction about deconstructing the Vioxx verdict. Certainly it might help members of the plaintiffs bar, some of whom attended the trial and must decide if the verdict is reproducible or an aberration. Could they use the same documents, tactics and arguments and apply them in their own Vioxx suits? Or would they lack the one magical component that made all the pieces fit and couldn’t be replicated: Mark Lanier?

VOIR DIRE AND MORE

That Lanier inspires fierce loyalty from those who surround him seems evident from the fact that Dallas jury psychologist and lawyer Lisa Blue volunteered her trial services for the Vioxx trial. “There are only a few things that would make me leave my family for six weeks and live in a hotel in Houston,” says Blue, who is also of counsel at Dallas’ Baron & Budd. “And Mark Lanier is one of them.”

“Lisa was incredibly important to me,” Lanier says. “She helped me understand the jury and the case—and she helped me understand me.”

Although Lanier fought to keep venue in Brazoria County where he had won a hefty verdict in an asbestos case, the perception that the county is a plaintiffs haven is more myth than fact.

“This was one of the most unfavorable plaintiff’s juries that I have ever seen,” says Blue, who helped develop a 20-page jury questionnaire. “Four jurors were 25 or under, and young people just don’t have the life experience with money to comprehend what hundreds of millions of dollars actually mean.”

All but two jurors were Republicans, as was the judge, says Blue, who spent three hours after the verdict debriefing jurors. “The jury was so religious, they started deliberations with a silent prayer.” But that just played into the strengths of Lanier, who seasons his arguments with biblical references and is a part-time Baptist minister. “I’ll try not to preach,” he informed the jury panel. “But that is my other occupation.”

When questioned during voir dire, “one female juror said she felt that Merck was a good company, and she would feel that way even after the trial,” Blue says. “Merck lawyers were thrilled when they found out during deliberations that she was the foreperson. … But she turned out to be our best juror.”

Gerry Lowry, Merck’s lead trial counsel and a partner in Houston’s Fulbright & Jaworski, conducted the voir dire examination. Although Lowry declines to comment about the case, Blue believes Lowry “was very tenacious in getting people to admit they had a bias against Merck.”

But it was Lanier who owned the courtroom from the beginning. “He is so animated—charismatic but boyish at the same time,” says George Otstott, a founding partner in Dallas’ Otstott & Jamison, who observed the voir dire in preparation for his own Vioxx suits.

From the get-go, Lanier seemed to empower the jury, telling the panel that the whole world was watching, which was obvious from camera crews that had infiltrated the courthouse. Their presence played into Lanier’s send-Merck-a-message theme, says Blue. “We wanted people who could understand that it is necessary to have lawsuits to control corporate behavior, because the government can’t do it.”

Both sides employed PowerPoint presentations to aid their opening remarks, but Merck attorney David Kiernan, a partner in Williams & Connolly and a medical doctor, read much of his openi
ng statement and sounded overly clinical, Blue says. Kiernan did not return a telephone call seeking comment before press time.

In Merck’s defense, its lawyers seemed to aim for the head—appealing to reason, responsibility, deliberation. Lanier on the other hand, was aiming at the heart—appealing to feelings of loss, outrage, retribution.

With no notes and an overhead projector behind him, Lanier went through 80 slides, rarely breaking eye contact with the jury, Blue says. Although his remarks appeared unscripted, he was deftly prepared; a small unseen computer at the base of the jury box flashed the same images as those on the projector. “Each slide had a picture on it with two or three words,” Blue says. “It showed a great understanding of the way people learn.”

Humanizing the plaintiff and her loss, a slide showed Bob Ernst running a marathon, next to the words “The Picture of Health”—that is, said Lanier, until he took Vioxx and died.

“I intend to prove that Merck knew that Vioxx would increase the risk of heart attacks, strokes and sudden cardiac arrest, and they marketed the drug anyway in fraudulent ways,” he told Texas Lawyer in a July interview. “They were losing the patent on six of their blockbuster drugs like Pepcid, and they needed a new drug that was going to pull them out of their financial nosedive.”

To illustrate the point, he showed a slide of an ATM, says Blue, next to the words “Merck was a cash business.” To illustrate that he intended to prove that even the Food and Drug Administration couldn’t protect the public from Merck’s aggressive rollout of Vioxx, he flashed an image of three walnut shells beside the words “Merck Duped the FDA.”

When he came to the issue of causation, Lanier adopted the language of Merck and contended that Ernst died of “a cardiovascular event” caused by a “Vioxx problem.” “Mark’s theme was that all these different doctors use different terminology, but they are all saying the same thing,” Blue says. “Whether i’ts ischemia or atrial fibrillation or myocardial infarction, they are all cardiovascular events.”

Kiernan contended that Ernst’s death, as tragic as it was, was not caused by Vioxx but by hardening of arteries, which triggered Ernst’s arrhythmia and sudden death. He also told the jury that the coroner, who had determined that the cause of Ernst’s death was arrhythmia, was just doing her job. “No one can argue that she was tainted by the influence of one side or the other,” he said. Even though she would not be called as a witness, Kiernan said, Merck would present two experts who agreed with her findings that there was no evidence of a clot-induced heart attack.

At least, there was no such evidence until Lanier presented his side of the case.

SURPRISE!

In a July interview with Texas Lawyer, Jonathan Skidmore, a partner in the Dallas office of Fulbright and a member of Merck’s defense team, maintained that Merck was a paragon of corporate ethics. “From researching the medicine prior to FDA approval in 10,000 patients, to monitoring it on the market, to voluntarily withdrawing it from the market [in 2004], the story of Merck acting responsibly will be told to the jury.”

But what the jury first heard was Lanier using Merck’s own documents—7 million were produced in the litigation—in an attempt to undermine those ethics (which he called Merck-y), attack Merck’s marketing as misleading and establish that Merck knew Vioxx was dangerous years before it pulled the drug off the market.

Rather than calling the plaintiff as his first witness—as is typically done in personal-injury suits—Lanier called Dr. Nancy Santanello, Merck’s corporate representative at the trial, as an adverse witness.

First, he confronted Santanello, the head epidemiologist who oversaw the Vioxx project, with a 2001 FDA letter warning Merck that it was misleading the public by underplaying the dangers of Vioxx, after a 2000 study showed that Vioxx was five times more likely to increase the risk of heart attacks than the over-the-counter pain reliever Naproxen. He questioned her about a Merck marketing technique called “Dodgeball” that he contended taught sales personnel to dodge questions from doctors about the drug’s hazards; he asked her about an internal document that said the Vioxx salespersons were to “neutralize” and “discredit” doctors who didn’t prescribe Vioxx.

During her six days on the witness stand, Santanello offered her explanations: “Neutralize” meant giving doctors information about the drug’s safety; “discredit” meant providing a pro-Vioxx doctor to speak at medical conferences; dodgeball was a teaching tool rather than some artful dodge. Her explanations weren’t helped by a letter Lanier produced from a Stanford University professor complaining to the Merck CEO that a Merck researcher had warned another Stanford professor to stop disparaging Vioxx in his lectures, or there would be consequences for himself and the university.

Lanier used these aggressive marketing techniques to his advantage, says Blue. “When Santanello wouldn’t answer a question directly, Mark accused her of “dodging’ it. When the defense lawyers crossed our experts, it was just an extension of Merck trying to “discredit and neutralize’ them.”

To show how Merck overwhelmed the FDA, Lanier filled the courtroom with 157 boxes of materials Merck had submitted to the agency in 1999 to get approval of the drug. According to the Houston Chronicle, Lanier kept stacking boxes until Lowry said she could no longer see the jury. Santanello said that Merck gave the data to the FDA on several electronic disks but Lanier had made his point. “It was more of his send-a-message theme to the jury,” Blue says. “No one but the jury had the power to tell Merck it couldn’t act irresponsibly.”

On July 25, three weeks into the trial, Lanier announced before the jury that he intended to call Dr. Maria Aranetta, the coroner who had performed Ernst’s autopsy, to the stand the following day. Merck attorneys claimed unfair surprise, trial by ambush—Lanier had only designated her as an expert witness on July 11, the day of opening statements.

The only problem was Merck had listed Aranetta as its own witness. Aranetta now worked in the United Arab Emirates but, with the assistance of two private investigators, Lanier says he found her in one day. He says his search was sparked by Merck’s opening statement regarding Aranetta, which he felt misrepresented her findings. “It’s Lawsuit 101,” says Lanier. “You don’t stand up and start interpreting someone else’s writings, unless you have that person under lock and key.”

In her deposition, Aranetta said she stood by her autopsy findings but felt they needed further explanation. While there was no evidence of a heart attack, she felt Ernst had died too soon to show the kind of heart damage normally associated with one. And while there was no evidence of a blood clot, she believed the vigorous CPR that was administered to Ernst might have caused the clot to dissipate in his arteries.

Although Judge Hardin refused to allow Lanier to refer to the opening statement, he did allow Aranetta’s videotaped deposition to be played to the jury—but not before Merck’s attorneys filed a writ of mandamus with the 14th Court of Appeals in Houston, and then with the Texas Supreme Court, both of which denied the writ without opinion.

It didn’t matter to Lanier—or to the jury for that matter—that Lanier had paid for Aranetta’s $6,000 business class plane ticket to Texas and put her up in the Four Seasons Hotel so she would be available to testify; he believed he had his blood clot, his heart
attack and his causation—he already had laid the groundwork for her testimony by calling other experts who held her same opinion. How did Lanier convince an 11th-hour witness who would, in essence, gut Merck’s defense? “She is an independent person, and she had already e-mailed me her opinions,” he says. “This is the God’s honest truth: I only spent 15 minutes with her before she testified.” Of course, other members of his trial team spent time with her as well.

Lanier rested his case with the testimony of Carol Ernst, who detailed a storybook marriage to her husband, albeit a short one. But her pain was still palpable, says Blue, which was why she thought it was a dangerous tactic for Lowry to cross-examine the grieving widow for 90 minutes. “The jury didn’t like it.”

Merck lawyers came back strong on causation when they began to present their case, says Blue. “Drs. [Craig] Pratt and [Thomas] Wheeler were particularly convincing.” Each testified that they agreed with Aranetta’s original autopsy finding, but Wheeler dismissed her explanation that vigorous CPR might have dissipated a blood clot as “preposterous.”

As the testimony drew to its close, Blue grew concerned that the evidence of causation was “weak.” The plaintiffs had hired a local shadow jury, and before closing arguments, its members voted 9-4 for the plaintiff with damages of $111 million, Blue says.

In a closing argument strategy session, Blue told Lanier that he needed to hit the issue of causation hard and convinced him to stress that “arrhythmia is a cardiovascular event.” She encouraged him to remind the jury of his Baptist preacher credentials and identified four jurors she felt were in their camp and two or three who weren’t. “I told him to shore up the strong ones who would then be able to win over the weak ones,” she says.

Lanier took much of Blue’s advice, and during his three-hour presentation, he repeatedly invoked his theme of enlisting the jury to send a message to Merck by doing what the FDA couldn’t do: “Punish Merck” with a big-money verdict—“Merck money,” he later argued.

Despite Lanier’s ability to bond with the jurors, says Blue, it did little to allay her causation fears. “Lowry’s closing was superb, and she did an excellent job putting doubt in the minds of the jury on causation. I was very concerned.”

But then Blue felt Lowry went too far: During her testimony, Carol Ernst had stated she felt guilty because she had recommended to her husband that he take Vioxx. Near the end of her closing argument, Lowry asked the jury “to do the right thing” by finding for Merck, because it would relieve Ms. Ernst of her guilt.

The statement seemed to “genuinely upset” Lanier, recalls Blue, and it gave his rebuttal “an emotional charge that helped Mark pull the case back to us.”

As he sat down after his close, Lanier hugged his client—and he hugged her again two days later, after the jury returned its $253.5 million 10-2 verdict after deliberating for more than 10 hours.

“It could have been prevented,” juror Derrick Chizer told The Associated Press. “That is the message. Respect us.” It only took an hour, jurors told Lanier, to resolve the causation issue, and the $229 million it awarded in punitives, although capped under Texas law at $1.65 million, was another message sent to Merck. “It was the amount Merck said it could save if it put off warning the public for four months that Vioxx caused cardiovascular events,” Lanier says.

Shortly after the verdict, Merck issued a press release, stating its intention to appeal. But it has no plans to change its litigation strategy of taking each case to trial despite the availability of Merck’s own documents, which now may help any plaintiffs lawyer bloody the company in subsequent litigation.

“We will continue to focus on the facts of each individual case and to tell the story of what really happened, a story of a company driven by science,” says Theodore Mayer, Merck’s national coordinating counsel for Vioxx litigation. “We think that’s a powerful story—a story that should resonate.”

But on Aug. 19, before a small-town jury and the formidable legal skills of Mark Lanier, it didn’t.

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