The first of more than 4,000 Vioxx lawsuits is underway in Texas, and plaintiffs’ lawyers are eagerly watching for clues to the defense strategy and for juror reactions to allegations that the pain medication caused serious heart damage.

The key to the case lies in the plaintiff’s ability to prove that pharmaceutical giant Merck & Co. deliberately concealed evidence that the drug was unsafe long before it pulled the product from the market last September.

Since the trial began last month, scores of plaintiffs’ lawyers have packed the courthouse in Angleton, Texas, a small town south of Houston, in hopes of learning how their cases might fare with jurors.

“I think we’ll find out a lot from this trial,” said Jere Beasley, a partner in Beasley Allen in Montgomery, Ala., whose firm has filed more than 100 Vioxx suits and is evaluating 10,000 more claims involving former Vioxx users who suffered heart attacks or strokes.

Several legal experts predicted that if the plaintiff in the current trial wins, the damages awarded would be used as a starting point for settlement negotiations throughout the country.

More than 4,100 lawsuits and 120 class-action suits have been filed since the product was pulled from the market in 2004, based on a study that showed Vioxx doubled the risk of heart attack or stroke if taken for 18 months or more.

Wall Street analysts have estimated Merck’s liability could reach $18 billion.

Meanwhile, Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana has tentatively set Nov. 28 for the first trial in the federal multi-district Vioxx litigation. It’s not yet clear which of the nearly 2,000 federal suits filed against the company will be heard.

According to a report filed in late July with Fallon, other Vioxx cases scheduled (in state courts) for trial within the next few months include:

  • Humeston v. Merck, New Jersey Superior Court, Sept. 12;
  • Guerra v. Merck, Texas District Court, Sept. 19;
  • Tomlin v. Merck, Florida Circuit Court, during the term from Oct. 3 to Dec. 30.

This first batch of cases will help determine where the litigation is heading, according to Thomas R. Kline, a plaintiffs’ personal injury lawyer with Kline & Specter in Philadelphia and a member of the plaintiffs’ steering committee in the multi-district litigation.

“This group of cases will give an early benchmark to the direction of the litigation. Oftentimes, the early cases are not definitive, but they certainly tend to be instructive in terms of litigation of this size,” he said.

Elizabeth Cabraser, a partner in Lieff, Cabraser, Heimann & Bernstein in San Francisco and a member of the plaintiffs’ steering committee, agreed.

“Generally speaking, a group of verdicts is a more meaningful predictor [than just one trial],” she said. “However, anything can happen, and decisive or dramatic testimony in Texas would transform the meaning of that trial instantly.”

What Merck Knew

The first suit to reach trial was filed by Carol Ernst, whose husband, Robert, a 59-year-old personal trainer and tri-athlete, died in his sleep four years ago of an arrhythmia, or irregular heartbeat. He had been taking Vioxx for about eight months to ease pain in his hands.

Ernst claimed the company knew of the potential dangers of the drug at least a year before it reached the market in May 1999, based on a 1998 study that showed Vioxx caused heart problems in dogs. An estimated 20 million people used the medication before Merck pulled if off the market.

In the opening week of the trial, the plaintiff’s attorneys focused on Merck’s failure to adequately test the drug in spite of warnings from its own scientists that it could cause heart problems.

Using a top Merck scientist, Nancy Santanello, as an adverse witness, plaintiff’s attorney Mark Lanier laid out his case that the company had prior knowledge of the drug’s ill effects. He noted that the 1998 study prompted another top Merck scientist to say he was “worried” about the drug’s safety and urge further testing.

But the company conducted no tests on the drug’s potential connection to heart attacks before putting it on the market – even after another study in 2000 that showed Vioxx users suffered five times more heart attacks than users of Naproxen, an older pain reliever.

In the first week of trial, Lanier also produced a previously undisclosed April 2001 letter to doctors in which Lanier claims Merck seriously understated the heart risks faced by patients taking Vioxx.

How that letter will play with jurors is unknown. But such evidence could be crucial, according to several legal experts.

“The punitive aspect will only come in if the jury believes that things were hidden, the truth wasn’t told, that information was being suppressed in the name of making money,” said Douglas Green, a trial consultant in Covington, La. who has worked on pharmaceutical litigation.

“Even just one smoking gun will turn an average juror into a punitive juror,” agreed Jason Bloom, a litigation analyst with Courtroom Sciences in Irving, Texas.

Bloom said that plaintiffs’ lawyers often use company documents during product liability trials to turn jurors against the defendant by implying there was a corporate cover-up.

“Usually you can find some internal documents are going to be a large part of the plaintiff’s case showing [company management] wanted to hide test results, or they weren’t going to disclose test results,” he said. “These types of documents generate a lot of juror enragement.”

“This notion of withholding information – that’s the issue that gets so much traction with jurors today,” said Green, the Louisiana trial consultant. “If the plaintiffs are able to establish that data was withheld from the FDA, that’s going to create some problems for the defendant.”

Richard Gabriel, a trial consultant and president of Decision Analysis in Los Angeles, said that one of the biggest challenges for Merck will be countering allegations that it put profit over safety in pushing the drug to market.

In 2002, Vioxx accounted for 10 percent of Merck’s profits – $2.5 billion of the company’s $21.63 annual sales – making it the company’s second largest selling drug.

“When you have the knowledge within the company of some sort of difficulty with the drug, then all of a sudden the theory of profit over protection becomes more palatable for jurors,” Gabriel said.

The defense “obviously needs to educate the jury about how much it costs to bring a drug like this to market,” he said.

The Causation Defense

The second part of the company’s defense focuses on the fact that the plaintiff died of an irregular heartbeat, not a heart attack. The company contends that there is still no evidence that Vioxx can cause an irregular heartbeat.

“The defense wants to show there’s a host of other factors contributing toward the death, whereas the plaintiff wants to pinpoint it onto the Vioxx,” Bloom explained.

Gabriel agreed.

“What the defense does in a case like this is say, ‘Let’s focus on the plaintiff and how incredibly diverse the symptoms and the individual biology of this person is, and take a look at what really could have caused this heart attack,’” he said.

Choosing a personal trainer – someone who presumably was physically fit – was a “wise choice for the plaintiffs,” according to Gabriel.

If someone was in generally good health, it will be harder for the company to suggest that a pre-existing health problem could ha
ve caused his heart problem, he explained.

“The case the manufacturer’s not going to want to try is a perfectly healthy person with no risk factors other than this drug,” Green commented.

Beasley Allen has a doctor and several nurses working full time, as well as outside help from a forensic pathologist and pharmacologist to determine whether the cause of each claimant’s heart problem can be directly linked to Vioxx.

“Obviously, Merck is going to try each case on a causation thing,” Beasley said. “They play hardball. But they can’t defend their actions. The company is morally corrupt in how they treated the public. They lied to the doctors, and they lied to the public.”

Popular Jurors

How these arguments play with the Texas jury will provide a good indication how the thousands of pending Vioxx cases might fare in court.

“I think the first case is hugely important, especially when you have national groups all over the country that are clearly looking at this,” said Gabriel. “Both juries and judges look at what the outcome is as a way of saying that’s the way others are likely to come out, too. Just in terms of human nature, this one is extremely significant.”

Bloom, the litigation analyst from Texas, agreed.

“The first trial is very, very important because it sets a precedent for all the others,” he said. “It’s really a test of the plaintiff’s theory and the plaintiff’s case, and if it’s successful it will lead to scores of more lawsuits with the same allegations and probably similar facts.”

The Vioxx litigation will “not rise or fall” based on the verdict in the Ernst case, Kline said. However, he added that the case “is an important trial, and I think it’s one of a series of cases between now and the end of the year which will set the context and tone of the litigation.”

No matter what the outcome is, once the Ernst trial ends, plaintiffs’ lawyers will be rushing to interview the seven men and five women on the jury – assuming the judge permits post-trial interviews, Bloom predicted.

“These will be very sought-after jurors when it’s all over with so everyone can pick their brains and learn from it and find trial strategies for future litigation,” he said.

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