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Try to imagine defense counsel’s dilemma as a plaintiff’s expert, answering jurors’ questions, takes over the trial. The witness, free of the constraints of direct examination, proceeds to expound, lecture and even stride the courtroom floor – sometimes straying from his area of expertise. It’s music to the jurors’ ears, because he’s answering their questions and speaking their language. Does the defense object, and thereby risk alienating the jurors’ affections? Or keep silent and let the damage be done? It’s a quandary posed by the practice – still new in New Jersey – of allowing juror questions, and there seem to be few guidelines to resolve it. Responses to juror questions are not bound by the same rules as conventional testimony. Lawyers can request direct or cross-examination, but judges will likely wait until all juror questions are answered. And objections are risky business. So defense lawyers in the Vioxx trial in Atlantic City, N.J., sat silent on March 16 as Harlan Krumholz, a Yale University Medical School epidemiology professor, answered a juror question about why the Federal Drug Administration would negotiate with Merck & Co., rather than demand that it prominently place a safety warning on the painkiller’s label. The question was, “Can you explain why the FDA and [Merck] negotiated? Why didn’t the FDA just insist on putting a label on so we could see it?” “That’s a good question,” said Krumholz, who is not an FDA expert, as he got out of the witness box to stand in front of the jury. “The FDA can force itself to do things, but as far as I’ve seen, they’ve rarely done that. They’re depending on companies to communicate with them. Ideally, you’d expect an exchange of information back and forth. They worked collaboratively; they tried to work it through rather than force it.” The next day, out of the presence of the jury, Merck asked Superior Court Judge Carol Higbee to strike Krumholz’s response, but she declined, as the cat was already out of the bag. That a response to a juror question should make waves is an anomaly to begin with. Few courts in New Jersey and other states allow such questions, particularly in complex cases. But Higbee has made it a practice since the state Supreme Court gave judges authority to do so in 2002. Professor Edward Ohlbaum, who heads the trial advocacy program at Temple University’s Beasley School of Law, said the juror questioning process is so new that judges and lawyers are trying to figure out how to keep witness responses narrowly focused. Ohlbaum said counsel should be as proactive and vigilant during juror questions as they are when their opponents are questioning the witness. “On some level, the opposing lawyer is in no different a position than if an opponent is asking questions and the witness has a soapbox,” said Ohlbaum. “What makes this trickier is that jurors are asking the questions, and lawyers don’t want jurors to get ticked at them for interrupting. A judge can soften it and tell jurors that counsel may interrupt. And lawyers can meet with the witness and say ‘you’re not going into areas A, B, C and D.’” The episode surrounding the FDA question raised some hackles among lawyers observing the Vioxx trial – notably on the plaintiffs’ side. “It raised the issue of who is going to control the witness when questions are asked that could take him into areas that are off limits. A savvy witness could use it to wreak havoc on evidentiary rulings,” said Samuel Davis, of Davis Saperstein & Salomon. “We find it’s particularly prejudicial to the party that is going first to have questions of this nature,” added Franklin Solomon, a partner of Robert Gordon, the lawyer for plaintiff John McDarby. “[T]he parties that go after can tailor their direct examinations and they know what the jurors are thinking,” said Solomon, of Weitz & Luxenberg. But products defense lawyer John Brenner of Newark, N.J.’s McCarter & English said judges typically instruct jurors that witness diatribes in response to juror questions are forbidden. Brenner noted that lawyers can follow up with cross-examination, which plaintiffs lawyer W. Mark Lanier, of Houston, Texas, did March 22 after jurors put 12 questions to Merck research executive Briggs Morrison. Three of those questions involved why Merck did overlapping studies and why it never did a study that focused on Vioxx’s cardiovascular outcomes when it knew in 2000 that the painkiller increased the risk of heart problems. The jurors’ last question for Morrison was, “While you were on the Vioxx team, were any of Merck’s clinical trials set up specifically to check for CV events in volunteers?” Morrison answered, “Throughout all our studies we did EKGs.” Lanier then interrupted Morrison: “In other words, no studies were set up specifically for heart problems, it’s just something you monitor if someone turns in a serious adverse examples. Do you know what it means to design a trial to see whether this drug causes heart problems?” “If your question is, ‘Was there a trial where the hypothesis was it causes heart problems,’ then the answer is ‘No,’” Morrison said. PREVENTION IS THE BEST CURE Merck lawyer Charles Harrell, of Butler Snow O’Mara Stevens & Cannada in Memphis, Tenn., said that a prescreening process, which subjects juror questions to a quasi-adversarial procedure, is the best way to control runaway witnesses, like Krumholz allegedly was. “In the prescreening process, some questions get put aside,” Harrell said. If at trial, the witness strays into a long or extraneous narrative, then attorneys have to decide whether to interrupt – politely – and ask for a sidebar, he added. Prior to jury questioning of Krumholz, Higbee did hear comments or objections of counsel outside the jury’s presence. She eliminated at least three questions, including one asking for copies of Krumholz’s book, The Expert Guide to Beating Heart Disease, and rephrased others before submitting 23 to the witness. Besides three FDA questions, 14 touched on medical and scientific areas, including doctors’ reliance on drug-company salespeople for safety information and the results of a 2000 study showing Vioxx patients had five times more heart attacks than those not on the painkiller. Except for one rambling response explaining the difference between the concepts of statistical significance and margin of error, Krumholz’s responses were restrained, which may be why Higbee allowed him to continue, said obervers. “No other witness has come close to getting the questions Krumholz did,” said Lanier. “Some of them were almost like, ‘Here is what is wrong with me. Am I going to have a heart attack?’” He said Higbee “followed the lawyers’ thoughts 90 percent of the time. Very few has she asked when one side or the other objected.” Lanier added, “I’ve never done the question thing before. I like it. It provides insight into the jury and also gives them a reason to stay in tune with what is going on.” Merck lawyer Harrell agreed. “From our standpoint, allowing jurors to ask questions allows both sides to figure out where we need to put our focus,” he said. The labeling issue addressed by Krumholz is central for plaintiffs McDarby, 77, of Park Ridge, N.J., and Thomas Cona, 59, of Cherry Hill, N.J., who claim that their use of Vioxx for more than 18 months caused their heart attacks. Lanier, representing Cona, and Gordon, representing McDarby, claim that Merck stalled the FDA in label negotiations after the company knew in 2000 that Vioxx caused an increased risk of heart attacks. The plaintiffs also claim that the label approved by the FDA in 2002 was buried in the precautions section and was meant only for patients with a history of heart disease. Lead Merck lawyer, Christy Jones of Butler Snow in Jackson, Miss., claims that the plaintiffs neither showed that Merck failed to adequately warn nor presented sufficient evidence to overcome the presumption that the FDA-approved label was adequate. In rejecting Merck’s motion for a directed verdict, Higbee found that the plaintiffs had presented enough evidence to overcome the presumption that the label was adequate. This story originally appeared in the New Jersey Law Journal, a publication of ALM.

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