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Merck exec denies downplay of Vioxx risk
Friday, October 21, 2005
BY GEORGE E. JORDAN
Star-Ledger Staff
Under aggressive cross-examination, a top Merck researcher yesterday denied suggestions the drugmaker intentionally downplayed the heart-attack risks of Vioxx.
Barry Gertz, Merck's executive vice president of clinical services, said the company's decisions about Vioxx were based on "good science," and it did not try to hide the truth about the painkiller.
Chris Seeger, lead attorney for plaintiff Frederick "Mike" Humeston, was interrupted several times by objections from Merck's legal team as he confronted Gertz with internal memos and e-mails in an attempt to raise questions about his credibility.
"You're there to interpret the data, not to put the best face on it?" asked Seeger.
"No, I give the best scientific interpretation I can," Gertz snapped.
After a day and a half of tense questioning marked by dozens of objections by both plantiff and defense attorneys, Gertz virtually ran out the door of the Atlantic City courtroom when told it was over.
"You're done, you can leave" state Superior Court Judge Carol Higbee said to Gertz. "I'm sure you can't wait to leave."
Merck, based in Whitehouse Station, withdrew Vioxx last year, citing links to heart attacks and strokes. The company is a defendant in more than 6,000 personal injury lawsuits.
Merck maintains Vioxx, which arrived in pharmacies in 1999, was tested properly, and all pertinent clinical-trial data were provided to the Food and Drug Administration.
Gertz's exit from the witness stand marked a turning point in the case, when the wear of the five weeks of testimony showed on the lawyers, judge and jury, which was sent home at lunchtime after only a couple hours of testimony.
The jury was dismissed for the day after Merck decided not to play videotaped testimony by Briggs Morrison, a Merck Research Labs executive and the drugmaker's opening witness, whose live testimony was thrown out on procedural grounds.
Before being sent home, the jurors were told by Higbee the defense would likely rest its cease next week.
"You've been a very good jury, a wonderful jury, showing up on time each day," the judge told the six women and three men. "We're still looking (to conclude) at the end of next week. We're only a few witnesses away."
Once the jury was out of the courtroom, Higbee convened a hearing on Merck's motion to reconsider her ban of an April 2005 FDA memo that concluded Vioxx poses no greater risk of heart attack than other so-called Cox-2 inhibitors.
Higbee has been reluctant to allow the FDA memo into evidence because, she has said, it was not based on science. "This is not something I can resolve easily," Higbee told the lawyers at the start of the hearing.
Former FDA official Lisa Rarick was led to the witness stand and questioned about the memo, which she described as a final FDA decision on the Cox-2's. Higbee is not expected to rule until Monday on whether to allow Rarick to testify about the memo.
George E. Jordan may be reached at gjordan@starledger.com or (973) 392-1801.
Merck exec denies downplay of Vioxx risk
Friday, October 21, 2005
BY GEORGE E. JORDAN
Star-Ledger Staff
Under aggressive cross-examination, a top Merck researcher yesterday denied suggestions the drugmaker intentionally downplayed the heart-attack risks of Vioxx.
Barry Gertz, Merck's executive vice president of clinical services, said the company's decisions about Vioxx were based on "good science," and it did not try to hide the truth about the painkiller.
Chris Seeger, lead attorney for plaintiff Frederick "Mike" Humeston, was interrupted several times by objections from Merck's legal team as he confronted Gertz with internal memos and e-mails in an attempt to raise questions about his credibility.
"You're there to interpret the data, not to put the best face on it?" asked Seeger.
"No, I give the best scientific interpretation I can," Gertz snapped.
After a day and a half of tense questioning marked by dozens of objections by both plantiff and defense attorneys, Gertz virtually ran out the door of the Atlantic City courtroom when told it was over.
"You're done, you can leave" state Superior Court Judge Carol Higbee said to Gertz. "I'm sure you can't wait to leave."
Merck, based in Whitehouse Station, withdrew Vioxx last year, citing links to heart attacks and strokes. The company is a defendant in more than 6,000 personal injury lawsuits.
Merck maintains Vioxx, which arrived in pharmacies in 1999, was tested properly, and all pertinent clinical-trial data were provided to the Food and Drug Administration.
Gertz's exit from the witness stand marked a turning point in the case, when the wear of the five weeks of testimony showed on the lawyers, judge and jury, which was sent home at lunchtime after only a couple hours of testimony.
The jury was dismissed for the day after Merck decided not to play videotaped testimony by Briggs Morrison, a Merck Research Labs executive and the drugmaker's opening witness, whose live testimony was thrown out on procedural grounds.
Before being sent home, the jurors were told by Higbee the defense would likely rest its cease next week.
"You've been a very good jury, a wonderful jury, showing up on time each day," the judge told the six women and three men. "We're still looking (to conclude) at the end of next week. We're only a few witnesses away."
Once the jury was out of the courtroom, Higbee convened a hearing on Merck's motion to reconsider her ban of an April 2005 FDA memo that concluded Vioxx poses no greater risk of heart attack than other so-called Cox-2 inhibitors.
Higbee has been reluctant to allow the FDA memo into evidence because, she has said, it was not based on science. "This is not something I can resolve easily," Higbee told the lawyers at the start of the hearing.
Former FDA official Lisa Rarick was led to the witness stand and questioned about the memo, which she described as a final FDA decision on the Cox-2's. Higbee is not expected to rule until Monday on whether to allow Rarick to testify about the memo.
George E. Jordan may be reached at gjordan@starledger.com or (973) 392-1801.
posted by Chris Placitella at 10:03 AM
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