Expert: Merck Ignored Vioxx Safety Risks

By JOHN CURRAN
Associated Press Writer

ATLANTIC CITY, N.J. - Fighting back tears, a heart expert told jurors Friday that Vioxx manufacturer Merck & Co. ignored evidence the painkiller posed safety risks before it hit the market in 1999.

Dr. Benedict Lucchesi, who was testifying on behalf of a man who blames Vioxx for his heart attack, was shown a series of internal Merck e-mails. Lucchesi, an expert on the heart and the effects of medications, appeared to fight back tears after plaintiff's attorney Chris Seeger referred to a 1997 message sent by Merck researcher Briggs Morrison to fellow company scientists.

In it, Morrison — discussing the proposed design of an upcoming clinical trial of the drug — advocated letting the patients in the study take aspirin at the same time as Vioxx.

"I know this has been discussed to death but real world is everyone is on it so why exclude" aspirin, Morrison wrote. Without aspirin's blood-thinning effects, he wrote, "you will get more (dangerous blood clots) and kill drug."

Lucchesi interpreted the statement to mean Merck feared that without aspirin to offset Vioxx's cardiac risk, those participating in the trial would be in greater danger and that would spell trouble for Merck as it pushed to debut Vioxx.

"When I first read that, I personally became enraged," said Lucchesi, 72, a professor at the University of Michigan who helped develop the first pacemaker.

"In my notes," he told Seeger, "I substituted `patients' for `drug.'"

Choked up, he paused in his testimony.

"These are my colleagues," he said, meaning fellow doctors.

"Do you think they're doing something wrong?" Seeger asked.

"They're putting profits before life," he replied.

Merck's attorneys, defending the company in a product liability suit brought by 60-year-old Boise, Idaho postal worker Frederick Humeston, didn't get the chance to cross-examine Lucchesi, who spent about six hours on the stand Friday.

Jim Fitzpatrick, a Merck spokesman who was in court for the testimony, said afterward that Lucchesi had misinterpreted the e-mail. He said Morrison would rebut it when he testifies as part of Merck's case later in the trial.

"What the e-mail referred to is that if you compare Vioxx to a traditional pain reliever, you'll see a difference in clotting events. What he meant was that a misinterpretation of that difference would kill the drug," Fitzpatrick said. "That e-mail was speculating that people would misinterpret it (the trial) as being a problem with Vioxx."

The testimony, in the third day of the product liability trial, came after Humeston's lawyer showed jurors evidence that Merck & Co. was told by its own experts about potential health risks of its painkiller Vioxx before it went on sale in 1999.

In a 1998 document, Merck's board of scientific advisers told the company that Vioxx and other Cox-2 inhibitors — painkillers meant to limit stomach bleeding and irritation — could lead to blood clots breaking loose and blocking blood vessels elsewhere in some patients, the plaintiff's lawyer told jurors.

Vioxx could create rupture-prone plaque in arteries and lead to insufficient blood flow to the heart, according to the document. It said the findings weren't conclusive but should be "taken as a basis for hypotheses that should be actively pursued."

Seeger also showed jurors a 1999 letter in which Dr. John Oates, a Vanderbilt University pharmacology professor and Merck consultant, told Merck's research chief the drugs could cause dangerous blood clots in some patients.

"The purpose of this communication is a heads-up," Oates wrote.

Lucchesi offered no opinion about Humeston's heart attack in particular. Seeger didn't ask him about it.

"There is a very big possibility that Vioxx does pose a risk to patients with underlying disorders," Lucchesi testified.

Lucchesi's testimony is to continue Monday, followed by Merck's cross-examination.

Merck, based in Whitehouse Station, withdrew Vioxx from the market last September after its own research showed the popular arthritis drug doubled risk of heart attack and stroke after 18 months' use. The drug giant faces more than 5,000 lawsuits filed in state and federal courts — about half of them in New Jersey state courts — by former Vioxx users alleging the medicine harmed them.

The first trial ended last month when the jury in the Texas case stunned Merck with a $253 million liability verdict, although that will be slashed to about $26 million because Texas caps punitive damages. Merck plans to appeal. Lucchesi testified against Merck in that trial.

In a separate development, the nation's first federal civil trial involving Vioxx has been moved from Katrina-ravaged New Orleans to Houston, but will still start as scheduled on Nov. 28. It is expected to last two weeks.

The ruling was made by U.S. District Judge Eldon Fallon, who is overseeing pretrial coordination of more than 1,800 federal Vioxx lawsuits to streamline document gathering and other steps common to the cases. Fallon and a handful of his staff moved from New Orleans to temporary quarters at the federal courthouse in Houston earlier this month.

Merck shares rose 14 cents to close at $28.90 in trading on the
New York Stock Exchange Friday. They rose 20 cents in after-hours trading.

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