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Saturday, September 17, 2005

Experts said to tell Merck about potential health risks regarding Vioxx before it went on sale

JOHN CURRAN
Associated Press Writer

ATLANTIC CITY, N.J. — Merck & Co. was told by its own experts about the potential health risks of its painkiller Vioxx before it went on sale in 1999, a plaintiff's lawyer told jurors Friday in a trial over whether the drug caused a Boise, Idaho man's heart attack.

In a 1998 document, Merck's board of scientific advisers told the company that Vioxx and other so-called Cox-2 inhibitors could create rupture-prone plaque in arteries and lead to insufficient blood flow to the heart. The document said the findings weren't conclusive but should be "taken as a basis for hypotheses that should be actively pursued."

Chris Seeger, lead attorney for plaintiff Frederick "Mike" Humeston, 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.

Seeger showed the documents to his first expert witness, Dr. Benedict Lucchesi, a University of Michigan professor and an authority on the impact of drugs on the heart. Lucchesi is testifying on behalf of Humeston, a 60-year-old postal worker who suffered a heart attack in September 2001, two months after he started taking Vioxx.

Lucchesi's testimony was to continue Friday afternoon, followed by Merck's cross-examination.

On Friday morning, Superior Court Judge Carol Higbee rejected a Merck motion to keep Lucchesi off the stand because, Merck said, there was no firm scientific evidence to support Lucchesi's conclusion Vioxx contributed to Humeston's heart attack. Higbee said the company's defense team had had ample opportunity to take a deposition from him or challenge his credentials previously and had not.

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 a Texas jury 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.

On Thursday, the company's lead lawyer, Diane Sullivan, challenged testimony of the first witness, Humeston's physician, suggesting he should have been aware of risks associated with Vioxx because of a 2000 medical journal report.

Dr. Gregory Lewer testified he believed Vioxx caused Humeston's 2001 heart attack and wouldn't have prescribed it if he knew of research linking it to cardiovascular problems.

"The total amount of information is overwhelming. Nobody can keep up on all of it," Lewer said.

Later, Sullivan told the jury stress and other problems were responsible for Humeston's heart attack.

In a separate development, the nation's first federal civil trial involving Vioxx has been moved from Katrina-ravaged New Orleans to Houston.

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 ruled that the federal trial, expected to last two weeks, will start as scheduled on Nov. 28. The judge and a handful of his staff moved from New Orleans to temporary quarters at the federal courthouse in Houston earlier this month.

Merck shares were down 4 cents at $28.72 in afternoon trading on the New York Stock Exchange.

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