Healthy Skepticism Library item: 3930

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Publication type: news

Driver A.
Merck ex-CEO denies hiding Vioxx data from FDA
Reuters 2006 Apr 6
http://news.moneycentral.msn.com/provider/providerarticle.asp?Feed=OBR&Date=20060406&ID=5624350

Notes:

Ralph Faggotter’s Comments:

So far, the results of the small handful of completed US trials have been mixed, but it appears now that plaintiffs(or their living representatives)in the US will need to establish that they had been taking Vioxx for 18 months to have a case.

Full text:

Merck ex-CEO denies hiding Vioxx data from FDA
By Anna Driver 12 minutes ago

Merck & Co.‘s former chief executive denied the company hid data on Vioxx from regulators as he took the stand on Thursday before a jury that will decide whether to award punitive damages to a man who said the painkiller caused his heart attack.

On Wednesday, the jury awarded 77-year-old John McDarby $4.5 million dollars in compensatory damages. To award punitive damages under New Jersey law, the plaintiff’s attorneys must prove that Merck misrepresented material information to the U.S. Food and Drug Administration.

Raymond Gilmartin, who led Merck during the development and withdrawal of Vioxx, repeatedly maintained the company did not try to mislead doctors or regulators.

“Merck wasn’t trying to hide data from the FDA?” asked Merck lawyer Christy Jones. “No,” replied Gilmartin, who took the stand for the first time in a Vioxx trial.

Merck stock fell 3.2 percent to close at $34.84 on the New York Stock Exchange, hurt by concerns over the size of the damages and Merck’s ability to defend itself in a slew of other Vioxx suits.

After Gilmartin’s testimony ended, Jones filed two oral motions for a mistrial. She argued that the plaintiff’s attorney Mark Lanier had talked loudly enough for the jury to hear during sidebars with the judge and said Lanier was presenting evidence that was not relevant.

Judge Carol Higbee denied the motion.

On Wednesday, the N.J. Superior Court jury found that Vioxx had been a substantial contributing cause of a heart attack suffered by McDarby. The jury decided the drug was not a significant cause of a heart attack suffered by a second plaintiff, Thomas Cona.

Merck, which faces nearly 10,000 Vioxx product liability cases, pulled the $2.5 billion-a-year drug off the market in September 2004 after a study showed it doubled the risk of heart attack and stroke among people who used it for at least 18 months.

Regarding that 2004 study Gilmartin told jurors, “The way science is, one can only say what that study showed.” He earlier testified that the drugmaker saw no increased heart attack risk after reviewing a 2000 study involving Vioxx.

“We saw no evidence there was increased risk of heart attack,” Gilmartin told the court.

The 2000 Vioxx study, known as Vigor, found higher rates of heart problems among patients taking Vioxx than among patients taking an older painkiller, naproxen. Merck has argued that the Vigor study showed the heart-protective qualities of naproxen rather than increased risks of Vioxx.

Lawyers for McDarby have argued throughout the trial that Merck, based in Whitehouse Station, N.J., put profits ahead of patient safety when marketing Vioxx.

Gilmartin resigned from Merck in May 2005, ahead of his scheduled retirement in 2006.

Under New Jersey law, any punitive damages, which can be awarded as a punishment to rectify a wrong committed by a defendant, would be capped at $22.5 million — five times compensatory damages.

“The compensatory damages amount by itself is already large, in our opinion,” Prudential analyst Tim Anderson wrote in a research note.

On Friday, the jury may hear testimony from Dr. Lisa Rarick, a former FDA official and witness called by Merck.

The McDarby case is the second multimillion-dollar Vioxx verdict against Merck.

In August 2005, Merck was ordered by a Texas jury to pay $229 million in punitive damages and $24 million for mental anguish and loss of companionship to the widow of a Texas man who took the drug for about eight months. The total award is set to be cut because of a Texas law limiting damages.

Rob Gordon, a McDarby attorney, said his New York law firm, Weitz and Luxenberg, has 1,000 Vioxx cases filed in Atlantic County and plans to file 1,500 more before September.

JP Morgan analyst Chris Shibutani said he still believes Merck has a strong case when it comes to whether Vioxx caused a heart attack in a particular case and whether the company adequately warned about the drug.

Merck shares dropped to the mid-20s after the company pulled Vioxx off the market. But the stock has risen about 30 percent in the past six months.

(Additional reporting by Julie Steenhuysen in Chicago)

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