Judge Intervenes in Testy Vioxx Witness

posted on:
September 20, 2005

author:
Staff

A key witness for a man blaming use of Vioxx for his heart attack returned to the stand Tuesday, aggressively defending his prior testimony and his criticism of scientists at drugmaker Merck & Co., who he said knew of Vioxx’s risks before it went on sale in 1999.

In a testy series of exchanges that twice prompted warnings by Superior Court Judge Carol E. Higbee, Merck attorney Stephen Raber chipped away at the testimony of Dr. Benedict Lucchesi.

Lucchesi, an expert on the heart and the effects of medicines who teaches at the University of Michigan Medical School, said he hadn’t seen data from Merck studies comparing Vioxx to other painkillers.

Lucchesi also told jurors that he had not reviewed a document attached to a 1997 e-mail message from a Merck scientist that Lucchesi _ in his testimony Friday _ said showed Merck tried to alter the design of an upcoming study by giving aspirin to patients on Vioxx to protect their hearts.

“They don’t mind killing patients,” Lucchesi had said about Merck scientists while on the stand Friday.

“You owe them an apology, don’t you?” Raber said Tuesday, adding the scientists believed at the time that Vioxx was safe.

“I don’t know that I owe them an apology,” Lucchesi said.

“You jumped to conclusions before you ever knew what they were talking about,” Raber said.

The exchanges between Lucchesi _ who had testified in a previous Vioxx trial _ and the Merck attorney triggered several objections from plaintiff’s attorney Chris Seeger and prompted Higbee to caution Raber.

Raber raised his voice as he pressed a point in questioning Lucchesi about an outside researcher’s study that appeared to support a Merck theory proposed after publication of a 2000 company study that raised the first public alarms about the safety of Vioxx.

“Does he have to scream at him, your honor?” Seeger said.

After another Seeger objection, Higbee told the two attorneys, “Let’s not attack each other.”

Seeger represents 60-year-old Boise, Idaho, postal worker Frederick “Mike” Humeston, who survived a September 2001 heart attack that has left him frequently fatigued and reliant on heart medications. Merck argues that excess weight and other cardiac risk factors, not Vioxx, caused Humeston’s heart attack.

The 2000 study found Vioxx users suffered many more heart attacks and other cardiovascular problems than study participants taking naproxen, an older painkiller. Merck then argued, without proof, the result was due to naproxen preventing cardiac problems, not side effects of Vioxx. A year later, the Food and Drug Administration had Merck add cardiac warnings to the Vioxx label.

But Raber said the FDA had determined on four separate occasions that Vioxx was “safe and effective.”

On Monday, Lucchesi testified that intermittent use of the drug _ or even a day’s use _ could cause a heart attack because Vioxx takes about 85 hours to clear out of the blood. That could be a key point in the trial, as Humeston had a heart attack after taking Vioxx for only two months and skipping some doses.

Vioxx, launched in May 1999, had peak sales of $2.5 billion in 2003. It was pulled from the market in September 2004 by Whitehouse Station-based Merck after research showed the drug doubled the risk of heart attack and stroke after 18 months’ use.

Plaintiff attorneys and some doctors have argued Merck knew the risks of Vioxx at least a few years before it took the drug off the market, yet downplayed its dangers and kept aggressively promoting the drug. Attorneys for Merck say the company acted responsibly, putting patients first and pulling the drug once the risks surfaced.

Merck 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, which will be slashed to about $26 million because Texas caps punitive damages. Merck plans to appeal.

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