Judge Interrupts Vioxx Testimony to Instruct Jury on Label Warnings

posted on:
March 16, 2006

author:
Staff

Eight hours into his testimony at the Vioxx trial in Atlantic City, N.J., last week, the plaintiffs’ first witness got a jolt.

The judge interrupted Merck sales and marketing executive David Anstice and gave jurors a curative instruction: Merck could have issued a safety warning at any time after it learned of the painkiller’s cardiovascular risks in March 2000.

Superior Court Judge Carol Higbee said she was acting to allay possible confusion over Anstice’s testimony that Merck marketed Vioxx responsibly and could not have added a warning about heart risks without approval from the Food and Drug Administration.

In contradiction, Higbee told the jury that FDA regulations would have permitted the company to add a warning label at any point.

“I just wanted to advise you that the law under FDA regulations does allow a company to change their warnings, to warn consumers and physicians about dangers they find out about after the label is approved,” Higbee told the panel. “They’re allowed to make those changes through a special procedure, without prior FDA approval.”

She prefaced her intervention by saying, “It’s up to you to make decisions on facts, and you alone decide the facts… . I tell you what the law is, usually at the end, but sometimes during the case, so you’re not confused.”

Merck attorneys objected to the curative instruction at a later sidebar, and Higbee noted the objection the next day.

It was not an altogether new element in the case. Before trial, Higbee had ruled that Merck could not argue it needed FDA approval to change the warning, says Merck spokesman Charles Harrell, a partner in the Memphis, Tenn., office of Butler, Snow, O’Mara, Stevens & Cannada.

Nonetheless, the instruction surprised lawyers, doctors and executives following the trial. “It’s highly unusual for a judge to instruct jurors on the law in the middle of a trial,” says a New Jersey mass-torts defense lawyer not involved in Vioxx litigation.

Lead plaintiffs lawyer W. Mark Lanier of Houston and New York was so pleased with the instruction that he decided against calling former Merck chief executive officer Raymond Gilmartin as a witness, say three lawyers familiar with the case. Gilmartin has not testified in any of the three Vioxx trials to date. Merck has won two and lost one.

KNOWING THE RISKS

The case on trial is the first test of Merck’s liability in long-term exposure cases. Thomas Cona, 59, of Cherry Hill, N.J., and John McDarby, 74, of Park Ridge, N.J., allege the heart attacks they suffered were brought on by taking Vioxx for 22 months and four years, respectively.

Merck did not warn of the risk of heart problems until April 2002, and it withdrew the painkiller in September 2004 when a study showed it doubled the risk of heart attacks after 18 months of use.

In his opening statement, Lanier, who won a $253 million verdict from an Angleton, Texas, jury last summer, flaunted the plaintiffs’ risk factors and said Vioxx was the ultimate factor that led to the heart attacks. He promised to show that Merck failed to provide critical safety information that would have warned patients like Cona and McDarby to stay away from Vioxx.

“We have a right to know all the risks, so that we can make intelligent decisions,” said Lanier, who showed a slide of a man near a cliff with a bottle of Vioxx pills pushing him closer to the edge. “When you’re taking Vioxx, you’re getting that extra shove.”

McDarby’s attorney, Robert Gordon of Weitz & Luxenberg in Cherry Hill and New York, said his client’s diabetes made it critical that he be informed of heart attack risks.

Gordon said McDarby’s doctor, John Braun, who testified by videotape on March 9, was visited 220 times by Merck sales representatives in five years.

“If [Dr. Braun] knew Vioxx was on the list of risk factors for heart attacks, he never would have put [McDarby] on the drug,” Gordon said.

Last fall, in the trial that ended in a defense win, the plaintiff had used Vioxx for four months and his lawyers admitted his risk factors only reluctantly. In the current trial, the plaintiffs’ lawyers are embracing their clients’ risks and invoking the theme that Merck had an obligation to tell everything about Vioxx’s dangers.

Lanier has been trying to chisel away at Merck’s credibility with the jury. He had Anstice describe the company’s $1 million launch party for Vioxx in the spring of 1999 on an island in San Francisco Bay and questioned Anstice on his advertising budget, by which Anstice spent as much on consumer ads in one year as Pepsi and Budweiser combined.

“We spent a lot of money on direct-to-consumer advertising,” said Anstice, adding that the ads “presented a very balanced picture.”

For two hours, Lanier grilled Anstice on Merck’s waiting 15 months, after getting results from its own scientific study of Vioxx showing an increased likelihood of cardiovascular problems, before adding a safety warning.

During that process, Lanier showed, Merck softened the proposed warning’s language and lobbied the FDA to place it in the secondary warnings section of the label. Lanier referred to an e-mail exchange between Anstice and a top Merck scientist that referred to FDA officials as “bastards” for the proposed warnings they wanted to require in light of a possible link to heart attacks.

”[T]he truth of the matter is back in 2001, through your office, Merck made projections” about how much a mild warning versus an actual warning would cost the company in sales, Lanier said.

Anstice replied, “We make all kinds of projections. We do it as a routine business practice; we forecast events.”

On March 8, Merck attorney Robert Brock of Montgomery, Ala.’s Rushton, Stakely, Johnston & Garrett sought to undo some of the damage during cross-examination.

“Was Merck cutting corners and compromising patient safety?” Brock asked.

“No,” Anstice answered. “All medications come with benefits and associated risks.”

Lead Merck attorney Christy Jones of Butler Snow in Jackson, Miss., focused her opening statement on causation. Cona had high cholesterol and heart disease, and was overweight, and McDarby had diabetes, she said.

The bottom line, she continued, was that “Merck and Merck scientists and doctors acted reasonably and responsibly in the development and testing of Vioxx.” And the company withdrew the product in 2004, when the potential risk became known.

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