Judge Limits Merck’s Vioxx Defense

Sep. 16–ATLANTIC CITY – A judge sternly reined in lawyers for Merck & Co. Inc. on the second day of its trial over the painkiller Vioxx, limiting their use of a powerful piece of evidence and barring mention of Merck’s voluntary recall of the drug.

Superior Court Judge Carol E. Higbee’s limitation of an April 2005 memo by the Food and Drug Administration appeared so unsettling to Merck’s attorney, Diane P. Sullivan, that she leapt to her feet and asked for a mistrial, an unusual move.

“This is unfair, this is really unfair,” Sullivan said to Higbee, shaking her head. The jury was not present. Sullivan then stepped aside to let her colleagues discuss the matter with Higbee, who denied the motion. But the flare-up reflected the high stakes and tensions behind the case.

The closely watched trial is the second for Merck, which recalled Vioxx a year ago. The first product-liability trial in Texas last month ended with a $253 million verdict against Merck, which has vowed to appeal. Under Texas law, the amount would be capped at $26 million.

The New Jersey trial is expected to last four to six weeks with its outcome important to each side’s future legal strategy in nearly 5,000 Vioxx-related cases that have been filed so far nationwide. Wall Street analysts have projected Merck’s ultimate costs could be $5 billion to $30 billion. The company, which is based in Whitehouse Station, N.J., has about 12,000 employees in the Philadelphia area, where much of the Vioxx legal, marketing and physician communications work was done.

The New Jersey case was brought by Frederick “Mike” Humeston, 60, a postal worker and Vietnam War veteran from Boise, Idaho, who sued Merck in 2003, two years after suffering a heart attack while on Vioxx and a year before Merck voluntarily recalled the drug after its own tests showed it to raise the risk of strokes and heart attacks after 18 months of use.

Humeston claims Vioxx caused his heart attack after barely two months of intermittent use and that Merck failed to warn physicians about its risks. Merck counters that Humeston was prone to heart attacks because of his age, occasional high blood pressure and weight, and that he was not taking Vioxx long enough to be hurt by it.

Humeston’s family physician and friend, Gregory Lewer, testified yesterday that he never saw clear information from Merck about the cardiovascular risk from Vioxx when he prescribed it to Humeston in May 2001 for chronic knee pain caused by shrapnel wounds.

Asked by Humeston’s attorney, Christopher Seeger, if he would have prescribed Vioxx knowing of its cardiovascular risk, Lewer said, “No.”

Lewer said he prescribed Vioxx because evidence showed it did not cause an upset stomach, like several other pain relievers he had tried. But Lewer said it was not until after his patient’s heart attack that he became fully aware of unconfirmed concerns about heart-attack risk. “I didn’t have enough information that I wish I had at the time of his heart attack,” he testified.

In cross-examination by Merck, Lewer revealed that Humeston suffered his heart attack one day after learning that his managers at the U.S. Postal Service had assigned investigators to videotape him to try to prove whether he was really ailing. Humeston had disagreements with his bosses on changing his hours because of his pain.

But Lewer said he did not think the stress of the surveillance triggered the heart attack. However, Merck later showed the jury that Humeston cited “anxiety and home stress” when he was admitted for the heart attack.

Merck, in its opening statement, signaled it would depend heavily on the actions and opinions of regulators at the FDA.

Leading up to the trial, Higbee ordered both sides to argue their sides strictly on scientific evidence presented by expert witnesses. She specifically told them not to mention unproven theories about a “class effect” of all drugs like Vioxx, known as cox-2 inhibitors, and not to mention a 19-page FDA memo that says many pain relievers like Vioxx, known as nonsteroidal anti-inflammatory drugs, may not all be risky but should all still bear safety warnings.

“There is no scientific foundation” for many statements in the memo, Higbee said, adding that she was considering barring it from the trial entirely, prompting Sullivan’s complaint. Higbee ultimately denied the mistrial request but left open whether lawyers could discuss the FDA memo if it came in cross-examination with expert witnesses who could discuss its validity.

Higbee chastised Sullivan for disparaging Humeston’s attorneys in her opening remarks, despite her orders never to do so in front of the jury. She said the order was meant to prevent Merck from playing on jurors’ possible concerns about excessive litigation against corporations.

The judge also barred both sides from discussing the fact that Merck withdrew the drug, a point that Merck lawyers hoped to use to show the company’s concern for patients despite its cost to the corporation.

She also barred both sides from mentioning that Vioxx had been withdrawn from the market. “There’s probably a hundred reasons why they took it off the market – for public relations, for legal reasons,” Higbee said.

Once the jury returned to the courtroom, Higbee gave them instructions to disregard statements in opening statements about Vioxx’s withdrawal.

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