Vioxx Study Correction will Bolster Calls for New Trials

posted on:
June 27, 2006

author:
Staff

NEW YORK – Lawyers who lost their Vioxx cases said Tuesday they see new ammunition in their fights to win new trials now that a prominent medical journal has contradicted a key defense used by Merck & Co.

On Monday, the New England Journal of Medicine issued a correction which reversed an article’s claim that Vioxx elevated the risk of cardiovascular problems only after 18 months of use. However, the correction didn’t state when the increased risk would begin.

Merck & Co. has used the 18-month threshold as a cornerstone of its defense in the Vioxx lawsuits, which now top 13,000. Merck pulled the drug from the market in September 2004 after the study known as APPROVe found the pain killer doubled patients’ risk of heart attacks and strokes after 18 months. But the correction casts doubt on that defense, and plaintiff lawyers plan to use the Journal’s about face in future cases as well as to win new trials.

So far, Merck has lost three cases and won three. Two of Merck’s three wins came in cases where the patient took the drug for a few months.

In the first Vioxx case in Merck’s home state of New Jersey, last November a jury absolved the company of causing the 2001 nonfatal heart attack suffered by postal worker Frederick “Mike” Humeston, after taking Vioxx for about two months. Lawyer Chris Seeger had already filed for a new trial soon after the verdict, citing the conduct of Merck’s attorneys. Seeger said within the next two days he’ll amend his motion with the correction.

“The correction shows they have been lying about the APPROVe data,” Seeger said.

Seeger charges that Merck manipulated the data so the drug would look safer than it is.

But Merck said it simply made a mistake when it described the type of method of analysis used in the study. The reference to treatment by-log-time interaction in the article should have referred to treatment by-linear-time-interaction.

However, New England Journal executive editor Dr. Gregory D. Curfman said in looking at the 100-page data analysis plan there was no reference to using a linear method.

“You can’t look at the data and then decide how to analyze it,” Curfman said. “Merck is suggesting that is OK to change (the plan). You must follow the data plan.”

Kent Jarrell, a spokesman for Merck’s outside counsel, said it was a “serious mistake” to confuse the two types of analysis in the study but that that the linear analysis provided a “better way to look at the data.”

Attorney Andy Birchfield filed a motion for a new trial last March because a Merck witness lied under oath about his credentials after a jury found Vioxx didn’t trigger the fatal heart attack suffered by Richard “Dickey” Irvin in 2001 after taking Vioxx for less than a month. Birchfield said the correction will bolster his motion because it shows Merck committed “fraud on the court” by saying Vioxx’s risks don’t appear for 18 months.

However, Merck plans to continue using the 18-month benchmark, noting that the Journal made the correction, not the company.

“We are comfortable with what we’ve presented in the past and will continue to present it in the future,” said Jarrell. He noted the correction wasn’t written by the studies authors, but the Journal said they participated in its formulation.

Meanwhile, earlier this year a New Jersey jury also cleared Vioxx of causing Thomas Cona’s heart attack but did find that Merck committed consumer fraud while marketing the drug. Cona’s lawyer Mark Lanier doesn’t think he’ll file a motion for a new trial because Merck plans to appeal the consumer fraud verdict, and he will just agree that the case should be retried.

There are ongoing trails in New Jersey and California and two more are slated to begin later this summer.

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