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Mistrial called in federal Vioxx case

Dec 12, 2005 | www.cbsmarketwatch.com

Citing a hung jury, the Houston judge overseeing Merck's first federal trial over its recalled drug Vioxx has declared a mistrial.

Federal Judge Eldon Fallon declared a mistrial of the case early Monday, stating that the jury had not been able to reach a verdict in a timely manner. The jury, which was based in Houston, had been deliberating on the case since Dec. 8.

A hearing to schedule a new trial has been slated for late next week.

Shares of Merck (MRK) were down 3.4% at $28.13.

The Houston case had been brought by the widow of a Florida man, Richard Irvin, who died suddenly of a heart attack in 2001 after taking Vioxx for about a month for back pain.

In a release early Monday, Merck said it was disappointed by the decision and is prepared to face a retrial. The company also asserted that Vioxx was not responsible for Irvin's heart attack, stating that Irvin had suffered from multiple cardiovascular risk factors.

"If a retrial is scheduled we will be right back with the same facts," said Kenneth Frazier, Merck's general counsel, in a statement.

"The Vioxx litigation will go on for years," Frazier added. "We have the resources and the resolve to address these cases, one by one, in a reasonable and responsible manner."

During a conference call Monday morning, Merck's lead defense attorney for the Houston case, Phil Beck, said Judge Fallon allowed the jury to deliberate for six additional hours after they had informed him they were deadlocked.

Beck added that if Fallon had allowed the jury to render a verdict after that point, the decision would have been "suspect," leading to speculation the decision had been made "out of exhaustion."

Merck abruptly took Vioxx off the market in September 2004 after a clinical study showed it raised the risk of heart attack or stroke in patients who took the drug for 18 months or longer. The drug had annual sales of around $2.5 billion when it was taken off the market.

The Irvin case is Merck's third Vioxx liability trial to date. In the first case, a Texas state jury awarded the widow of a former Vioxx user $253 million in damages, a verdict that Merck said it would appeal.

The company was later found not guilty in a New Jersey case involving a Vioxx user who survived a mild heart attack after taking the drug for a couple of months.

Merck currently faces almost 7,000 cases over its handling of Vioxx.

Journal accusations not a factor

The mistrial decision Houston comes in the wake of accusations by the prestigious New England Journal of Medicine that Merck-sponsored scientists manipulated cardiovascular data from a Vioxx study published in that periodical in 2000. The NEJM made its assertion shortly after its executive editor testified about the study at the Houston trial.

In an editorial released late last week, the NEJM said that Merck had failed to include three additional cases of heart attack amongst Vioxx users in the study before it was published. As a result, Vioxx's cardiovascular risks in the study's conclusions were understated.

Perhaps most damaging, editors of the medical journal accused the study's authors, which included two senior Merck scientists, of knowingly omitting the data from the publication's final draft.

On Monday, Merck's lawyers reiterated that the three heart attacks in question were not included because they were reported after the NEJM's deadline for submission. They also maintained that the omission did not skew the study's conclusions.

Merck's lawyers added that the heart attacks were promptly reported to the Food and Drug Administration about a month before the NEJM issue featuring the study hit newsstands. The data was later publicly presented during a special agency panel hearing on the drug in 2001.

"The information was provided to the FDA in a timely manner," said Beck, during the conference call. He added that the NEJM editorial did not disclose any information that had not already been released to the public over the years.

Beck and Frazier also said they did not think the NEJM's accusations would have an impact on the Houston case, if it is retried.

"Typically speaking, editorials don't come in as evidence," said Beck, adding that he would have no problem putting the Merck scientist who authored the study back on the stand.

Consolidation of cases on horizon

Meanwhile, the state judge overseeing the approximately 3,500 cased filed in the state of New Jersey, where Merck is headquartered, is still pushing to have some of the cases consolidated.

Judge Carol Higbee is requesting that the next Vioxx trial in her court be comprised of two cases. The next N.J. trial is slated for Feb. 27, Merck's lawyers said.

For the most part, Merck's lawyers have been opposed to consolidating Vioxx cases.

"We have the right to defend each and every case on its own facts," said Frazier. He added that Merck would be working with Higbee in the hopes of developing a "fair and orderly process for selecting the cases to be consolidated."

Last month, Higbee said she also wanted to see the next cases involve only plaintiffs who took the drug for 18 months or longer. Given that Merck's own study showed Vioxx can cause cardiovascular trouble in some patients after 18 months, such cases would obviously be harder to defend.

Merck's attorneys said Monday that still plans to take on these long-term use cases, noting narrowing the cause of a heart attack or stroke down to just Vioxx can be hard to prove. Central to these cases will also be Merck's steadfast defense that in acted responsibly and in a timely manner when Vioxx's cardiovascular risks were eventually discovered.

Meanwhile, Merck's next state case in Texas is slated for March 2006. The next federal case, which will also be heard in Houston, is scheduled for February.


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