June 1, 2006

Merck to Face Grandmother in Next Vioxx Trial

By Bill Berkrot

NEW YORK -- Merck & Co. will be back in court in Atlantic City, New Jersey, next week as the next Vioxx liability trial gets under way with the drug maker facing a 68-year-old grandmother who blames the withdrawn pain drug for her 2004 heart attack.

Elaine Doherty says she used Vioxx daily for three years to treat pain from arthritis of the hands and knees, and even continued to take the medicine after suffering a heart attack in January of 2004.

"She had no idea that Vioxx could cause heart attacks," Michael Galpern, one of Doherty's attorneys, told Reuters. "She relied on Merck's untruthful advertisements and she continued to take it up until it was withdrawn."

Merck, which is facing more than 11,500 Vioxx lawsuits, pulled the drug from the market in September 2004 after a study showed it doubled the risk of heart attack and stroke in those who took it for at least 18 months.

That study was once again called into question this week when Merck disclosed errors in the statistical method used to analyze the results. Merck said the error did not alter its conclusions, but critics disputed that, saying there could be evidence that Vioxx was harmful prior to 18 months of use.

Galpern said the correction to the study would not have bearing on this case as Doherty was a long-term Vioxx user, but "it's further evidence of Merck's mismanagement of the whole Vioxx data collection system."

Merck's legal team will argue, as it has in past trials, that the plaintiff had a host of other risk factors that led to her heart attack.

"The evidence is going to show Mrs. Doherty unfortunately had severe atherosclerosis disease in multiple vessels in her heart, and that was caused by multiple risk factors, including bad cholesterol, high blood pressure, diabetes," said Jim Fitzpatrick, one of Merck's outside attorneys.

"We think the evidence will be very clear in this case that it was those risk factors and that the heart attack had nothing to do with Vioxx," added Fitzpatrick.

Merck must also convince a jury it did not hide the heart risk of its former $2.5 billion a year medicine from doctors and patients in order to protect profits, as the plaintiff's attorneys will argue.

"We intend to put on evidence that will show that Merck behaved responsibly, studied the drug carefully, and made the appropriate disclosures every step of way," Fitzpatrick said.

Galpern said Doherty's diabetes, cholesterol and blood pressure had been "brought well under control" prior to her heart attack.

"My client was fairly typical of Merck's target Vioxx audience," Galpern said.

"Merck sold a cardio-toxic drug to the elderly population, the majority of whom have other risk factors, and now they're running from court to court claiming that it was not the cardio-toxic drug but the other risk factors that caused the problem," Galpern said.

New Jersey Superior Court Judge Carol Higbee, who is well versed in all things Vioxx by now, will preside over the trial. Higbee was on the bench for the previous two Vioxx trials in New Jersey state court, and thousands more Vioxx cases have been filed with her.

Higbee this week handed Merck a defeat in preliminary maneuvers, ruling that she will allow the jury to see videotaped testimony by Dr. Eric Topol, one of the nation's most influential cardiologists and one of Merck's harshest critics.

Of six Vioxx cases to go to trial so far, Merck has won three and lost three, including a split decision in the last New Jersey trial in which Higbee tried two cases simultaneously.

In that trial, a jury in April awarded $13.5 million to 77-year-old John McDarby and his wife after finding that Vioxx contributed to his heart attack and that Merck failed to warn of the drug's risk. The same jury found that Vioxx did not cause the heart attack of the second plaintiff, Thomas Cona.