Merck's Next Vioxx Trial May Test Heart Risk of Short-Term Use
Nov. 16 (Bloomberg) -- Merck & Co.'s next trial over its Vioxx painkiller will test the company's argument that short- term use of the drug doesn't cause heart attacks, as the widow of Richard ``Dicky'' Irvin Jr. claims in a lawsuit.
Merck, the third-largest U.S. drugmaker, withdrew the drug last year when a study showed it doubled the risk of heart injury after 18 months of daily use. Merck lost its first Vioxx trial in Texas against the widow of a man who took the drug for seven months and won a second in New Jersey against a man who used it for just two months.
The Irvin trial, which begins Nov. 29 in Houston, presents Merck with a chance to prove its argument that using Vioxx for less than 18 months isn't dangerous. As many as 40 percent of the lawsuits Merck faces over Vioxx may involve such short-term exposure, the presiding judge in the New Jersey case estimated.
``If Merck wins this one, they should be feeling pretty good about the short-term cases,'' said attorney Michael Kelly of McCarter & English LLP, who has represented other drugmakers. ``Stated very crassly, Merck could say this guy was a walking time bomb who was going to die soon no matter what.''
Evelyn Irvin-Plunkett says her 53-year-old husband's use of Vioxx for about 23 days triggered his 2001 heart attack at the fish wholesaler where he worked in St. Augustine, Florida. Merck argues that Irvin's age, weight, clogged arteries, family history and physical inactivity are to blame, not Vioxx. Irvin's life may be put on trial as much as Merck's drug, lawyers said.
Whitehouse Station, New Jersey-based Merck faces billions of dollars in potential liability and has vowed to fight every case. The company has set aside $675 million for litigation costs and nothing for Vioxx damages in the 6,400 lawsuits filed against it.
Heart Attack Victims
At the first Vioxx trial in August, a Texas state-court jury awarded $253 million to Carol Ernst, the widow of a Vioxx user, an amount that will be cut to $26 million because of a cap on punitive damages. On Nov. 7, a New Jersey state-court jury ruled against Frederick Humeston, 60.
Jurors in the Irvin case, which is to be heard in federal court, are scheduled to hear evidence for six days a week about the science of heart attacks, the research Merck did on the drug's health risks and the marketing of a medicine that reached sales of $2.5 billion a year.
At the heart of the case is the life and health history of Dicky Irvin, a native of Hastings, Florida. He won a football scholarship to the University of Richmond, where he played nose guard for three seasons. His team won Southern Conference championships in 1968 and 1969, and he was awarded all- conference honors.
Hall of Fame
Irvin, who was later named to the Richmond Spiders Athletic Hall of Fame, spent a year playing for the Montreal Alouettes in the Canadian Football League. He came back to Florida, got married, had four children and sold cars with his father, Richard Sr. He announced football games at a local high school.
``Everybody liked him and he liked everybody,'' said Richard Sr., 79, whose other child died of lupus at age 32. ``He was one that regardless of whatever his mother fixed at the table, he would get up and say that was the best meal he ever had.''
Irvin took a job with the Seafood Shoppe in St. Augustine, which supplied snapper, grouper and shrimp to local restaurants. Irvin worked in retail before making deliveries and unloading boats with up to 5,000 pounds of fish, said company owner John Weeks. Irvin made about $45,000 a year.
``I trusted him and could leave him to run the office when I wasn't there,'' Weeks said in an interview. ``He was a bull. He was physically strong. I don't see how he could have worked like that and had health problems.''
Avoided Doctors
Irvin rarely visited a doctor. He had a stress test in 1994, and the results are unknown, court records show. When he cut his finger in 1998, his blood pressure was 149/90, a high level, records show.
He complained to his daughter, Allesha Schirmer, in April 2001 about back pain. She called her husband, Christopher, a physician, who prescribed two painkillers that made Irvin ill. Irvin had gotten free samples of Vioxx from a friend, and they worked, records show. His son-in-law then prescribed 30 Vioxx tablets without examining him, court records show.
On May 15, 2001, Irvin called Weeks from work about 7 a.m. and said he wasn't feeling well. Minutes later, a coworker found him slumped over at his desk. He never revived.
An autopsy report showed that plaque blocked 60 percent to 70 percent of a major coronary artery. He was 6 feet tall and weighed 230 pounds, which is considered obese. He often ate fast food for lunch, and several relatives had heart problems, according to pre-trial depositions.
Other Possible Causes
A Merck cardiology expert, J. Michael Gaziano, said in a report that the autopsy showed that Irvin's ``moderate to severe'' heart disease caused an abnormal heart rhythm. The autopsy ``helps explain why Mr. Irvin's short-term use of Vioxx had nothing to do with his death,'' Merck said in court papers.
``Mr. Irvin's known atherosclerosis, obesity and sedentary lifestyle caused his death -- much like they do each year for tens of thousands of American men in their 50s who have never taken Vioxx,'' Merck said in court filings.
Irvin's widow, who has remarried, wasn't available to comment, said her attorney, Andy Birchfield. He has scheduled a press briefing on the case for today in Montgomery, Alabama, where his office is based.
Irvin was ``in good health for most of his life,'' and Merck attorneys won't be able to use medical records to attack him in person as they did the plaintiff in the Humeston trial in New Jersey, Birchfield said.
Coming After Him
``I'm sure they are going to come after him, but they've got a lot less to work with here,'' he said. ``We also have autopsy records showing that Mr. Irvin wasn't a sick man and that his arteries weren't any more clogged than the average 50- year-old American man.''
Merck's records on clinical trials show that Vioxx patients had heart attacks well before 18 months, which contradicts the drugmaker's stated position, Birchfield said.
``We're hoping the jury in Houston will give that evidence, which comes from Merck's own studies, serious consideration when deciding whether Vioxx caused Mr. Irvin's heart attack,'' he said.
Merck may also get some quick guidance soon on how vulnerable it is in long-term cases. The judge who presided over the New Jersey case is managing 3,500 Vioxx suits and said last week that she wants her next 12 trials to focus on heart attack victims who took the drug for at least 18 months.
Merck, the third-largest U.S. drugmaker, withdrew the drug last year when a study showed it doubled the risk of heart injury after 18 months of daily use. Merck lost its first Vioxx trial in Texas against the widow of a man who took the drug for seven months and won a second in New Jersey against a man who used it for just two months.
The Irvin trial, which begins Nov. 29 in Houston, presents Merck with a chance to prove its argument that using Vioxx for less than 18 months isn't dangerous. As many as 40 percent of the lawsuits Merck faces over Vioxx may involve such short-term exposure, the presiding judge in the New Jersey case estimated.
``If Merck wins this one, they should be feeling pretty good about the short-term cases,'' said attorney Michael Kelly of McCarter & English LLP, who has represented other drugmakers. ``Stated very crassly, Merck could say this guy was a walking time bomb who was going to die soon no matter what.''
Evelyn Irvin-Plunkett says her 53-year-old husband's use of Vioxx for about 23 days triggered his 2001 heart attack at the fish wholesaler where he worked in St. Augustine, Florida. Merck argues that Irvin's age, weight, clogged arteries, family history and physical inactivity are to blame, not Vioxx. Irvin's life may be put on trial as much as Merck's drug, lawyers said.
Whitehouse Station, New Jersey-based Merck faces billions of dollars in potential liability and has vowed to fight every case. The company has set aside $675 million for litigation costs and nothing for Vioxx damages in the 6,400 lawsuits filed against it.
Heart Attack Victims
At the first Vioxx trial in August, a Texas state-court jury awarded $253 million to Carol Ernst, the widow of a Vioxx user, an amount that will be cut to $26 million because of a cap on punitive damages. On Nov. 7, a New Jersey state-court jury ruled against Frederick Humeston, 60.
Jurors in the Irvin case, which is to be heard in federal court, are scheduled to hear evidence for six days a week about the science of heart attacks, the research Merck did on the drug's health risks and the marketing of a medicine that reached sales of $2.5 billion a year.
At the heart of the case is the life and health history of Dicky Irvin, a native of Hastings, Florida. He won a football scholarship to the University of Richmond, where he played nose guard for three seasons. His team won Southern Conference championships in 1968 and 1969, and he was awarded all- conference honors.
Hall of Fame
Irvin, who was later named to the Richmond Spiders Athletic Hall of Fame, spent a year playing for the Montreal Alouettes in the Canadian Football League. He came back to Florida, got married, had four children and sold cars with his father, Richard Sr. He announced football games at a local high school.
``Everybody liked him and he liked everybody,'' said Richard Sr., 79, whose other child died of lupus at age 32. ``He was one that regardless of whatever his mother fixed at the table, he would get up and say that was the best meal he ever had.''
Irvin took a job with the Seafood Shoppe in St. Augustine, which supplied snapper, grouper and shrimp to local restaurants. Irvin worked in retail before making deliveries and unloading boats with up to 5,000 pounds of fish, said company owner John Weeks. Irvin made about $45,000 a year.
``I trusted him and could leave him to run the office when I wasn't there,'' Weeks said in an interview. ``He was a bull. He was physically strong. I don't see how he could have worked like that and had health problems.''
Avoided Doctors
Irvin rarely visited a doctor. He had a stress test in 1994, and the results are unknown, court records show. When he cut his finger in 1998, his blood pressure was 149/90, a high level, records show.
He complained to his daughter, Allesha Schirmer, in April 2001 about back pain. She called her husband, Christopher, a physician, who prescribed two painkillers that made Irvin ill. Irvin had gotten free samples of Vioxx from a friend, and they worked, records show. His son-in-law then prescribed 30 Vioxx tablets without examining him, court records show.
On May 15, 2001, Irvin called Weeks from work about 7 a.m. and said he wasn't feeling well. Minutes later, a coworker found him slumped over at his desk. He never revived.
An autopsy report showed that plaque blocked 60 percent to 70 percent of a major coronary artery. He was 6 feet tall and weighed 230 pounds, which is considered obese. He often ate fast food for lunch, and several relatives had heart problems, according to pre-trial depositions.
Other Possible Causes
A Merck cardiology expert, J. Michael Gaziano, said in a report that the autopsy showed that Irvin's ``moderate to severe'' heart disease caused an abnormal heart rhythm. The autopsy ``helps explain why Mr. Irvin's short-term use of Vioxx had nothing to do with his death,'' Merck said in court papers.
``Mr. Irvin's known atherosclerosis, obesity and sedentary lifestyle caused his death -- much like they do each year for tens of thousands of American men in their 50s who have never taken Vioxx,'' Merck said in court filings.
Irvin's widow, who has remarried, wasn't available to comment, said her attorney, Andy Birchfield. He has scheduled a press briefing on the case for today in Montgomery, Alabama, where his office is based.
Irvin was ``in good health for most of his life,'' and Merck attorneys won't be able to use medical records to attack him in person as they did the plaintiff in the Humeston trial in New Jersey, Birchfield said.
Coming After Him
``I'm sure they are going to come after him, but they've got a lot less to work with here,'' he said. ``We also have autopsy records showing that Mr. Irvin wasn't a sick man and that his arteries weren't any more clogged than the average 50- year-old American man.''
Merck's records on clinical trials show that Vioxx patients had heart attacks well before 18 months, which contradicts the drugmaker's stated position, Birchfield said.
``We're hoping the jury in Houston will give that evidence, which comes from Merck's own studies, serious consideration when deciding whether Vioxx caused Mr. Irvin's heart attack,'' he said.
Merck may also get some quick guidance soon on how vulnerable it is in long-term cases. The judge who presided over the New Jersey case is managing 3,500 Vioxx suits and said last week that she wants her next 12 trials to focus on heart attack victims who took the drug for at least 18 months.
posted by Chris Placitella at 6:39 AM
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