"It is clear that Vioxx increases the risk of heart attack. And that increase in risk begins with the first tablet a patient takes," said Dr David Graham, associate director for science in the Office of Drug Safety at the FDA, in an editorial accompanying the online JAMA studies.
"For tens of thousands of patients who experienced MI (myocardial infarction) while taking (Vioxx)," he said, "the drug may have been the decisive risk factor, over and above any other risk factors, that contributed to the occurrence of this life changing and potentially fatal event."
In the editorial, Dr Graham also points the finger of blame for the Vioxx disaster at the FDA. "In this case," he wrote, "they knew before the drug came on the market that Vioxx increased the risk of heart attack."
This past spring, much to the dismay of Merck's legal team, Vioxx plaintiffs subpoenaed Dr Graham's testimony as an expert witness, and his deposition testimony is expected to used in several Vioxx lawsuits.
A mistrial was declared in the first federal Vioxx trial to go to a jury, on December 12, 2005, when the panel was unable to reach a verdict after three days of deliberations. The lawsuit was filed on behalf of the widow of Richard Irvin, a Florida man who died of a heart attack in 2001, after using Vioxx for about one month.
According to a court decision filed in the case on February 2, 2006, Mr Irvin was a 53-year-old man with severe lower back and hip pain, weighed approximately 230 lbs, and was 6' tall.
On April 9, 2001, he asked his son-in-law, an emergency room physician, to give him something for pain. He gave Mr Irvin a prescription for Vicoprofen and Methocarbrnol, which he was unable to tolerate because it produced severe nausea and vomiting and provided no significant pain relief.
Subsequently, Mr Irvin received some samples of Vioxx from a friend and it reduced his pain. On April 15, 2001, he contacted his son-in-law and requested a prescription for Vioxx and the prescription for 30 tablets was filled on April 22, 2001.
Less than a month later, on May 15, 2001, Mr Irvin suffered a heart attack at work. Extensive resuscitative efforts were carried out but were unsuccessful, and according to court documents, Mr Irvin was pronounced dead at 9:02 am on May 15, 2001.
Mr Irvin's wife, Evelyn, brought the lawsuit against on behalf of herself and Mr Irvin's two minor children, alleging that Vioxx was a defective product, that Merck knew Vioxx was defective, and failed to adequately warn Mr Irvin.
Merck argued that none of the tests specifically showed that Vioxx ingested for less than a month can increase the risk of adverse cardiovascular events.
The jury could not agree on a verdict and a mistrial was declared. On February 17, 2006, after sitting through a retrial, a New Orleans jury ruled in favor of Merck
The next trial was held in New Jersey. On April 5, 2006, the jury held Merck liable for the heart attack of 77-year-old John McDarby, and awarded Mr McDarby $4.5 million in compensatory damages based on Merck's failure to properly warn of Vioxx safety risks.
After a hearing on April 11, 2006, the jury also awarded Mr McDarby an additional $9 million in punitive damages.
The same jury found Merck not liable for the heart attack of 60-year-old Thomas Cona, a second plaintiff in the trial.
Mr McDarby had suffered a heart attack on April 15, 2004, and subsequently broke his hip when he collapsed. He sought compensatory damages for both the heart attack and hip fracture.
"For tens of thousands of patients who experienced MI (myocardial infarction) while taking (Vioxx)," he said, "the drug may have been the decisive risk factor, over and above any other risk factors, that contributed to the occurrence of this life changing and potentially fatal event."
In the editorial, Dr Graham also points the finger of blame for the Vioxx disaster at the FDA. "In this case," he wrote, "they knew before the drug came on the market that Vioxx increased the risk of heart attack."
This past spring, much to the dismay of Merck's legal team, Vioxx plaintiffs subpoenaed Dr Graham's testimony as an expert witness, and his deposition testimony is expected to used in several Vioxx lawsuits.
According to a court decision filed in the case on February 2, 2006, Mr Irvin was a 53-year-old man with severe lower back and hip pain, weighed approximately 230 lbs, and was 6' tall.
On April 9, 2001, he asked his son-in-law, an emergency room physician, to give him something for pain. He gave Mr Irvin a prescription for Vicoprofen and Methocarbrnol, which he was unable to tolerate because it produced severe nausea and vomiting and provided no significant pain relief.
Subsequently, Mr Irvin received some samples of Vioxx from a friend and it reduced his pain. On April 15, 2001, he contacted his son-in-law and requested a prescription for Vioxx and the prescription for 30 tablets was filled on April 22, 2001.
Less than a month later, on May 15, 2001, Mr Irvin suffered a heart attack at work. Extensive resuscitative efforts were carried out but were unsuccessful, and according to court documents, Mr Irvin was pronounced dead at 9:02 am on May 15, 2001.
Mr Irvin's wife, Evelyn, brought the lawsuit against on behalf of herself and Mr Irvin's two minor children, alleging that Vioxx was a defective product, that Merck knew Vioxx was defective, and failed to adequately warn Mr Irvin.
Merck argued that none of the tests specifically showed that Vioxx ingested for less than a month can increase the risk of adverse cardiovascular events.
The jury could not agree on a verdict and a mistrial was declared. On February 17, 2006, after sitting through a retrial, a New Orleans jury ruled in favor of Merck
The next trial was held in New Jersey. On April 5, 2006, the jury held Merck liable for the heart attack of 77-year-old John McDarby, and awarded Mr McDarby $4.5 million in compensatory damages based on Merck's failure to properly warn of Vioxx safety risks.
After a hearing on April 11, 2006, the jury also awarded Mr McDarby an additional $9 million in punitive damages.
The same jury found Merck not liable for the heart attack of 60-year-old Thomas Cona, a second plaintiff in the trial.
Mr McDarby had suffered a heart attack on April 15, 2004, and subsequently broke his hip when he collapsed. He sought compensatory damages for both the heart attack and hip fracture.
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