Janice Hopkins Tanne
New York
A jury in New Jersey has awarded $4.5m (£2.6m; 3.7m) in compensatory damages to a 77 year old man who claimed that rofecoxib (Vioxx) had caused his heart attack. The jury decided that Merck, the maker of the cyclo-oxygenase-2 inhibitor, had deceived the US Food and Drug Administration about the safety of the drug and awarded the man an additional $9m in punitive damages.
Merck said it had given the FDA all the necessary information about rofecoxib and would appeal the ruling.
The jury decided that the heart attack of a second man in the same trial had not been caused by rofecoxib and awarded him only the cost of his drugs: $45. The judge, the former malpractice lawyer Carol Higbee, who is overseeing 4500 rofecoxib cases filed in New Jersey against Merck, has grouped several cases together.
Merck faces nearly 10 000 cases in the US relating to rofecoxib. The company has said it would fight each one. Nearly half a million people in the UK have taken rofecoxib, and several hundred are considering suing. Cases will be heard in the US.
This is the second time that a jury has awarded punitive damages in cases concerning rofecoxib. The first was a case in Texas, in which the widow of a man who died after taking rofecoxib was awarded $253m. That award will be reduced by state law to about $26m (BMJ 2005;331: 471
In the trial in New Jersey a former FDA official testified that Merck had disclosed the appropriate material to the administration. Merck's former chief executive officer, Raymond Gilmartin, testified that Merck had not withheld safety data from the FDA.
Merck had performed a trial in which rofecoxib was compared with the non-selective non-steroidal anti-inflammatory drug naproxen in terms of gastrointestinal effects (New England Journal of Medicine 2000;343: 1520-8
Rofecoxib was removed from the market in 2004 after a study showed that it doubled the risk of heart attacks and strokes when taken for more than 18 months (BMJ 2004;329: 816
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BMJ 2005 331: 471.[Extract] [Full Text]
BMJ 2004 329: 816.