Court awards claimant $13.5m in rofecoxib lawsuit

New York

Janice Hopkins Tanne

328;25

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.

New Jersey law requires that when a jury awards punitive damages the case must be referred to the state’s attorney general for a criminal investigation. Merck could be investigated for consumer fraud on the grounds that it misled doctors and the FDA and for “wanton and willful conduct,” says Bloomberg.com, the online financial news service (http://bloomberg.com, “Merck Vioxx jury awards $9 mln in punitive damages,” 11 April). Merck said in a press release that it had not misled doctors and the FDA and that punitive damages should not have been awarded.

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<thin>000 cases in the US relating to rofecoxib. The company has said it would fight each one. Nearly half a million people in the United Kingdom 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). Merck plans to appeal.

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 shown to cause fewer gastrointestinal problems, but further analysis showed that patients taking rofecoxib had more heart attacks and strokes than the patients taking naproxen. Merck interpreted this to mean that naproxen was cardioprotective.

Rofecoxib had sales of $2.5bn a year and was used by about 20 million Americans before it 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).

The plaintiff in the New Jersey case, John McDarby, a retired insurance agent with diabetes and atherosclerosis, had taken rofecoxib for four years to alleviate arthritis in his hands and knee. He had a heart attack in 2004 and fell, breaking his hip. He was hospitalised and had rehabilitation treatment but later fell again and fractured the other hip. He is now confined to a wheelchair.

His main carer, reports the Associated Press, is his 70 year old wife, Irma, a church secretary. The couple say they need the money to pay for more help.