Q&A: Vioxx Lawsuit
Vioxx was withdrawn from sale in September 2004
US pharmaceutical giant Merck has been ordered to pay $253.4m (£141m) to the widow of a man who died from a heart attack blamed on the popular painkiller Vioxx. The BBC News website answers key questions about the case and about what happens next.
Q: What is Vioxx?
Vioxx is the trade name for rofecoxib, a type of painkiller known as a Cox-2 inhibitor.
The drug was sold around the world in the late 1990s. In all it was taken by about 20m people, including 400,000 in the UK.
It provided pain relief, mainly for arthritis sufferers, without the side-effects of stomach problems which can be triggered by aspirin and other types of painkillers.
But research then uncovered side-effects of a different sort. Experts concluded that an entire class of Cox-2 inhibitors significantly raised the risk of patients suffering heart attacks and strokes.
The drugs have either been withdrawn from the market, or are accompanied by strong warnings of the possible damaging effects on health.
Q: Who took the decision to pull Vioxx from the market?
Merck voluntarily pulled Vioxx from the market in September 2004, five years after it had been approved for sale.
The firm was reacting to research carried out by its own teams, which discovered that taking the drug for 18 months or longer could double the risk of patients suffering a heart attack or stroke.
A US government study reached a similar conclusion of the drug’s dangers the same month.
The research, by the US Food and Drug Administration, concluded that 27,785 heart attacks or deaths might have been caused by Vioxx in the previous five years.
Q: What were the claims filed in the lawsuit?
A Texas woman, Carol Ernst, claimed Vioxx was to blame for her husband Robert’s death.
Mr Ernst, 59, had been taking the drug for eight months when he died of heart arrhythmia in his sleep in 2001. He was a marathon runner and triathlete who was using the drug to treat pain in his hands.
Merck insisted its drug was not to blame for Mr Ernst’s death. It said he had suffered from an irregular heartbeat and clogged arteries and it was these factors which led to his death.
But the jury agreed with his widow, and awarded her huge damages, including a large sum - £229m - specifically in punitive damages.
Q: What is in store for Merck?
The Texas trial was the first in what could ultimately be thousands of cases brought against Merck, both inside the US and around the world.
Key to this will be two more trials due to begin in the US later this year, in September in New Jersey and November in New Orleans.
If Merck loses those cases, it could open the floodgates, or force the drug company to settle cases out of court.
If it wins, many of the lawsuits may never be brought.
Merck says it will appeal against the first ruling and will fight any future lawsuits.
Analysts speculate that Merck’s liability if it loses could reach $18bn.
The markets have already reacted nervously to the Texas jury’s decision.
The company’s shares lost 7.7% of their value after the jury’s decision was announced, closing at $28.06. That wiped $5.2bn from the company’s value.
Q: Do drugs like Vioxx have a future?
Vioxx was one of Merck’s most important drugs, generating $2.5bn in sales in 2003, which accounted for about 10% of the company’s total revenue.
Some of the biggest pharmaceutical firms, including Merck but also GlaxoSmithKline, Novartis, Pfizer, have refused to abandon their believe in Cox-2 inhibitors.
They are conducting extensive research into the safety of other drugs in the same class, trying to prove they have a future of safe and effective pain control.
Merck still sells another drug in the Cox-2 class, Arcoxia. Although not approved in the US, it is approved in other 54 countries.
Celebrex, manufactured by Pfizer, is the only Cox-2 still available in the US market. Sales are said to be improving after the loss in confidence provoked by the withdrawal of Vioxx.
Source: BBC News August 20, 2005
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