US drug giant Merck & Co has revealed its new strategy and trial tactics at the start of the second trial claiming injury from its controversial analgesic Vioxx (rofecoxib). This courtcase – which began in Atlantic City on September 12 and is expected to last six weeks - has been brought by Frederick Humeston, a 60-year-old Vietnam war veteran who contends that the medicine was responsible for a heart attack in 2001, and that Merck misrepresented the drug’s safety risks.
But, according to CNN, Merck’s lawyers will argue that “there is no evidence that the clot would have been smaller or less significant without Vioxx, much less that it wouldn't have happened at all.” Merck’s lawyers insist that the case presents “little more than guilt by temporal association – that is, he had [the heart attack] while on Vioxx so Vioxx must have caused it. This is not the kind of rigorous and well-supported scientific reasoning demanded by New Jersey law.”
Having criticised the conclusion of the first trial, saying the case presented to the jury was "fundamentally flawed" because it was "allowed to hear testimony that was not based on reliable science and that was irrelevant," the US giant appears to have changed tactics. The Financial Times reported that, in the opening statement, Merck’s lawyers attempted to attain a more effective balance between its scientific arguments, and requested that jurors use common sense to untangle allegations that the firm misrepresented the risks associated with the drug.
Merck voluntarily withdrew Vioxx, which was generating sales of over $2.5 billion a year, in September last year, after evidence linked its use to a substantially increased risk of heart attacks and stroke, causing its share price to plunge and throwing the safety of the whole class of COX-2 inhibitor drugs into question. The drugmaker’s earlier plea to delay the start of the second trial, because of what it termed as "torrent" of bad publicity from the first Vioxx case in Texas, was denied by New Jersey Superior Court Judge Carol Higbee.
The news follows a landmark ruling in the first civil trial, which awarded in excess of $250 million to the widow of Robert Ernst, who died suddenly in his sleep after taking Vioxx for tendonitis. Although this could be slashed significantly because of state legislation capping punitive damages, the decision will likely encourage a wave of additional lawsuits, sending the numbers sharply upwards to an anticipated 100,000. And estimates of Merck’s liability have been raised to a staggering $50 billion.
- Meanwhile, Reuters reports that a Merck lawyer has been reprimanded in court for contravening an earlier warning about making reference to the plaintiff’s attorneys. Judge Higbee said it could bias the jury and lead to a possible mistrial.