Despite the company putting a brave face, Merck is getting overwhelmed by Vioxx litigation. According to latest reports provided by the company, the number of lawsuits filed against it has shot to as many as 6,400 lawsuits as of September 30, 2005. This is pretty much in line with the earlier estimates.

Some earlier forecasts say that the total number of plaintiffs may cross 100,000 making Vioxx litigation the largest product liability case in the world. Not all victims have filed their cases yet - particularly those who live overseas. But they are moving in the right direction. For instance, Merck is reporting that approximately 3,000 claimants have entered into Tolling Agreements with the Company, which halt the running of applicable statutes of limitations.

The Humeston versus Merck trial is currently in progress in Altantic City and Guerra versus Merck has been postponed to April of next year, but Judge Eldon E. Fallon has issued an order setting the Evelyn Irvin Plunkett v. Merck case as the first case to be tried in the MDL scheduled to begin on Nov. 28, 2005, in Houston, Texas.

Judge Fallon has also scheduled three additional trials in the MDL in February, March, and April of next year. In addition, there are other state court trials currently scheduled in the next six months and beyond, including Zajicek v. Merck in March 2006. Merck is also being sued by attorneys general in several states, stockholders, and other entities.

Recommended article: Merck unlikely to prevail in Humeston case

As initially reported about the plans of Vioxx consumers in Israel to sue Merck, they have now grouped together and filed a class action lawsuit against the company in the United States. These victims join a rapidly growing list of foreign victims from Italy, England, France, Australia, Canada, New Zealand, South Africa, Germany, the Netherlands and Poland that have filed cases in the American courts.

Related article: Merck may lose the Humeston lawsuit

While Merck struggles to explain why its studies on animals about safety of Vioxx was good enough to show that the drug was safe for humans too, its attorneys are clearly having a tough time behaving in a civil manner in the court.

Diane Sullivan, who has behaved so unprofessionally throughout the trial and was almost thrown out of the court at one time by Judge Carol Higbee, misbehaved one more time this week. That prompted another round of shouting match. And this time Sullivan argued even with one her colleagues that also included use of an expletive that the whole court could hear.

Several analysts have debated if Sullivan's behavior is part of a legal strategy designed to discredit the credentials of Judge Carol Higbee so that either Merck can ask for yet another mistrial (it has already asked for mistrials six times) or use the heated exchanges as an issue during the appeal. Most legal experts expect Merck to lose this case.

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CNN is reporting that the third Vioxx trial in the lawsuit filed by the family members of Anna Guerra. The plaintiffs are represented by Mark Lanier - the same attorney who represented Carol Ernst. She won a little over billion dollars in damages from Merck for causing the premature death of her husband Robert Ernst.

Anna Guerra died after taking Vioxx when she was not even 40. Mark Lanier, who impressed everyone with his excellent litigation skills, claims that Merck will have to pay even more in damages to the family of Guerra than the company paid to Ms. Ernst. He is quoted as telling CNN that, "I want Merck to see that Ernst was a conservative verdict. I'm going to spank them hard."

The trial in the Humeston case is still ongoing and most analysts expect Merck to lose. The Federal trial is scheduled to start after Thanksgiving in Houston.

Related article: Merck getting buried in Vioxx litigation

You might recall Merck scientist, Briggs Morrison. He testified as a witness on behalf of Merck but after it was found out that he was not an expert in the area that he was testifying about, Judge Carol Higbee got so mad at the defense attorneys for misleading her that she threw out his testimony.

Well, things are still not going so well for Morrison. He is now being trashed by his own colleagues because in an email that he wrote in 2001, he said that Merck engaged in "wishful thinking" when it claimed that no evidence linked its painkiller Vioxx to heart attacks. He was merely saying what everyone outside the company already knew but Merck, with the use of its slick advertising, was able to drown their voices.

So how does Merck react to his disclosure of the truth about the dangers of Vioxx? Alise Reicin attacked him by calling him as the "worst critic." In other words, some company researchers were so delusional that not only did they chose to ignore hard data but also the doubts of their own scientists.

According to the FDA, as many as 140,000 Americans alone have been injured after taking Vioxx and about 60,000 are dead.

Related article: Merck keeps saying contradictory things about safety of Vioxx

On one hand Merck keeps arguing that Vioxx was always a safe drug and it is so sure about that it would like to market it again worldwide. But then it has a hard time defending data that shows that Vioxx was so dangerous that it killed as many as 60,000 Americans.

Merck scientist Alise Reicin admitted in the trial today that the company had considered an additive to the drug so that its side effects on the heart will be much lower. But do not start to believe that Merck was being open with the public when it was considering reformulating the painkiller. On the other hand the company was aggressively promoting Vioxx as the safest drug ever made in the history of mankind.

So the natural question everyone is asking if Vioxx was so safe and such a great drug, why would Merck want to change its formula?

That is a question that will be answered in the trial of the lawsuit brought by Frederick "Mike" Humeston, the plaintiff who claims that his heart attack was caused by the drug.

Related article: Merck gets drowned in lawsuits

According to research completed by The Associated Press, since the verdict was announced in the Carol Ernst case, the number of lawsuits has exceeded over 6,000. The vast majority of lawsuits filed is in the State of New Jersey where Merck is based. There are two benefits to filing the lawsuit there.

1. The cases can not be moved to a Federal Court that tend to anti-consumer.
2. The state has a 2-year period to sue so that victims have at least till September 2006 to file their cases.

In the meantime, foreign victims of Vioxx are also coming forward to sue the company in the United States.

Several lawyers are reported saying that the number of lawsuits is "just a drop in the bucket." According to U.S. District Court Judge Eldon Fallon who is handling the litigation the number is likely to exceed 100,000.

Related article: Germans sue Merck in the United States

In one of those rare instances when the FDA employees were actually doing their job (they have clearly not done it in many cases) - ensure drug safety in America - they were blasted by Merck executives who called them "grade D high school students" and used four-letter words to describe them. The Merck folks were incensed that FDA was actually worried that Americans could die, while the company was more concerned about beating Pfizer's drugs Celebrex and Bextra.

It was clear yesterday that when Edward Scolnick apologized for his choice of words, and said, "My language was clearly, clearly inappropriate and was not respectful to the FDA," he was not really changing his opinion of the drug regulatory agency as an evil to deal with, he was merely trying to help Merck.

While analysts and legal experts are confounded by Merck's reasoning that it was OK to ignore trial data and rely instead on the beliefs of scientists, the jury is likely to think otherwise. When a company statistician, Joshua Chen, found that rate of deaths from Vioxx was 3X that from a placebo, his colleagues not only decided to ignore the evidence but also report fabricated data to the FDA.

According to the FDA estimates, as many as 60,000 Americans have died due to Vioxx.

Related article: Merck tactics show that it expects a defeat in the Humeston case

It would be nice if Merck scientists would pay more attention to data than trust their guts. After all, human lives are at stake. If you believe Alise Reicin, vice president of clinical research at Merck Research Laboratories, then you get the impression that Merck research folks are so convinced about their gut feelings that even when data proves them wrong, they don't want to believe it.

"We really thought, based on the totality of the data, that naproxen was cardioprotective," she said today as Merck attorneys presented their defense after a long weekend in the Humeston lawsuit trial. "In addition, we knew there were benefits of Vioxx." She was referring to a study that found that Vioxx was killing more people than Aleve. While any reasonable person would have concluded that Vioxx was more dangerous than Aleve, Merck scientists twisted the result to conclude that Aleve was much better at protecting the heart.

Hope other drug scientists in America don't think like that and trust numbers more than their guts.

Related article: Testimony of top Merck scientist thrown out by judge

While legal experts believe that Merck is highly likely to lose the Vioxx lawsuit by Mike Humeston in the ongoing trial in New Jersey, the company has some more lawsuits to deal with - this time from The Netherlands. Kenneth B Moll & Associates - a class action and mass tort law firm in the US that is working with victims in as many as 57 countries - filed the first class action on behalf of all Dutch consumers who took the painkiller and suffered personal injuries.

Related article: German victims of Vioxx sue Merck

Has Merck already conceded defeat in the ongoing Vioxx trial in Atlantic City and preparing for the next trial in the appeals court? That is a theory rapdily developing after the behavior of Merck's legal team during the course of the trial, but particularly, during last week.

It is very clear that right now Merck attorney Diane Sullivan is more interested in getting things on record rather than actually defending Merck. The shouting match that she had with Judge Carol Higbee was clearly designed to build a stronger case when the company appeals the decision (if it loses - though experts believe that all indications point to Frederick "Mike" Humeston winning the case).

The company has been dealt several severe blows throughout the trial resulting in total demolition of its legal strategy. With Briggs Morrison's testimony completely thrown out, the company does not have a whole lot of ammunition left to defend itself. And Merck's general counsel Ken Frazier might very well be referring to the future trial in the appeals court when he said that "(Judge Higbee's decision) effectively denies Merck its fundamental right to a fair trial." The company said something similar when they responded to their defeat in the Carol Ernst versus Merck case.

A defeat in this trial will not only be disastrous to Dechert LLP but also to Merck that might be forced to bring back its now withdrawn offer of settlement.

Related article: Merck's desperation obvious in its legal tactics

"Quite frankly, I felt sick yesterday afternoon. I realized how I have got sucked into this. I feel that I was misled during the testimony," says Judge Carol Higbee who is presiding over the Merck versus Humeston trial in Atlantic City. Her comments can came when the company's legal team brought a scientist, Briggs Morrison, who had essentially looked at data on rats and mice to justify the safety of Vioxx.

Judge Higbee was so mad at Merck's desperate acts that she struck the testimony from the record and directed the jury to ignore it.

Diane Sullivan, the Merck attorney, who has been a troublemaker since the start of the trial, was not about to take this blow lightly though. Her protest was so unprofessional that Judge Higbee had to raise her voice to ask her to shut up. But she wouldn't listen. Finally, she had to use a threat of force to quiet her down, "Miss Sullivan, sit down and be quiet. Sit down or I will have you taken out of the courtroom."

Related article: Merck manipulated data to justify Vioxx safety

While only time will tell if Merck is able to prevail over Frederick "Mike" Humeston in the second Vioxx lawsuit trial in Atlantic City, New Jersey, if one were to interpret the signals from the company's lawyers, it is clear that they expect a defeat. After asking for mistrials as many as five times, Merck's legal team asked for a "directed verdict" after Chris Seeger, the plaintiff's attorney, wrapped up his case.

So what is a directed verdict?

A very simple definition of a "directed verdict" is a ruling made by a judge at the end of the presentation of evidence by a plaintiff's attorney, but prior to the start of the defendant's presentation. At this point, the judge has concluded that the plaintiff has done such a terrible job in support of her case, that it would be a waste of time to proceed any further. The case is then decided in the favor of the defendant.

If anyone has been following this case, only an idiot would think that a directed verdict is needed. On the contrary, it seems that while Seeger may not have done as well as Mark Lanier, he still has a very fair chance of getting a decision in his favor. No surprise then that Judge Carol Higbee rejected Merck's request.

Why is Merck so desperate this time?

A lot is at stake. While the company might try to downplay two defeats in a row, a lot more skepticism will develop about the company's arguments about doing the right thing about selling Vioxx despite knowing its dangers. So the best way to deal with this case is to delay it - a mistrial will clearly help Merck. A look at the Merck's stock chart shows that investors are clearly expecting a Merck defeat.

Company's stock has continued to slide since the recall of Vioxx last year and yet another defeat will put pressure on the company to settle - a huge liability that is expected to be as large as $65 billions by some analysts.

The folks who working in marketing and public relations are generally masters at spinning facts and Merck marketing executives were no exception. So when it was found that Vioxx was killing more people than Aleve, instead of admitting that Vioxx was indeed a dangerous drug, Merck simply declared that Aleve was a better drug for the heart.

One of the architects of this spin was Charlotte McKines, executive director of integrated marketing for Merck. In the ongoing trial in Altantic City, she was deposed by the attorneys for Mike Humeston, the plaintiff. Below is a telling example of how Merck played with words.

Plaintiff's attorney: Is it important for a doctor to know whether a drug could kill people?"

McKines: Among other things.

Plaintiff's attorney: As a patient, do you want to know if it could kill you or not?

McKines: That depends on the risks and benefits of the people involved.

Related article: Merck wants a mistrial in the Humeston case

When you or a family member is ill and takes a medicine, you better make sure that you have a record of what drug was taken, in what amount, and how frequently, because that is exactly what a lawyer might ask you if you ever need to sue the drugmaker for a personal injury. At least that is what Merck's legal team has asked Mike and Mary Humeston. The major point of contention is not if Vioxx causes heart attacks or kills; it is if Humeston took enough of it to trigger his'.

In moving testimony from Mary Humeston, she recounted how the heart attack has left Mike Humeston a different person and their relationship is no longer full of the passion that they had prior to it. "He was a big boy, he used to take care of himself," she said. She was so concerned that her testimony might hurt him, that she asked her husband to leave the courtroom for the duration of her testimony.

Merck has also been trying to show that Mike Humeston was already at risk of a heart attack and Vioxx had nothing to do with it, but doctors think otherwise. Dr. Graham Wetherley, the cardiologist at Saint Alphonsus Regional Medical Center in Boise, Idaho, who treated Humeston when he arrived in the emergency room after the heart attack, thinks that he has the arteries of a marine. Humeston was a fit man and followed the healthy lifestyle that any typical retired marine would have.

Related article: Merck's repeated requests for mistrial denied by Judge Carol Higbee

While many experts believe that Chris Seeger, the attorney for plaintiff Mike Humeston, may not have done as good a job as Mark Lanier did, Merck apparently is afraid that it will lose this case as well. To save itself from the consequence of a second defeat in a row, the company's legal team has asked five times that Judge Carol Higbee declare a mistrial.

Judge Higbee has rejected all requests, saying, "There is absolutely no chance that these jurors do not know that Vioxx was taken off the market...There is no reason for a mistrial." The idea is that the jury should not be told that was Vioxx was recalled. In fact the drug was recalled around this time last year and the media coverage for the withdrawal has been so widespread that even those who had never heard of the drug, now know more than they need to konw.

Related article: German Vioxx victims file lawsuit against Merck in the US

German Vioxx victims sue Merck

The list of non-American Vioxx victims who are joining the lawsuits against Merck is steadily growing. According to AFP, a group of four German victims have joined a class action lawsuit.

According to preliminary estimates, the number of victims in Germany runs into a few hundreds, and this is expected to be the start of the process.

In other developments, the trial in the lawsuit filed by Frederick Mike Humeston continues. While it is unclear at this time if his attorney Chris Seeger has established a strong case that his heart attack was a result of Vioxx, it remains to be seen how the Merck legal team convinces the jury that their drug, that has been established to be responsible for higher incidence of heart attacks and strokes, did not cause his heart attack. The news that Merck actually let Vioxx trial patients die may rattle any jury that is evaluating high ethical a company is.

While everyone agrees that Humeston was in great physical shape (he is a decorated Marine), but his mother suffered a heart attack and that may increase his risk as well. His personal physician also said Humeston did not smoke nor did he have diabetes. He also did not have other signs of people likely to get heart attacks, for example, high cholesterol or high blood pressure.

Related article: Vioxx patients in South Africa sue Merck