Merck’s legal team will have to confront and neutralize the compelling testimony of a formidable medical expert and one of Vioxx longest-standing and harshest critics if it hopes to prevail in first federal trial.

It really is no secret that Merck will continue to face a mountain of damaging evidence in every Vioxx case it tries. The litigation (now almost 8,000 cases) has already damaged the companies credibility and financial stability and has hastened a major corporate restructuring that includes massive firings and numerous facility closings.

Although each case is dependent on expert scientific testimony to advocate each sides medical theories, the underlying categories into which the cases fall are surprisingly few. There are the (1) short-term-use cases (estimated to be about 25% of the total), and (2) long-term-use cases. In each of those categories are; (1) death cases, or (2) cases where the plaintiff survived but suffered serious permanent injuries. Finally, the length of use and extent of injuries can be subdivided one more time into cases where; (1) the plaintiff was suffering from conditions that, in and of themselves or cumulatively, could have caused the cardiovascular event attributed to Vioxx use; or (2) the plaintiff was otherwise heart-healthy and free of complicating medical problems.

As the trials are organized and scheduled by the judges charged with supervising large numbers of cases (N.J. state judge Carol Higbee and U.S. District Judge Eldon E. Fallon) many elements that may have favored Merck has been systematically eliminated.

In New Jersey, Judge Higbee, who controls the progress of some 3,500 Vioxx cases pending in that state, has ordered the next 10 trials involve plaintiffs who took Vioxx for at least 18 months. The judge denied Mercks motion challenging that decision

That ruling is quite significant in that Merck itself has already acknowledged the existence of an increased risk of heart attacks in long-term Vioxx users and even pulled the drug from the market for that very reason.

Thus, legal analysts see Judge Higbees ruling as one that will make it very difficult for Merck to duplicate its recent short-term-use victory in those upcoming long-term-use cases.

Merck was therefore pinning its hopes on the short-term-use case now on trial in U.S. District Court in Houston. That apparent advantage vanished, however, when that U.S. District Court Judge Eldon E. Fallon ruled that the plaintiff will be permitted to offer expert testimony that even short-term use of Vioxx carries with it an increased risk of cardiovascular problems including heart attack.

Judge Fallon based his decision on the fact that the very same scientific evidence is being interpreted differently by each sides highly qualified experts. Thus, there is no basis for the court alone to decide which experts are more credible or whether Merck has eliminated the issue of causation to the point where it should not be submitted to a jury for determination.

Thus, many of the loose ends that permitted Merck to boast of its intention to try each case to verdict have been tied up. The wiggle-room has been eliminated and all that remains is the evidence with respect to (1) Vioxx as an unsafe drug, and (2) the individual plaintiffs medical conditions. While the health of each plaintiff will always remain an attack point for Merck, very few legal analysts see the evidence as being anything but lopsided against Merck on the question of safety and the way in which Vioxx was marketed.

What all of this leads inescapably to is that Merck is in deep trouble if it is forced to confront the ghosts in Vioxx past. Those ghosts take the form of: (1) massive scientific evidence placing the cardiovascular safety of COX-2 inhibitors (generally) and Vioxx (specifically) in question; (2) extensive internal documentation from Mercks own files that cast doubt on both the safety of the drug and Mercks motives for many of its corporate decisions and marketing strategies involving Vioxx; and (3) long-time critics of the drug who are eminently qualified scientific experts and not simply consumer advocates.

From the beginning of the Vioxx saga the two constants that Merck has feared the most are (1) the paper trail of negative evidence, and (2) Dr. Eric Topol, chairman of cardiovascular medicine at the world-renowned Cleveland Clinic.

Until now, Dr. Topol has been silent, having not been asked to testify at either of the prior state court trials in Texas and New Jersey. As the first federal trial got under way, however, Judge Fallon ruled the jury will be allowed to see a videotaped deposition from Dr. Topol himself.

In that deposition (taken last week), Dr.Topol openly accused Merck of scientific misconduct, misrepresenting facts and endangering patients. He also testified that Merck’s former chief executive complained to a top Cleveland Clinic official about his activities.

In order to understand the significance of Dr. Topols entry into the litigation, one must consider the earliest evidence that Vioxx was a potentially dangerous drug and how Dr. Topol was immediately concerned about the cardiovascular risks posed by Vioxx and its COX-2 siblings.

Going back as far as 1996, the evidence is clear and consistent when it comes to the potential risks posed by Vioxx and the other COX-2 inhibitors like Bextra and Celebrex.Many critics believe that included withholding critical and damaging data and other information from the FDA and the public.

On Nov. 21, 1996, a Memo by a Merck official shows the company wrestling with the issue of Vioxx’ (Rofecoxib) involvement in increased cardiovascular events. At this early date, Merck avoided a trial to prove Vioxx gentler on the stomach than older painkillers because in such a trial, “there is a substantial chance that significantly higher rates” of cardiovascular problems would be seen in the Vioxx group.

On February 25, 1997, an internal Merck e-mail warned that if a proposed Merck trial was carried out “you will get more thrombotic events” – more blood clots – “and kill [the] drug.”

In response, Alise Reicin, later a Merck vice president for clinical research said in an e-mail that the company was in a “no-win situation.” She went on to propose that people with high risk of cardiovascular problems be kept out of the study so the difference in the rate of cardiovascular problems between the Vioxx patients and the others “would not be evident.”

On November 18, 1999 a meeting of the Data and Safety Monitoring Board (DSMB) discussed concerns over the “excess deaths and cardiovascular adverse experiences” that was observed in the group using Vioxx as compared to the patients taking Naproxen.

On March 9, 2000, Merck’s research chief, Edward Scolnick, e-mailed colleagues that the cardiovascular events “are clearly there” and stated “it is a shame but it is a low incidence and it is mechanism based as we worried it was.”

Worried about the affect on Vioxx, Dr. Scolnick wrote that he wanted other data available before the results were presented publicly, so “it is clear to the world that this” was an effect of the entire Cox-2 class, not just Vioxx.

That same month, however, the company’s public statements continued to reject the link between Vioxx and increased intrinsic risk. Merck made no mention that the study found a “mechanism based” connection between Vioxx and the statistically significant increase in cardiovascular events.

The VIGOR study (VIGOR – Vioxx Gastrointestinal Outcomes Research) sponsored by Merck was submitted to the FDA in June 2000. The study was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding.

While the study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patie
nts taking another drug, Naproxen, it revealed a statistically significant increase in the number of cardiovascular events (over 100% increase), myocardial infarctions/heart attacks (approx. 400% increase) and strokes in patients who have taken Vioxx compared to those receiving Naproxen.

The VIGOR study was published in the November 2000 issue of the New England Journal of Medicine but did not provide detailed information about other serious cardiovascular complications such as strokes or blood clots.

In February, 2001, a letter by Dr. James Fries, senior professor and medical doctor from Stamford University Medical School to Merck complained about the intimidation by Merck’s investigators including the threatening of the loss of funding because of the school’s discussion of cardio-vascular events associated with Vioxx.

On February 1, 2001, a Memo by Dr. Shari L. Targum, Medical Officer, Division of Cardio-Renal Drug Products of the FDA documented the serious cardiac events and myocardial infarctions and related deaths for participants in the study who were using Vioxx.

She also discussed the November 18, 1999 meeting of the Data and Safety Monitoring Board (DSMB) where concern was raised over the “excess deaths and cardiovascular adverse experiences” in the group using Vioxx as compared to the patients taking Naproxen.

On February 8, 2001, the FDA Arthritis Advisory Committee Meeting discusses the VIGOR study expressed concern over the unexpected findings of cardiovascular risks and myocardial infarctions associated with the use of Vioxx that was disclosed in the VIGOR study. Merck eventually was required (April, 2002) to add some of the data as to cardiovascular events to their label.

On August 22, 2001, the concerns arising out of the VIGOR study were crystallized by Drs. Debabrata Mukherjee, Steven Nissen, and Eric Topol in Journal of the American Medical Association (JAMA) in their review paper specifically highlighting the cardiovascular side-effect profile of COX-2 inhibitors. The doctors indicated that Vioxx was linked to a 200% increase in blood clots, heart attacks and strokes based on their review of previous clinical trials.

In August of 2002, Dr. Topol and Dr. Falk, a Cleveland Clinic gastroenterologist, published an editorial in The Lancet, encouraging further warnings and labeling regarding the cardiovascular effects of Cox-2 drugs. Even following these warnings, and in the face of mounting evidence for the cardiovascular side-effects of Vioxx, aggressive direct-to-consumer marketing of Vioxx continued unabated.

Immediately after Vioxx was pulled from the market, Dr. Topol, Chief of Cardiovascular Medicine and Chief Academic Officer of the Cleveland Clinic, who was a co-author of the VIGOR Study discussed above told the Washington Post (10/1/04) that Mercks action was the right decision about three years too late. This is the sort of thing that Merck should have studied earlier, but they were too busy refuting the warning signs.

According to The Wall Street Journal, in his deposition, Dr. Topol countered several crucial aspects of Merck’s defense in the Vioxx litigation. Legal observers say it is almost certain that aspects of Dr. Topol’s testimony will be used in the wider litigation. A transcript of the sealed deposition was reviewed by The Wall Street Journal. In addition, Dr. Topol said that a colleague at the Cleveland Clinic, Richard Rudick, the director of clinical research, told him that Raymond Gilmartin, the former chief executive and chairman of Merck, called a Cleveland Clinic board of trustee member to complain about Dr. Topol. The call came in mid-October 2004, two weeks after Merck withdrew Vioxx from the market and after Dr. Topol published harsh criticisms of Merck over Vioxx in the New York Times and the New England Journal of Medicine.

Clearly, Dr. Topol is both a formidable expert to reckon with and not just a hired gun brought on board by the plaintiff to bolster the case. In fact, he shuns testifying as much as possible.

He was blowing the whistle on Vioxx and the COX-2 inhibitors long before the public and medical community as a whole were even aware of the potential disaster looming ahead. Thus, he cannot be painted as a Johnny come lately or as someone with a predisposition against Merck or Vioxx. First and foremost, however, he is a respected expert in his field with impeccable credentials and the very last person Merck wanted to confront in this trial.

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