One way or another, the day of reckoning is getting closer for Merck & Co., as the first of some 3,800 state and federal VIOXX-related lawsuits enters jury selection in Brazoria County, Texas.

State District Judge Ben Hardin preliminarily refused to grant Merck’s request for a two-month postponement of the wrongful death action brought by the estate of Robert Ernst, who died in 2001 of an irregular heartbeat (arrhythmia) while taking VIOXX for pain relief.  

Merck argued pretrial publicity had tainted the potential jury pool and a “cooling off” period would help dissipate any bias resulting from the recent announcement of the lawsuit brought by the state of Texas against Merck.
In addition to $168 million in damages, the state is seeking additional civil penalties. Texas Attorney General, Greg Abbott, believes the state can prove total damages in excess of $250 million including treble (triple) reimbursement of $56 million (or $168 million) for five years of filled VIOXX prescriptions.

It is estimated that 700,000 VIOXX prescriptions were filled through Medicaid during those five years in Texas alone. Abbott sees these prescriptions as part of a willful misrepresentation on Merck’s part as to the safety of the drug. To him, the entire affair represents nothing more than “a prime example of a company’s drive for profit steamrolling its duty to be safe.”

Judge Hardin intends to review the answers given by the first 100 potential jurors on their questionnaires in order to gauge if there is evidence of bias before making a final determination on the postponement request.
Merck’s publicly stated position is that it acted responsibly at all times with respect to the development, clinical trials, approval process, marketing, and ultimate withdrawal of VIOXX from the market last September. The company intends to “defend these cases individually over many years” according to Kenneth C. Frazier, Merck’s general counsel.

To successfully convince any jury of its noble intentions, however, Merck will have to overcome an enormous amount of damaging evidence including the following:

•In May, documents released at a congressional hearing showed Merck’s sales representatives had been given intensive training with respect to deflecting doctors’ questions and concerns about the safety of the drug. Every aspect of the representatives’ interactions with doctors was carefully orchestrated by Merck to minimize both the scope and the duration of risk-related discussions. Those risks were to be downplayed and even trivialized.

•The Associated Press reported it had acquired an additional internal document that was “mistakenly provided by Merck” to attorneys representing the plaintiffs in one of many ongoing VIOXX lawsuits. The “communication between Merck researchers and the company’s patent department stated that the way VIOXX works to reduce pain might also increase cardiovascular problems.” The document reveals a desire to reformulate VIOXX to combine it with an agent that would lessen the cardiovascular risk of the drug. In suggesting this approach, the document clearly discusses a potential mechanism which may be the cause of the problem. Thus, while Merck has maintained it was always convinced of the drug’s safety, the company’s “desire to reformulate the drug suggests a level of urgency that goes beyond previously disclosed internal e-mails that discussed safety risks.”

•VIOXX was approved for sale by the FDA on May 20, 1999. Almost immediately thereafter evidence began to emerge that the risks associated with the drug were far more serious than Merck had led the FDA to believe. A safety study done in 2000, and published in the New England Journal of Medicine, showed that VIOXX faced a significantly higher risk of heart attacks and strokes than people taking a traditional pain reliever, naproxen. Merck took the position that the study was inconclusive. Merck argued that the study only demonstrated that naproxen probably reduced the risk of heart attack and stroke and not that VIOXX increased that risk. Merck continued to advertise VIOXX in a way that virtually ignored the results of this study (VIGOR).

• In April of 2001, Public Citizen (www.citizen.org/), a well-respected national non-profit public interest organization, advised the public not to use VIOXX because of potential heart-related risks. Despite the results of the study and the warnings from Public Citizen, Merck continued to promote the drug in a way that minimized this risk.

•On September 17, 2001, the FDA issued an 8-page warning letter to Merck concerning its false and misleading promotional campaign. The FDA found: “You have engaged in a promotional campaign that minimizes the potentially serious cardiovascular findings that were observed in the VIOXX Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for VIOXX. Specifically, your promotional campaign discounts the fact that the VIGOR study patients on VIOXX were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).”

When it came to defending every challenge to its claims that VIOXX was a safe drug, Merck appears to have ignored the mounting evidence that VIOXX was, indeed, the potential killer numerous highly qualified experts had always suspected it of being. This is all the more obvious when one considers the following facts:

•Kaiser Permanente, the largest HMO in the United States, found the incidence of sudden cardiac death to be three times greater for VIOXX than Celebrex among its patients.

•Cigna Health Care regarded VIOXX as a “non-preferred medication” for its policy holders.

•Aetna, Inc., the third largest health insurer in the United States, announced that VIOXX was the subject of an ongoing study and recommended “alternative drugs” be prescribed in its place.

•Every study ever conducted with respect to VIOXX between 1999 and 2004 showed an increased risk of heart attack.

•Several medical research organizations consider the entire COX-2 class of drugs to have an increased cardiac-related risk.

•A study done at Vanderbilt University, and published in The Lancet on October 5, 2002, noted that patients taking 50mg. of VIOXX for more than 5 days demonstrated a 70% greater likelihood of developing coronary heart disease (CHD).

•Despite requests from the American Heart Association, the National Stroke Association, and the Arthritis Foundation that Merck conduct additional safety studies, Merck claimed that VIOXX was safe and that it did not plan to conduct any such study.

•An early 2004 study, which was actually funded by Merck, disclosed that VIOXX posed a risk of heart attack and stroke which was three times greater than that of other COX-2 pain relievers. When this finding was made, Merck had the name of its scientist removed from the list of authors on the study.

Although Merck attempted to make the best out of a very bad situation by making it appear as if its voluntary withdrawal of VIOXX was motivated by concern for the public, the evidence does not support that position.
Most business experts have little doubt that the removal of VIOXX from the market was anything but a purely financial consideration on the part of Merck which stood to lose $700 to $750 million in the fourth quarter of 2004 alone. The lawsuits were piling up and some of the cases were close to trial.

Corporate analysts who commented on Merck’s action saw it as a sound business move under the circumstances. They did not attribute it to any sudden pangs of conscience on the part of Merck’s CEO or Board of Directors.

Thus, if Judge Hardin determines Merck is able to receive a fair trial without the need for a postponement, the stage will be set for the opening battle of what promises to be a very long and bitterly fought war.    

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