On September 30, 2004, pharmaceutical manufacturer, Merck & Co., Inc., pulled its popular arthritis and pain medication Vioxx off the worldwide market. Vioxx accounted for $2.5 Billion in sales for Merck last year. This withdrawal came about after a recent study was discontinued due to the increased risk of cardiovascular events, including heart attack and stroke, noticed in patients taking Vioxx as compared to those taking a placebo. As this news has reached the public at large, Plaintiff’s attorneys have been contacted in large numbers regarding what constitutes a claim worth pursuing.
Vioxx is member of the category of medications known as coxibs. Specifically, it is a COX-2 inhibitor. These medications were developed on the hypothesis that by inhibiting on the COX-2 enzyme, rather than both the COX-1 and COX-2 enzymes like traditional non-steroidal anti-inflammatory medications (NSAIDs), the patient could get the anti-inflammatory benefits without the gastrointestinal irritation that is the major complication of NSAIDs.
In January 1999 the Vioxx Gastrointestinal Outcomes Research (VIGOR) trial was initiated to test this theory. The findings of the study with regard to cardiovascular events were not favorable. It was noted that in those taking Vioxx, the incidence rate of myocardial infarction was increased five-fold over those taking naproxen. While these results did cause some concern within the medical community, it was suspected that naproxen might have a cardioprotective effect, like other NSAIDs. To date, studies on the cardioprotective nature of naproxen have been inconclusive.
In February 2000, enrollment began in the Adenomatous Polyp Prevention on Vioxx (APPROVe) study. This study was to evaluate the effectiveness of Vioxx in preventing recurrence of colorectal polyps, a known benefit of NSAIDs. The external safety monitoring board notified Merck in September 2004 that the midpoint results indicated that the incidence rate of those suffering heart attack and stroke during the trial was nearly double that for those receiving a placebo. Accordingly, after 18 months of testing, the external safety monitoring board recommended that the APPROVe study be terminated prior to its scheduled end date.
It was the recommendation for early termination of the APPROVe study that motivated Merck to withdraw Vioxx from the worldwide market. The increased incidence rate was seen in those taking 25 mg daily after a period of 18 months. It should be remembered that those participants in the APPROVe study had been screened and did not have preexisting cardiovascular conditions. Dr. Eric Topol of the Cleveland Clinic has surmised that as the study participants were limited to those without preexisting cardiovascular conditions, the impact on the incidence rate of significant events for those with prior conditions may be much higher.
What Plaintiff’s Counsel Should Consider
As the mechanism by which Vioxx causes an increased risk of cardiovascular events remains unknown, the screening attorney should keep an open mind with regard to possible presentations. Heart attack and stroke are those that the studies have identified at higher rates in patients taking the medication. If Vioxx does cause increased clot formation and vasoconstriction though, other possible complications could include kidney failure, deep vein thrombosis, pulmonary embolus, or transient ischemic attack (TIA).
It is necessary to identify all predisposing conditions to the complication the client endured, so that you may make a detailed and accurate evaluation of the merits of the claim. Pertinent portions of the patients medical history to consider may include: smoking history, and if they stopped, when did they stop; patient age; high blood pressure, and whether it was controlled by medication; high cholesterol, and if controlled by medication; previous heart attack or stroke; family history of heart disease; diabetes, including type and if controlled; obesity; and stress level.
Establishing the client’s baseline health may also be critical to proceeding with a suit. To do so, the attorney should evaluate and consider what objective tests are available and the subjective recordings of the client’s physicians. The objective tests can help to establish general baseline health and limit the ability of the drug manufacturer to point to alternative causes. For example, the drug manufacturer would be hard pressed to argue that a client had poor preexisting heart function if cardiac catheterization from before the client began taking Vioxx showed an ejection fraction of 55%. Similarly, the client’s treating physicians may be the greatest asset if prior objective testing hadn’t been performed. The jury often views these physicians as unretained experts and they would have an established relationship with the patient and be most familiar with the patient’s overall medical health.
Status of Litigation
As has been expected, a multi-district litigation steering committee has been formed with regard to Vioxx claims. This MDL committee is set to meet in mid December and it is expected that at that time decisions will be made with respect to where the MDL will be established and its role in the litigation.
The responsibility of testing to ensure the safety of all prescription drugs in the United States falls to the Food and Drug Administration. While it is naïve to expect that all potentially harmful side effects of all medications could be discovered during the testing process, the effort must be made. In instances such as this, Merck knew of potentially deadly side effects of it’s product in 2000, but failed to act because of concern over how it would appear to the market while it was in the midst of competition from Celebrex and Pfizer. An effort should have been made to confirm the results of the VIGOR study rather than waiting more than four years to withdraw a drug prescribed hundreds of thousands of times in the interim. The task of ensuring that large corporations remain responsible to the American public falls to trial lawyers.