Merck’s Worst Nightmare, a Study that Shows Vioxx Heart Attack Risk Linked to (Very) Short-Term Use

Throughout the Vioxx saga, Merck has always taken refuge behind its assertion that short-term use of the COX-2 inhibitor cannot be linked to an increased risk of heart attack or stroke. Merck itself, however, acknowledges long-term use of the drug does carry such an increased risk. In fact, the long-term adverse implications of <"">Vioxx use led to the voluntary withdrawal of the drug in September, 2004.

To a great extent, Merck has legitimized its strategy of refusing to settle any of the roughly 12,000 Vioxx personal injury and wrongful death cases on the basis of its conviction that it should ultimately prevail on all of the short-term cases (by dismissal, verdict, or on appeal) thereby eliminating about half of the cases.

Merck also believes that even many of the long-term-use Vioxx plaintiffs suffered their injuries (or deaths) as a result of one or more chronic medical condition such as cardiovascular disease, diabetes, hypertension, or obesity.

Thus, the pharmaceutical giant sees no reason to enter into a global settlement of all pending lawsuits against it as long as the company and its attorneys still perceive so many “defensible” cases exist.

Unfortunately for Merck, however, things have not turned out that way since it has already lost three lawsuits, including two short-term-use cases, and has been found liable for punitive damages, which are not covered by insurance, in each of those cases. Nonetheless, the lack of definitive proof linking short-term use of Vioxx to an increased risk of heart attack and stroke has kept Merck on the offensive and putting plaintiffs to their proof.

Now, however, that confidence has to have been shaken by the results of a Canadian study published in the Canadian Medical Association Journal. That study analyzed data on 114,000 patients and reported that 239 people in Quebec, 66 and over, suffered heart attacks while taking Vioxx between 1999 and 2002.

None of the Vioxx users had a history of heart attack. The Celebrex users did not exhibit any such statistical increase in heart attack risk.

An analysis of the data indicates that over 25% of those people had their heart attacks within two weeks of their first prescription for Vioxx. The team found that “among elderly users of predominantly low doses of these agents, short-term use of rofecoxib is not without risk, and that risk of MI [heart attack] is not restricted to continuous users nor accentuated with longer-term use.”    

Thus, the researchers see the need for early monitoring of COX-2 side-effects as well as continued monitoring of patients after the discontinuance of the medication. Some 30,200 Vioxx and 45,000 Celebrex users were studied for about 2 ½ years.

Of the 239 heart attacks in Vioxx patients, 65 took place within only 9 days of starting Vioxx therapy.  

Plaintiffs’ attorneys see the Canadian study as a major setback for Merck’s defense strategy that will make even the shortest-use cases more viable and far less defensible. It could also prompt Merck to reconsider its position on settlement.

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