Vioxx: A case against tort reform
A Times EditorialPublished November 10, 2004
The best argument against the kind of tort "reform" aimed at limiting damage awards for plaintiffs is emerging in the current scandal over Merck's arthritis drug Vioxx.
Though Merck pulled the drug from the market Sept. 30 when a study indicated increased risk of heart attack and stroke among users, evidence surfaced recently that the drugmakers may have - or at least should have - known for years that Vioxx produced such elevated hazards. Both the Justice Department and the Securities and Exchange Commission have opened investigations.
In a report published in the British journal Lancet, Swiss researchers pooled the results of 29 different studies, many completed before 2001, to show subjects who took Vioxx experienced double the risk of heart attack. Claiming the company did not analyze the data properly, researchers concluded "(Vioxx) should have been withdrawn several years earlier." Merck has challenged the study's validity.
The medical journal's report surfaced days after a Wall Street Journal story alleging the drugmaker actively concealed evidence of elevated risks caused by Vioxx. According to the story, while Merck's research director was admitting a clear connection to cardiac problems on internal e-mails, the company was advising staffers to dodge questions publicly and suing one researcher who wrote on the issue.
The New York Times reported last week on e-mails from a drug safety reviewer at the Food and Drug Administration indicating his superiors delayed publication of a study that also outlined increased risk of heart ailments for Vioxx users. The story suggests an environment at the FDA that resisted reports critical of high-profile medications, though an agency spokesman said such e-mail exchanges are part of their normal peer review process.
If these reports are true, Merck allowed 20-million Americans to take their arthritis drug with full knowledge it could increase their risk of stroke and heart attack - a textbook case of corporate negligence and deception.
With $2.5-billion in Vioxx sales last year, Merck could emerge as Exhibit A for those who argue sizable damage awards are needed to curb gigantic corporations seeking profit while concealing risks to customers. If the company sinks under the weight of lawsuits, it will be a vivid example of the risks of putting profit ahead of consumer safety.