Merck's heart attack.
A Texas jury has ordered that Merck & Co. pay more than a quarter of a billion dollars in damages to the widow of a man who died after taking the painkiller Vioxx - even though Vioxx probably didn't cause his death. With 7,500 other Vioxx lawsuits already filed, Merck's potential liability is a big number followed by a string of zeroes. Texas has limits on punitive damages that will reduce the award, but even so, the verdict is a blow to Merck - and a barometer of how the public feels about the pharmaceutical industry.
The victim, a 59-year-old triathlete named Robert Ernst, died of arrhythmia or an irregular heartbeat, according to his death certificate. Vioxx is not suspected of causing those conditions. Patients who take the drug have an elevated risk of heart attack or stroke. To reach their verdict the jurors had to make a speculative leap, accepting the possibility that Vioxx caused a problem that was undetected by the coroner.
Jurors' readiness to make such a leap is bad news for Merck and other makers of the pain medicines called COX-2 inhibitors. Merck's lawyers thought Ernst had a relatively weak case, and that the scientific evidence presented in the courtroom favored the company. But the jury saw the case in a wider context: They perceived the company as working to divert public attention from Vioxx's cariovascular effects while continuing to promote its lucrative product.
Evidence of Vioxx's link to heart attacks and strokes emerged even before the drug won approval by the Food and Drug Administration in 1999. The fact that a drug might cause adverse reactions is not surprising - the earlier generation of pain medications for which COX-2 inhibitors were a substitute cause stomach and other problems in some patients. But Merck advertised Vioxx without clear reference to the risks.
In 2001 the FDA warned Merck of misrepresentation in its marketing of Vioxx, and a year later approved a new label containing more explicit information about strokes and heart attacks. Last September the company suspended sales of the drug, but by then the pattern perceived by the Texas jurors had been set: Merck, under the tolerant eye of the FDA, placed sales above safety.
The case provides a lesson about the pitfalls of mass marketing of pharmaceuticals. Such advertising is intended to get people to seek a prescription for a drug; information that might cloud the message is downplayed or screened out. The ads are aimed at people who know little about medicine or pharmacology. Facts about small but statistically significant effects are presented in tiny print or recited at an auctioneer's pace. In the case of blockbuster drugs like Vioxx, which was taken by 20 million Americans, a small risk can affect thousands of people - enough to ruin a company if a jury sees its actions as self-serving or deceptive.
Merck insists that it will "vigorously defend against individual Vioxx cases one by one." But the Texas verdict suggests that the company is in for a long slog through to courts, and that jurors will sympathize with plaintiffs claiming to have received insufficient warnings about health risks. The simple, positive messages of 30-second TV spots are poorly suited to the field of medicine, where one size rarely fits all and exceptions can be found to every claim.
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|Title Annotation:||Editorials; Vioxx verdict is marketing's boomerang|
|Publication:||The Register-Guard (Eugene, OR)|
|Date:||Aug 23, 2005|
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