Sam Uretsky

Merck's Burned

After a six-week trial, a Texas jury awarded Carol Ernst $253.5 million for the death of her husband, who had died after taking Merck & Company's painkiller drug rofecoxib (Vioxx®). Texas law, which is particularly protective of the well-being of the Fortune 500 (Merck is #83), will automatically drop the actual award to about $26 million, but with about 4,000 more lawsuits in the wings, Merck CEO Raymond Gilmartin may not be worth $40,654,477 a year.

Arguably, there is no clear scientific evidence that rofecoxib was the cause of Ernst's death. Jonathan Skidmore of Fulbright & Jaworski, a member of Merck's defense team, said, "We believe that the plaintiff did not meet the standard set by Texas law to prove Vioxx caused Mr. Ernst's death. There is no reliable scientific evidence that shows Vioxx causes cardiac arrhythmias, which an autopsy showed was the cause of Mr. Ernst's death, along with coronary atherosclerosis."

Rofecoxib has been statistically linked to an increased frequency of heart attacks and strokes as compared with placebo controls, but there is no clear cause and effect relationship. Consider that those patients most likely to need rofecoxib are often at increased risk of heart attack and stroke. The association may in time be found, or it's possible that Vioxx will turn out to be like Bendectin®, that rare case of a good drug chased off the market by lawsuits.

Bendectin, a combination of doxylamine and pyridoxine, was widely used for control of the nausea and vomiting associated with pregnancy. Perhaps because the drug was so widely used, a percentage of the children born to mothers who had used the drug had birth defects, including cleft palate and limb shortening similar to that seen with thalidomide. There were a large number of lawsuits, and eventually the manufacturer pulled the drug off the market, not because of scientific evidence but because of the cost of the lawsuits.

The March of Dimes has issued a statement saying, "There is a large body of available epidemiologic research, including both case-control and cohort studies involving thousands of births. These findings lead to the conclusion that Bendectin is not associated with increased risk of major congenital malformations, including heart disease, cleft palate, cleft lip with or without cleft palate, or limb-reduction defects."

Similarly, a 2003 review, published in the journal Birth Defects Research Part A: Clinical and Molecular Teratology, concluded that Bendectin poses no risk to the fetus when used during pregnancy. From 1983, when Bendectin was withdrawn from the market, to the present time, women have been needlessly suffering from morning sickness.

Bendectin might be considered the poster child for those who consider trial lawyers to be two rungs below sea slugs on the evolutionary scale. Similarly, the science that's currently available is pretty much on Merck's side. Morality isn't. Evidence at the trial showed that Merck tried to hide the data linking rofecoxib and heart attacks and stroke. The company did all it could to minimize the information provided to physicians.

It fought the Food & Drug Administration, hardly known for rough treatment of pharmaceutical firms, over putting warnings on the package inserts. When it included the warnings, they were so well hidden that they might as well have been written in cuneiform.

Merck sales representatives were taught to avoid and evade questions about the risks of heart attack and stroke. Merck didn't perform the kinds of studies that might have revealed the truth about the drug's safety -- there was no profit in it for them, and it was too easy to limit studies to those that would only give the results they wanted. The hard evidence that linked rofecoxib to an increased risk of heart attacks and strokes came only through a study that was planned to expand the market for the drug, not evaluate its risks.

According to the New York Times, the $229 million punitive damages figure was not picked at random, but referred to a 2001 Merck estimate of additional profit the company might make if it could delay an F.D.A. warning on Vioxx's heart risk. The jury decision was based not on science, which really wasn't there, but on outrage that Merck had engaged in a broad scale cover-up. The hazards, which might have been acceptable as a tradeoff for the reduced risk of gastric ulcers, were unacceptable once they were hidden away, both from the patients at risk and from the physicians who were responsible for selection of the drug. The issue had less to do with drug safety than with deceit.

This was not a jury trying to do a favor to a sympathetic plaintiff, or a jury out of control, or even one deluded by a particularly adept trial lawyer; it was a clear statement that even in President Bush's home state, ordinary people think they have a right to know the facts. Real people feel that even huge corporations have a moral obligation to tell the truth and not hide behind shield laws that limit punitive damages or tame regulatory agencies. People may vote for representatives who portray trial lawyers as barnacles on the the ship of prosperity, but given the facts of a case, juries make rational decisions.

The issue in the Vioxx case turned out to be less the matter of proximal cause than revulsion at a cover-up. The lesson could, and should, be applied elsewhere in our society, and the rest of us should be every bit as indignant as a Texas jury.

Sam Uretsky is a writer and pharmacist living on Long Island, N.Y.

From The Progressive Populist, Oct. 1, 2005

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