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Frederick Humeston knew the odds were stacked against him in Atlantic City’s casinos, but his lawyer thought the odds were in his favor in one Atlantic City courtroom. Humeston was suing makers of the anti-inflammatory drug Vioxx, and despite weaknesses in his case, he stood to make millions.
His gamble proved wrong. That may be bad news for him, but it's good news for the rest of us.
An Atlantic City jury concluded Thursday that Vioxx did not cause Humeston’s September 2001 heart attack, and that New Jersey pharmaceutical company Merck in no way misrepresented Vioxx’s safety risks. Humeston took the drug for just seven weeks, and there’s no evidence at all that Vioxx caused him any harm.
A similar lack of evidence didn’t prevent a Texas jury from awarding the widow of another Vioxx user $253 million in a case decided in August, however.
Both cases were built around the claim that Merck failed to warn physicians and consumers adequately about the risks posed by Vioxx, which the company pulled from the market last year after studies found it increased the risk of heart attacks and strokes when used for 18 months or more.
In Texas, plaintiff Carol Ernst sued Merck when her husband Robert died of a probable arrhythmia after taking Vioxx for eight months. None of the various safety studies conducted on the drug even hinted that Vioxx caused arrhythmia, let alone that it raised any cardiac risk in patients who took the drug for less than a year and a half. So, it would have been impossible to warn patients like Ernst.
In addition, the added cardiac risk posed by Vioxx is so slight that it did not appear in Merck’s pre-commercial tests of over 10,000 patients.
Nevertheless, jurors found Merck liable for Robert Ernst’s death, and they awarded his wife $24 million in compensatory damages and a whopping $229 million in punitive damages. Texas law caps damage awards, so that sum will be reduced to about $26 million in total.
Still, the verdict spelled trouble for Merck, which now faces over 7,000 Vioxx-related lawsuits and could face thousands more in coming months. Those cases could drag on for a decade or more and cost the firm tens of billions of dollars.
That’s why Merck’s victory in Atlantic City is good news – and not just to Merck shareholders. For one thing, it appears that Merck’s defense team has figured out how to present its case in a way that makes sense to laymen. Members of the Texas jury told reporters that they found Merck’s voluminous scientific data overly complex and indecipherable. Humeston’s case suggests that juries can understand scientific evidence, so long as it’s presented in a careful manner.
That lesson notwithstanding, the next Vioxx trial could easily turn out more like the Texas case than this one. After all, the Texas jurors heard essentially the same evidence regarding Vioxx’s safety in short-term use, and they heard that a panel of independent scientists advising the Food and Drug Administration recommended last spring that Vioxx be put back on the market.
The Texans found Merck liable anyway, simply because Vioxx has some risk associated with it.
Jurors from that trial told the Los Angeles Times that they ruled against Merck because the company “seemed to care more about profits from the drug than the public’s welfare.”
That may be so, but it’s worth reviewing the reason why Vioxx was hailed as a therapeutic breakthrough when the FDA approved it in 1999. Used primarily as an arthritis treatment, Vioxx was the first in a class of drugs known as cox-2 inhibitors that have begun to displace conventional anti-inflammation drugs such as aspirin and ibuprofen in the treatment of chronic pain. Though we now know that cox-2 drugs do raise slightly the background risk of cardiac events, daily use of conventional anti-inflammation drugs is known to cause a much bigger problem: a fairly high risk of stomach and intestinal bleeding and gastric ulcers. Daily use of drugs like aspirin and ibuprofen hospitalizes an estimated 100,000 Americans every year and kills more than 16,000.
Cox-2 inhibitors, including Vioxx, provide superior pain management with an over all safety benefit. Jurors may claim that Merck should have erred on the side of caution by keeping Vioxx off the market, but such a claim can only be made if we ignore the annual loss of 16,000 human lives.
The Texas jurors said “they ordered Merck to pay $229 million in punitive damages to send a message to the company and other pharmaceutical companies.” If the New Jersey jurors had followed suit, every pharmaceutical company in the country would have heard one message loud and clear: It is legally better to keep a new drug off the market if anyone anywhere will be hurt by it. More outcomes like the Ernst trial in Texas could mean a more dangerous world for patients, not a safer one.