Sunday, June 27, 2010

Judge Allows Class Action Suit to Require Philip Morris to Pay for CT Scans for Smokers

A Massachusetts judge has ruled that an unusual class action lawsuit against Philip Morris may proceed. The judge's ruling certified the class, but it does not relate to whether the legal basis for the suit is sound. The ruling means that the judge has found that the legal issues involved are common to all plaintiffs, and thus the case can proceed as a class action suit. The class consists of all Massachusetts adults ages 50 and older who smoked Marlboros at an intensity of at least one pack per day for at least 20 years.

The case is unusual, because unlike most cases, it does not involve the pursuit of damages for smokers who have already suffered diseases or death that are allegedly due to their smoking. Instead, it seeks costs for medical monitoring of "healthy" smokers for early detection of lung cancer. Specifically, the suit seeks payment for annual chest CT scans. The reasoning behind this request is that the plaintiffs allege that these CT scans will detect lung cancer early, at a more treatable stage, and thus will save lives.

According to the article in the Boston Globe: "The plaintiffs claim that if they do eventually develop the disease, the screenings will increase their likelihood of survival almost six-fold. No class member would be eligible if they have been diagnosed with lung cancer or are under a doctor's care for suspected lung cancer, and all must have smoked Marlboro cigarettes within Massachusetts, she wrote. Marlboro cigarettes are designated because that is the brand the two plaintiffs smoked. Richard Daynard, a law professor at Northeastern University and chair of its Tobacco Products Liability Project, said that if the plaintiffs win, the case will likely spawn dozens of similar suits in federal courts across the country. 'It's a tremendously important case,' he said. The case before Gertner, he added, will probably turn on whether the chest scans save lives. A growing body of evidence, he said, indicates that they do."

The Rest of the Story

Unfortunately, there is no scientific evidence at present demonstrating that CT scan screening for lung cancer among smokers is effective in saving lives. In contrast, the existing evidence demonstrates that the procedure is inappropriate as a screening test because it has an unacceptably high false positive rate, and that its implementation would certainly lead to morbidity and even mortality among smokers.

Why would there be morbidity and mortality among smokers? For two reasons. First, the many false positive results would require further diagnostic testing, some of which involves invasive procedures or surgery. There is a significant level of morbidity and mortality associated with such procedures. In addition, the anxiety produced for thousands of smokers who would be told they may have lung cancer would be substantial.

Second, CT scans involve considerably high doses of radiation and exposing a large population of asymptomatic individuals annually to this radiation would actually increase the risk of cancer in the population.

While one might argue that these risks are worth taking if the procedure has been shown to save lives, the existing evidence has not demonstrated that this is the case. Therefore, the risk-benefit equation is currently very strongly on the side of risk. And it would be unjustified to require Philip Morris to pay for a screening procedure that poses more potential risk than benefit.

Studies are currently underway to evaluate whether CT scanning of smokers for lung cancer could save lives. But until such studies are concluded, the evidence base simply does not support the use of this procedure on a population-basis, as is being proposed in this lawsuit. For this reason, no national medical organization currently recommends the use of CT scan screening.

The rest of the story, then, is that the existing scientific evidence does not support the use of CT scans for early detection of lung cancer. The current evidence demonstrates that such a procedure, implemented on a large scale, would undeniably result in a significant amount of morbidity and mortality, but that there is no guarantee that the procedure would save lives. Since the fundamental tenet of medicine is "to do no harm," the existing evidence does not justify the use of CT scans for early detection of lung cancer on a population-basis.

Therefore, I believe that the suit should not succeed.

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