Like millions of Americans, Sylvia Coupel took diet drugs a few years ago. So far as she can tell, she hasn't suffered any of the heart-valve damage that prompted American Home Products Corp. to suspend sales of two of the most popular brands.
But Mrs. Coupel and several hundred others are now suing American Home Products, seeking a novel remedy: regular checkups so they can keep tabs on their health. "I am just scared," says Mrs. Coupel, who helps run a senior center in Pierre Part, La., and doesn't have insurance to cover the costs of the tests.
Medical monitoring may seem a sensible remedy, but it raises a thorny legal question: whether people who have been exposed to potentially hazardous drugs or chemicals should be compensated even if they are currently healthy. Usually, you have to suffer a demonstrable injury to win a suit. But some courts are allowing people to recover out-of-pocket costs for checkups when they can show they have been put at an increased risk of disease as a result of a defendant's negligence or misconduct.
American Home denies wrongdoing with its diet drugs, and in court one of its lawyers called the idea of medical monitoring "quite radical." But plaintiffs' lawyers say that the company's legal team has been quietly feeling them out about the possibility of settling the "fen-phen" case, including some sort of monitoring plan. American Home made the "fen" component of the diet-drug cocktail, as well as a chemical cousin, known as Redux, which was Mrs. Coupel's drug of choice.
A settlement is far from certain. But any monitoring deal would likely dwarf previous cases, covering perhaps several hundred thousand people or more. The two sides disagree about how many people should be covered, as well as the nature and extent of any tests. Another issue: If a settlement is reached and a monitoring program is established, can plaintiffs in the class action who are subsequently diagnosed with serious health problems pursue full-blown lawsuits against American Home?
American Home, with headquarters in Madison, N.J., declines to comment on the possibility of a settlement.
Medical monitoring started hitting its stride in the 1980s in suits over polluted landfills and toxic-waste sites, where workers or residents were exposed to carcinogens with lengthy latency periods. Lately, the plaintiffs' bar has transported the idea into suits over drugs and medical devices. Among other selling points, they say, regular monitoring boosts the likelihood of early detection and treatment of disease. In the fen-phen case, periodic exams "will no doubt save thousands of lives," Michael Fishbein, a Philadelphia plaintiffs' lawyer, said at a recent court hearing.
In March, Telectronics Pacing Systems Inc., a now-defunct company, agreed to pay millions for medical monitoring to settle a class-action suit on behalf of several thousand people implanted with pacemakers with faulty lead wires. One of the earliest medical-monitoring cases involved a group of refugee children from Vietnam who survived a military-transport plane crash and were considered at risk for brain and cognitive injuries from the depressurization of the plane's cabin.
"It seems like the perfect remedy," says Robert Wones, a professor at the University of Cincinnati medical school. As part of a settlement of a pair of class-action suits, doctors at the school are helping monitor thousands of people who worked or lived in the vicinity of an old federal uranium-processing facility. "I think we will be able to demonstrate that this population will live a little longer" because of checkups and early diagnoses, Dr. Wones says.
Yet some experts say monitoring has the potential to overwhelm courts. "You can imagine a lot of situations of people not manifesting disease after exposure to a toxic substance who are going to want some recovery," says Andrew Klein, a professor at the Cumberland School of Law of Samford University in Birmingham, Ala. The U.S. Supreme Court, he notes, rejected a monitoring suit under a federal railroad-worker statute in a 1997 case where the plaintiff was a pipefitter working underground at New York's Grand Central Station. The job brought the worker in regular contact with asbestos-laden insulation, but the court dismissed the suit because he didn't have any symptoms of illness.
The toughest critics of medical monitoring say it mainly boosts the income of plaintiffs' lawyers, adroitly bringing together a huge number of marginal cases. "It is a cynical use of what sounds like a very moving human experience," says David Bernick, a Chicago defense lawyer who has encountered monitoring claims defending tobacco companies and breast-implant makers.
A fen-phen monitoring class would be unusually ambitious. In federal court in Philadelphia, plaintiffs are seeking a program covering every person who took any of the diet drugs for a month, and who don't have insurance -- about one million people. If the federal case falls through, there are other suits seeking monitoring on a state-by-state basis.
The plaintiffs' lawyers envision certified health centers around the country conducting checkups, overseen by a court-appointed trustee. At the very least, they contend, all the pill takers should have an echocardiogram, which uses ultrasound to evaluate the structure, function and blood flow of the heart. The test, not counting any follow-up, can run $1,000 or more, indicating a total cost of more than $1 billion, although the lawyers say American Home can likely trim the figure by seeking a volume discount.
In court, American Home says that such exams are overkill and that it's unfair to saddle the company with the cost. It contends that many people who took fen-phen have other conditions, such as obesity, requiring them to see doctors regularly.
"We have pre-existing diseases galore," Peter Zimroth, an attorney at the Washington firm of Arnold & Porter, who represents American Home, said in court recently. In any event, the company says most problems, at least initially, can be diagnosed with a stethoscope.
Barring a settlement, the next big step is for a federal judge to determine whether a national monitoring plan is workable. After that, the case would go to trial to determine whether American Home was culpable in marketing the drugs and thus liable for any damages.
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