The Wolverine State has the curious distinction of being the only state with a law that bars its citizens from filing product-liability lawsuits against drugmakers. The rationale - the FDA should be the last word on safety and effectiveness. And so a state court judge or jury can’t second-guess the federal regulator. In other words, the agency’s authority trumps, or prempts, a state court action. The FDA also has a rule to this effect, which drugmakers would like to see adopted nationwide.

As you might imagine, consumers groups (and trial lawyers) are fighting this effort, because the implications are enormous. Merck, for instance, has used this reasoning to defend Vioxx lawsuits, with mixed results. So has Wyeth in its Prempro litigation. Now, the Supreme Court may decide the matter.

To gain perspective from someone who lives with this restriction, Pharmalot rang Hank Greenspan, a social ethics lecturer and faculty scholar in integrated medicine at the University of Michigan Medical Center. Two years ago, he helped organize Justice In Michigan, a group of mostly doctors and academics who worked unsuccessfully to repeal the state’s preemption law. Here’s what he had to say….

Pharmalot: What’s it like to live in a state with preemption?
Greenspan: It’s bizarre. If somebody is harmed, or believe they were harmed, or their estate believes harm was done, they don’t have the right to their day in court. Our own law prevents that.

Pharmalot: Why does such a law exist in Michigan, though?
Greenspan: It was passed in 1995 and championed by John Engler, who was the governor at the time. He saw himself as part of the conservative revolution epitomized by Newt Gingrich and favored less government regulation. And Upjohn was a big company here, although it was bought by Pharmacia (which was later acquired by Pfizer).

Pharmalot: Why should anyone not living in Michigan care about this issue?
Greenspan: Because we are your future.

Pharmalot: But preemption already exists for medical devices, on a national basis. Why not extend the same reasoning to prescription drugs?
Greenspan: There’s no logical reason why devices are covered by preemption. So, I’ll put it this way - Why make the same mistake twice?

Pharmalot: Why should a state judge or jury, though, have a chance to effectively overrule the FDA? The drug-approval process is complicated and they don’t live with it. The FDA does.
Greenspan: We ask juries all over the country, every day, to contend with many complexities that I don’t see as being less complex than this. Look, the heart of the matter is FDA compliance, which means that a product has met FDA requirements. And the core doctrine of preemption is that if a drug is in compliance, then it should be exempt from civil liability. But compliance doesn’t cover all activities or issues, or delinquencies.

Pharmalot: How do you mean that?
Greenspan: For example, a company gathers side effect reports for Medwatch, but doesn’t go out of its way to red flag problematic reports. Or you could have a company that intimidates a researcher who raises flags about a drug, which we’ve read about with Vioxx or, more recently, with Avandia. Or how about clinical trial data that doesn’t get published?

Pharmalot: So you’re saying such episodes would only come to light if someone filed a lawsuit?
Greenspan: These are examples of situations than are often outside the purview of the FDA, but can be uncovered and considered appropriately relevant in the context of a lawsuit. The discovery process in civil trials can lead to unearthing critical health data that we may not learn about any other way. Don’t forget that the civil liability and FDA regulations lived side by side all this time, and it’s worked.

A company may meet basic and minimal requirements to be in compliance, but do they need to do other things to be immune or is compliance really the whole ballgame? I don’t believe it is. One can be in compliance and still be able to delay or camouflage a problem. At the end of the day, the issue is whether FDA compliance is a sufficient condition that it should trump a system that would, otherwise, ask whether a company should or could have done more. We need our day in court to know that.