Henry Greenspan

Preempting Preemption: Will Congress have the will to state its will?

In my last blog for Tort Deform , I argued that the Food and Drug Administration Revitalization Act (FDARA) passed the Senate overwhelmingly (93-1, the nay being Bernie Sanders) mainly because it wouldn't change anything. The final bill was so watered down by compromises that it didn't even make good sausage. But for the pharmaceutical industry it promised a continuing supply of filet mignon.

I also predicted that FDARA's illusory strengthening of the FDA, if the bill became law, would provide a pretext for the next troop surge for "FDA preemption." It would be argued that, now that the FDA's has been "fixed," there was no reason to withhold it full preemptive authority. Imagine Dan Troy, Tiger Joyce, and friends on the Abraham Lincoln. Mission Accomplished.

Unfortunately for the ATRAnauts, I was not alone in anticipating the strategy. A number of sources have now reported that several drafts for the House version of the FDA reform bill included the following sentence:

"Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law."

Any reasonable reading of the statement would see it as pretty mild stuff - nothing more than an assertion of the status quo. FDA regulation and civil liability would both continue to exist (except in my own state of Michigan). Whatever improvements in the agency's drug safety system – modest at the very best – will not change that.

Small stuff indeed. But you would never have known that from the response of the boating crowd. John Engler, now head of the National Association of Manufacturers and formerly Governor of Michigan (and responsible for our own drug shield law) submitted an op ed to the Detroit News that was little short of raving. Directly referring to the statement quoted above, Engler exclaimed: "This one sentence in legislation would result in the most fundamental change in prescription drug and medical device law in the past thirty years." According to Engler, jobs would be destroyed, innovation would cease, plagues and locusts would stalk the land. The sentence was "cleverly hidden," wrote Engler, in order to create a "bureaucratic nightmare only benefiting thousands of trial lawyers in the hunt for the big payoff."

The trial lawyers who represent drug companies were no less apocalyptic. The Drug and Device Law blog, manned by Jim Beck and Mark Hermann, described the same one sentence as a "stealth amendment" and a "poison pill." It reveals trial lawyers (the other ones) "pretense" to care about anyone but themselves. "Obviously the trial lawyers and their fellow travelers don't really care about increasing safety," the blog concluded. They care only about lawyer lucre.

My goodness. Most of us haven't heard this much about "fellow travelers" since Joe McCarthy. And all because of a sentence which, in actuality, only affirms reality as it is, rather than as the FDA preemption folks would like it to be.

Still, we should not be coy. This is a tough political fight between those who defend the industry and hate lawsuits against it (for every motive from principle to greed) versus those who defend civil liability (also for every motive from principle to greed). I'm not a lawyer of any kind - I'm not even a "fellow traveler" - so I get to say things like that.

Still, the sides are anything but equivalent in terms of whose goals would represent the most radical change in policy. If FDA preemption became the law of the land, it would mark the most profound shift in federalist balance – an assumption of power by the center – of anything that we have seen in many, many years. In my personal view, not only would the result be a nightmare for state and individual rights, but ultimately for the pharmaceutical industry as well. Imagine a Vioxx-scale disaster occurring in a context in which there is no organ of oversight and accountability but some version of the FDA. Imagine how many years and deaths would go by, how many clues and more would be missed or ignored or denied, before the truth finally emerged. We're not talking Mission Accomplished here. From the point of view of public trust – which is always the real bottom line – we're talking irremediable Meltdown.

That is why that one sentence is, indeed, so important. At core, all preemption arguments rely on an interpretation of the intent of Congress, explicit or implied. So the question is: Will Congress have, or not have, the will to state its will?

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Posted at 10:14 AM, Jun 21, 2007 in
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I carry no water for John Engler, but Michigan is already bleeding pharmaceutical jobs, isn't it? Maybe it's just a coincidence, but at least a couple of significant plant-closings were announced earlier this year when the legislature in Lansing was considering a repeal of the Engler-passed FDA pre-emption law.

How working stiffs and voters in Michigan, with the worst state economy in the nation, can still think that more lawsuits are the answer to all their problems is beyond me.

Posted by: Darren | June 21, 2007 3:12 PM

We now have the answer to the question with which my piece ends.


The Energy/Commerce committee took out the sentence.

Alex Sugerman-Brozan has an excellent analysis of the implications over at PAL,

Keep the faith (in the right people).

Posted by: Henry Greenspan | June 21, 2007 3:24 PM

Darren - I don't know anyone in Michigan (or anywhere else) who thinks that "more lawsuits are the answer to all their problems." I do know some people whose husbands or wives died of liver failure while taking the drug Rezulin. Unlike the association of Vioxx with cardio problems, there is essentially no ambiguity about causality in such cases. Read sometime about the way Warner-Lambert "handled" the problem during the long period during which they knew about it. Then think about whoever is the closest person to you in your life. And imagine that person dying of liver failure while on Rezulin, knowing what you've learned about the whole story. And then imagine hearing: "Sorry. There is no accountability for problems like your sweetie. Later."

As far as Michigan, the irony is that Pfizer left the one state in which there _is_ total immunity from lawsuits. And moved their folks (those they moved) to states like New York, Connecticutt, and Massachusetts. Do those states sound like tort reform heaven?

And, btw, Pfizer had nothing to fear about the Michigan law being rescinded. The state Senate was, and remains, on their side of that issue.

Posted by: Henry Greenspan | June 21, 2007 5:05 PM