Thursday, July 03, 2008

NEJM Editorial on Preemption

We must say, we were surprised last night and this morning when a half dozen folks forwarded to us copies of an editorial that just appeared in The New England Journal of Medicine -- "Why Doctors Should Worry about Preemption," by Gregory D. Curfman, Stephen Morrissey, and Jeffrey Drazen. Here's a link.

We don't often receive multiple e-mails about the same breaking news.

But we're always happy to be educated, and we're generally happy to write things up and spread the word.

On the other hand, don't feel bashful about sending us fully-written "guest posts." That would spread the word, too. And it would free up the two of us to do a little more client work. And we've got a great post coming out later today -- about "no injury" claims in the drug and device field -- that still requires a little work.

But thanks for sending us the NEJM piece, and here's our take:

1. The authors (M.D.'s and Ph.D.'s, and editors of the journal) oppose preemption in both the drug and device fields.

2. They write that, "It has been argued . . . that Congress, not unelected appointees of a federal agency, has the power to decide whether preemption should apply." [We always struggle with that grammatical point -- should that be Congress "has the power" or unelected appointees "have the power"? But whether or not we agree with these guys on preemption, they edit a leading journal, so we'll defer to them on grammatical issues.] Congress certainly has the power to decide whether a federal statute should displace state law. If Congress is unhappy with the result caused by a law, then Congress can pass a new law.

That's not true for implied conflict preemption. Whether or not there's a statute, if federal and state law conflict, then the Supremacy Clause of the Constitution dictates that federal law controls, and conflicting state law is displaced. Congress can't directly do anything about that.

(If society is unhappy with that result, then it can amend the Constitution -- but if America couldn't pass the Equal Rights Amendment, don't count on us amending the Constitution over drug or device preemption.)

3. The editorial says that FDA approval of a drug "is not a guarantee of safety." Of course not. Human beings are imperfect, and any system will make mistakes. The policy question is whether experts at the FDA are more or less likely to decide difficult scientific questions correctly than are lay juries. Readers of this blog know where we come out on that question. In any event, we certainly agree that the FDA should be given ample funding to hire necessary staff and do its job properly.

4. We thought we heard a whisper of self-interest on page 3 of the editorial: "If injured patients are unable to seek legal redress from manufacturers of defective products, they may instead turn elsewhere." As a matter of theory, of course, this shouldn't happen -- product liability claims are distinct from medical malpractice claims. As a matter of practice, we would hope that the pharmaceutical industry and physicians can work together as appropriate. (And we don't mean to criticize the editors of the NEJM for being economically self-interested. Lord knows, that's allowed in this country -- so long as the self-interest is appropriately disclosed, as it was here.)

5. The editorial argues that Congress should pass legislation to overturn the Supreme Court's decision in Riegel and, if the Court rules in favor of industry in Levine, should do the same there.

Whether that proposed legislative change would be effective turns on whether preemption arises from a statute or from the Constitution. Even if Congress reverses the statutory preemption involved in Riegel, there's still a chance that Constitutional implied preemption would continue to bar plaintiffs' claims involving allegedly defective medical devices. Only time (and case law) would tell.

Depending on the result in Levine, it may or may not be possible to overturn the decision by passing a new law. We'll have a better idea on that score after we read the decision (which we'll presumably see some time in the first half of 2009).

Thanks for letting us know about this editorial, and keep those cards and letters coming in.


HG said...

The editorial is available free on-line (no rx needed) for anyone interested. What a country (indeed)!

I confess some surprise that there is always a "self-interest" angle inferred in this blog when opponents of preemption speak out.

If it isn't the "greedy trial lawyers," it's the greedy politicians looking for moolah. If it's not the pols, it's the docs afraid of being sued or losing business.

Greed, greed, and greed, everywhere you look.

There is a big world out there in which people think in terms of good and bad policy, and you often present yourselves as part of it.

Please grant the same privilege to those of us who profoundly disagree with you (many of whom are not lawyers, docs, pols, or Indian chiefs).

Happy 4th.

Justinian Lane said...

One of the major problems I have with the notion that the FDA makes better decisions than juries is the fact that thanks to discovery, juries often see information the FDA does not. It's not "second guessing" if you're the first one to see certain data.

Does it really make sense to preempt lawsuits since the FDA lacks subpoena power to turn up the documents these lawsuits do?

Anonymous said...

Constitutional preemption? Yeah, that was relied upon heavily in the Supreme Court's opinion. But you are right, our Founding Fathers would have wanted it that way. I actually think Madison wrote a lot about the FDA. Well, he never used the words FDA per se. But when he spoke of liberty, I think that code for FDA and preemption. Yeah, I think that is a fair reading.