The Solicitor General, on behalf of the FDA, has recently filed amicus briefs in both the Riegel v. Medtronic and Warner-Lambert v. Kent (formerly Desiano) Supreme Court preemption cases. We’re doing a separate post on Riegel, but we did this one first because it’s more in the nature of “breaking news” – it was only filed yesterday. However, so as not to keep our more impatient readers waiting here’s the link to the Riegel amicus brief.
Now, on to Kent. For the same reason, to satisfy those of you who’d rather read the Kent brief yourselves than wait for us yak things up, right up front, here’s a link to the Warner-Lambert/Kent amicus brief.
Everybody who read us by now knows that we like preemption as a defense. Where preemption applies, it’s relatively clean and it doesn’t get us too deeply involved the ins and outs of the peculiar facts of the case. Most important of all, though, preemption is an absolute defense, entitling our clients to summary judgment (it’s dangerous to raise preemption on less than a full record, as we’ve discussed before) and dismissal from the case – regardless of the merits of the underlying claims under state law.
That’s why after reading the federal government’s amicus briefs in Kent and Riegel, we feel a bit like Christmas came early this year. But why are we making such a big deal of these briefs, you might ask (especially if you’re not a litigator). Isn’t a brief just a brief?
No, not if the brief is by the government – especially if the government brief is on behalf of the administrative agency charged with running a particular regulatory scheme, as the FDA is with the FDCA.
This gets into an arcane field generally called “administrative deference.” Lawyers and judges, being the inveterate hair-splitters that we are, have created a bunch of gradations of deference – Chevron (the best), Skidmore (also pretty good), Auer (not quite as good, but nothing to sneer at, either), and more – but it all boils down to the same thing. An administrative agency’s (read “FDA” here) say-so about how it interprets the statute and regulations it is charged by Congress with administering (read “FDCA” and “MDA” here) is entitled to deference from the courts.
Yes, even the Supreme Court gives deference – although typically not all nine justices agree on what deference is due in what situations, even (especially) in preemption cases. “Chevron,” “Skidmore,” and “Auer” are the names of the Supreme Court cases recognizing various formulations of administrative deference applicable in different situations.
Anyway, what deference means as a practical matter is that these SG/FDA amicus briefs have independent significance. They command attention/deference not only from the Supreme Court in the cases in which they are filed, but also from any other court in the country, state or federal (although, realistically, federal courts institutionally tend to be more willing to grant deference to the views of a federal agency than state courts). Anyway, deference is one big reason why we think that these briefs are a big deal.
The other is what they say. So enough prologue you guys. What exactly did the government say?
Kent, as we’ve discussed at some length here, here, here, here, here, and here (we’re obsessive, aren’t we?) raises questions about how broadly allegations of “fraud on the FDA” are preempted.
We don’t like fraud on the FDA – we so much don’t like it that over ten years ago we invented the preemption arguments that percolated up in the Bone Screw litigation and eventually became Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), in the Supreme Court. Buckman, as most of you probably know (otherwise, why are you here?) is where the Supreme Court unanimously held that claims of fraud on the FDA – which were designated as such by the Bone Screw plaintiffs – were preempted, because (and this is greatly simplified) allowing state courts to ignore FDA actions because supposedly they were fraudulently pretty much unavoidably conflicts with those very actions (which, by definition, are still in effect). Also this type of claim would put state-law courts in the position of second-guessing federal agencies, cause cautious manufacturers to inundate the Agency with unwanted information, and generally muck up the administration of the FDCA.
We also don’t like fraud on the FDA because we don’t like plaintiffs being able to call our clients fraudsters, criminals, and the like before juries.
Anyway, enough nostalgia. The Second Circuit comes along in Desiano/Kent and basically neuters Buckman. It held that, as long as the plaintiff isn’t so stupid (after Buckman) to call a claim “fraud on the FDA,” it can make all the FDA fraud allegations it wants in the context of “traditional” tort claims, and there will be no preemption. In this particular context, a Michigan statute basically immunized FDA-approved drugs from product liability unless there was fraud on the FDA. Desiano/Kent thus created a loophole big enough to drive the largest mass tort litigation through.
You can see why the Supreme Court might be interested in that case.
You can see why we’re interested in it, too.
The precise question presented that the government addressed in Kent (from now on, no more double case name business) is:
Whether federal law preempts state law to the extent that it requires a court to determine whether a drug manufacturer committed fraud on FDA and whether FDA would have denied or withdrawn approval of a drug but for that fraud.
Kent SG brief at I.
Under the Michigan law, unless the plaintiff proves...
