Both of your humble scribes attended the American Conference Institute Drug and Medical Device Litigation Conference in New York last week. Here are a few stray thoughts that we picked up along the way:
1. Herrmann used his best material on this crowd. He explained that only one person in the world tells MDL jokes — and it’s him, of course! He then told his two MDL riddles (which reflect not his own personal views, but the views of certain jaded lawyers who have lived through an unsuccessful MDL or two):
Why is an MDL like The Field of Dreams?
If you build it, they will come.
Why is an MDL like a Roach Motel?
Cases check in, but they never check out.
Okay, okay. You come up with an MDL joke that’s actually funny.
2. The American Tort Reform Association has a website that collects the status of tort reform in all fifty states. Click here for a map of the United States; then, click on the state that interests you to find out what tort reforms have been enacted and whether they’ve been upheld as constitutional.
3. During the Colacicco oral argument, apparently one judge asked whether the drug company had proposed, and the FDA had refused, the very warning that the plaintiff now says should have been given. The implication was that perhaps only that conflict is sufficiently stark to trigger implied preemption. This is just silly.
First, in Colacicco, members of the public had filed Citizens’ Petitions asking the FDA either to ban, or to add warnings about suicidality to, SSRI antidepressants. That’s about as stark a conflict as exists in the real world.
Second, if courts require companies to request, and the FDA to reject, specific warnings to trigger preemption, then drug companies will be encouraged to bombard the FDA with proposed warnings. Companies will submit defensive filings meant to tee up issues before the FDA and get decisions, one way or the other. Precisely that concern — that drug companies would give the FDA more information than it needed or wanted — motivated the Supreme Court in Buckman to find that claims of fraud on the FDA are preempted.
Finally, no matter what proposed warning the drug company submits to the FDA, plaintiff’s counsel in a later lawsuit will say that the warning should have been slightly different. It should have been a “warning” instead of a “precaution;” or a statement that an adverse reaction was “caused” by the drug, rather than “associated” with it; or the quantification of the rate at which the adverse event occurred was misleading.
It’s not possible to propose the very warning that a plaintiff will later seek, because, no matter what the warning says, the later plaintiff will see the existing warning and say it wasn’t any good. That’s how litigation works; we sure hope the Third Circuit isn’t fooled.
4. Why Riegel (the device preemption case argued last week) may inform Levine (the drug preemption case with a certiorari petition pending): Since express preemption in the device context turns on whether a federal requirement conflicts with a state requirement, the express preemption analysis can feel an awful lot like the implied preemption analysis for drugs. Thus, depending on how the Supreme Court resolves Riegel, we may get a pretty strong sense of what’s likely to happen when the Court decides Levine (or some other drug preemption case presenting the same issue).
5. Finally, a thought on how companies might want to conduct themselves under the new Final Labeling Rule, effective in 2006, that adds a Highlights section to the package insert: Don’t just delete adverse events from the label because they’re too insignificant to list under the new labeling regime. Rather, write to the FDA saying that you propose to delete the adverse event. If the FDA agrees in writing with the deletion, then you’ve built your necessary regulatory record to establish preemption. If the FDA disagrees with the deletion, continue to list the adverse event.
See? It’s happening already! If preemption turns on causing the FDA to speak on a particular issue (to show a conflict), then companies will do everything in their power to entice the agency to speak. Unless we want a system that’s terribly distorted by companies and the FDA doing a constant preemption tango, conflict preemption must exist more broadly than only when the FDA has considered and rejected a specific warning.