Plead preemption as a defense, where appropriate, in drug and device cases. And develop the necessary record to present that defense.
Bad things happen to people who don't.
In the recent case of Sherman v. Winco Fireworks Inc., 532 F.3d 709 (8th Cir. July 3, 2008), Winco, the defendant fireworks distributor, did not plead Federal Hazardous Substances Act preemption in its answer. Winco did seek leave to file an amended answer to plead that defense 17 months after the deadline for amending pleadings had passed.
The trial court granted the motion, granted in part a motion for summary judgment that relied on the preemption defense, and limited plaintiffs' expert testimony at trial based on that ruling.
The Eighth Circuit reversed. The court held that Federal Rule of Civil Procedure 15(a) requires that leave to amend pleadings be freely granted, but Rule 16(b) says that scheduling orders that set deadlines can be revised only on a showing of good cause. According to the Eighth Circuit, Winco had not shown good cause to amend the scheduling order, so the trial court erred in allowing the preemption defense.
That type of reasoning isn't limited to preemption under the Federal Hazardous Substances Act. In the old (pre-Lohr) First Circuit case of Violette v. Smith & Nephew Dyonics, 62 F.3d 8 (1st Cir. 1995) (here's a link to the case at the First Circuit website), the defendant did plead Federal Food, Drug and Cosmetic Act preemption in its answer, but then never again mentioned the defense until after an unfavorable jury verdict. The First Circuit held that this conduct waived the preemption defense.
Don't make that mistake: For an example of how to plead preemption as an affirmative defense, look at our post from last month on affirmative defenses, where preemption is number 14.
Here's our riddle of the day:
Why is raising the preemption defense like voting in the City of Chicago?
Do it early; do it often.