We’re rather tired of the other side, abetted by the flawed reasoning in Desiano v. Warner Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008), attempting to distinguish Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), into oblivion as relating to nothing more than a “separate, freestanding” claim for “fraud on the FDA.”  We’ve argued until we’re blue in the face that Buckman (which was unanimous, but with a concurrence) was so much more than that; specifically an implied preemption case with broad implications.  Most courts get it, but enough don’t that we thought we’d investigate a little further.  So we’ve asked ourselves the question, What has the Supreme Court itself had to say about Buckman in the decade-plus since it’s been decided?
We ran a quick search and found that the Supreme Court has cited its Buckman decision seven times.  We’ll look at the drug/device cases first.  In PLIVA v. Mensing, 131 S. Ct. 2567 (2011), the Court cited Buckman as a “cf.” (that’s an abbreviation of the Latin “confer” meaning to compare/consult) to the plaintiffs’ “take steps” argument (which the Court rejected) that the manufacturer should have asked the FDA for help.  Id. at 2578.  Did the Mensing majority limit Buckman to a freestanding count for fraud on the FDA?  Hardly.  Instead, it described Buckman just the way we do, as “holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA.”  Id.  That’s how Buckman should be read − that any state-law claims purporting to intrude on a defendant’s communications with the FDA are preempted.  The quality of a regulated entity’s communications with a federal agency is simply none of state law’s business.
That’s one.
Then there’s Wyeth v. Levine, 555 U.S. 555 (2009), the case we most love to hate.  Levine also discussed Buckman, albeit in dueling footnotes, this time in the context of the “presumption against preemption.” Id. at 565 n.3.  Buckman was not, the majority noted, apt precedent for rejecting that presumption entirely in implied preemption cases, because it “involved state-law fraud-on-the-agency claims, and the Court distinguished state regulation of health and safety as matters to which the presumption does apply.”  Id.  Even in this worst case (which is what Levine is) scenario, the discussion is confined to the scope of a presumption (which later couldn’t muster a majority in Mensing) rather than addressing preemption directly.  Levine certainly is not limited to anything about freestanding claims.Continue Reading What Is Buckman?