Law

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.

The Levine dissent, of course, gave Buckman an even broader application:

Petitioner’s dealings with the FDA were prompted by federal law, and the very subject matter of petitioner's statements to the FDA were dictated by federal law.  Accordingly − and in contrast to situations implicating federalism concerns and the historic primacy of state regulation of matters of health and safety − no presumption against pre-emption obtains.

Id. at 624 & n.14 (citation and quotation marks omitted).  While we obviously prefer the Levine dissent, there doesn’t seem to be any support − in the Levine majority or dissent − for not applying Buckman’s rationale to any situation implicating the information submitted by a regulated entity to its regulating authority.

That’s two − actually call it 2½, since Buckman was string-cited (with no separate discussion) for basically the same presumption-related proposition by the dissent in Altria Group, Inc. v. Good, 555 U.S. 70, 99 (2008) (the majority in Good not mentioning it at all).

The Court’s most recent invocations of Buckman are in Arizona v. United States, 132 S.Ct. 2492 (2012), and Chamber of Commerce v. Whiting, 131 S.Ct. 1968 (2011), both involving immigration.  In Arizona all but one of the provisions of a state statute were held preempted by federal law.  The mere fact that both the majority and the dissent considered Buckman relevant indicates that it can’t be cabined in the manner plaintiffs so often attempt.  The majority cited Buckman as authority (albeit “cf.” authority) for the proposition that “[p]ermitting the State to impose its own penalties for the federal offenses here would conflict with the careful framework Congress adopted.”  Id. at 2502-03 (describing Buckman holding as “States may not impose their own punishment for fraud on the Food and Drug Administration”). That’s all federal offenses, folks, not just the FDCA.  The dissent in Arizona essentially agreed:

In some areas of uniquely federal concern − e.g., fraud in a federal administrative process . . . this Court has held that a State has no legitimate interest in enforcing a federal scheme.

Id. at 2518.  The dissent in Arizona just didn’t think that “federal alien registration” was as uniquely federal as litigation involving the sanctity of federal administrative proceedings.  Id.  Again − nothing in either opinion supporting a limitation based upon how a plaintiff chooses to plead such “fraud.”

In Whiting, a plurality (this case is split in more ways than are worth describing) distinguished Buckman on grounds similar to the dissent in Arizona.  Buckman involved a “uniquely federal area[] of regulation,” specifically “state actions that directly interfered with the operation of a federal program.” 131 S.Ct. at 1983.  Buckman was:

[a] determin[ation] that allowing a state tort action would cause applicants before a federal agency to submit a deluge of information that the agency neither wants nor needs, resulting in additional burdens on the agency’s evaluation of an application, and harmful delays in the agency process.

Id. (citation and quotation marks omitted).  Thus, whenever such “interference” − which impacted upon the quality and quantiy of information submitted to a federal agency (notably the Court substituted “agency” for “FDA”) − was present, preemption would exist.  Id.  The dissent agreed, relying on Buckman’s holding that the “relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.”  Id. at 2006.  Thus we find in Whiting (in more than one of its multiple opinions) additional support for a broad reading of Buckman as applicable to all communications with all federal agencies.

Finally, Buckman has also been cited solely in dissents and concurrences.  In Thompson v. Western States Medical Center, 535 U.S. 357 (2002), Justice Thomas’ dissent cited (“cf.” again) Buckman for an extremely broad proposition − that “flexibility” is “necessary if FDA is to pursue difficult (and often competing) objectives.”  Id. at 389.  It’s only one justice, but again Buckman is recognized as standing for a proposition much more extensive than what to do with a peculiar type of claim.  In Sorrell v. IMS Health Inc., 131 S.Ct. 2653, 2678 (2011), Buckman was also cited by the dissent (once again as a “cf.”), this time for its discussion of off-label use.  That’s a more limited issue, but still one that’s not limited by any particular claim.

What we make of all this is that, on several occasions − in Mensing, Whiting, and Arizona for sure, and to a lesser extent in Levine − the Supreme Court has had occasion to comment upon what its holding in Buckman was all about.  In those cases, Buckman has been described as relating to state-law-based evaluation of the communication between a regulated person (including but not limited to drug/device manufacturers) and its federal regulating authority (including but not limited to the FDA).  In no case has the Supreme Court held, described, or suggested that Buckman is somehow limited to how a plaintiff denominates such a claim in his/her pleadings.  In sum, there’s no support in any Supreme Court case for the rationale followed by the Second Circuit in the Desiano case, and only Justice Roberts’ unfortunate recusal prevented the Supreme Court from tossing it then and there.

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Posted By Bexis to Drug and Device Law at 8/31/2012 05:43:00 PM

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