As practically anybody bothering to read this blog knows, a large bipartisan majority of Congress just passed, and the president signed, a new bill that strengthens the FDA. Like just about everybody else, we thought that, overall, what Congress produced was a good idea. It seems that these days all statutes have to have names, but you would think the folks that think of them could have been a little more creative than the “Food and Drug Administration Amendments Act of 2007.” Well, they didn’t, so we’re going to have to call it “FDAAA” – don’t ask how to pronounce that.

Anyway, the ink’s hardly dry on the FDAAA before the plaintiffs are at it again, claiming that an obscure “rule of construction,” facially applicable only to a single section of the new act, somehow undermines preemption as to the FDCA as a whole. “Poppycock” doesn’t begin to describe how we view this latest gambit – but this is a G-rated blog (not that we’d expect any children to read it, but you know what we mean).

So where to start? How about with the practical? Probably the most basic reason that the FDAAA, or more specifically Pub. L. 110-85 §901(a) – to be codified at 21 U.S.C. §355(o)(4)(I) (we told you the ink wasn’t dry yet) – can’t possibly do what plaintiffs claim is that it was passed with overwhelming support from industry. Regular visitors to this blog will remember that, once upon a time, during the history of the FDAAA, the plaintiffs’ crowd actually did try to slip an anti-preemption poison pill into the bill. We blogged about that a couple of times here and here. That provision read:

Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law).

Well, the effect of that ploy was immediate and far-reaching. Industry – our clients – threatened to withdraw its support from what became the FDAAA, and within days the offending provision was promptly removed. We blogged about that, too.

Compare that reaction to industry’s response to the “rule of construction” currently being put forward by the plaintiffs – which is to say nothing at all, or at most a collective shrug of the shoulders. If this little snippet attached to the tail end of §901(a) really did what plaintiffs claim, there wouldn’t have been an FDAAA. We’ve already explained why preemption means a lot to our clients. Well, our clients were paying close attention, and nothing as destructive of preemption as plaintiffs claim the “rule of construction” is could possibly have found its way into the FDAAA without a huge legislative dust-up.

Enough about the dog that didn’t bark.

Let’s look at what plaintiffs are baying at the moon about these days. Section 901(a) is entitled “Postmarket Studies and Clinical Trials – Labeling.” It has five sections, most of which have subsections and sub- subsections. In short, it’s something that would look right at home in the Internal Revenue Code. Subsection 4, “Safety Labeling Changes Requested By Secretary,” has nine sub-subsections, the last of which is our friend the “Rule of Construction.” If you want to see precisely how this “rule” looks statutorily, tucked into its overall context, take a look at pages 8-9 of the “preemption Roundup” we linked to a little more than two weeks ago.

That “rule” isn’t very long. It’s entire text is:

This paragraph shall not be construed to affect the responsibility of the responsible person or the holder of the approved application under section 505(j) [that means the drug manufacturer] to maintain its label in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 601.2 of title 21, Code of Federal Regulations (or any successor regulations).

21 U.S.C. §355(o)(4)(I).

The first thing that positively jumps out from subsection (4)(I) – compared to the true anti-preemption poison pill plaintiffs’ congressional allies attempted to insert earlier – is its facially limited scope. The real poison pill applied to the entirety of the Food and Drug Act, beginning “Nothing in this act or the amendments made by this act….” This “rule of construction” applies only to this “paragraph,” which means only §355/901, and nothing else.

From that limited scope alone, it should be evident, without having to look past the plain language that the provision, that it can’t possibly alter the scope of preemption generally. It doesn’t purport to affect anything more than the new FDA post-marketing powers over safety-relate labeling changes. The FDAAA augmented the FDA’s post-approval powers to make labeling changes. There’s certainly nothing in §355/901 that gives manufacturers any more freedom to make unilateral changes in the labeling contrary to prior FDA instructions or FDA labeling requirements.

And even then, all the new “rule” does is to ensure that the pre-existing “responsibilities” of drug manufacturers (that’s what’s in 21 C.F.R. §314.70 (§601.2 isn’t generally applicable to drugs)) with respect to post-approval label changes aren’t adversely “affect[ed]” by the new powers granted to the FDA. That makes sense too. Congress was attempting throughout the FDAAA to augment the FDA’s post-approval powers over labeling (and drug safety generally), not to reduce them by some unintended implied repeal of what the FDA already could do.

Well, it should be immediately obvious that this “rule” can’t possibly affect any preemption argument based upon the FDCA as it stood prior to the addition of the FDAAA, since the “paragraph” to which that “rule” refers didn’t even exist then. All of the prescription drug preemption arguments we’ve ever seen relate to the FDA’s exercise of its pre-FDAAA powers. Some of those arguments seek to maintain the primacy of decisions the FDA took more than a decade ago.

That the “rule” couldn’t possibly affect anything that went before is also self evident from the face of FDAAA itself. The 2007 amendments weren’t even in effect until quite recently. See FDAAA §909 (“This subtitle takes effect 180 days after the date of enactment of this Act”). Given when the FDAAA was enacted, that date was September 27, 2007. So it is impossible for the “rule” to affect any FDA action – no matter what it could be – taken before that date, since before that the FDAAA, and the “rule,” didn’t exist. There’s nothing in the FDAAA making it retroactive.

So what does the “rule” in fact do? It affects the FDA’s powers under the new §901. That section enhances FDA’s power to supervise the safety and labeling of prescription drugs after they’re approved and on the market. To take one of many examples, §901 authorizes FDA to demand that manufacturers undertake additional post-approval studies or clinical trials to assess either a “known serious risk” or “signals of serious risk” related to the use of a drug, §901(3)(b), and to implement new safety labeling changes on an expedited basis depending on what such studies show (or upon receipt of any other new information). §901(4)(A). The “rule” makes sure that these new FDA powers don’t displace the Agency’s pre-existing authority under existing FDA regulations – such as the Changes Being Effected (“CBE”) provisions of 21 C.F.R. §314.70.

Thus, under the “rule of construction” the new FDA powers conferred by §901 explicitly don’t displace anything that already existed – both the arguments that defendants in prescription drug product liability litigation use to advance implied preemption, and the arguments that plaintiffs use to oppose implied preemption are preserved by the explicit terms of the “rule.” That’s what the “rule” says, and that’s why, as we pointed out before, the industry did not find anything obnoxious about it, as opposed to the previous anti-preemption poison pill that so briefly surfaced during FDAAA’s path to enactment. In terms of preemption, the “rule” is a standstill agreement, nothing more.

Beyond the statutory language, the new plaintiff arguments that we’ve seen also excerpt snippets from the FDAAA’s legislative history. Our first response to that is “so what?” As we’ve just finished discussing, the text of §355(o)(4)(I) seems clear enough as to what it affects and what it doesn’t. That being the case, there’s no occasion, under fairly basic principles of statutory construction, to look to legislative history at all. There are more cases on this point than we care to think about, but here are a few: Lamie v. United States Trustee, 540 U.S. 526, 534 (2004) (“when the statute’s language is plain, the sole function of the courts – at least where the disposition required by the text is not absurd – is to enforce it according to its terms”); FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 132 (2000) (“If Congress has done so, the inquiry is at an end; the court must give effect to the unambiguously expressed intent of Congress.”); United States v. Gonzales, 520 U.S. 1, 6 (1997) (“there is no reason to resort to legislative history” where a “straightforward statutory command” exists particularly where “the legislative history only muddies the waters”); Ratzlaf v. United States, 510 U.S. 135, 147-48 (1994) (rejecting reliance on Senate and House Reports, concluding that “we do not resort to legislative history to cloud a statutory text that is clear”).

Beyond that, what the plaintiffs are trying to pass off as “legislative history” is pretty lame. The best legislative history – the stuff we lawyers can find in the big books in the library (U.S.C.C.A.N.) – is in the formal reports published about legislation by the Senate and House of Representatives committees that put the legislation together in the first place. E.g., Thornburg v. Gingles, 478 U.S. 30, 44 (1986) (committee reports are “the authoritative source for legislative intent”). T’aint none of that here. The House Report on the FDAAA doesn’t say anything about the “rule of construction.” The Senate didn’t issue a report on FDAAA, and neither did the conference committee that reconciled the two bodies’ differences.

Thus, plaintiffs have nothing that even purports to represent the combined views of even one house of the Congress. Nope, all they’re offering is a few statements by individual members of Congress. Well, you know and we know that congresspeople love to talk. When a major bill is passed, it’s usually possible to find somebody saying just about anything either side might want. The courts know this too. That’s why reliance upon statements by individual legislators isn’t worth very much. Again there are plenty of cases to this effect, so we’re only being representative here. E.g., General Dynamics Land Systems., Inc. v. Cline, 540 U.S. 581, 599 (2004) (“the remarks of a single legislator, even the sponsor, are not controlling in analyzing legislative history”); Chrysler Corp. v. Brown, 441 U.S. 281, 311 (1979) (same); Zuber v. Allen, 396 U.S. 168, 186 (1969) (“[f]loor debates reflect at best the understanding of individual Congressmen”).

Another aspect of “legislative history” – equally slippery, to be sure – but probably a more accurate taking of Congressional temperature given its recency, is to look at what the FDAAA as enacted did not contain. Only a few months before, Congress had a chance actually to do what plaintiffs falsely claim that it did. The anti-preemption poison pill that surfaced over the summer would have put Congress on record against preemption with respect to the entire FDCA. It didn’t pass. In fact, the total lifespan of an explicit attempt to eliminate prescription drug preemption in the current Congress was measured in days.

In light of the abject failure of plaintiffs’ allies in Congress to persuade that body to restrict preemption in prescription drug product liability litigation, the current effort by plaintiffs to recast the “rule of construction” into the anti-preemption language that Congress refused to pass only weeks before positively reeks. If somebody who wasn’t a lawyer (say, one of our clients) tried to do the same thing in a non-litigation context (such as, in an advertisement), that person would be open to prosecution for consumer fraud as a bait and switch.

To us, that’s what the current plaintiffs’ arguments amount to – a legislative “bait and switch.” Plaintiffs’ allies couldn’t get Congress to do what they wanted, expressly disapprove preemption, so they seize upon something innocuous, and through a few speeches they gave on the floor, seek to switch that innocuous provision into something that they couldn’t get Congress to do. Only in litigation….

Not only that, the current plaintiffs’ arguments we’ve seen mischaracterize what was actually said in those speeches. What seemed to attract the individual speakers’ ire was “field” preemption, not the kind of conflict preemption that we’re raising on behalf of our clients. Thus, the “additional views” of 12 House members – not included anywhere in the House Report– say only that by giving FDA new post-approval, safety-related powers (in their individual views) Congress did not “intend to occupy this regulatory field.” Additional Views accompanying H.R. Rep. 110-225 (July 11, 2007), at 197. That’s field preemption if we’ve ever seen it. The remarks made by Senator Kennedy are the same. See 153 Cong. Rec. S11832 (“We do not believe that the regulatory scheme embodied in this act is comprehensive enough to preempt the field or every aspect of state law. . . . It is absurd to argue that the FDA, even with the enhanced resources provided by this legislation, commands the field when it comes to postmarket drug safety.”). Either ATLA didn’t give its friends the right talking points, or ATLA’s friends (probably accurately) realized that actually attacking implied preemption would have brought about the same fate for the “rule of construction” as had befallen the earlier anti-preemption poison pill provision – its removal from the legislation.

To the extent that implied preemption based upon conflict with FDA actions was actually discussed during the passage of the FDAAA, individual members of congress supported it. See, 153 Cong. Rec. S11839-40 (discussing correctness of preemption holding in Dowhal v. SmithKline Beecham, 88 P.3d 1 (Cal. 2004), that plaintiffs could not pursue state law claims for manufacturer’s failure to provide warnings determined by FDA to be scientifically unsubstantiated); id. at 11840 (endorsing approach to preemption taken in Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007), – another case we like – where court found state law claims barred by conflict preemption).

We’re not saying that we’re comfortable supporting our preemption position with the statements of individual members of Congress – we don’t think that’s a very strong argument – only that it goes to show that mining the “legislative history” of a bill is sort of like mining the Bible: if you look hard enough, you can find support for practically any proposition.

Another thing that should be considered is that Congress knew full well the preemption “lay of the land” when it passed the FDAAA. Specifically it had to know about the FDA’s views about prescription drug preemption as expressed in the preemption preamble to the January 24, 2006 drug labeling Final Rule. Notwithstanding that knowledge, Congress elected to leave the FDA’s well-known views intact. So what, you say? Well legally, that has the effect of an implicit endorsement. Here, there was “remedial legislation” (the anti-preemption poison pill) proposed in Congress. It was not enacted. Courts are loath “to overturn. . .judicially” something that “Congress, by its positive inaction, has allowed. . .to stand.” Flood v. Kuhn, 407 U.S. 258, 283-84 (1972). The same rule has been applied in the FDCA context, where the administrative “backdrop” and Congress’ acquiescence in it narrowed the “range of plausible meanings” that the FDCA could have. Brown & Williamson, 529 U.S. at 144-45. Here, if Congress disagreed with the FDA’s 2006 position on prescription drug implied preemption, the FDAAA was a golden opportunity for it to do something about it. It had the anti-preemption poison pill before it and did not enact it. Instead, it reinforced the FDA’s own powers, making the need for supposedly “parallel” state tort litigation even less necessary. See Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349, 352 (2001) (that FDA “has at its disposal a variety of enforcement options that allow it to make a measured response” shows lack of need for supposedly “parallel” state tort proceedings). If anything the history of the FDAAA reinforces the validity of implied conflict preemption.

At bottom, though, we think the whole FDAAA business is a tempest in a teapot. This isn’t a case of express preemption. The FDAAA (or at least this part of it) has nothing to do with medical devices. Preemption in the prescription drug context is based entirely on implied, conflict preemption. If you’re not sure what the difference between express and implied preemption in the FDCA world is all about read our prior post. The important thing is that implied preemption involves actual conflict between federal law and state-law contentions. It’s not affected by anything Congress puts in a statute.

In the prescription drug context, implied conflict preemption (not field preemption, either) arises from the authoritative federal actions of the FDA acting within the scope of its congressionally delegated authority. It does not turn on whether Congress has occupied the field, or what Congress said generally (in Dowhal Congress had expressly tried to save the state statute in question), but arises because the FDA addressed a specific question and the plaintiffs are saying that state law can reach a contrary conclusion. State law that would require different warnings from what the FDA has determined to be appropriate conflicts with FDA’s authority and is thus preempted.

Ne’er the express and implied twain shall meet. The United States Supreme Court looked at this point repeatedly and has held that “neither an express pre-emption provision nor a saving clause ‘bar[s] the ordinary working of conflict pre-emption principles.’” Buckman, 531 U.S. at 352 (2001); Geier v. American Honda Motor Co., 529 U.S. 861, 869 (2000) – to name two. In Geier, for example, the Court held that even an express savings clause that explicitly preserved “state law” could not immunize a tort claim from preemption where the claim conflicted with federal agency action.

That’s with an express saving clause. The “rule of construction” plaintiffs advance is nothing of the sort. That “rule” mentions neither preemption nor state law. Plaintiffs have to pile inference upon inference just to connect up §355(o)(4)(I) to preemption in the first place (they make this jump because §314.70, which the “rule” references, is something they use in their anti-preemption arguments). But even if the FDAAA had contained something worthy of the description “savings clause,” that provision would have no effect upon implied conflict preemption. Such provisions have no bearing upon the workings of implied conflict preemption – which arises by virtue of the direct operation of the Supremacy Clause, and not by virtue of anything stated, or not stated, in any statute or regulation.

Thus the plaintiffs’ seizing upon the FDAAA bears no little resemblance to the flailings of a drowning man. The “rule of construction” in §355/901 doesn’t even purport to affect anything other than that section or to affect anything that went before. Their supposed “legislative history” is so weak as to be non-existent and ignores that Congress, only weeks earlier, had the opportunity to do precisely what plaintiffs wanted – but declined. And we’re dealing with implied, conflict preemption anyway, as to which the conflict itself, not any “saving” language (assuming there were any) controls.