Thursday, November 06, 2008

Our Own Analysis Of The Wyeth v. Levine Oral Argument

We’ve had a chance now to read – no, make that “study” – the Wyeth v. Levine oral argument transcript for ourselves now. Our best guess, which as before could be way off the mark, is that implied preemption will be recognized as viable in the prescription drug context in Levine, but that the preemption ruling will be narrowly crafted to the case's drug-specific facts – specifically, that: (1) the FDA had already considered the risk in question, gangrene from Phenergan administered by “IV Push,” and (2) the FDA approved the drug's labeling with all the relevant information about this risk being before it.

As for the first proposition, we base our belief that the Supreme Court will establish preemption in drug product liability on the basis of exchanges like this:


JUSTICE ALITO: Well, suppose the record showed that the FDA clearly considered whether IV push should be contraindicated and concluded it should not be and prescribed the label that now appears on the drug; and then. . .the very day after the FDA made that ruling, Ms. Levine was injured. Would you still -- would she still have a claim in your view, a non-pre-empted claim?

MR. FREDERICK: That [sic, would] be pre-empted. And the reason it would be pre-empted is because the FDA would have considered and rejected on the basis of the same information or similar information the very duty that underlies the State claim.
Transcript at 32-33 (all emphasis is ours throughout); accord 39-40 (responses to questions by Justice Souter).

Bingo. The other side actually conceded the existential preemption point. If there’s no new information for the FDA to consider with respect to the risk in question, and the Agency has rejected a plaintiff’s position concerning that risk – even the plaintiff side in Levine concedes there is preemption. Arguments that tort preemption cannot exist at all, already on life support after Geier and Buckman and Riegel, just got thrown under the bus.

From now on, the argument is only going to be about how much conflict preemption there is, and under what circumstances, not whether it exists at all. Like in the old joke, all we’re doing now is “haggling about the price.”

But wait, there’s more along the same lines.

JUSTICE STEVENS: Mr. Frederick,. . .I understood you to agree with Justice Alito that there is a hypothetical case in which there would be pre-emption, and would you tell me what particular fact distinguishes your case from his hypothetical?

MR. FREDERICK: The fact is there was no consideration and rejection of a stronger IV push warning. There was no consideration by the FDA of IV push as a means of administration distinct from other intravenous forms that would lead to a different kind of risk-benefit balancing. So with the – in the case where there would be pre-emption, FDA would be asked, we – we want to put a stronger warning as against this – FDA says: We don't think there is scientific evidence. Do not put that warning on the label.

Transcript at 39-40.

Good stuff! We recognize that fact pattern as being SSRI/suicide preemption. After reaffirming the general concession that conflict preemption exists for prescription drugs, plaintiff’s counsel goes on to give up SSRI suicide claims, which involve the FDA rejecting warnings as scientifically unfounded (see, e.g., our prior discussion, here, at point 7). We hope that, in crafting its opinion the Court will review the amicus brief filed by DRI, as well as that part of the government’s argument, Transcript at 16-17, both of which address which address preemption of SSRI claims involving suicide risks.

Given the other side’s concessions, we think that it’s quite likely that the Court in Levine will recognize that there are situations in which FDA labeling decisions preempt state-law product liability claims that seek to overturn those decisions.

The $64,000 question is how broadly? That gets us to our second proposition. Early on in the oral argument, Wyeth tried to interest the Court in its broader preemption positions. In response to the very first question (from Justice Kennedy) Wyeth’s counsel stated the defendant’s broad preemption position, “could they use. . .the precise label that in approving the application in 1998 the FDA required Wyeth to use, and also use the label that the Vermont jury determined should be used[?]” Transcript at 4.

Wyeth articulated its broader preemption position twice more. Transcript at 5 (“The [preemption] question is what did the labeling say and upon what information was the labeling decision made.”); 13 (describing “two positions” – a narrow position based upon “the absence of new information,” and a broader position a jury cannot re-evaluate “the same information that the labeling that the FDA had approved” and reach a different safety/efficacy result). The Court, however, seemed more interested in narrowing its focus to the facts of the case.

Thus, Wyeth also addressed what it did not come within its view of the scope of preemption:


[W]e are not seeking here a rule of field preemption. We are not seeking to preclude tort remedies for conduct that violates Federal law.
Transcript at 11. The government made similar statements as amicus arguing in support of Wyeth. See Transcript at 15 (“we are not arguing. . .that tort remedies. . .are pre-empted as a general matter”), 16 “if the State standard was the same as the Federal standard, there wouldn’t be any conflict”), 16 (“if you failed to provide it [new information to the FDA] altogether, there would not be. . .a pre-emption defense”), 18 (“we are not arguing that there is preemption in a situation where there is new information that is not brought to FDA’s attention”).

Thus it’s quite apparent that neither side went to court in Levine looking for the sort of broad, sweeping preemption ruling that both sides – but especially plaintiff-oriented folks – have publicly suggested might be the result. If neither side asks for a result from the United States Supreme Court, the chances are good that the Court isn’t going to reach that result.

And at this point, a narrow ruling in favor of preemption is probably something that our side should be satisfied with, given the current political situation. We don't want to overreach. As we’ve discussed before, Congress could only eliminate implied preemption by getting rid of the underlying substantive conflict between FDA control of labeling and state tort litigation. To do that Congress would have to gut the FDA’s control over labeling and give final say to state-law juries. There are lots of public health reasons – why the FDA was created in the first place – not to go that route. But a really broad preemption ruling might prompt a pro-plaintiff Congress to expend the political capital necessary to upset the FDA applecart. Conversely, a narrow ruling probably wouldn’t prompt such drastic action. A narrow win in Levine lets our side go to work broadening our beachhead in the lower courts, and by the time the issue percolates back up to the Supreme Court, well, perhaps the political situation will be more auspicious.

So is that kind of ruling in the cards?

We’d say yes, based on the argument.

The Court heard a lot about the particular facts of the Levine case. Indeed, we believe that Wyeth’s counsel set the direction for the argument early on with a very precise and powerful presentation of four ways in which the record demonstrated that the FDA had specifically considered the risk of IV push in connection with its approval of the drug’s labeling:


JUSTICE GINSBURG: . . . [A]s I understand this, the FDA was aware of the IV use and a certain risk. But did it ever, ever discreetly consider IV push versus IV administered the usual way by a drip bag?

MR. WAXMAN: Yes it did, Justice Ginsburg. . . . [T]here are. . .four separate references that, as we explained in footnote 11 of our reply brief, only apply to IV push. There is a reference to the use of the Tubex system. That is a direct IV push system. There is a reference to rigid plungers and small-bore needles. Again nothing to do with drip. There is a reference to a maximum rate of administration. Drip is gravity. The testimony in the case was that an instruction that a particular rate of administration not be exceeded only referred to IV push. And finally, there are cautions on the label about how the ordinary aspiration of blood to see if its bright or dark, which is only done in the context of a needle that is being used to push something into a vein.
Transcript at 5-6. See id. at 22-23 (government agreeing with Wyeth on facts in response to question from Justice Kennedy).

How did the FDA address the risk in Levine? Let Wyeth count the ways.

In our opinion Wyeth’s four points were key. After that, plaintiff could not argue credibly that the FDA had not considered IV push in making its labeling decisions. The case became one about the “heartland” of preemption. Transcript at 11.

If the FDA looked at a specific risk and ordered specific labeling, can a state court overturn that? In light of what was in the label, Chief Justice Roberts did not seem to think so. Transcript at 25-26. Even Justice Ginsburg, whose votes suggest that she is the most anti-preemption member of the Court, was troubled by Wyeth’s four points and asked plaintiff’s counsel to address them. Transcript at 42. He had a hard time:


I will acknowledge that the references in some instances suggest IV push. There is no doubt that the FDA knew that IV push was a method of intravenous administration, but our point is a starker one, and that is that the FDA never was put to the test of deciding comparative risks and benefits of IV push versus IV drip.
Id. Ouch! He had to cut the salami pretty thin to wiggle around that one.

Indeed, plaintiff’s counsel was doing a great deal of salami-slicing in Levine, given the problematic facts. He offered two arguments. First, as we just quoted, he claimed that the FDA didn’t conduct a risk-benefit analysis specifically between IV push and IV drip – another form of intravenous administration. See also Transcript at 25 (in response to a question from Justice Scalia); 41 (in response to a question from Justice Stevens). Somehow, we think the Court might not be inclined to let plaintiff cut the salami that fine:

So, as I understood your answer to be, all we have to do is simply look at the record, and if we think the FDA considered specifically IV push risks as opposed to general arterial exposure, then you lose, and if we determine that they did not, then they lose.

Transcript at 41 (Roberts, C.J.).

Second, plaintiff argued (we’d say tautologically) that the FDA couldn’t have conducted a risk/benefit analysis at all, because no “reasonable” analysis would have kept IV push on the label. Transcript at 26 (in response to a question from Chief Justice Roberts). Justice Scalia, at least, didn’t think much of that point, seeing it as a direct attack on the reasonableness of the FDA’s determination:

JUSTICE SCALIA: Well, you’re just contradicting the label. The fact is they could not have approved that label unless they made that determination.

Now, if you’re telling me the FDA acted. . .irresponsibly, then sue the FDA.

Id. Neither did Justice Souter, Transcript at 43 (asking plaintiff’s counsel what evidence he had of FDA non-consideration “[a]part from” this argument), or (again) Justice Scalia, Transcript at 44 (pointing out that the label discusses IV push separately from IV drip).

Another way in which Wyeth’s four-points evidence influenced the oral argument involves novelty. As its counsel forcefully argued, plaintiff had no evidence that Wyeth withheld anything from the FDA:

That is what is so wrong. That is why he [plaintiff’s counsel] stood up and said [during closing argument at trial] the FDA doesn't decide this question. You decide this question. And there was never, ever a suggestion in the record in this case, nor could there have been, that Wyeth ever failed to bring every single adverse-event report to the FDA's attention, every analysis that it did to the FDA's attention.

Transcript at 52.

The lack of any “new” information that plaintiff could point to highlighted the regulatory paradox in the plaintiff’s position. If one argues (as plaintiff tried to do, e.g., Transcript at 35-36) that new information was not a prerequisite to state-law claims that defendants must “strengthen” their labels, that means that “FDA approval. . .doesn’t give you any protection at all” (Transcript at 36 (Scalia, J.)). Plaintiff’s position amounts to an argument that a common-law duty to supplement can arises the moment after FDA approval of drug labeling:

It would be fundamentally inconsistent with a prior approval system to have a regime in which the very next day State law could require the manufacturer to change the very labeling that FDA has struck a balance.

Transcript at 22 (government argument in response to question from Justice Breyer). Not surprisingly, this “next day” issue was what prompted Justice Alitio’s question that we quoted at the very beginning of this post – which in turn led plaintiff to concede that preemption does occur under certain facts.

Without novelty, the CBE (“changes being effected”) argument that defendants have the power to change their labels without FDA pre-approval is simply illogical. Even very skilled counsel couldn’t pull that off in Levine.

Now, all the Court has to do to find preemption is resolve the “new” information question in favor of Wyeth on the facts of Levine.

So novelty – specifically how much novelty the CBE regulation requires – dominated large portions of the Levine oral argument. The government also took a strong position on novelty, “[n]ew information means new information about a risk that is greater in severity or frequency,” which it cast as a “long-standing interpretation.” Transcript at 18-19 (responding to a question from Justice Breyer), accord id. at 24 (same, in response to a question from Justice Scalia). Since we put our finger on this critical preemption issue early in our blogging experience, we were gratified (but not surprised) to see it become so central in the Levine oral argument.

Several of the justices indicated that, in the absence of novel information, they are likely to find that the FDA’s consideration of a risk and subsequent approval of risk-specific labeling gives rise to preemption. See Transcript at 25, 28, 37 (Scalia, J.), 30 (Roberts, C.J.), 32, 36-37 (Souter, J.), 34 (Alito, J.), 44-45 (Kennedy, J.). That’s five right there – the magic number.

Even Justice Stevens, a usually reliable “no” vote on preemption, seemed to accept novelty as the proper framework; his response was to try to get plaintiff’s counsel (who seemed surprisingly balky) to fit his facts into a “new information” context. Transcript at 44-47.

There’s a wild card in all this – Justice Breyer. At several points, he pursued questioning that strongly suggested he thought the novelty issue had been waived. See, e.g., Transcript at 20 (“nobody brought up this new information point” in the lower courts), 50 (“nobody said anything about the FDA’s claim that the information necessary to just go ahead and change the label had to be new”). At the very end of his rebuttal, Wyeth’s counsel explained that, with preemption removed from the case through summary judgment early on, there hadn’t been any opportunity to develop the “new information” point at trial. Transcript at 53. Who knows if that’ll be enough to sway Justice Breyer?

Justice Breyer’s position, raises the possibility of a Lohr-type situation where he authors a lone opinion (none of the other justices seemed impressed by the waiver point, especially Justice Kennedy (see Transcript at 22, 48)), that is abstractly favorable to preemption but avoids the issue in the context of the case. We certainly hope not, given the mess that Lohr produced.

And we don’t think it will.

As we’ve already stated, we count at least five justices (Roberts, Scalia, Souter, Alito, and Kennedy) inclined towards the novelty requirement even without Justice Breyer. Given the facts – and plaintiff’s concessions that implied preemption exists in the FDCA arena – a relatively narrow opinion, based upon explicit FDA review of gangrene/IV push and the lack of any novel information not brought to the FDA’s attention, should be enough to garner the support of a majority. And that’s without considering Justice Thomas, who (as is his practice) asked no questions during the Levine oral argument. All we can say about Justice Thomas is that he supported preemption in Lohr and (with qualifications) in Buckman, but was probably, like Justice Souter, a vote against preemption in Kent.

Hence our prediction, based upon a close reading of the transcript, is that there will be a narrow decision supporting preemption of plaintiff’s failure-to-contraindicate claim on the basis of drug-specific facts. The vote? Now we’re really going out on a limb. How about 6-1-2, but with everyone (except maybe Justice Ginsburg) agreeing that, upon a sufficiently strong set of facts, FDA-approved labeling can create implied preemption of prescription drug product liability claims.

Another prediction: If we’re right about Levine, look for lots of preemption litigation involving “new” analyses of “old” information. It won’t be hard for plaintiffs to find experts ready to reanalyze anything that any given defendant submitted to the FDA and then to opine, based upon that after-the-fact reanalysis, that the defendant should have unearthed and disclosed – surprise! – something more about the risk that injured the plaintiff.

So we don’t think we’ll be seeing prescription drug litigation vanishing from the face of the earth any time soon.

But we’ll keep trying.

4 comments:

hg said...

Genuinely to clarify - and going by your last couple of sentences - the ideal world for DDL would be one without any "failure-to-warn" state tort suits whatsoever over FDA-approved drugs, and even including cases (rare as they are) in which FDA/DOJ successfully prosecuted felony fraud in the FDA approval or compliance process (as FDA/DOJ argued in Kent)?

Is that a fair summary of the ideal? A genuine thanks for clarifying.

Re: your summary of Levine, excellent.

varnaboy said...

Nice blog.Keep it writing.Good luck.

Soronel Haetir said...

HG,

Of course our blog hosts would love a world without liability for their clients, they have said so more than once. Doesn't mean they ever expect to see such a world.

OTOH the cases that will lead toward pre-emption if any are going to are those cases where the drug/device maker can hardly be said to be at fault. I see that as being the case in Levine, as I did with Riegel.

hg said...

I understand, Soronel. Yet there are instances in prescription drug litigation in which defense and plaintiff counsels have agreed that a settlement was fair and just.

It is probably true that the defense side would have preferred no settlement at all. But, somewhere, what is fair and just probably should not be (to quote from this blog entry) "thrown under the bus" under all circumstances; a view that clients often enough share as well.

Agree re: Levine, btw.