Thursday, June 19, 2008

Users' Guide To Defense Amicus Briefs - Wyeth v. Levine, Part II

A confession: There wasn’t supposed to be a Part II to this post.

When we posted our earlier users guide to the Levine defense amicus briefs, we thought we had included everything – we really did.

Shows what we know.

It seems our “good ol’ boys” approach to collecting the defense amicus briefs had a few holes in it. We called up some folks we thought were likely to have copies and asked them to send what they had to us. We checked the Supreme Court’s docket, too, but we should have known it was: (1) not that current, and (2) not 100% accurate. So we missed two – there were also amicus briefs filed by DRI (we should have known those guys wouldn’t miss this party) and by the Generic Pharmaceutical Association. We missed DRI’s appearance because the docket had them listed with the plaintiff-side counsel (we do hope they’ll get that fixed - that's not where the “The Voice Of The Defense Bar” belongs). We missed the GPA (great acronym) because they’re new kids on the block, and because pioneer and generic pharma don’t talk to each other enough about this kind of thing.

Anyway, we’ve got ‘em now, so here goes:

Part II

We’ll do DRI’s brief first because … well … they’re DRI, and because Dan Troy wrote it – and he’s one of our preemption heroes.

But heroism aside, what does DRI have to say that’s interesting and different?

It’s not new, but DRI does highlight plaintiff’s counsel’s closing argument tirade against the FDA in the very first paragraph of the summary of argument. We observed both in Part I and in our initial post on Levine that plaintiff’s explicit attack on the FDA is one of the best things the defense side has going for it in this case. It’s really hard for the other side to tell the jury it should disregard the Agency, and then to argue before the United States Supreme Court, with a straight face, that there’s no conflict between the verdict the plaintiff obtained and the Agency’s actions.

Good facts make good law.

We’ll skip over DRI’s lengthy description of the FDA’s New Drug Application process – not because there’s anything wrong with it (it’s quite good, actually, and contains a minimum of filler between the relevant citations), but because at least four of the briefs we’ve already read have something similar in them. We do particularly like the quote from 50 Fed. Reg. at 7470 about the effects of “substantive changes in labeling.” If you ever find yourself needing to write something similar in your own cases, remember that this is here.

Plagiarize. Let no other lawyer’s work evade your eyes (which is, in and of itself, plagiarized from Tom Lehrer).

One part of DRI’s administrative argument that is distinctive is the relatively lengthy discussion of the enhancement of the FDA’s powers by the recent FDAAA. DRI br. at 12-14. This goes to show that there’s a right way (congressional action) and a wrong way (complaining in state-law litigation) to deal with perceived deficiencies in FDA regulations. The 2007 FDAAA might not be directly relevant to regulatory actions that occurred in the 1990s and before, but it sure as heck will be relevant to new litigation that comes in the door – so we’re happy to have the analysis.

The most notable “new” argument that DRI brings to the table is the detailed discussion of why and how the FDA is inherently better suited to making society-wide safety judgments about the risks and benefits of the products it regulates. Other defense briefs have this point, but none with the thoroughness of DRI. DRI’s argument starts with judicial deference to administrative decision-making:

Congressional design requires federal courts – never mind state law and state lay juries – to accept and defer to FDA’s expert judgment and exercise of discretion about such difficult issues. Determining reliable scientific data is not the judicial function. Congress vested that responsibility in the FDA and [courts] will not preempt its presumed expertise. Indeed, the Court has observed that it is enough for us that the expert agency . . . has determined that such regulation is desirable for the public health, for we are hardly qualified to second-guess the Secretary’s medical judgment.
DRI br. at 17-18 (all sorts of citations and quotations omitted).

Using the judicial deference cases as sort of an extended a fortiori argument, DRI turns to the heart of the FDA’s administrative advantage – the point, already accepted by seven justices in Riegel, that state-law juries are “poor substitutes” for the FDA at making drug safety decisions that affect everyone in our society:

A dramatic gulf separates the competence of FDA from that of state jurors who, absent preemption, are called on to “police” prescription drugs and second-guess federal regulators. Laypersons applying state law cannot substitute for FDA, the expert agency congressionally delegated the role of meticulously balancing nuanced and sometimes competing nationwide goals. FDA’s regulation of prescription drugs is, as shown above, governed by a sweeping network of federal law individually applied to each drug. A lay jury lacks the expertise and the broader perspective of FDA and thus cannot adequately adjudicate individual patient risks in the context of population benefits – quintessentially the kind of issue FDA must confront every day. Without preemption, however, state juries are asked to do just that. See, e.g., Pet. Br. 23 (“‘Thank God we don’t rely on the FDA to . . . make the safe[ty] decision. You will make the decision.’”) (quoting JA 211).
DRI br. at 19-20. That’s the DRI’s main preemption argument in a nutshell – beginning with a paraphrase of the Supreme Court’s conclusion about juries vs. the FDA in Riegel and ending with plaintiff’s counsel’s anti-FDA tirade to the jury in the Levine trial.

Pretty powerful stuff, we think.

Good enough to win? We hope.

The next portion of DRI’s brief is devoted to analysis, much of which we haven’t seen before, that supports the propositions stated in its opening paragraph. It makes great reading for defense-side fellow-travelers like us.

  • The complexity of the FDA’s decision-making. DRI br. at 20.

  • The limitations of the tort system in dealing with unavoidably unsafe products. Id. at 20-21.

  • The limited perspective of juries. Id. at 21.

  • Research on juror tendencies to overrate low-probability risks. Id.

  • Justice Breyer’s remarks about the FDA versus jurors during the Kent argument, and similar statements. Id. at 21-22. We blogged about his little speech before.

  • Juror inability to engage in the sort of tradeoffs that the FDA is called upon to make. Id. at 23.
DRI then does something else that we were hoping to see – it puts before the Court the preemption issues presented by the SSRI-suicide litigation. DRI br. at 23-26. We’ve mentioned before that, as excellent as the Levine facts are for the defense preemption position, the SSRI cases arguably present even better facts for preemption – "because of the sheer magnitude of more than a decade of intense FDA involvement, and the Agency’s repeated conclusions (through the present day) that the plaintiffs’ warning proposals lack scientific support.”

We’re delighted that DRI took the time to explain this other preemption situation to the Court.

For good measure, DRI also discusses (br. at 26-27) the Dowhal litigation (we’ve addressed that here) – another specific situation where preemption was extremely appropriate, given the amount of consideration that the FDA had given to the relative risks of the smoking cessation devices at issue.

DRI ends its brief with policy: tort liability leading to overwarning and defensive labeling (br. at 28-30); tort liability as a disincentive to innovation (id. at 31); and tort liability as an incentive to remove valuable products from the market (at least in this country) (id. at 31-33), and the tort tax that all this litigation exacts from the health care system. Id. at 33.

The other Levine amicus brief we overlooked before was filed by the GPA – on behalf of the generic drug manufacturers. The mere fact that we did so is worrisome to us. As GPA points out, over 60% of all drug prescriptions are generic these days. GPA br. at 1.

But we don’t represent generics.

Why not?

Conflicts of interest, real or potential. The problem is that in so many areas (other than product liability), the pioneer drug manufacturers (our clients) and the generics are engaged in almost constant litigation with each other. Groups on the opposite side of that much litigation don’t tend to use lawyers who also represent the other side. There are all kinds of real or potential conflicts of interest that prevent cross-representation, and thus cross-fertilization of legal thinking. In fact, just last weekend, we jokingly referred to the pioneers and the generics in the same breath as the Hatfields and the McCoys.

But on an issue like preemption in product liability litigation, the pioneer and the generic manufacturers are almost entirely on the same side. Colacicco was an example of that – where both types of manufacturers were sued in the same case. We’ve fretted before that, because the generics are relative newcomers to product liability litigation, their lawyers might lag a bit on the learning curve on an issue like preemption, where the lawyers representing pioneer manufacturers have had to think about the issue so much more – simply because their clients have been sued so much more frequently.

Indeed, one reason we launched this blog was to create a place where all defense lawyers could exchange ideas on a wide range of defense issues – with no conflict issues to complicate that exchange, because everything here’s both public and free.

(On the other hand, you get what you pay for.)

All of that is basically a lead in to this: We’re pleased and relieved to see the generics – represented by a top drawer firm – jump fully into the fray on preemption. (Although, as we noted before, one generic did nice work in Gaeta v. Perrigo and another in Mensing v. Wyeth.) We hope to see the generics around as amici more often.

So what does GPA have to say?

What would you expect?

GPA mostly explains how preemption works in the somewhat different statutory framework that applies to generic drugs. We’d already seen some of this in Colacicco, but the Third Circuit never reached any issue peculiar to the generic manufacturer’s situation.

In this brief, the generics give it to the plaintiffs with both barrels.

GPA sees preemption in the generic drug context as “even stronger” than with the pioneer manufacturers that we represent. GPA br. at 2.

We wouldn’t go that far, but we understand why GPA would.

Why? Well, here’s what GPA argues:

  • Generic manufacturers don’t have control over their own labels. By statute, generic labels must be the “same” as the label used by the original pioneer manufacturer of the drug. 21 U.S.C. §355(j)(2)(A)(v). GPA br. at 5, 9.

  • Because of the statutory “sameness” requirement, the FDA does not allow generics to change their labels without pre-approval for any reason – there’s no “changes being effected” exception for generic products. E.g., 73 Fed. Reg. 2848, 2849 n.1 (FDA Jan. 16, 2008). GPA br. at 6, 11.

  • The FDA considered, and rejected, providing CBE procedures for generic drugs. GPA br. at 9-10. Interesting - we didn’t know that.

  • Even when the pioneer manufacturer uses the CBE exception to change its labeling without prior FDA approval, a generic manufacturer may not deviate from the last FDA-approved labeling. E.g., 57 Fed. Reg. 17950, 17961 (FDA Apr. 28, 1992). GPA br. at 6, 10.

  • It is therefore impossible for an generic manufacturer to comply with both a state law determination that its warning is inadequate and the federal “sameness” mandate. 21 C.F.R. §314.150(b)(10). GPA br. at 7, 11-12.
We give GPA a 4.0.

We’re now much better informed about the generic manufacturers’ preemption arguments than we were before. We’ll try to keep our eyes open for anything new and interesting that’s relevant to generic drug product liability litigation. And we invite attorneys who represent generics to alert us to this type of information.

Remember: If nobody tells us, we can’t share.

So that’s it. Now we’re sure we’ve looked through everything that our side has filed in Levine.

But if we’re wrong, tell us.

1 comment:

Seymour said...

I know little about the law, but I think I know a bit about fairness & justice. Before the Supreme Court hears this case, I suggest they experience an injection of phenergan the same way it was injected for Mrs. Levine, do you think they have enough confidence in the FDA to go through with it?
Or better yet, why not a little Ketek.

As you would have it, there may be sound legal basis to favor Wyeth's position, but at what point do we hold the manufacturers responsible & accountable for producing a safe product? Just because the FDA approves the product for use & has labeling standards, does not mean the product is necessarily safe. With your competitive desire to win this case with little regard for patient safety, I hope that you don't have an illness in the future that relies on the use of
drugs.