Thursday, April 17, 2008

Colacicco and Judicial Notice

We’ve previously offered our collective four cents worth about tactical considerations that pharmaceutical defendants need to think about in deciding whether or not to bring preemption motions in particular cases. Given the importance of the issue, and (until 2008) the relative equipoise in the opposing positions, we strongly recommended the Hippocratic Oath – “First, do no harm.” Or, as they say more bluntly in Herrmann’s Chicago, “Don’t back no losers.”

That’s impossible, of course. There’s no way, short of never filing any preemption motions at all, not to risk ending up with a decision that goes on the minus side of our drug preemption scorecard (updated, of course, to include Colacicco). Still, there are considerations that raise or lower the odds.

One of those odds shifters that we discussed was procedural posture. We’ve discouraged raising preemption through motions to dismiss, because as we learned in Civil Procedure 101, Rule 12 (and state equivalent) motions are based solely on the allegations in the plaintiff’s complaint. In litigating conflict preemption, it’s critical that the record demonstrate the full scope of the preemptive conflict as clearly and as starkly as possible. Defendants can’t do that if their side of the story is procedurally irrelevant. We’d pointed out in our prior post that Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the biggest preemption loss our side has suffered, was decided on a motion to dismiss.

We’d even been worrying (in private, of course) that procedural points about what was and was not properly before the court in the two consolidated Colacicco appeals could lead to a bizarre result. That’s because, while Colacicco itself was brought on a motion to dismiss, the companion case, McNellis, arose from a summary judgment motion where the full FDA record, in all its detail, was indisputably properly in evidence. We’d wondered whether the Third Circuit might recognize preemption on the full FDA record in McNellis, affirm dismissal of GSK in Colacicco on independent state-law grounds (GSK didn’t even make the generic product that the plaintiff actually took in Colacicco), and remand Apotex (the generic manufacturer) in Colacicco for “further proceedings” that would have been an almost immediate summary judgment motion to take advantage of the postulated McNellis ruling.

See how hypertechnical lawyers can get?

And how wrong. That didn’t happen, of course. And the reason it didn’t happen was judicial notice. We’ve discussed judicial notice before, in a somewhat different context. Judicial notice, we explained then, was a quick way to get facts into the record that were sufficiently established that there couldn’t really be a fight about them:


Again, so that non-lawyers aren’t left scratching their heads, “judicial notice” is when something is so definitively known (for any number of reasons) that it doesn’t have to be proven with first-hand testimony of that fact. Judicial notice is usually concerned with facts that aren’t really subject to dispute, such as did a particular date fall on a Tuesday, or is a town being located in a particular county or state. In such situations, it’s a waste of time to require evidence to prove that kind of fact. So the judge “notices” it – conclusively declaring it to be so.
There, that's probably the first time we've ever block quoted ourselves.

In the Colacicco half of Colacicco v. Apotex Inc., 521 F.3d 253, 2008 WL 927848 (3d Cir. April 8, 2008), the Third Circuit judicially noticed just about the entire history of FDA regulatory activity involving (generic) Paxil specifically, and SSRI antidepressants more generally. Here’s a rundown of exactly what items the Third Circuit took judicial notice of in the Colacicco half of the Colacicco opinion:
  • The FDA’s rejection of three citizen’s petitions, filed against Prozac, a drug not involved in Colacicco. 2008 WL 927848, at *12.
  • Several FDA approval letters for Paxil. Id. at *13 n.16.
  • The FDA’s 2003 approval letter for generic Paxil. Id. at *13.
  • FDA talk papers from 2003 and 2004. Id. at *13, 15.
  • The FDA’s 2003 Public Health Advisory, concerning pediatric suicide. Id
  • The labeling for Paxil. Id. at *15 n.18.
  • The FDA’s 2007 public notice on “Antidepressant Use in Children, Adolescents and Adults.” Id. at *16.
  • The FDA’s 2007 class revisions to SSRI labeling. Id. at *16 & n.20.
  • An FDA news bulletin about the 2007 class revisions. Id. at *16.
The first thing that needs to be pointed out is that the Colacicco court didn’t do this for the purpose of deciding whether the FDA had ultimately made the right decision. That would have been an improper use of judicial notice, because whether SSRIs cause suicide was hotly disputed. Rather, the court took judicial notice of the fact that the FDA had considered the issue of suicide warnings on quite a few occasions, and also of the fact that the FDA had resolved that issue, at various times, on the evidence before the Agency, and in ways that left no doubt that it would not have permitted the different warnings the plaintiffs were urging. See Colacicco, 2008 WL 927848, at *12 n.13 (judicial notice is “not for the truth of their [FDA public records] contents” but only as demonstrating the “information” that was “provided by [the FDA] to the relevant regulated parties”).

Again, the Court never offered any opinion about whether the FDA made the “right” decision. Id. at *18 (“we express no view as to the merits of the issue whether SSRIs contribute to adult suicidality. . . . That is within the FDA’s authority”). The FDA’s actions were of independent significance. The “fact” that the FDA had acted, rightly or wrongly, was important. That’s because the scope of the FDA’s actions taken within its delegated “authority” were what determined the scope of preemption. Id. at *14, 16, 18.

For those of you out there contemplating preemption motions in the aftermath of Colccicco, and wondering if you can save your client the (considerable) expense of discovery by raising the issue on the pleadings, you’re going to have to look for precedent that supports the kind of judicial notice that the Colacicco court allowed. Colacicco cited Anspach v. City of Philadelphia, Dep’t of Public Health, 503 F.3d 256, 273 n. 11 (3d Cir. 2007) (taking judicial notice of FDA public records). 2008 WL 927848, at *12 n.13.

Is there more than that?

You betcha. Why do you think we’re blogging on this issue?

Doing what we do best, here’s a head start – some more cases we’ve found on judicial notice of FDA records. Meyers v. Bayer AG, 735 N.W.2d 448, 467-68 (Wis. 2007) (drug approvals and possibly other FDA documents); Horne v. Novartis Pharmaceuticals Corp., 541 F. Supp.2d 768, 2008 WL 818819, at *5 (W.D.N.C. March 25, 2008) (“the Court may take judicial notice of and consider the public records of the FDA, such as the Public Health Advisory”); Schering-Plough Healthcare Products, Inc. v. Schwarz Pharma, Inc., 547 F. Supp.2d 939, 2008 WL 582738, at *5 n.1 (E.D. Wis. Feb. 29, 2008) (“The court may take judicial notice of the FDA letters submitted by the parties”); In re Amgen Inc. Securities Litigation, 544 F. Supp.2d 1009, 2008 WL 999058, at *7 (C.D. Cal. Feb. 1, 2008) (judicially noticing several items, including drug labeling, FDA health advisories, and the transcript of an FDA drug advisory committee meeting); Ebel v. Eli Lilly & Co., 536 F. Supp.2d 767, 781 (S.D. Tex. 2008) (drug labeling); Matthews v. Donald, 2007 WL 2593086, at *1-2 (N.D. Ga. Sept. 4, 2007) (FDA press release); Rozzelle v. Rossi, 2007 WL 2571935, at *7-8 (W.D. Pa. Aug. 31, 2007) (drug labeling); Wright v. Henderson, 2007 WL 2484317, at *2 (N.D. Ga. Aug. 28, 2007) (FDA press release); Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 293, 295, 310 (E.D. Pa. 2007) (FDA talk paper; FDA vaccine approvals; FDA guidances); Fellner v. Tri-Union Seafoods, L.L.C., 2007 WL 87633, at *1 (D.N.J. Jan. 9, 2007) (FDA consumer advisory; FDA letter to state attorney general; FDA compliance guide). We’ll stop there. These ten cases are just the leading edge – FDA judicial notice cases going only back to the beginning of 2007. There are lots more out there. We’ve barely reviewed a third of the cases that a very simple computer search generated.

The takeaways from this little exercise are two: First, the Third Circuit’s use of judicial notice in Colacicco, while extensive, is well supported by precedent (probably why the dissent in Colacicco raised no objection to the majority’s use of judicial notice), and second, because of judicial notice, we may have to re-evaluate some of our previously stated views on preemption motions and procedural posture.

In Colacicco, judicial notice became the vehicle for ensuring that, notwithstanding Rule 12’s restrictions on looking beyond the complaint, the entire FDA regulatory history of a drug could be put before the court on a motion to dismiss. Where any motion requires a court to decide whether there’s a conflict with FDA activity that warrants preemption, the availability of a complete regulatory record demonstrating what the FDA actually did is critical.

Judicial notice can also be taken of the records of prior legal proceedings. Colacicco, 2008 WL 927848, at *12 n.13, citing Jean Alexander Cosmetics, Inc. v. L’Oreal USA, Inc., 458 F.3d 244, 256 n. 5 (3d Cir. 2006). This is a common use of judicial notice, so no free research. From this proposition, the Colacicco court goes on to cite one of the FDA’s amicus briefs in SSRI cases as further evidence of what the FDA’s position was on the suicide/causation question at a particular time. See 2008 WL 927848, at *13 (citing the FDA’s 2002 Motus brief).

Colacicco thus stands in stark contrast to the court’s refusal to even consider FDA amicus briefs in Collins v. Smithkline Beecham Corp., 2008 WL 744070 (Pa. C.P. Philadelphia Co. March 11, 2008), a case we’ve already discussed. In Collins the court dismissed the FDA’s briefs as “hearsay.” We don’t think that FDA briefs, at least when considered for the limited purposes of establishing what positions the FDA took and when, are hearsay at all, since they’re not being admitted for the truth of what they say (for non-lawyers, “for the truth” is the classic definition of hearsay). But even if they were, judicial notice (not mentioned in Collins) would have been another alternative.

Pa. R. Evid. 201, concerning judicial notice, “adopted” “the approach of the Federal Rule.” Id., Official Comment. The Pennsylvania rule even makes clear that “Judicial notice may be taken at any stage of the proceeding,” in order to overturn precedent that disapproved of judicial notice “at the pleading stage.” Id. Thus, judicial notice of FDA regulatory positions has been approved by other Pennsylvania courts. Cosom v. Marcotte, 760 A.2d 886, 893 (Pa. Super. 2000) (several FDA actions involving bone screws), vacated on other grounds, 808 A.2d 177 (Pa. 2002); Bacon v. Upjohn Co., 2 Phila. Co. Rptr. 285, 296 (Pa. C.P. Philadelphia Co. 1979) (drug approval). It doesn’t appear from the opinion that judicial notice was sought in Collins.

Was that a mistake? We can’t say that, and here’s why.

Any defendant considering whether to request judicial notice must ask if a judge – like the judge in Collins – who is not favorably disposed to preemption in the first place, would nevertheless permit a defendant to make its record through judicial notice. That’s a judgment call that counsel must make in each case based upon their familiarity with the judge. That’s the same basic consideration inherent in deciding to make the preemption motion in the first place.

We will say this. If judicial notice is available in a particular case, then a lot of our hesitation about making early preemption motions goes away.

As defense counsel, there’s nothing we like better than to win cases without putting our client through the great time and expense of discovery. Not only is it cheaper and faster, but anytime discovery is avoided, so is the possibility that somebody on the other side will make improper use of what our clients have to produce. Winning preemption on motions to dismiss, rather than through summary judgment, accomplishes this.

Colacicco demonstrates the value of judicial notice. Through judicial notice defendants can build the kind of detailed record of administrative history necessary to establish the existence of preemptive conflicts – notwithstanding procedural limitations that otherwise restrict the ability of the court (and the parties) to look beyond the allegations of a plaintiff’s complaint. But the “judicial” half of “judicial notice” provides the final cautionary note. Defendants need to think long and hard about the inclinations of the judge hearing their case when choosing this route.

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