Photo of Bexis

We promised you that we would be “mining the depths” of Third Circuit’s opinion in Colacicco v. Apotex Inc., 521 F.3d 253, 2008 WL 927848 (3d Cir. Apr. 8, 2008), affirming implied prescription drug preemption. That, of course, assumes that our doing so is a good thing. But we have to believe that most of the eyeballs that stop this way are, if not quite as interested in (some would say obsessed with) preemption as we are, at least it’s close. So that’s what we’re assuming – and that’s what we’re going to do.
We’ve got our shovels out and we’re ready to start digging. But it’s a big job, so don’t expect us to finish it in one post. We don’t have that much free time on our hands, since we’re busy incorporating Colacicco into our pending briefs, for one thing.
Colacicco, of course is only one opinion by one circuit court, so it’s important to keep things in perspective – especially with the Supreme Court poised to tackle many of the same issues next term in the Levine case. That said, winning sure beats losing, and we’re quite happy with the perspective that the Third Circuit did take.
The Third Circuit points out that, “The FDA has actively monitored the possible association between SSRIs and suicide for nearly twenty years, and has concluded that the suicide warnings desired by plaintiffs are without scientific basis and would therefore be false and misleading.” Colacicco, 2008 WL 927848 at *12.
Why start there? Well it goes back to our Bone Screw days, where we adopted the unusual strategy of trying to beat a mass tort by surviving the MDL and then winning the individual cases on remand. But how can you possibly do that? you ask. Weren’t there hundreds of them? There sure were – thousands actually – but there was also stare decisis (for you non-lawyers, that’s the doctrine that courts, for the sake of legal stability, are supposed to follow their previous decisions). And that’s what ultimately helped us win.
We realized that the Bone Screw cases, factually, were not very sympathetic for the plaintiffs. The details don’t matter, because the point is that the relatively good facts for us gave us a leg up on a variety of legal propositions – from alternative designs in design defect determinations, to warning causation under the learned intermediary rule, to preemption of fraud on the FDA, to Daubert motions – and we set out to make as much good legal precedent as we could. The strategy was that we’d win enough motions, and then enough appeals, that the other side would eventually cave once they figured out that stare decisis meant that all this pro-defense precedent we were creating would be around to haunt them for quite some time.
It took us over 180 grants of summary judgment, but it worked, and the rest of the cases ended up settling very cheaply. We were right about stare decisis, too. The good law we made is still tripping up the other side, almost a decade after we started getting it. Ever heard of Buckman? It was a Bone Screw case. So are three quarters of the favorable FDCA negligence per se decisions in Florida, the construction of the design defect statute in Louisiana, the absence of cross-jurisdictional class action tolling in Tennessee and Virginia, application of the learned intermediary rule to medical devices in Ohio…. We could go on and on.
We could see the same thing happening with the SSRI suicide cases and preemption. If the other side is going to insist on bringing them, defendants might as well try to use the very favorable facts – especially the regulatory facts – in those cases to create as much favorable preemption (and other) precedent for the defense side as possible. Maybe the other side, as with the Bone Screw plaintiffs, will eventually decide that the suicide cases aren’t worth the candle.
If they do, we hope that there will be plenty of good precedent left behind for us to cite for the next decade or more to come.
We know that there will, at least, be Colacicco.
The dissent in Colacicco refers to a “sea change” with respect to preemption. Id. at *26. Judge Ambro was specifically discussing the FDA’s attitude towards preemption, but we already had that phrase written down in our marginal notes well before we ever got to the dissent.
We think we might just be seeing a sea change in judicial attitudes toward preemption in tort cases. When we were still relatively new at this game, and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), came down, we were quite surprised. Preemption in product liability cases wasn’t something we even thought about very much, it was that rare. So then we started thinking about it. When Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), came down and took preemption away from us in most of the medical device cases we were handling at the time, we were disappointed, but not particularly surprised. Preemption was still something that didn’t happen much in product liability cases.
When Geier v. American Honda Motor Co., 529 U.S. 861 (2000), came down, we were relieved and grateful. We did no-airbag cases back then, and we knew how much time, effort, and coordination that industry had put into getting the law to that point – and still the Geier decision was only 5-4.
But implied preemption had come to product liability litigation.
Not only did Geier kill the no-airbag litigation, but it was another example of product liability litigation being fought on a battlefield where the facts favored the defense. Under stare decisis, that precedent is still paying dividends.
Then we Bone Screwers brought implied preemption to the FDA’s regulatory scheme with Buckman. That decision was 8-1, and the preemption beachhead grew a bit.
Now it’s just possible that we’re seeing a preemption breakout – with the SSRI cases playing the role of Patton’s tanks heading across northern France. We’ve already discussed the Supreme Court’s recent similarly lopsided decision in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (U.S. 2008). One of the things that struck us about Riegel was the tone of the discussion – the Court’s attitude towards preemption was no longer grudging. Preemption was no longer an odd thing, but now an affirmatively a good thing.

[E]xcluding common-law duties from the scope of pre-emption would make little sense. . . . Indeed, one would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation [than a] state statute, or a regulation adopted by a state agency [which], could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA. . . . A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court. . . . [I]t is implausible that [Congress] meant to grant greater power (to set state standards different from, or in addition to federal standards) to a single state jury than to state officials acting through state administrative or legislative lawmaking processes. That perverse distinction is not required or even suggested. . .in the MDA, and we will not turn somersaults to create it.

Riegel, 128 S. Ct. at 1008 (emphasis added) (various internal quotation marks and citations omitted). Seven justices signed onto this indictment of the tort system in Riegel, at least in the product liability context.
There’s a similar, although not as blunt, tone to Colacicco (indeed, the language of both the majority and dissent in Colacicco is quite measured) – a tone that is more accepting of the role of preemption in protecting society from the excesses we’ve discussed of the modern product liability/mass tort litigation game.
The Third Circuit’s attitude towards preemption in Colacicco indicates that it’s now an accepted defense, and that the “presumptions” against it are beginning to fall away. We see that in the court’s conclusion about the role of “explicit” congressional preemptive intent:

[T]he lack of a Congressional directive expressly approving or rejecting preemption in the context of drug labeling regulations is not determinative. Rather, the conflict preemption analysis is designed to determine the propriety of preemption where Congress has not explicitly stated its intent. Seen in this light, [defendant’s] argument that the presumption against preemption is inapplicable in the context of implied conflict preemption has more force [than plaintiffs’ arguments].

Colacicco, 2008 WL 927848, at *8 (emphasis added).
Hallelujah. One of our very first substantive posts, way back in November, 2006 when we first began blogging (that seems a lot longer ago to us than it does to you, dear reader, because you don’t have to feed the blog beast), was that the “presumption against preemption” shouldn’t apply at all to conflict preemption cases. We demonstrated that the Supreme Court in fact hadn’t applied that presumption in conflict preemption cases – those that arose from the direct operation of the Constitution’s Supremacy Clause. The scope of the actual conflict, we argued, should determine the scope of preemption without any thumb on the scale.
Well Colacicco heard us – or more likely paid heed to some of the excellent briefing, including amicus briefing by PLAC and others, that made the same argument we had made in our post. The Colacicco court’s analysis, 2008 WL 927848, at *8, of the role that the presumption against preemption did and did not play in Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707 (1985), in particular, could have been taken straight out of our inaugural post. Thus we enthusiastically agree with Colacicco’s discussion of “the tension between such a presumption, which emphasizes the “clear and manifest purpose of Congress,” and implied conflict preemption, which analyzes preemption in the absence of any explicit intent.” 2008 WL 927848, at *8 (quoting Lohr, 518 U.S. at 485).
While it’s not entirely clear from the Third Circuit’s discussion of the presumption against preemption in Colacicco whether it’s “recognizing” that preemption only in some general sense, or in the particular case, 2008 WL 927848, at *8, we think that the dissent’s characterization of the weight the majority gave to the presumption against preemption in its analysis is pretty accurate. “[T]he presumption is performing virtually no analytical work” in the majority opinion. Id. at *20.
After Colacicco, the propriety of applying any presumption against preemption at all in conflict preemption cases is nicely teed up for briefing in and decision by the Supreme Court in Wyeth Laboratories v. Levine. Since we’ve already done a case by case analysis of every time the Supreme Court has mentioned the presumption against preemption, we’re confident in stating that the existence of any such presumption in conflict preemption (as opposed to field or express preemption) cases is quite an open question. If the Supreme Court in Levine (contrary to the Third Circuit in Colacicco) were to apply a presumption against preemption, it would be doing something it has never done before.
That’s just one place where we see a more accepting attitude towards preemption in Colacicco. Another is its view of the role of that branch of conflict preemption called “obstacle” or “frustration” preemption (there’s an excellent discussion of the different flavors of conflict preemption on pages *9-10 of the opinion). Obstacle preemption, the Third Circuit holds, is an “established” part of “ordinary preemption principles” in product liability litigation:

It is not only state statutes that may stand as obstacles to the achievement of federal objectives. It is now established that law suits based on state tort law, as well as on state statutes, may be viewed as presenting obstacles to the federal objectives and hence barred as preempted. . . . [O]rdinary preemption principles apply to a state tort action where an actual conflict with a federal objective is at stake.

Colacicco, 2008 WL 927848, at *10 (emphasis added). When we were starting out as product liability defense attorneys, implied preemption of common-law tort actions was anything but “established” and anything but an application of “ordinary tort principles.”
The times they are a changin’ (we hope).
The notion that the common law was somehow “different” than state statutes or regulations for preemption purposes has been thrown at us by the other side in preemption cases for as long as we can remember. It’s dead as a doornail now – run over by one of Patton’s tanks.
Another place where we detect that “sea change” change in judicial attitudes towards preemption is a little further on, in the course of the Third Circuit’s comparison of the FDA’s long history of administrative activity concerning suicide and SSRI (that’s “selective serotonin reuptake inhibitor,” for you gluttons for punishment) anti-depressants to the extensive administrative record concerning airbags in Geier. Sounding a lot like our prior quotation from the Supreme Court in Riegel (although Riegel is not cited for the point), the Third Circuit discusses one of the problems with product liability litigation that preemption protects against:

State common-law tort actions based on the manufacturers’ failure to warn present the pharmaceutical manufacturers with particular difficulties. State standards of care undoubtedly differ from state to state. Absent a determination that the FDA-approved labeling and the FDA’s refusal to require the warnings suggested by plaintiffs in this case preempt state tort actions, the manufacturers may be subjected to considerable liability based on varying standards, with no benchmark that they should follow.

2008 WL 927848, at *11 (emphasis added). This is every bit as fundamental a critique of the chaotic nature of product liability litigation (and, indeed, of the tort system as a whole), as the Supreme Court’s appraisal of the jury system in Riegel. Preemption, the Third Circuit holds, is what the constitution has provided to ensure that, once the FDA has taken what the court calls “actions taken pursuant to. . .statutory [or “regulatory”] authority,” those actions are not subject to challenge in state-law tort actions. Id. at *14, 16, 17.
That’s all we have time to do today. There are lots of other aspects of Colacicco that merit discussion:

  • The court’s extensive use of judicial notice in the context of a motion to dismiss, and how that might impact the tactical decision of what’s the best procedural posture in which to raise the preemption defense.
  • The preemptive effect that the court gives to a variety of FDA administrative actions other than notice-and-comment rulemaking. There are other cases giving preemptive effect to FDA actions less formal than agency regulations, but no other decision discusses the issue in so much depth.
  • The role of congressional intent in implied preemption situations (we’ve just scratched the surface of that).
  • The court’s fascinating discussion of deference to the FDA, and the distinctions it draws between factual determinations and legal positions.
  • The (quite respectful) back and forth between the majority and the dissent concerning whether the FDA has been “inconsistent” in its positions towards preemption, as to which we would offer our own “original research” on what the FDA has actually published in the Federal Register about preemption since 1977.
  • The court’s refusal to require defendants asserting preemption to jump through formalistic hoops (such as submission of CBE supplements) that the FDA does not require as a matter of administrative practice.
  • The court telling plaintiffs arguing fraud on the FDA to take their complaints to the FDA.
  • The preemption questions that the court specifically states it is not deciding.
  • The role of administrative activity in setting the boundaries of conflict preemption.
  • The court’s treatment of the “conflict” language in the 1962 FDCA amendments.

However, you’ll just have to wait. This particular tank covered a lot of ground, and it will take us foot soldiers some time to fully occupy it.