To the surprise of absolutely nobody, the Plaintiffs filed their petition seeking rehearing en banc in Colacicco/McNellis late on Tuesday. We obtained a copy late yesterday (thanks Chilton!). The plaintiffs could have decided not to seek rehearing and could have proceeded with a certiorari petition to the Supreme Court. Instead, they’ve decided to slow the Colacicco appeal down.

We think the main reason for that is that the Colacicco/McNellis plaintiffs do not want any chance for the facts of these two cases to get to the Supreme Court before the Levine appeal is decided. Now, we’ve said before that we’re quite happy with the facts in Wyeth v. Levine: (1) good, FDA approved warnings about the precise risk at issue (mentioning it 4 times, including in bold-face, all-caps print), (2) prior, specific FDA review of the precise risk and precise medical procedure involved, resulting in ratification of the label’s language; (3) the case fits within one of the six situations where the FDA has taken a position that there should be preemption; and (4) of no suggestion of any regulatory violation or withholding of information from the FDA. We reiterate that we like the factual positioning of Levine.

But while Levine has excellent facts, Colacicco/McNellis are SSRI-suicide cases, and those cases present what are probably the best possible 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. See Colacicco v. Apotex Inc., 521 F.3d 253, 2008 WL 927848, at *12-13, 15-16 (3d Cir. April 8, 2008), describing in detail this long history of FDA review.

Indeed, it was the SSRI litigation that caused the FDA to file its first amicus brief supporting implied preemption in an otherwise ordinary product liability case involving a prescription drug. The FDA has briefed SSRI preemption five times, far more than any other preemption fact pattern. Readers can find all those briefs here.

So we can understand why the plaintiffs would want to keep Colacicco/McNellis as far away from the Supreme Court as possible.

They won’t be able to keep Colacicco away from the rest of the court system, though. Just recently an Illinois district court in Mason v. Smithkline Beecham, 546 F. Supp.2d 618 (C.D. Ill. Apr. 23, 2008), relied upon Colacicco to find preemption in yet another SSRI suicide case. The handwriting’s on the wall for this type of claim, it appears, but our side will keep trying to produce more good preemption (and other) precedent as long as SSRI/suicide claims are being litigated.

So with the preliminaries out of the way, what are the plaintiffs saying to try to change the Third Circuit’s mind?

You can tell before even getting to the petition itself that plaintiffs’ are hanging their hat mostly on a Supreme Court case, Sprietsma v. Mercury Marine, 537 U.S. 51 (2002). In a “statement of counsel,” (required to deter frivolous petitions), they claim that there’s a “direct conflict” with Sprietsma. They, of course, proceed to make the same argument in their papers. Petition at 7-12.

We frankly don’t see where Sprietsma gets plaintiffs – and neither did the plaintiffs in Colacicco/McNellis the first time around, at least not very much.

In McNellis (#06-5148), the plaintiff’s appellate brief mentioned Sprietsma exactly once, on page 52, and made no claim of any “conflict” direct or otherwise, between that case and what the defendants were arguing. In Colacicco (#06-3107) the plaintiff did make a Sprietsma argument, but not very prominently – only as the third argument, only for about 4 pages. And the plaintiff’s reply brief in Colacicco did even less with Sprietsma than his initial brief.

The plaintiffs’ desultory reliance on Sprietsma is reflected in the Third Circuit’s Colacicco opinion. Sprietsma is cited only twice: a “see, e.g.” cite as a “minimum standards” case, 2008 WL 927848, at *12, and a “cf” cite (the weakest possible positive cite), id. at *14, for the proposition that agency action can have preemptive effect.

What’s more, the dissent in Colacicco – which otherwise favored the plaintiffs’ position – thought so little of plaintiffs’ Sprietsma arguments that it didn’t cite the case at all.

And now plaintiffs are trying to make Sprietsma the centerpiece of a rehearing petition? Ouch!

It looks like plaintiffs have been using Sprietsma to play bait and switch with the court – hide it, invite “error,” and then seek rehearing.

Then again, there are very good reasons why plaintiffs did not argue Sprietsma very strongly the first time around. Those same reasons demonstrate that their belated attempt to gin up a conflict now doesn’t hold water.

Sprietsma involved a decision of an administrative agency not to regulate.

Colacicco/McNellis involves – as we’ve said and as the court lays out in excruciating detail – over ten years of intensive, affirmative agency action.

Let’s take a short look at Sprietsma. The case involved outboard motors, not drugs, and the Coast Guard rather than the FDA. The Coast Guard considered whether or not outboard motor propellers should be covered with guards to protect swimmers (and manatees) against being cut up if they were run over, but couldn’t reach a definitive conclusion. While the guard would protect against the propellers themselves, the size of the guard was much larger than just the propeller, so the guard would cause more collisions with more things.

So the Coast Guard closed its consideration of propeller guards without doing anything.

The question in Sprietsma was whether that failure to regulate had preemptive effect against a common-law tort claim that failure to guard an outboard propeller was a product defect. The Court held unanimously that it did not. First of all, Sprietsma involved express preemption – the interpretation of statutory preemption language (which Colacicco does not). 537 U.S. at 62-63. The preemption clause in Sprietsma was limited only to state “law or regulation,” which the Court found, in the context of that statute, meant only “positive” state enactments. Id. at 63.

Implied conflict preemption of the sort involved in Colacicco has been applied over and over again to common-law tort claims, most notably in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and Geier v. American Honda Motor Co., 529 U.S. 861 (2000). So simply as a legal proposition, any analogy between Sprietsma and Colacicco doesn’t hold water.

As a factual proposition, the analogy is even worse. The Sprietsma Court held:

It is quite wrong to view that decision [not to adopt a regulation] as the functional equivalent of a regulation prohibiting all States and their political subdivisions from adopting such a regulation. The decision in 1990 to accept the subcommittee’s recommendation to “take no regulatory action,” left the law applicable to propeller guards exactly the same as it had been before the subcommittee began its investigation.

537 U.S. at 65.

The Bush Justice Department (which plaintiffs usually can’t resist attacking) filed an amicus brief in Sprietsma supporting the proposition that mere agency inaction is not preemptive. Id. at 67-68. The Supreme Court relied in its decision on the fact that the result it reached was in line both with the position of the agency and Justice Department. Id. at 68 (“the Solicitor General, joined by counsel for the Coast Guard, has informed us that the agency does not view the 1990 refusal to regulate or any subsequent regulatory actions by the Coast Guard as having any pre-emptive effect”).

The SSRI facts could hardly be more diametrically the opposite of the agency inaction scenario in Sprietsma – well over a decade of FDA administrative action, repeated FDA review and Agency conclusions that the scientific data do not support the warnings plaintiffs demand, all kinds of FDA pronouncements to that effect, and repeated amicus filings stating that the FDA did intend that its decision on this precise matter should have preemptive effect. 2008 WL 927848, at *12-13, 15-16.

The Sprietsma situation just ain’t here, folks.

Not unless black is white.

Even better, the Supreme Court had advice in Sprietsma for agencies that, unlike the Coast Guard in the case before it, wanted their decisions not to enact formal regulations to have preemptive effect. The court “recognized” that a no regulation decision by an administrative agency can have preemptive effect under certain circumstances:

[W]e have recognized that a federal decision to forgo regulation in a given area may imply an authoritative federal determination that the area is best left unregulated, and in that event would have as much pre-emptive force as a decision to regulate.

537 U.S. at 66 (citations omitted) (emphasis added). Thus an agency can’t just decide not to act if it wants there to be preemption. Rather, the agency must “take the further step of deciding that, as a matter of policy, the States and their political subdivisions should not impose” what the agency had decided not to do. Id. at 67.

And unfortunately for the Colacicco plaintiffs, an “authoritative federal determination” is exactly what the FDA has provided in the SSRI area. The FDA has said so five times in amicus briefs, and again in the 2006 Preemption Preamble that it intends its multiple decisions not to require adult suicide warnings to have preemptive effect.

Again, we go back to the facts. On the SSRI facts, Sprietsma actually becomes a pro-preemption decision. That’s why we like to argue preemption in SSRI/suicide cases. The facts are so good that they flip cases like Sprietsma.

What else besides Sprietsma is there in the plaintiffs’ rehearing petition? They continue to make the argument, contrary to the very purpose of implied preemption, that express congressional “intent” is required. Petition at 6. We’ve already discussed the Colacicco court’s recognition that the entire reason there is such a thing as “implied” preemption, is to address situations where preemption arises by conflict, rather than intent. We think that logic is unavoidable – it’s what “implied” means.

There’s another rehash of the presumption against preemption. Petition at 6-7. We also addressed that in our prior post. The simple fact is that plaintiffs cannot and do not point to a single Supreme Court case applying a presumption against preemption in an implied conflict preemption case.

What plaintiffs really want to do is abolish implied preemption altogether: “Predicating preemption only on positive federal law – statutory or regulatory law – preserves judicial focus on … congressional intent.” Petition at 9 n.1. Their claim that only formal regulations can be preemptive is contrary not only to all the other cases holding SSRI suicide claims preempted, but also, at least, to Dowhal v. Smithkline Beecham Consumer Healthcare, 88 P.3d 1, 10 (Cal. 2004); and Whitson v. Safeskin Corp., 313 F. Supp.2d 473, 477-78 (M.D. Pa. 2004), which also find preemption in the absence of formal FDA regulations. There are undoubtedly more decisions on this point, but we’re trying to get this post done.

The petition also attacks the majority opinion in Colacicco for giving any deference to the FDA’s preemption position. Petition at 12-13. Actually, as we’ve pointed out before, judicial deference to administrative positions on preemption, typically expressed in amicus briefs, has more or less been the rule, rather than the exception. In fact, the only recent case in which the Supreme Court hasn’t agreed with the relevant administrative agency’s position on preemption is Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), and even there the Court still found some preemption.

Next plaintiffs argue that the Colacicco majority “failed to appreciate” the essential “harmony between tort law and FDA regulation.” Petition at 13-14. Aside from sounding rather New Age, this claim of “harmony” is belied by what the petition says – specifically that “State courts provide a check on agency power.” Id. at 14 (quoting Colacicco dissent).

Since when has it been the role of a state court to “check” anything the federal government is doing? Not in the last century and a half, anyway. We fought a civil war over precisely this point. “Interposition” is dead – just as dead as John C. Calhoun.

Sure, a state court can declare something the feds do to be unconstitutional, but that’s not at all what the plaintiffs want here. They just want money. Specifically, they want the defendants to pay them despite having obeyed to the letter what the FDA told them – specifically and repeatedly – to say in their warnings about these drugs and suicide.

Beyond that, and putting aside plaintiffs’ rather unique view of state power under the Supremacy Clause, the very idea of state tort suits intentionally seeking to “check” the exercise of federal administrative authority doesn’t exactly fit with the argument they are trying to make – that there’s “harmony” between these tort suits and the FDA’s regulation of the drugs at issue.
A “check” isn’t “harmony.” Nor are state-law tort suits somehow a fourth branch of the federal government – not any more than Dick Cheney.

The last point the plaintiffs’ petition makes (p.15) was the first one we made. Plaintiffs’ urge the pendency of the Wyeth v. Levine matter in the Supreme Court as a reason to grant rehearing in Colacicco – essentially to have the Third Circuit sit on these appeals and wait for Levine. We said at the outset that the main thing we think that these plaintiffs are trying accomplish is to keep these cases, which are the most advanced SSRI appeals, away from the Supreme Court until after Levine. This final argument only confirms the accuracy of our initial reaction to the plaintiffs’ decision to seek rehearing in Colacicco.