Monday, December 10, 2007

Colacicco: A Report From the Courtroom

Michael Imbroscio, of Covington & Burling, attended the oral argument today in the Colacicco/McNellis appeal in the Third Circuit in Philadelphia. He just sent us this report describing the argument. Your dynamic blogging duo had nothing to do with this report; it's entirely Mike's work, for which we thank him:

In a packed courtroom, the Third Circuit heard arguments for nearly two hours this morning in the companion preemption cases of Colacicco and McNellis. Seven different lawyers presented spirited arguments to an extremely active bench, with the first question coming before the first speaker even opened his mouth. In the end, the varied comments and questions from the bench made rational prediction difficult and likely left all sides with at least some feeling for optimism.

As noted in a previous post, former Third Circuit Chief (and still active) Judge Doris Sloviter presided. Judge Thomas Ambro and Court of International Trade Judge Jane Restani, sitting by designation, comprised the panel. All three were extremely well prepared and asked tough and compelling questions, though at times the panel seemed to get a little lost in the details and practicalities of pharmaceutical regulation. At the conclusion of the argument, the Court directed the parties to prepare the transcript of the argument, which is due to be filed by December 24. In the meantime, below are a few highlights from this morning’s session. The quotes utilized are intended to capture the gist of the exchange and of course are not verbatim.

Derek Braslow argued first for Mr. Colacicco. Judge Ambro’s first question, before Braslow even began, asked: “FDA says there is preemption, so your argument is, what?” Early on, the panel seemed to put to rest the “presumption against preemption” and the “lack of congressional intent” to preempt issues. Judge Sloviter asked rhetorically whether this issue was controlled by the Court’s recent Zeneca decision, and continued that, by definition, conflict preemption occurs in the absence of a Congressional statement of preemption.

Much of the argument instead focused on whether there existed an actual conflict in these cases. Judge Restani seemed to question whether there in fact was an actual conflict since FDA had not explicitly rejected a request by one of the companies to amend their labeling to note an increased risk of suicidality. Sloviter seemed to extract a concession out of Braslow when she went through the history and asked, “Why isn’t that a conflict? Do you concede there is a conflict?” and Braslow responded, “Right,” and proceeded to talk about how the CBEs nevertheless provided a way out of the conflict. Sloviter pushed him further by asking him whether FDA’s position that it would reject such a change “is a lie,” to which Braslow responded to a visibly bothered Sloviter, “Yes, it’s not true.” Ultimately, Braslow said that an individual labeling determination does not amount to “an authoritative message of federal law” under Sprietsma. Braslow’s argument ended with an exchange with Ambro on the level of deference the Court owes to the FDA’s position. In one of the more humorous moments, Braslow responded, “None,” which Sloviter gasped aloud “None?” and Ambro rejoined, “As in zip?”

Sol Weiss argued next for the McNellis family. The argument began with Judge Restani pointing out that the McNellis plaintiffs had discovery. She questioned whether Plaintiffs were claiming that “secret” data had not been made public or provided to the FDA. Judge Ambro interjected here and once again later to point out that the FDA does not have subpoena power and doesn’t conduct its own testing, a common refrain from the Plaintiff’s bar seeking to minimize the scrutiny and tools of FDA. At several points, Judge Sloviter seemed to be annoyed with Weiss, beginning when Weiss talked over one of her early questions and a few minutes later when Sloviter chastised him, “If you don’t want to listen to the question, fine.” Questions from both Sloviter and Restani seemed to emphasize that all of the labeling determinations needed to go through the FDA.

Charles Becker next argued as amicus for the Pennsylvania branch of the trade association formerly known as the America Trial Lawyers Association. He spoke for about 10 minutes, and seemed to be a good clean-up hitter for the Plaintiffs. The Court seemed receptive to his style and his responses seemed to better answer some the Court’s more pointed questions. Much of his argument focused on the “actual conflict” issue -- Was there really a definable conflict in these cases, as opposed to a hypothetical conflict.

First up for the manufacturers was Chilton Varner. Almost immediately, Judge Restani picked up on the prior exchange and asked whether GSK ever made the explicit request to FDA to change the labeling. Varner responded that the data has never existed to support such a request. Near the end Varner seemed to bring the actual conflict issue back into focus a bit when she succinctly summarized that “a warning declared adequate under federal law cannot be deemed inadequate under state law.”

Sharon Swingle for the DOJ spoke next, and the panel seemed eager to inquire of her the basis for FDA’s position. She began by noting that the broad preemption issues implicated in the Preamble were not necessarily implicated in this case, which presents an unmistakable case for a clear, actual conflict. Ambro and others pressed her on this point, and on the level of deference that the Court should show to the FDA’s position, both in the briefs and in the Preamble itself. Near the end, Swingle made a strong point that the regime that some of the Court’s questions seemed to be inviting -- submissions by companies to protect itself against lawsuits even though there is insufficient data and even though the request had been essentially already rejected -- would present a significant administrative burden on the FDA. She did not mention Buckman specifically, but the support for this point lies firmly in Buckman. It was not clear to me, however, that any of the panel members picked up the importance of this relatively quick exchange. Swingle also made a passing reference to the recent FDAAA drug safety amendments, but no judge followed up on her point (and there has not been any Rule 28(j) letter submitted to the panel on the FDAAA and Rule of Construction.) The exchange ended with Ambro pressing Swingle on the FDA’s current “24 and under” increased risk position, implicitly suggesting that it has been the SSRI litigation itself that has resulted in these labeling changes and getting Swingle to acknowledge that FDA in the past has noted the salutary effect that private civil litigation can have on regulatory safety.

Arthur Kepple spoke for Apotex next, and the argument revolved around whether generics have the ability on their own, post-approval, to submit a CBE. Ambro tested his “no obligation” position intensely, asking what Apotex would be obligated to do if it came into possession of such risk information (Kepple: approach FDA to discuss) and how long it might take (Kepple: agreed it could take months). Throughout this exchange, Ambro seemed to be genuinely bothered by the FDA’s statement promulgating the labeling rule in 2000 that no federalism and preemption claims were implicated.

Mal Wheeler batted clean-up for the manufacturers, though somewhat unfortunately he was essentially limited to his originally allocated 10 minutes because the argument had gone on so long. Wheeler addressed the differences in the Bates case and also argued that the 2000 labeling rule’s comments about preemption really were aimed toward disavowing any field preemption intentions. He cited briefly to the earlier Motus litigation as well and the November 2000 FDA amicus position in the SDNY advertising case. Much of his argument, however, got taken up with some of the details of the SSRI “under 24” determination and how this later determination might impact the preemption issue presented.

Braslow returned to the podium for a brief rebuttal. He first dealt with Apotex’s position that it could not do a CBE, disputing the reliance on 21 C.F.R. 314.150 cited by Kepple. He then launched further into the facts surrounding the 2003/2004 SSRI labeling changes, emphasizing that GSK had done a Paxil CBE for all ages in May 2004, which has never been explicitly rejected by FDA, he alleged.

As we said earlier today, we'll post the transcript of the argument as soon as we see a copy.

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