You all know this is a defense blog. You all know we focus on defense victories. So, it shouldn’t be surprising that when a defense win comes at the hands of some questionable calculations (or miscalculations) by plaintiffs’ counsel, we find it blog worthy. (Stay tuned, we have another one for you tomorrow too.)
The issue addressed by today’s case is fairly routine in drug and device suits – it’s a discovery motion over confidentiality. Or, to be more specific, it’s a motion by plaintiffs to remove the confidentiality designation of certain documents produced by defendants so they can be disclosed to the public. In this case, the public being the FDA. Now, we admit plaintiffs’ arguments about the public’s health and safety interest sound better when the intended recipient of the information is the FDA rather than the New York Times. But neither the FDA nor the press is a party to the lawsuit. So, with respect to material protected by a confidentiality order, the rules are the same. To allow disclosure, the court needs to find that either the materials aren’t in fact confidential or that there is a public interest that trumps defendant’s confidentiality interest.
That brings us to today’s case – a decision in In re Denture Cream Products Liability Litigation, 2013 U.S. Dist. LEXIS 8114 (S.D. Fla. Jan. 18, 2013). Plaintiffs wanted to give the FDA copies of their expert reports and the documents cited therein – a large number of which had been produced in discovery as “Confidential” or “Attorneys’ Eyes Only.” Id. at *25. The current motion sought to de-designate or unseal those documents so that they could be turned over to the FDA. So, the first question for the court was: did defendant have good cause to designate the materials confidential? The Eleventh Circuit has four factors to consider in answering this question – 1) did defendant closely guard the information; 2) the value of the information to defendant; 3) the value of the information to defendant’s competitors; and 4) the value derived from the effort to create and protect the information. Id. at *41. Defendant submitted a declaration explaining why the documents met all four factors and plaintiffs did not dispute defendant’s assertions on factors 2 through 4. Id. at *42-44.
That left plaintiff with one argument on confidentiality – waiver. Plaintiffs claimed that the defendant had “waived its right to keep the documents at issue confidential by disclosing those documents to the FDA.” Id. at *45. Now, if this dispute was really over documents that had already been disclosed to the FDA, we doubt we’d be blogging about it. In fact, we doubt there would have been the need for an opinion by the court because there probably wouldn’t have been a dispute. Defendant would likely have conceded that documents already available to the FDA could be disclosed to them again.
But that wasn’t the case here. And plaintiffs completely lost their waiver argument by over-arguing the need for disclosure. The court essentially cited back to plaintiffs their own allegations, such as: “Defendants have gone to great lengths . . . in order to keep critical safety information from the FDA” or “the FDA has not had access to any analyses of the data other than [defendant’s]” or “Plaintiffs’ expert reports contain analyses of underlying raw data . . . that [defendant] did not submit to the FDA” or (our favorite) plaintiffs’ expert reports “includ[e] the underlying . . . documents that the FDA has never seen.” Id. at *46-47. We think they doth protest too much. Leading the court to reach the only logical conclusion:
Thus, despite the Plaintiffs’ contentions to the contrary, the information, data and materials that the Plaintiffs seek to submit to the FDA are those very materials that have not been previously disclosed by [defendant] to the FDA.
Id. at *47.
Plaintiffs also tried to argue that they were sure that at some point in the future defendant would make these documents public – by say submission to the court in the context of Daubert motions – thereby waiving their confidentiality. But the court wasn’t willing to buy into a crystal ball theory of waiver either. The court “will not speculate as to whether the documents at issue may at some time in the future, lose their protected status.” Id. at *49. Therefore the court concluded that defendant satisfied all four factors and demonstrated “good cause” for designating the information as confidential.
So, that brought the court to the second question: did the public’s health and safety interest outweigh the defendant’s confidentiality interest? First, we want to point out that the court emphasized “the fact that there is no indication or assertion that the FDA has requested the disputed documents, or even the Plaintiffs’ expert reports, to be produced.” Id. at *52-53. We like a court that defers to the FDA – if they want it, they know how to get it. In fact, the confidentiality order contained a provision for responding to subpoenas like one that the FDA could have issued if it so chose. Id. at *54.
But, what really interested us here is that plaintiffs lost their need for disclosure argument by over-arguing waiver:
In fact, the Plaintiffs’ contention that portions of the documents at issue have either been already produced to the FDA or have been filed in [other pending] litigation arguably supports a finding that the release of the documents at issue in this case is not necessary for public safety. Rather, if the Plaintiffs are correct, similar documents presumably addressing similar concerns and reaching similar conclusions relevant to the public interest are already accessible to the FDA and public. This necessarily lessens the need for the release of the confidential documents in this case.
Id. at *54-55 n.12. When you sum up plaintiffs’ two primary arguments like that – the fundamental flaw in their reasoning is obvious. Either defendant waived confidentiality by making this information available to the FDA, in which case the FDA doesn’t need it -- or the FDA really needs this stuff because they don’t have it, in which case defendant hasn’t put it out there and so there’s no waiver of confidentiality. There’s pleading in the alternative and then there’s pleading in the impossible. This is an example of the latter. As well as, you can’t eat your cake and have it too. Really who wants to simply have the cake, eating it is the best part. But, if you are someone – like plaintiffs here – who truly just want to look at that cake, we recommend you put down your fork.