Discovery can be very expensive. Defendants really like to win on motions to dismiss in part because they get to avoid the costs of discovery. We can pile on these shockingly obvious statements with two more. From a defense perspective, a narrow scope of discovery tends to be a good thing. If narrow discovery leads to summary judgment, then that is a really good thing. Why are we dispensing such platitudinous nuggets? It could be that we are just impressed with the straightforward reasoning of the decision we will discuss. Or that we could not think of some clever introduction.
Just the other day, we told you about a federal court’s rejection of innovator liability under Wisconsin law. Well, that plaintiff also took the branded defendant’s prescription drug, so the case continued after partial summary judgment. A continuing case meant discovery and, in this case, discovery would focus on preemption. The basic facts of the case screamed preemption under Albrecht and maybe even under Levine. A prescription drug for asthma was approved in 2008 and prescribed to the minor plaintiff in 2010. He took the branded drug for under two years and then switched to a generic version for another two and a half years. About halfway through his time on the generic, he allegedly begin exhibiting a range of “severe neuropsychological side effects,” which later resulted in hospitalization at a psychiatric facility and a number of diagnoses of major psychiatric issues. In 2020, after reviewing adverse event data, FDA required the addition of a black box warning for “the risk of mental health side effects.” The same year, plaintiff (through his mother) brought a suit that alleged, among other things, that the branded manufacturer had provided inadequate warnings. Plaintiff served a bunch of broad discovery on the branded manufacturer and motions practice followed its response. That brings us to R.S.B. v. Merck & Co., Inc., No. 20-C-1402, 2021 WL 6128191 (E.D. Wisc. Dec. 28, 2021).
We have written a bunch over time on preemption of warnings claims against prescription drug manufacturers and we will not attempt to recap the subject or even provide a bunch of links. Instead, we will note a few basics before we get into the discovery dispute. First, Albrecht set out a standard for how judges are supposed to decide preemption as a question of law. Second, that standard focuses on newly acquired evidence received after approval of a label that allegedly should have triggered an independent label change through a CBE. Third, there is not too long of a time between this drug’s approval in 2008 and plaintiff’s initial prescription in 2010 or even his last use of the branded drug in 2012; there is even less time between a May 2010 approval of a label change and the August 2010 initial prescription. Fourth, it is hard to read backwards from a black box warning being added in 2020—something that FDA controls and cannot be added through a CBE—to suggest new risk information that should have triggered a change in the warnings was received in the early years after approval. That is part of why we say the case screams preemption.
To try to defeat preemption, the plaintiff will have an opportunity to get discovery on whether there was such newly acquired evidence of risk received at the relevant time. The discovery is basically one-way because the manufacturer presumably knows the regulatory record and what evidence of risk it had when. We have noted previously how the plaintiff bar has touted a strategy of invasive discovery as a way to avoid summary judgment post-Albrecht. (See here and here.) We have also noted at least one case where the defendant won on preemption a second time after a reversal and remand for discovery based on Albrecht. But R.S.B. is the first case we have seen that spells out the contours of discovery, at least written discovery, post-Albrecht.
In response to plaintiffs’ requests for production and interrogatories, the defendant produced 455,000 pages of documents, including three NDAs, relevant adverse events, and some non-NDA correspondence with FDA. 2021 WL 6128191, **1-2. Plaintiff wanted much more. The first issue in dispute was that plaintiff wanted all correspondence with FDA whenever it occurred and the defendant applied a time restriction. “The Court agrees with Merck that the relevant period is the time between when Singulair’s label was last approved by the FDA and the date R.S.B. last used Singulair [the branded drug].” Id. at *3. Not only would this be a narrow time period for this case, but it would be much narrower than plaintiffs would generally seek. Specifically, in terms of pre-approval correspondence, “Plaintiffs fail to demonstrate how communications between Merck and the FDA prior to 1998 could impact Merck’s ability to unilaterally change their label for Singulair through the CBE regulation.” Id.
The next dispute related to plaintiff fishing for safety information. Apparently following the old version of Rule 26, plaintiff claimed that his broad requests for communications with third-parties “may lead to the discovery of evidence” that he wanted. However, the current Rule 26 has a proportionality standard and this request did not meet it:
But requiring Merck to examine two decades of communications on the speculative basis that the communications may contain unfavorable study data is not a sufficient reason to require Merck to undertake the production of what is likely to be tens, if not hundreds, of thousands of pages.
Id. The proportionality analysis is case-by-case, so this ruling is not as broad. However, the ruling that the defendant did not have to produce “all clinical and preclinical trial [sic] data” beyond what was in the NDAs it produced could apply broadly. The court reasoned that NDAs should contain descriptions and analyses of the clinical studies and other data relevant to evaluating the safety and efficacy of the drug, so production of the 46 clinical studies and 80 preclinical studies in the three NDAs was plenty. Id.
Knowing how drug litigation can go, the next ruling may be the most important. Plaintiff sought raw data so he could have his retained experts reanalyze it to gin up some sort of safety signal or perhaps misrepresentation to FDA. Although this sounded close to the relevant standard, the court saw the important difference.
But “new analyses of previously submitted data” does not mean an analysis conducted by an expert in preparation for litigation with the benefit of hindsight. Instead, it refers to the scenario in which “the sponsor [of a drug] submits adverse event information to FDA, and then later conducts a new analysis of data showing risks of a different type or of greater severity or frequency than did reports previously submitted to the FDA.” [Levine], 555 U.S. at 569 (quoting 73 Fed. Reg. 49607).
Id. at *4. “In other words, Plaintiffs are not entitled to create their own ‘newly acquired information’ through the use of experts; rather, they must point to the existence of newly acquired information that Merck possessed during the relevant time period.” Id. This is an important distinction not just for discovery but for the substantive preemption analysis down the road.
The disputes over the interrogatories followed a similar path. Presumably as a predicate to requesting a bunch of depositions, plaintiff sought the identity of every regulatory affairs employee at the company since 1996. Defendant countered with names of the regulatory liaisons “who had responsibility for Singulair over its entire lifecycle.” Id. at *5. Plaintiff again argued that he needed more names because he wanted to prove that the defendant downplayed or “buried” data in what it submitted to FDA. With the NDAs in hand, the names of the liaisons were enough. “Absent something more than a mere hunch that Merck had some form of ‘newly acquired evidence’ in their possession, the Court will not require Merck to provide more information that they already have.” Id. We think many plaintiffs in this posture will not have more than a hunch about there being important safety information that was newly acquired between the last approval of the label and the plaintiff’s last use of the drug. We also suspect that the next fights in this case will arise in the context of depositions of the company witnesses. While those are often a battleground for a range of larger discovery disputes, when it comes to discovery on the narrow preemption inquiry under Albrecht, holding the line on scope makes sense.