Look what just fell into our lap. Our blogging about the favorable California Risperdal preemption decision last week shook loose from that same case a subsequent denial of reconsideration of a summary judgment motion in favor of the defendant based on preemption. Risperdal and Invega Prod. Liab. Cases, 2017 WL 4479317 (Cal. Super. July 24, 2017). So what, you say? Old news, you say? Permit us to explain.
As we recounted last week, a California judge granted summary judgment to the defendant based on Wyeth v. Levine “clear evidence” preemption. Six days after that sound and wise ruling, the very unsound and unwise Third Circuit Fosamax decision stumbled into the world. Not surprisingly, the plaintiffs in the Risperdal/Invega litigation cited Fosamax as a basis for the California judge to reconsider the preemption ruling. And while we refer to “California” you should know it was the Los Angeles County Superior Court that ultimately rejected the Third Circuit’s silliness, and, to be even more specific, you should know that the reconsideration-denying judge sits in the Los Angeles Central Civil West Courthouse, not-so-affectionately known by defense hacks as “The Bank.” Plaintiffs often do very well in The Bank. But not this time. So while we’re writing about an Order from almost three months ago, it’s new to us, and it makes for a nice exclamation mark after our recent discussions of the certiorari petition and amicus brief urging SCOTUS to reverse the Third Circuit. Even woefully inattentive readers of this blog will recall how the Third Circuit held that it was up to the jury whether or not a defendant had come up with “clear evidence” (transmogrified into “clear and convincing evidence”) that the FDA would have rejected the warning suggested by the ever-helpful plaintiff lawyers. We hated to call an opinion by our hometown circuit pure hogwash, but that’s what it was. The fact that a judge from The Bank also pronounced the Third Circuit’s ruling to be hogwash is nothing short of remarkable.
The California judge characterized the issue as “who decides” federal preemption. The Third Circuit’s folly in Fosamax was to give the decision to the jury. The California judge held that “Fosamax is not controlling and is wrongly decided.” He then reaffirmed the preemption decision. Unlike the Third Circuit’s decision, the California decision followed authority and was well-reasoned. The California judge looked to two other judges who rejected Fosamax. First, in a hearing earlier this year in the Xarelto itigation, Judge Fallon stated that the clear evidence preemption issue was “a question of law, not for the jury. I’m not even sure they know what preemption is.” In re Xarelto (Rivaroxaban) Prods. Liab. Litig., Dckt. No. 14-MD-2592 (E.D. La. May 1, 2017). We think when Judge Fallon said he wasn’t sure “they” know what preemption is, he was referring to the jury, not the Third Circuit. But we’re not certain. Either way …. Second, in Utts v. Bristol-Myers Squibb, Co., 2017 U.S. Dist. LEXIS 70317 (S.D.N.Y. May 8, 2017), Judge Cote also declined to follow Fosamax. Judge Cote “cogently noted the importance of resolving these matters of federal supremacy as early as possible in the life of a case (which is only possible when the issue is properly considered a ‘question of law’ for judicial resolution without the jury).” Exactly right. And that is exactly what the Third Circuit missed. Under the Third Circuit’s rule, preemption wouldn’t be decided until a jury returns a verdict, perhaps one containing many zeroes and zero analysis.
The California judge went on to observe that the trial judge in Levine v. Wyeth and the SCOTUS justices in the same case “all simply assumed that the federal preemption question was a matter reserved for the judge and not a jury question.” The same can be said for a squadron of decisions applying Levine. Thus, “Fosamax stands out as an outlier under the circumstances.” In conclusion, the California judge stood by his earlier decision that clear evidence led to preemption, and that “[b]oth the questions of whether proposed label changes are based on ’newly acquired information’ and whether there is ‘clear evidence’ FDA would have not approved the proposed label changes are legal questions for the Court to decide.” The California judge is right about that.
The California judge also “does not see this as a close question but as the only correct ruling that could be made here.” He’s right about that, too.