Bexis is updating the preemption chapter of his prescription medical product liability treatise, and with Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), being so new, he collected a bunch of law firm blogs/client updates about the case to see what potential issues other lawyers out there might have spotted. Bexis didn’t limit himself to the defense side. Indeed, one of the most intriguing comments came from Motley Rice:
I read this to mean that where the “facts” concerning clear evidence are in dispute, the Court must essentially apply a summary judgment test and hold the claims preempted only where, on the undisputed evidence, it is clear that the FDA rejected the warning that state law requires with full knowledge of all material information concerning the proposed warning.
Evaluating what the Supreme Court had just declared to be “a legal question for judges” 139 S. Ct. at 1680, by a “summary judgment test” seemed odd to us. We’ve always considered the summary judgment standard – that facts, and factual inferences, must be viewed in “the light most favorable” to the non-moving party (almost always the plaintiff in preemption cases) – exists because ultimately the evidence is being evaluated with an eye towards factual disputes being determined by juries.
That’s most emphatically not what is supposed to happen with preemption after Albrecht, since the Court held:
We understand that sometimes contested brute facts will prove relevant to a court’s legal determination about the meaning and effect of an agency decision. . . . But we consider these factual questions to be subsumed within an already tightly circumscribed legal analysis. And we do not believe that they warrant submission alone or together with the larger pre-emption question to a jury. Rather, in those contexts where we have determined that the question is for the judge and not the jury, we have also held that courts may have to resolve subsidiary factual disputes that are part and parcel of the broader legal question.
139 S. Ct. at 1680 (citation and quotation marks omitted) (emphasis added). Indeed, Albrecht specified how judges are to arrive at preemption rulings – rejecting any thumbs being put on the scales of justice. “[T]he judge must simply ask himself or herself whether the relevant federal and state laws irreconcilably conflict.” Id. at 1679.
The Albrecht Court also found preemption analogous to the construction of patents, relying on a 1996 patent decision in Markman v. Westview Instruments, Inc., 517 U. S. 370 (1996), which had found evaluation of patent terms to be a legal issue. 139 S. Ct. at 1680. That means that over 20 years of patent precedent exists that would have addressed whether or not a summary judgment standard applies to such “subsumed” factual issues.
So we took a look.
We were right – meaning that the Motley blogpost was largely wishful thinking. With the patent construction issue solely for the court, not a jury, the pool of evidence relevant to that legal determination has consistently been weighed in patent cases without courts invoking any “most favorable” summary judgment standard applicable to the patent issue. Indeed, it is often a striking difference, since patent construction is often discussed in close proximity to the ultimate issue of whether infringement has occurred, the latter being a jury question to which the “most favorable” review standard still applies.
After Markman, a two-step process that has developed in patent cases – first a judicial construction of the patent itself (sometimes involving a so-called “Markman hearing” to address factual questions), followed by, second, a jury deciding whether the patent (as construed by the court) was infringed by whatever the defendant had done. Critically, the “most favorable” summary judgment standard only applies to the infringement question – not the court’s prior construction of the patent.
A court determines patent infringement by construing the claims and then applying that construction to the accused process or product. This court reviews claim construction without deference. In the context of summary judgment, this court reviews the second determination for genuine disputes of material facts that would preclude a grant of summary judgment. Thus, [the moving defendant] is entitled to summary judgment of no infringement only if the facts and inferences, when viewed in the light most favorable to [plaintiff], would not persuade a reasonable jury to return a verdict in favor of [plaintiff], the non-moving party.
Business Objects, S.A. v. Microstrategy, Inc., 393 F.3d 1366, 1371-72 (Fed. Cir. 2005) (emphasis added). For additional appellate patent decisions making essentially the same holding – whether or not the defendant was ultimately entitled to summary judgment – see, e.g., Searfoss v. Pioneer Consolidated Corp., 374 F.3d 1142, 1148 (Fed. Cir. 2004); Advanced Cardiovascular Systems, Inc. v. Scimed Life Systems, Inc., 261 F.3d 1329, 1336 (Fed. Cir. 2001); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1304 (Fed.Cir. 1999).
Indeed, for present purposes, patent cases that defendants lose are more significant than those they win. For example take, Advanced Cardiovascular. The Federal Circuit reversed because it concluded that “summary judgment was based on an erroneous construction of [several patent] terms.” Id. at 1331. The Federal Circuit spent several pages (id. at 1332-36, 1341-44) critiquing the district court’s patent construction, including “extrinsic evidence.” Not once did the Federal Circuit in Advanced Cardiovascular state that anything was to be construed in a “light most favorable” to the non-movant. That standard was irrelevant. “The parties’ arguments present a question of claim construction.” Id. at 1343.
Thus, based on: (1) the Albrecht Court’s description of how judges should approach the legal issue of preemption – “simply” deciding whether or not a preemptive conflict exists; and (2) how patent construction issues have been treated after Markman, we believe that it’s time to end the summary judgment practice of viewing facts “most favorably” to the non-moving party in preemption cases. With nothing for a jury to decide, preemption is a straight up legal issue, like patent construction, to which plaintiff-friendly standards of review “simply” don’t apply.