While the evidence and experts in the two cases differ, the basis for the decisions and the judges’ approach in making their rulings are identical: Both found that the plaintiffs’ experts’ testimony was scientifically unreliable under Daubert, concluding that the experts cherry-picked studies favoring the plaintiffs and disregarded those supporting the defense without adequate explanation. This practice, the courts concluded, rendered their testimony unreliable and inadmissible.
Early reports from the legal press suggested that the appellate judges in the Zantac cases were leaning in favor of the plaintiffs. Indeed, legal reporter Amanda Bronsted questions whether Judge Rosenberg “was … a little too thorough,” reporting that
“The U.S. Court of Appeals for the Eleventh Circuit appeared ready to pick apart U.S. District Judge Robin Rosenberg 's pivotal 2022 ruling tossing all the plaintiffs' experts in the Zantac multidistrict litigation.”
The hearing was similarly discussed by other legal commentators, with David Minsky of Law 360 reporting, “Zantac MDL Suits Were Improperly Tossed, 11th Circ. Told”
Cassandra Burke, one of my students in scientific evidence at Elon Law School, attended the two-hour hearing and has a somewhat different take. Here is her ringside report:
On October 10, Judges Adalberto Jordan and Barbara Lagoa of the Eleventh Circuit, joined by Judge Virginia Covington from Florida’s Middle District, heard arguments addressing whether Judge Rosenberg rightly excluded the plaintiffs’ ten expert witnesses under Daubert and Federal Rule of Evidence (FRE) 702.
Under Daubert, judges must ensure that expert testimony is based on sound, reliable science before allowing juries to weigh causation. In a 341-page opinion, Judge Rosenberg ruled that the plaintiffs’ evidence failed that test.
Ashley Keller, representing the plaintiffs, attempting to defuse palpable tension in the court, opened with light humor referencing a Princess Bride analogy that Judges Jordan and Lagoa had used in a past opinion: noting that “a case, like life or death, cannot be “mostly dead.” The comment underscored how the exclusion of all experts effectively killed the litigation.
Joe Petrosinelli, arguing for the defendants, Glenmark Pharmaceuticals, supported Rosenberg’s decision by highlighting methodological inconsistencies and unreliable statistical practices in the plaintiffs’ analyses. Keller countered that Rosenberg’s “gatekeeping” veered into scientific overreach, colorfully claiming
“that what should have been ‘gatekeeping' by Judge Rosenberg may have turned into ‘putting on the white lab coat’.”
This lead to a discussion of whether flaws in the experts’ work should have been left to cross-examination rather than serve as grounds for exclusion. Judge Jordan offered a sliver of hope for plaintiffs, noting, “I don’t think it’s an across-the-board yes or no for [the plaintiffs] or for the defendants on the Daubert issue.”
Judge Covington observed that if Rosenberg’s Daubert ruling stands, dismissal of the cases follows naturally, prompting Keller to argue that the judge erred in merging rulings meant to address individual issues with the MDL general causation issue. However, as the purpose of multidistrict litigation (MDL) is to promote efficiency by consolidating complex scientific and legal questions under a single ruling [1], it might be argued that Judge Rosenberg’s exhaustive 341-page decision reflects a thorough engagement with the science, fulfilling her gatekeeper role, rather than judicial overreach.
A broader issue lingered: should a non-scientist judge evaluate the reliability of complex scientific testimony to this extent, or should juries play that role? A quick decision seems unlikely. However, Judge Jordan hinted that certain issues might be resolved in stages, offering some hope for "partial progress.”
Scope of Review of Daubert Decisions
Appeals of Daubert decisions have been ongoing since the case was decided in 1993. Interestingly, the scope of review, or the limit of appellate oversight —a linchpin of the appellate decision-making process —seems not to have been raised. Generally, unless there is an egregious error, appellate review of factual issues (such as in a Daubert hearing) is limited to clear error, and trial judges are afforded broad discretion. Since Judge Rosenberg’s major concern over cherry-picked results is a common bug-a-boo of judges rejecting causation testimony, and surely is within her discretion to assess, overruling her decision would contradict a large body of law.
Daubert and FRE 702: Who Decides What and How?
It does seem the 11th Circuit is put off by Judge Rosenberg’s didactic review (as evidenced by their pointed reference to the length of her decision), suggesting they feel she may have delved too deeply into the studies for their comfort. On the other hand, if the judge is barred from identifying buried clues within manipulated testimony, does the appellate court seriously think this is something a jury is equipped to do?
Further, the very purpose of Daubert is to mandate such review by judges. Federal Rule of Evidence 702, requiring relevance, reliability, and fit, was initially implemented in 1970. Twenty-three years later, Daubert imposes an additional role on the court: the role of gatekeeper. Yet, it is this responsibility that is the very predicate of the plaintiffs’ objections and the seeming appellate court’s reservation.
Another concern raised by Daubert is how judges will make their reliability decisions. In addition to the suggested tests noted in the case, over the last three decades, additional tests have been judicially created, including rejecting unexplained cherry-picking data practices methods employed by plaintiffs’ experts.
Should the appellate court reject Judge Rosenberg’s analysis without providing alternative precise tests for future judicial review, it would be casting judges adrift.
Delaware and Daubert Discord
Plaintiff's Attorney, Keller, argued that opinions regarding the extent of the gatekeeping function vary widely across jurisdictions, appealing to the appellate judges to provide clarity on Daubert’s application. Keller’s point is without merit. The highest state court in the Delaware Zantac litigation addressed the same point – rejecting the trial court’s imposition of a weaker, less invasive, more plaintiff-friendly approach, as championed by the plaintiffs here, which sends expert testimony to the jury with the expectation that cross-examination will ferret out flaws. The Delaware trial court also held that federal courts were in discord over Daubert, a notion soundly rejected on appeal, which found no daylight between Daubert standards across jurisdictions.
Portents of Supreme Court Intervention?
Likely, the Second Circuit will affirm Judge Cote’s rulings in the Acetaminophen cases, given the customary deferential standard of review. The Eleventh Circuit’s decision is less certain. But if it reverses Rosenberg and creates a circuit split, we can expect the Supreme Court to sound in, trying to resolve the question of how deeply judges should delve into scientific evaluation under Daubert. It’s hard to fathom just how they will do that.
[1] couched as general causation, precisely to incorporate all plaintiffs' contentions, before addressing them individually as specific causation.
