Experts Examined
The Pending Amendments To Rule 702
In June 2022 the Judicial Conference Committee on Rules of Practice and Procedure approved amendments to Federal Rule of Evidence 702. The amended rule features two main changes. First, the amendments explicitly incorporate the preponderance of the evidence standard requiring a proponent of expert evidence to show it is more likely than not that the expert’s opinion is reliable. Yet, as the Committee notes, the preponderance of the evidence standard was already the proper standard. The “amendments” are really a reminder for courts that “the sufficiency of an expert’s basis, and the application of the expert’s methodology” are questions that go to admissibility rather than merely weight. Second, the amendments adjust the language relating to an expert’s reliable application of methods. Again, the Committee emphasizes this is not “new” but instead is a reminder that some experts make unreliable leaps from their reliable methodology to their opinion that jurors may lack the “specialized knowledge” to spot.
If approved, the amendments will take effect in December 2023. Yet courts have begun to cite the pending changes—and the comments—in their Rule 702 analyses. For instance, in Sardis v. Overhead Door Corp., the Fourth Circuit noted that their “insistence on district court’s compliance with rule 702’s plain gatekeeping requirement” was borne of the same concern which prompted the Committee's amendments—the failure of district courts to apply the preponderance standard. 10 F.4th 268, 284–85 (4th Cir. 2021). In holding that expert testimony was improperly admitted, the Fourth Circuit concluded that their reversal was “consistent with [] existing law—and in accordance with the Committee’s pending rule.” Id. at 285. Similarly, when a West Virginia district court was confronted with an expert opinion rife with assumptions that plaintiffs claimed the expert “was allowed to make as an expert witness,” the court cited the pending rule and its commentary that “many courts have [incorrectly] held that the critical questions of the sufficiency of an expert’s basis [for his testimony], and the application of the expert's methodology, are generally questions of weight and not admissibility.” Bishop v. Triumph Motorcycles Am. Ltd., 2021 WL 4316810, at *19 n.8 (N.D.W. Va. Sep. 22, 2021). So, too, in In re Payment Card Interchange Fee & Merch. Disc. Antitrust Litig., the district court noted that it was “mindful of the proposed amendments’ purpose of ‘emphasiz[ing] that the court must focus on the expert’s opinion, and must find that the opinion actually proceeds from a reliable application of the methodology.’” 2022 WL 15053250, at *4 n.9 (E.D.N.Y. Oct. 26, 2022) (citation omitted).
Takeaway: Some courts are already citing the amendment and commentary to Rule 702. Because the comments emphasize that the changes merely clarify the existing rules, we expect courts will continue to rely on the pending amendments over the coming year.
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Zantac MDL Judge Grants Defendants’ Daubert Motions
Last month, Judge Robin Rosenberg (S.D. Fla.) granted each of Defendants’ Rule 702 motions to exclude Plaintiffs’ general causation experts in the Zantac (ranitidine) multi-district litigation (“MDL”), finding that Plaintiffs’ experts failed to offer reliable scientific evidence that ranitidine causes any of the five cancers at issue (bladder, esophageal, gastric, liver, and pancreatic cancer). The decision was delivered in a 341-page opinion that systematically reviewed various methodological flaws in Plaintiffs’ experts’ analyses and provided multiple, independent grounds for their exclusion. See In re Zantac (Ranitidine) Prods. Liab. Litig., 2022 WL 17480906 (S.D. Fla. Dec. 6, 2022). Because Plaintiffs were left with no admissible and sufficient evidence on general causation, the Court also granted Defendants’ motions for summary judgment. The decision was a major win for the Defendants, who had been steadfast in their denial that Zantac causes cancer and eager to frontload general causation.
The Court underscored several important points. First, Plaintiffs’ general causation theory was that NDMA forms in ranitidine, NDMA causes cancer and, therefore, ranitidine causes cancer. The Court framed the question more directly: does ranitidine cause cancer? The most relevant and reliable evidence to assess that question were epidemiological data in patients taking ranitidine—not studies on NDMA in other contexts. Second, even where Plaintiffs’ experts used a “weight of the evidence” approach, their litigation-driven reasoning and inconsistent methods could not pass muster. Third, Plaintiffs’ experts’ testing as to the amount of NDMA in ranitidine had many indicia of unreliability, including a lack of validation and inconsistencies with testing done by any other laboratory. Finally, the Court carefully explained that the FDA’s voluntary recall of ranitidine in 2020 was based on a conservative, protective regulatory limit on NDMA and did not reflect causation.
Ultimately, the Court emphasized that “there is no scientist outside this litigation who concluded ranitidine causes cancer” and “Plaintiffs’ scientists within this litigation systematically utilized unreliable methodologies with a lack of documentation on how experiments were conducted, a lack of substantiation for analytical leaps, a lack of statistically significant data, and a lack of internally consistent, objective, science-based standards for the evenhanded evaluation of data.” Id. at *3. In other words, though law may lag science, Plaintiffs could not escape the fact that the science that had emerged since the litigation began overwhelmingly favored Defendants.
Takeaway: The Zantac MDL Court recently excluded each of Plaintiffs’ general causation experts, finding that they failed to offer reliable scientific evidence that Zantac (ranitidine) causes cancer. The Court noted that even though ranitidine was recalled by the FDA in 2020, the scientific evidence that had developed since then did not support a finding of causation, and Plaintiffs’ experts’ opinions to the contrary were litigation-driven and unreliable.
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