The Committee Notes to the newly implemented amendments to Federal Rule of Evidence 702 make clear that the “[j]udicial gatekeeping” of expert evidence is “essential.” Federal courts in New York have played an important role in pioneering and developing this concept. Indeed, the idea of courts as gatekeepers in the expert context finds its roots in the Eastern District of New York, with the late Chief Judge Weinstein coining the term in a 1985 opinion in In re Agent Orange Product Liability Litigation. Three decades later, the Southern District of New York offered one of the most thorough illustrations of careful judicial gatekeeping in In re Mirena IUS Levonorgestrel-Related Prod. Liab. Litig. (No. II). Now, New York can also call itself home to the first MDL-wide decision to exclude experts under Rule 702’s new formulation.
Subject: Birth Defects
Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL
Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks – for example, a recent systematic review and meta-analysis concluded that use of ondansetron during pregnancy was associated with a reduced incidence of miscarriage but “was not associated with abnormal pregnancy outcomes,” including a variety of birth defects. Nevertheless, plaintiffs have alleged that Zofran causes birth defects and that the warnings accompanying the drug should have said so. Those claims were dismissed in 2021 when the district court held them preempted, and the First Circuit recently affirmed that decision in In re Zofran (Ondansetron) Products Liability Litigation, — F.4th —, 2023 WL 128570 (1st Cir. Jan. 9, 2023).
Plaintiffs in the Zofran MDL alleged, among other things, that the defendants failed to warn of birth defects observed in certain animal studies. Because such claims implicate the warnings accompanying an FDA-approved drug, they are preempted unless the manufacturer could have unilaterally amended the label through the Changes Being Effected (CBE) regulation. The CBE regulation permits a manufacturer to amend a product’s labeling without prior FDA approval “to reflect newly acquired information” and thereby “add or strengthen” the warnings where there is “evidence of a causal association” between the drug and the subject on which the warnings are being amended.
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Experts’ Disagreement with Medical Literature Leads to Exclusion
Peer-reviewed literature can be a powerful tool in attacking an opposing expert’s opinions. A solid, on-point article can do more than merely satisfy several of the so-called Daubert factors for assessing reliability – by showing a court that others in a challenged expert’s field disagree with his or her opinions, literature can remove any expert “aura” that might discourage a lay judge from discharging his or her duty as a gatekeeper. Presenting literature that directly undermines the expert’s opinion can make the difference between winning and losing a motion to exclude, especially where the expert’s opinion is not supported by other literature accepted in the field.
A recent example is U.G. v. United States, 2022 WL 7426212 (S.D.N.Y. Oct. 13, 2022), a medical malpractice action under the Federal Tort Claims Act in which plaintiff suffered a shoulder injury during his birth and was later diagnosed with permanent Erb’s palsy, or brachial plexus injury. He alleged that the obstetrician caused the injury by using excessive force on his head and shoulders during delivery. In support of his claims, he offered two causation experts – an obstetrician/gynecologist and a pediatric neurologist– both of whom claimed the “totality of the circumstances” ruled out several possible alternate causes and thus showed that the defendant caused the injury.
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The Rule 702 Toolbox: Cherry-Picking Is a Recipe for Exclusion
Most courts (but certainly, and unfortunately, not all of them) recognize that cherry-picking is a cardinal sin under Rule 702. Science generally requires a rigorous and conservative approach to evaluating cause-and-effect relationships. This schema inherently clashes with litigation, an arena where parties prioritize results over neutral principles of process purity.
“Cherry-picking” involves the selective consideration of facts and data to support a desired or pre-determined result, rather than the analysis of all relevant facts and data to find a scientific truth (or determine that the truth remains elusive based on the available facts and data). It evades the scrupulous adherence to principles of objectivity, rigor, and process validity that are the hallmark of the scientific method. In Daubert-speak, such a methodology does not produce “scientific knowledge.” Rather, cherry-picking represents a failure of methodology that cannot be waived off as a matter of weight rather than admissibility.
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