WHOLEY v. AMGEN INC (2024)

Order, Supreme Court, New York County (Mary V. Rosado, J.), entered on or about June 16, 2023, which adopted the April 19, 2023 report and recommendation of the Special Master in its entirety, granted defendants' motion to exclude the opinions by plaintiffs' general causation experts, and granted defendants' motion for summary judgment dismissing the complaint, unanimously affirmed, without costs.

Supreme Court providently exercised its discretion in excluding plaintiffs' causation experts from testifying at trial, as plaintiffs failed to sustain their burden of showing that their experts' theory of causation is generally accepted in the relevant scientific community (see (Frye v. United States, 293 F. 1013 [D.C. Cir. 1923];  see also People v. Brooks, 31 N.Y.3d 939, 941, 73 N.Y.S.3d 110, 96 N.E.3d 206 [2018];  Marso v. Novak, 42 A.D.3d 377, 378, 840 N.Y.S.2d 53 [1st Dept. 2007], lv denied 12 N.Y.3d 704, 879 N.Y.S.2d 50, 906 N.E.2d 1084 [2009]).  Plaintiffs' experts acknowledged there were no clinical studies or medical literature to support their position that plaintiff Lauren Wholey's use of defendants' Enbrel product to address her rheumatoid arthritis had caused her to develop squamous cell carcinoma of the tongue (SCCT) (see Parker v. Mobil Corp., 7 N.Y.3d 434, 446–447, 824 N.Y.S.2d 584, 857 N.E.2d 1114 [2006]).  Plaintiffs' experts also failed to establish that their reliance upon an individual case occurrence, as well as FDA warnings and adverse case reports related to the use of Enbrel, amounted to an accepted methodology of determining a causal connection between plaintiff's SCCT and her use of Enbrel (see Knafo v. Mount Sinai Hosp., 184 A.D.3d 478, 479, 124 N.Y.S.3d 188 [1st Dept. 2020]).  Indeed, we have held that “observational studies or case reports are not generally accepted in the scientific community on questions of causation” (Heckstall v. Pincus, 19 A.D.3d 203, 205, 797 N.Y.S.2d 445 [1st Dept. 2005]).

Plaintiffs have cited no New York cases that support their “steppingstone methodology” argument, and to the extent they rely on a federal case to advance that argument (In re Neurontin Mktg., Sales Practices, & Prods. Liab. Litig., 612 F.Supp.2d 116 [D.Mass. 2009]), the Special Master persuasively distinguished the case, noting that the class of drugs analyzed there was understood to share the same mechanism of action.  Here, by contrast, plaintiffs' experts did not rebut the statements of defendants' experts that Enbrel had a unique mechanism of action compared with other similar drugs.  In any event, federal expert admissibility standards are less stringent than New York's Frye rule (see Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 [1993]).

As there is no other evidence in the record to create a factual issue as to whether Wholey's use of Enbrel caused her SCCT, dismissal of the complaint was warranted (see Milian v. Bailyn, 177 A.D.3d 574, 574, 110 N.Y.S.3d 848 [1st Dept. 2019]).