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Court Largely Grants Class Certification, But Narrows Walker Process Claims over Biologic Drug Stelara on Summary Judgment

California Lawyers Association E-Briefs, News and Notes
February 26, 2026

Case No. 2:23-cv-629-JKW-LRL, 2025 WL 3497098 (E.D. Va. Dec. 5, 2025); 2025 WL 3634085 (E.D. Va. Dec. 15, 2025); 2026 WL 114415 (E.D. Va. Jan. 14, 2026)

by Matt Veldman

In opinions released on December 5 and December 15, 2025, Judge Walker (E.D. Va.) granted Plaintiff CareFirst’s motion for class certification on its Sherman Act claims (though not as to state-law consumer protection and unjust enrichment claims), denied cross-motions to exclude expert testimony, and denied CareFirst’s motion for partial summary judgment on market power, while also denying in large part Defendant Johnson and Johnson (J&J)’s motion for summary judgment. Then, on January 14, 2026, after J&J moved for reconsideration, the court further narrowed Plaintiffs’ Walker Process claims.

CareFirst brought claims on behalf of a class of third-party payers (TPPs) against J&J for allegedly delaying competition from biosimilar drugs for its ulcerative colitis drug Stelara. Plaintiffs alleged a Walker Process fraud claim for J&J’s conduct prosecuting the relevant ‘307 patent at the PTO and a monopolization claim based on J&J’s acquisition of Momenta, a company which had in its portfolio four patents that could have helped a competitor develop a biosimilar for Stelara.  

Class Certification, Case No. 2:23-cv-629-JKW-LRL, 2025 WL 3497098 (E.D. Va. Dec. 5, 2025) 

Plaintiffs overcame challenges to ascertainability and predominance to certify a class of TPPs for their Sherman Act claims against J&J.

Ascertainability. In the Fourth Circuit, class members must be “readily identifiable … in reference to objective criteria,” with some “administratively feasible way for the court to determine whether a particular individual is a member at some point” to certify a class. Id. at *4 (quoting EQT Prod. Co. v. Adair, 764 F. 3d 347, 358 (4th Cir. 2014); Krakauer v. Dish Network, LLC, 925 F. 3d 643, 648 (4th Cir. 2019)).

The court was satisfied that CareFirst met this standard by demonstrating that 90-95% of the class was readily identifiable. Here, the highly regulated, data-heavy pharmaceutical industry aided Plaintiffs: the six largest pharmacy benefit managers (PBMs) process 90-95% of all outpatient prescription drug transactions, the records of which contained detailed transaction information.

Plaintiffs presented a plan to subpoena, compile, and analyze the relevant data from PBMs and from Rawlings, a healthcare data company. Then, during claims administration, TPPs could access their own claims data, filter for Stelara purchases during the class period, and submit a claim form attesting to the steps taken. The court was satisfied that this methodology was administratively feasible.

Predominance. J&J attacked Plaintiffs’ class expert for focusing on class-wide injury, ignoring individualized factors like how rebates varied among TPPs. But the court found that the expert sufficiently accounted for those factors. 

J&J also faulted Plaintiffs’ yardstick aggregate damages methodology, since analogizing to other drugs may not yield an accurate yardstick, and because averaging masks price variation between individual TPPs. The court found, however, that using averages was a widely accepted method of proving injury and damages on a class basis, and similarly that the yardstick approach was a common and appropriate model given the inherent difficulty of identifying a precise but-for world. 

Summary Judgment, Case No. 2:23-cv-629-JKW-LRL, 2025 WL 3634085 (E.D. Va. Dec. 15, 2025); 2026 WL 114415 (E.D. Va. Jan. 14, 2026)

Monopoly Power. Plaintiffs moved for summary judgment on monopoly power, arguing that Stelara did not exhibit cross elasticity of demand with other drugs, but the court found that J&J introduced sufficient factual disputes about Plaintiffs’ cross elasticity analysis to preclude summary judgment.

CareFirst’s argument relied extensively on the In re Zetia decision, where the court granted summary judgment to plaintiffs on the relevant market. In re Zetia (Ezetimibe) Antitrust Litig., 587 F. Supp. 3d 356 (E.D. Va. 2022). The court distinguished Zetia, finding thatthe evidence there was significantly stronger. In Zetia, the plaintiffs used actual data of generic entry for Zetia in their natural experiments, including using an AIDS pricing model to measure cross elasticity of demand. Here, by contrast, sufficient biosimilar entry data was not yet available. Instead, plaintiffs’ model analyzed prior biosimilar entry for two potential therapeutic substitute drugs, Humira and Remicade, to evaluate whether biosimilar entry for those drugs affected price or demand for Stelara.

Without actual biosimilar entry data for Stelara, the court found that J&J’s critiques of Plaintiffs’ model, along with evidence of J&J’s increased rebates (and therefore decreased net prices), was enough to raise material questions of fact on market power to deny summary judgment. 

In denying summary judgment, the court also denied cross-motions to exclude expert opinions on market power, finding the disputes were “quintessentially jury questions and not questions of admissibility.” 2025 WL 3634085, at *8.

Walker Process. Turning to J&J’s motion, the court trimmed Plaintiffs’ Walker Process claims, finding that one of the three prior studies Plaintiffs relied on and one of three alleged misrepresentations made by J&J’s attorney to the PTO could survive summary judgment. Plaintiffs produced sufficient evidence that J&J withheld a prior study involving Ustekinumab and ulcerative colitis in prosecuting its patent with the PTO. This, along with J&J’s statement to the PTO that there were no prior studies conducted with Ustekinumab and ulcerative colitis, was sufficient to withstand summary judgment. 

J&J acquiring Momenta patents. After initially allowing CareFirst to proceed on its theory that J&J anticompetitively acquired four patents in its Momenta acquisition, the court reversed course on reconsideration. After correcting for its misapprehension of the record on how Plaintiffs planned to use J&J’s privilege logs to prove the acquisition was anticompetitive, the court found that the intended negative inference about privileged communications was impermissible, and granted summary judgment to J&J on the Momenta patent theory.

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The opinions expressed are those of the authors and do not necessarily reflect the views of the firm or its clients. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

This article was originally published in the California Lawyers Association E-Briefs, News and Notes: February 2026

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