As we have previously reported, a group of health insurers and health insurance administrators (collectively, “CareFirst”) filed a class action complaint in 2023 against Johnson & Johnson and Janssen Biotech, Inc. (collectively, J&J), alleging multiple violations of federal and state antitrust laws arising from J&J’s STELARA® (utsekinumab) product, as well as violations of state consumer protection laws and unjust enrichment claims. On December 5, 2025, the U.S. District Court for the Eastern District of Virginia granted-in-part and denied-in-part CareFirst’s motion for class certification, and on December 15, 2025, the court denied CareFirst’s motion for partial summary judgment and granted-in-part and denied-in-part J&J’s motion for partial summary judgment.
CareFirst sought to certify two classes, a “Damages Class” and an “Unjust Enrichment Class,” which include certain third-party payers who indirectly purchased or paid for STELARA® as part of a prescription drug benefit between January 1, 2024 and December 31, 2025. The court certified both classes as to CareFirst’s federal and state-law antitrust claims, but not as to Counts III and IV, CareFirst’s state law consumer protection and unjust enrichment claims.
As the court explained, Fed. R. Civ. P. 23(a) provides four prerequisites to certify a class: (1) the class is so numerous that joinder of all members is impracticable, (2) common questions of law or fact exist, (3) typicality of claims or defenses, and (4) the representative parties will fairly and adequately protect the class interests. See Order at 5. In granting the motion to certify two classes under Fed. R. Civ. P. 23, the court found that the proposed classes are numerous, as Plaintiffs estimated that “there are thousands of third-party payers (TPPs) who meet the class definitions.” Id. at 6. Further, the court ruled that the class is ascertainable and that class members are identifiable “in an administratively feasible way.” Id. at 9, 22. The court determined that CareFirst established typicality and adequacy of representation— CareFirst’s interests “are aligned with those of absent class members because they each seek to prove that J&J acted unlawfully . . . by delaying competition.” Id. at 8.
Finally, the court found that common issues predominate as to the federal and state-law antitrust claims, but not for the state-law consumer protection and unjust enrichment claims. Id. at 7, 50. CareFirst asserted that it “will use common evidence to prove that J&J unlawfully prolonged its monopoly and delayed biosimilar competition for Ustekinumab and that absent such anticompetitive conduct, biosimilar products would have entered the market in October 2023.” Id. at 42. J&J did not contest that common questions of antitrust conduct predominate, but did contest whether common issues of antitrust injury predominate. As to antitrust injury, CareFirst asserted—and the court agreed—that are common issues of injury predominate given that virtually all class members suffered overcharges as a result of J&J’s conduct, and that, if not for J&J’s conduct, health plans would have purchased biosimilar ustekinumab products instead of STELARA®.
The court further held that CareFirst had not carried its burden to demonstrate that state-law consumer protection and unjust enrichment law issues predominate. Whereas the states included in CareFirst’s class definitions interpret their antitrust laws in harmony with federal law, the same was not true with respect to the relevant state consumer protection statutes.
Additionally, the court denied J&J’s motions to exclude three expert opinions under Fed. R. Evid. 702. The court also approved the appointment of the claims administrator as well as their notice plan to notify all class members.
With respect to the Order on the parties’ cross-motions for summary judgment (“SJ Order”), the parties sought relief on four elements: (1) CareFirst’s motion as to monopoly power; (2) J&J’s motion as to whether J&J committed fraud on the USPTO; (3) the parties’ cross-motions as to whether J&J’s acquisition of Momenta manufacturing patents was anti-competitive; and (4) J&J’s motion as to antitrust injury.
First, the court denied CareFirst’s motion for summary on monopoly power because J&J raised genuine disputes about the relevant product market definition. See SJ Order at 21. CareFirst alleged that the relevant product market is STELARA® and biosimilar ustekinumab products, while J&J asserted that “numerous other monoclonal antibodies approved to treat the same conditions as Stelara compete in the same product market.” Id. As the court explained, “[m]easuring market power in the pharmaceutical industry begins with identifying therapeutic alternatives for the drug at issue and showing the economic interchangeability of those alternatives,” and the “key consideration for economic interchangeability is cross-price elasticity of demand.” Id. at 21–22. The court held that J&J raised material questions of fact on circumstantial evidence of market power; specifically, whether CareFirst’s model of price elasticity adequately factors in inputs such as overall demand for STELARA®. See id. at 24.
Second, the court denied-in-part J&J’s motion for summary on judgment on CareFirst’s Walker Process fraud claim. The court held that CareFirst had raised a genuine dispute as to whether J&J withheld documents from the USPTO examiner and made misrepresentations during prosecution, and whether J&J’s patent manager had the requisite intend to defraud the USPTO. See id. at 39.
Third, the court denied J&J’s motion for summary judgment on CareFirst’s claim that J&J’s acquisition of four Momenta manufacturing patents constitutes a “willful acquisition or maintenance of [monopoly] power—as opposed to simply superior products or historic accidents.” Id. at 39. According to the court, “the relevant question is whether J&J could have reasonably considered Momenta, through its manufacturing patents, to be a potential competitor and therefore a ‘nascent threat’ to J&J’s alleged monopoly power.” Id. at 43. The court held that there was a genuine dispute as to whether J&J’s Global Head of IP Litigation “had knowledge beyond mere awareness of the patent number—that is, whether J&J had meaningful knowledge of the four Momenta patents in such a way that J&J could view Momenta as a potential competitor or nascent threat in any potential relevant market.” Id. at 45.
Fourth, the court denied J&J’s summary judgment motion on antitrust injury, finding that a reasonable jury could conclude that but for J&J’s anticompetitive acquisition of the Momenta patents and U.S. Patent No. 10,961,307, biosimilar manufacturers would not have settled and delayed market entry. Additionally, the court denied both motions to exclude expert testimony, finding the economic opinions to be relevant and admissible.
Stay tuned to Goodwin’s Big Molecule Watch as we continue to monitor CareFirst’s class action litigation against J&J.