Key Takeaways

  • A California trial court granted Allergan summary judgment in two BIOCELL bellwethers, foreclosing damages to asymptomatic plaintiffs who elected to have their implants removed while signaling that the issue is likely headed for appellate review.
  • Appellate review of the Khan rule could be significant, for both BIOCELL explant-only damages across the JCCP and, more broadly, for the viability of “fear of future harm” litigation.

In 2019, Allergan voluntarily recalled its BIOCELL textured breast implants and tissue expanders following FDA communications regarding the “uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).” The FDA did not recommend removal or replacement in patients without symptoms. Nevertheless, some asymptomatic patients elected explant and later sued to recover damages associated with the surgery. Many of those cases are coordinated in JCCP No. 5104 in Los Angeles Superior Court (approximately 1,700 individual suits). The bellwethers present a novel question: whether plaintiffs who elected prophylactic explant after the recall—without developing BIA-ALCL and without any device malfunction—could recover damages tied to the surgery and its aftermath. See Order Defs.’ Mot. Summ. J. & Summ. Adjudication, Donovan v. Allergan, Inc., No. 30-2021-0207615 (Cal. Sup. Ct., Aug. 4, 2026) (hereinafter “Donovan”); Order Defs.’ Mot. Summ. J. & Summ. Adjudication, Rodriguez v. Allergan, Inc., No. 30-2024-01448006 (Cal. Sup. Ct., July 31, 2026) (hereinafter “Rodriguez”).

In Rodriguez and Donovan, the bellwether plaintiffs conceded their claimed damages arose solely from “the explant procedure and its resulting medical, physical, economic and emotional consequences,” rather than physical injury caused by the device. On that record, the court granted summary judgment for Allergan, concluding plaintiffs could not establish causation where the implants never malfunctioned, plaintiffs had no BIA-ALCL diagnosis, and the explant was undertaken without FDA guidance or a physician recommendation.

The court grounded its ruling in Khan v. Shiley Inc., 217 Cal. App. 3d 848 (1990), which held that the recipient of a recalled-but-functional heart valve could not recover for fear of injury based on the possibility of a future device malfunction; absent a defect causing present injury, causation is lacking. Khan, 217 Cal. App. 3d at 855. As in Kahn, the recall here did not include a recommendation that asymptomatic patients undergo device replacement. See id. at 853. The court held the Khan rule controlled and rejected plaintiffs’ attempt to distinguish Khan by characterizing BIOCELL devices as “already defective” and capable of causing a later disease—calling it a distinction “without legal difference” under binding California precedent.  Donovan at 2, 10; Rodriguez at 2, 9. Instead, the court tasked the plaintiffs with persuading the Court of Appeal that their “distinction takes this case out of the Khan rule.” Donovan at 10–11; Rodriguez at 9.

The orders vacated the first bellwether trials and may support a stay of other coordinated cases pending appellate review, to which the court’s opinion alluded.