Product Liability Litigation and Settlements: J&J faces significant financial and reputational risks from ongoing and potential future litigation related to product safety, such as talc-based products and opioids.

Intense Regulatory Scrutiny and Compliance Costs: The company operates in highly regulated environments, requiring substantial investment in compliance and facing potential penalties, product recalls, or delays for non-adherence to health and safety standards.

Competition and Patent Expirations: J&J's pharmaceutical and medical device segments are subject to intense competition from generic and biosimilar manufacturers, as well as new innovative products from rivals, leading to pricing pressure and market share erosion.