Risk of Adverse Effects from New Drugs, Product Recalls and Discontinuation of Sales
First written in FY2016. 3 of 6 entries say "Restated". Latest entry: FY2023.
The whole theme swung hardest in 2026: 6 of 20 companies on the "Worse" side.
36 other companies' latest entry also says "Restated".
- FY2023RestatedAnnual report
「Pharmaceutical products and medical devices may give rise to unexpected serious adverse reactions that affect their safety profiles. In such cases, it may be necessary to discontinue development or sales, revise package inserts, conduct recalls or take other measures.」
The risks of discontinuing development or sales and conducting recalls as a result of adverse reactions continue to be disclosed. - FY2018MitigatedAnnual report
「On 15 February 2019, we agreed with the representative of the plaintiffs to establish a settlement program to resolve all claims filed as of 28 January 2019.」
The disclosure states that an agreement was reached to establish a settlement program to resolve the claims already filed in the U.S. product liability litigation relating to Abilify. It does not state that the litigation has ended completely. - FY2018-Q3RestatedAnnual report
「Product Liability Litigation Relating to Abilify: We have received numerous claims for damages in U.S. federal and state courts from plaintiffs alleging that Abilify caused compulsive gambling or other impulse-control disorders.」
U.S. product liability litigation relating to Abilify is ongoing. The cases pending in federal court were consolidated in the U.S. District Court for the Middle District of Florida, and proceedings are continuing. - FY2018-Q2MaterialisedAnnual report
「Product Liability Litigation Relating to Abilify: We have received numerous claims for damages in U.S. federal and state courts from plaintiffs alleging that Abilify caused compulsive gambling or other impulse-control disorders.」
Product-related litigation arising from adverse reactions has actually occurred. The cases pending in federal court were consolidated in the U.S. District Court for the Middle District of Florida, and proceedings are continuing. - FY2017RestatedAnnual report
「Our group maintains appropriate insurance to cover various liabilities, including product liability, in preparation for such situations. However, there is no guarantee that insurance proceeds equivalent to the full amount of compensation ultimately borne by our group will be paid.」
The risks of product recalls, discontinuation of sales and compensation claims arising from adverse reactions continue to be disclosed, with insurance coverage identified as a mitigation measure. - FY2016First statedAnnual report
「Patients who are actually administered a new drug may experience unexpected adverse reactions. Accordingly, if problems such as adverse reactions arise in connection with pharmaceutical products manufactured or sold by our group, substantial costs related to product recalls or discontinuation of sales may be incurred, potentially having a material impact on our group’s operating results and financial position.」
The risks of recalls, discontinuation of sales, compensation claims and reputational damage arising from adverse reactions are identified as formal material risks.