title: Is the evidence of the Supreme Court Ruling of gefitinib litigation in Japan scientific?
abstract: BACKGROUND
  Plaintiffs of the gefitinib (Iressa) lawsuits in Japan started in 2004 were defeated in the Supreme Court in 2013. The Court judged it was not possible to foresee the outbreak of deaths caused by interstitial pneumonia due to gefitinib from death cases before approval of this drug.
  
  
  OBJECTIVE
  We attempted to verify validity of this judgment.
  
  
  METHODS
  We estimated the 95% confidence interval (CI) of the proportion of onset and death cases among 23 onset and 13 death cases occurring from "within 1 week" to "within 4 weeks" from clinical data before approval of this drug using data admitted to the Court.
  
  
  RESULTS
  For death cases, all of the upper limits of the 95% CI exceeded 50% within 1-4 weeks. This fact suggested that the cases of acute interstitial pneumonia were included in the clinical trial before the approval of gefitinib.
  
  
  CONCLUSIONS
  It was possible to foresee the outbreak of death cases after drug approval. This conclusion showed the Court's ruling was not reasonable and was unscientific.
authors.affiliation: Faculty of Social Welfare, Niigata University of Health and Welfare, Niigata, Japan Institute of Clinical and Social Pharmacy, Saitama, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Katahira
authors.affiliation: Institute of Clinical and Social Pharmacy, Saitama, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Yoshikawa
authors.affiliation: Postgraduate student of Niigata University of Health and Welfare, Niigata, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Enoki
authors.affiliation: Drug Information Center Asahi, Osaka, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Teraoka
authors.affiliation: Graduate School of Human Science, Waseda University, Tokyo, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Tsuchiya
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D004349:Drug Packaging; D000077156:Gefitinib; D006801:Humans; D007564:Japan; D017563:Lung Diseases, Interstitial / Q000401:mortality*; D008175:Lung Neoplasms / Q000188:drug therapy; D011358:Product Surveillance, Postmarketing; D011799:Quinazolines / Q000009:adverse effects*
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib
keywords: Gefitinib; acute interstitial pneumonia (AIP); estimation; lawsuit; predictability