Addressing Pharmaceutical Injuries: The US Landscape

Clin Pharmacol Ther. 2018 Mar;103(3):384-385. doi: 10.1002/cpt.774. Epub 2017 Aug 29.

Abstract

The legal landscape for addressing an injury related to the use of a pharmaceutical product varies from country to country. Approximately 10 countries have adopted some form of no-fault compensation, in which an individual must establish that they sustained an injury caused by the medicine, but need not demonstrate that the manufacturer acted negligently in order to recover. This commentary compares and contrasts the approach taken in Japan with that in the United States.

MeSH terms

  • Drug Industry
  • Drug-Related Side Effects and Adverse Reactions*
  • Humans
  • Insurance, Liability
  • Japan
  • Legislation, Drug / trends*
  • Malpractice
  • United States
  • United States Food and Drug Administration