This lecture will examine a question which has major implications for the producers of pharmaceutical products accessing the EU marketplace, viz., to what extent are they liable in respect of personal injuries allegedly attributable to defects in those products? In answering this question, Professor Alex Schuster will make extensive reference to the most recent judgments of the Court of Justice of the European Union on the interpretation of the EU Product Liability Regime (which applies in all 28 Member States of the Union).