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What the ECJ’s landmark ruling on defective products liability means for life sciences manufacturers

A magnifying glass focusing on a shattered glass
Photo: MarioGuti/Getty Images

This article covers the expanded litigation risk, the steps life science companies should take to reinforce their product safety, and risk‑management governance.

On March 26, 2026, the European Court of Justice (ECJ) issued a significant and precedent-setting judgment, LF v Sanofi Pasteur SA, reshaping the liability landscape for defective products in the pharmaceutical sector.

Although the case concerned a medicinal product (a vaccine), the Court’s reasoning extends in practice to medical device manufacturers, even