Product Liability
The legal responsibility of a manufacturer or seller for harm caused by a defective product. In the pharmaceutical context, product liability applies to manufacturing defects, design defects, and failure to provide adequate warnings about known risks associated with peptide drugs.
Technical Context
Product liability in pharmaceuticals encompasses: manufacturing defects (deviation from intended design — e.g. contamination, wrong concentration, sterility failure), design defects (inherent product characteristic causing unreasonable danger — e.g. inherently toxic formulation when safer alternative exists), and failure to warn (inadequate labelling about known risks — most common pharma liability claim). The learned intermediary doctrine (in most US states) means the manufacturer's duty to warn runs to the prescriber rather than directly to the patient, because the prescriber exercises independent medical judgement. Defences include: compliance with regulatory requirements (not always a complete defence), state-of-the-art defence (risk was not known or knowable at time of marketing), and adequate warning (risk was disclosed in labelling). For peptide drugs, product liability litigation has involved: compounded product quality failures, injection device malfunctions, and claims of inadequate warnings about adverse effects.