Pharmaceutical product liability

To complicate matters in some countries, liability may also arise in tort without proof of fault. This is known as strict liability. An important example of strict liability for pharmaceutical companies is what is commonly referred to as the European Products Liability Directive , which introduced a Europe-wide scheme of strict liability for defective products, (see Chapter 52 on Pharmaceutical Product Liability ). As liability is strict, the defences that are available in the legislation are most important. The UK legislation, for example, includes a development risk defence. This essentially means that, if the state of scientific knowledge was such that the producer could not have discovered the defect, this will provide a defence to the claim. 

Since the early 1980s, thousands of pharmaceutical product liability cases have been brought against the manufacturers of DES. These plaintiffs had a stronger strict liability design defect claim than those for thalidomide because DES, marketed to prevent miscarriages, had no demonstrable... 

Ferguson PR. 1992. Pharmaceutical products liability 30 years of law reform Juridical Rev. 3 226-239. 

Garbutt BJ, Hofmann ME. 2003. Recent developments in pharmaceutical products liability law failure to warn, the learned intermediary defense, and other issues in the new millennium . Food Drug Law J. 58(2) 269-286. 

I Overall Trends in Pharmaceutical Product Liability Litigation... 

Figure 7-1—Filing Patterns of Federal Pharmaceutical Product Liability Cases, 1974-86...

In overview, courts in various countries have interpreted pharmaceutical product liability law in various ways. The inconsistent court interpretations may be partially responsible for the increased... 

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