Friday 21 November 2008

Liability for off-patent drugs made by others: an insurable risk?

"Liable For Generics? You Are Now!", posted on Corante, discusses the recent legal ruling in California in Conte v Wyeth. This case involved metaclopramide, sold by Wyeth as Reglan before going off-patent in 1982. Conte was prescribed the generic version of the drug, contracted a rare and serious neurological side effect and sued Wyeth, the original producer of the drug, rather than the drug's manufacturer. The Court ruled:
"We hold that Wyeth’s common-law duty to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent. The risk of harm to such a patient is foreseeable to Wyeth. To hold otherwise in this case would ignore the reality of the breadth and effect of Wyeth’s representations in modern commerce and depart from firmly established principles of fault based tort liability".
Plenty has been written about this decision and even more is likely to be, but I'm just confining myself to one small point: is liability of this nature the sort of product liability in respect of which original drug manufacturers would be insured under existing policies and, if not, would it generally be regarded as an insurable risk -- and at what cost?

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