US Court Finds Against Upjohn Over Strict Liability

The California Supreme Court has ruled that prescription drugmakers can be sued for failing to warn of certain known dangers with their products even if the Food and Drug Administration has directed them not to do so. The ruling resulted from a case against the Upjohn unit of Pharmacia & Upjohn, which was sued by a woman for failing to warn of nervousness and injuries she claimed resulted from a drug. The case was settled with a $2,500 payment, but Upjohn asked the court to clarify the standards of liability applying to drugmakers.

Court papers said Upjohn claimed it was liable only under a negligence standard, but the court upheld the standard of strict liability. Under a negligence standard, companies can only be sued for failure to warn of risks they were instructed by the FDA to mention, but the strict liability standard means the manufacturer can be sued for a danger that the FDA had instructed it not to mention. The court noted the difference is important for drugmakers, since there is an industrywide practice of not providing warnings of all potential hazards. In some cases, the FDA prohibits listing warnings relating to a nonapproved use of a drug. Under the California ruling, a suit could be brought even for injuries obtained through an unapproved use.