Pre-emption ‘can lead to overwarning’

Washington Legal Foundation (WLF) said the US Supreme Court’s recent 6-3 decision that federal law generally does not pre-empt state law product liability suits challenging the adequacy of safety warnings may lead to “overwarning” that can be dangerous for the public. 

WLF had filed a brief urging the court to support FDA pre-emption and said that the court’s “disappointing decision fails to take account of FDA determinations regarding what warnings should and should not appear on product labeling.”

A WLF litigation update said the brief gave examples of instances in which overwarning of health risks had caused harm by inducing individuals to not pursue needed treatment. The adverse effects of underutilization of drugs exceeds the adverse health effects, WLF said.

Among the examples cited by WLF were: warnings that adolescent use of SSRIs is associated with suicidal thoughts led to a drop in use of the drugs and an increase in suicide; warnings that pregnant women reduce fish consumption due to high mercury concentrations led to decreased consumption and to lower child IQ scores; warnings on oral contraceptive safety led European women to abandon contraceptives and  led to an increased abortion rate; and warnings on vaccine dangers led to numbers of parents choosing to forgo childhood vaccinations and later to increases in measles outbreaks.