In November 2007, Merck & Co. settled US$4.85 B for Vioxx® (rofecoixb) signaling the near end of a 3-year legal battle. The fear that drug makers have the FDA going too far by evaluating drugs with criteria beyond its legal mandate is perhaps valid. The analyst article reviews the change in attitudes of US regulators and defence strategies in drug companies facing mass litigation due to this greatest pharmaceutical controversies and suggests that pharmaceutical industry had learnt valuable lesson from this painful legal controversy.