This case involves an otherwise healthy 39-year-old woman with a history of trouble conceiving who was told by her physician that taking Vitamin E supplements could increase her chance of conception. The woman purchased a bottle of over-the-counter Vitamin E supplements manufactured by the defendant pharmaceutical company. After taking several doses of Vitamin E, the woman experienced nausea, stomach cramps, and violent diarrhea, which led to her sudden death. Upon autopsy, her system was clean except for the Vitamin E. The pathologist linked the death to Vitamin E toxicity. It was alleged that the warning label on the Vitamin E bottle did not sufficiently caution against the dangers of consuming too much Vitamin E. An expert familiar with over the counter drugs was to review the warnings and determine if they were adequate enough to meet FDA standards.