CASE 22.2—QUESTIONS (PAGE 433)
WHAT IF THE FACTS WERE DIFFERENT?
Suppose that the Phenergan label had contained a stronger warning against the IV-push method without
explicitly stating that the method should not be used. Would the result in Levine’s case have been the
THE LEGAL ENVIRONMENT DIMENSION
In a 2006 preamble to a regulation, for the first time the FDA expressed the opinion that state-law
actions “threaten FDA’s statutorily prescribed role as the expert Federal agency responsible for
evaluating and regulating drugs.” What might have motivated this dramatic change in the agency’s
traditional position? According to the Court in the Levine case, “the FDA long maintained that state law
CASE 22.3—QUESTIONS (PAGE 436)
1A. What did the court mean when it stated that strict product liability laws are “not fully congruent”
with classical tort law? A major difference between classical tort law and strict product liability has to
do with fault. Strict liability, and thus strict product liability, is liability without fault. In other words, a
person does not have to intend to commit a wrongful act, or even commit the act through his or her
negligence, to be liable in strict liability. As the court noted in this case, “In strict products liability, the
focus is on the nature of the product rather than the conduct of either the manufacturer or the person
injured.” Another important difference between classical tort law and strict product liability has to do
with the purpose of the laws. The basic purpose of classical tort law is to provide remedies for the
invasion by one party of the protected interests of another. These interests include personal physical
safety, the security of personal property, and intangible interests in such areas as privacy and repu-
tation. The basic purpose of strict product liability has to do with, as the court stated, “the relationship
between manufacturers and consumers.” Generally, manufacturers have the advantage over
consumers in terms of bargaining power, and strict product liability laws are designed to overcome this
imbalance to some extent by protecting the consumer against unsafe products. Additionally,
manufacturers are deemed to be in a better position to assume liability for their defective products,