Prescription Drugs and Design Defect Liability

By Eric Lindenfeld


District judges apply three approaches to Section 402A of the Second Restatement of Torts in dealing with prescription drugs and design defect liability: the case-by-case approach, the blanket immunity approach, and the Third Restatement’s approach. Given the fundamental disagreements between these three approaches, this Article argues that the blanket immunity approach— employed by the minority of the courts—offers the most consistency, is the most equitable, and is socially and economically beneficial. In doing so, this Article examines the role of the FDA regulatory process in approving prescription drug designs, as well as the proper role of courts in reviewing claims of defectively designed pharmaceutical products. Additionally, this Article argues that the U.S. Supreme Court’s growing skepticism of the current state of state tort liability and the recent trend of preempting all state court tort claims, indicates the need for state courts employing the case-by-case approach to adopt the blanket immunity approach instead. Under the blanket immunity approach, the tort system does not unduly interfere with the FDA’s regulatory scheme, and still serves its compensatory role in pharmaceutical liability by allowing for negligence claims. Decisions regarding whether a drug’s benefits outweigh its risks are essentially left to those who are better equipped to make those decisions. The blanket immunity approach’s preclusion of strict liability also keeps costs associated with litigation at a minimum—leading to lower costs of medication and a greater incentive to innovate.

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