CHAPTER § 9.01 Introduction

• Jurisdiction: United States

§ 9.01 Introduction

Manufacturers of pharmaceutical drugs and medical devices face an array of unique issues when confronted with a lawsuit in which a plaintiff alleges injuries caused by use of their drugs and devices. This chapter explores these issues and sets out some of the l egal defenses and techniques to consider when defending product liability claims.

First, the chapter provides a brief overview of eight of the most common l egal defenses to pharmaceutical product-liability claims: (1) the Restatements; (2) statutes of limitations and repose; (3) off-label promotion; (4) illegality; (5) lack of privity; (6) lack of reliable expert testimony on causation; (7) innovator liability; and (8) the adequacy of a warning as a matter of law.

Second, the chapter examines what is often a central feature of product-liability claims involving prescription drugs and devices: the application of the "learned-intermediary" doctrine. Often, the essence of product-liability actions involves claims that the manufacturer failed to adequately warn of the risks of its product. In the context of prescription drugs and medical devices, failure-to-warn claims are limited by the learned-intermediary doctrine, which provides that the manufacturer's duty to warn runs only to the doctor—the "learned intermediary" between the manufacturer and the consumer—and not directly to the consumer. The chapter provides...