Brooklyn Law Review Volume 74 Issue 3 SYMPOSIUM: Article 9 The rP oducts Liability Restatement: Was it a Success? 2009 This Is Your Products Liability Restatement on Drugs Lars Noah Follow this and additional works at: https://brooklynworks.brooklaw.edu/blr Recommended Citation Lars Noah, This Is Your Products Liability Restatement on Drugs, 74 Brook. L. Rev. (2009). Available at: https://brooklynworks.brooklaw.edu/blr/vol74/iss3/9 This Article is brought to you for free and open access by the Law Journals at BrooklynWorks. It has been accepted for inclusion in Brooklyn Law Review by an authorized editor of BrooklynWorks. This Is Your Products Liability Restatement on Drugs Lars Noah† TABLE OF CONTENTS I. INTRODUCTION ................................................................................................ 840 II. FLAWS IN PRODUCTION .................................................................................... 841 A. Manufacturing Defects ........................................................................... 841 B. Design Defects ........................................................................................ 842 1. MUDs and Child’s Play .................................................................. 848 2. Snowflakes (and Cost-Consciousness) in Medical Practice ............ 855 3. Myths About Designer (and “Lifestyle”) Drugs ............................. 861 C. Case Studies ........................................................................................... 868 1. Ritodrine ......................................................................................... 869 2. Thalidomide .................................................................................... 872 3. Finasteride ...................................................................................... 874 4. Polio Vaccines ................................................................................ 876 5. Isotretinoin ...................................................................................... 881 D. Designing Access Restrictions ................................................................ 884 III. INFORMATIONAL DEFECTS ............................................................................... 888 A. Learned Intermediary Doctrine .............................................................. 890 B. Debate over an Advertising Exception ................................................... 894 1. Norplant Litigation ......................................................................... 897 2. Satisfying an Expanded Duty to Warn ............................................ 901 IV. MISCELLANEOUS ISSUES .................................................................................. 905 A. Experimental Drugs and the Duty to Keep Testing ................................ 905 B. Generic Drugs ........................................................................................ 909 C. Medical Devices ..................................................................................... 912 1. Are Device Designs Different? ....................................................... 913 2. Tissue Engineering and Manufacturing Defects ............................. 915 D. Links in the Chain of Distribution .......................................................... 917 1. Physicians, Pharmacists, and Compounding ................................... 918 2. Will Pharmacogenomics Change Everything?................................ 922 3. Hospitals and SUDs ........................................................................ 923 V. CONCLUSION ................................................................................................... 925 [I]ll health offers adventure; no one has a better chance to live dangerously than the ill who must take their medicine. 1 —Roger Traynor † Professor of Law, Univ. of Florida. My title alludes to a public service ad campaign (showing an egg in a frying pan) aired by the Partnership for a Drug-Free America in 1982. 839 840 BROOKLYN LAW REVIEW [Vol. 74:3 I. INTRODUCTION Lawsuits against the manufacturers of drugs and medical devices have become increasingly important in the last few decades, both in their volume and in the conceptual challenges that they have presented,2 and courts have created a variety of special rules to accommodate products liability litigation against the sellers of medical technologies.3 The work of the American Law Institute (ALI) has played an important role in this process, though so far the special provisions of the Products Liability Restatement applicable to prescription drugs and devices have had little discernable impact. These provisions have, however, provoked a great deal of scholarly commentary, and the few courts to consider the issue have uncritically relied upon the published critiques. As explained at length herein, I find little merit in most of these negative assessments, though I point out a number of flaws, ambiguities, and arguable inconsistencies in the new Restatement’s special provisions that seemingly no one else has identified. This Article attempts to offer a comprehensive evaluation of the various facets of the Products Liability Restatement that relate to medical technologies, and it does so from a perspective rooted in the regulatory as opposed to the doctrinal challenges posed by these products. Part II addresses production defects, focusing on the heated debate over what standards to use in deciding whether a prescription drug suffers from a defective design. Part III considers defects related to the information that accompanies prescription drugs, especially those advertised directly to consumers. Finally, Part IV touches on some of the peculiar issues raised by investigational products, generic drugs, prescription medical devices, and the duties of non-manufacturing sellers. 1 Roger J. Traynor, The Ways and Meanings of Defective Products and Strict Liability, 32 TENN. L. REV. 363, 368 (1965). 2 See Alex Berenson, Drug Industry Braces for New Suits over Even More of Its Products, N.Y. TIMES, Apr. 22, 2006, at C1 (“As Merck reels from 11,500 suits over Vioxx, its arthritis drug, the rest of the industry is girding for challenges over another half a dozen widely used [and still marketed] medications [including Seroquel, Ortho-Evra, Prempro, and Fosamax] that plaintiffs’ lawyers say have hidden and severe side effects or were improperly marketed.”); id. (“Eli Lilly agreed to spend $700 million to settle 8,000 lawsuits over Zyprexa . Wyeth has spent $15 billion since 1998 to resolve lawsuits over its fen-phen diet-drug combination . .”); Lisa Girion, State Vioxx Trial Is Set as Drug Suits Boom; An Explosion in Litigation Spurs Calls for Legal Reform and Regulatory Changes, L.A. TIMES, June 27, 2006, at C1 (calling “the pharmaceutical industry the nation’s No. 1 target of product liability lawsuits,” adding that “[m]ore than 71,000 drug lawsuits have been filed in federal courts since 2001 and . now account for more than a third of all product liability filings”); Julie Schmit, More Drugs Get Slapped with Lawsuits, USA TODAY, Aug. 23, 2006, at 3B. 3 See LARS NOAH, LAW, MEDICINE, AND MEDICAL TECHNOLOGY chs. 5-8 (2d ed. 2007); M. Stuart Madden, The Enduring Paradox of Products Liability Law Relating to Prescription Pharmaceuticals, 21 PACE L. REV. 313 (2001) (describing at length some of the older case law). Classic treatments of the subject include Richard A. Merrill, Compensation for Prescription Drug Injuries, 59 VA. L. REV. 1, 29-50, 87-120 (1973), and Paul D. Rheingold, Products Liability—The Ethical Drug Manufacturer’s Liability, 18 RUTGERS L. REV. 947, 970-1018 (1964). 2009] RESTATING DRUG PRODUCTS LIABILITY 841 II. FLAWS IN PRODUCTION A product must have some sort of defect before an injured consumer may recover damages from the manufacturer or other member of the chain of distribution. This Part discusses, in turn, manufacturing and design defect claims against pharmaceutical manufacturers. It reviews several case studies that other commentators have offered, concluding that the most important potential design feature relates to the manner in which sellers restrict access to pharmaceutical products. A. Manufacturing Defects The Products Liability Restatement uses the same standard to define manufacturing defects in prescription drug and medical device cases as it does for other consumer goods.4 Thus, if a product falls out of specifications for any reason, then it has a defect (a true strict liability standard).5 Manufacturing defect claims involving pharmaceuticals, such as instances of product contamination, generally pose few difficulties for courts.6 As with other types of consumer goods, however, plaintiffs may have to rely on circumstantial evidence of such flaws, seeking an inference of defectiveness from the occurrence of an obvious malfunction.7 Although patients injured by medical devices may rely on a product malfunction approach,8 injuries associated with drug products 4 See RESTATEMENT (THIRD) OF TORTS: PRODS. LIAB. § 6(b)(1) (1998) (cross- referencing § 2(a), which provides that a product “contains a manufacturing defect when the product departs from its intended design even though all possible care was exercised in the preparation and marketing of the product”). 5 See, e.g., Transue v. Aesthetech Corp., 341 F.3d 911, 917-20 (9th Cir. 2003) (holding that the trial judge erred in failing to use a strict liability instruction on a manufacturing defect claim involving silicone-gel breast implants); id.