Failure-to-Warn: Facing up to the Real Impact of Phamaceutical Marketing on the Physician's Decision to Prescribe

76 INTRODUCTION 77 I. PHARMACEUTICAL MARKETING: AN EXPENSIVE ENDEAVOR THAT RELIABLY AFFECTS PRESCRIBING DECISIONS 78 A. Pharmaceutical Companies use Social Psychology to Create a Relationship that Influences Physicians at the Subconscious Level ... 79 1. Pharmaceutical Marketing is Grounded in Social Science Research 80 2. Pharmaceutical Marketing Results in no Increase in Prescribing Quality—Only a Decrease in Prescribing Quality and Increases in Cost 83 B. Pharmaceutical Representatives Offer Carefully Selected Information that Often Downplays the Documented Risks 84 II. A HOST OF REGULATIONS AND NEW ETHICS INITIATIVES DO NOT DECREASE AGGRESSIVE MARKETING AND ANTI-WARNINGS 88 A. Extensive Regulations Apply to Pharmaceutical Labeling and Promotional Materials 88 B. Promotion and Advertising are Regulated 90 C. Self-Policing and Ethics Policies have made some Inroads but Remain Incomplete 91 D. FDA’s Collaborative Approach to Enforcement Leaves Gaps for NonCompliance 93 III. COURTS SHOULD CONSIDER BOTH WARNINGS AND ANTI-WARNINGS 95 * Associate Professor of Law, Thurgood Marshall School of Law. J.D. 1999, The University of Texas School of Law; B.A. 1991, University of Houston. I am grateful to Danyahel Norris and Eric Hopkins for their excellent research assistance. I thank all those who participated in the American Society of Law, Medicine, and Ethics Health Law Scholars program at Saint Louis University School of Law, where I presented this paper. Additionally, Professors Nathan Cortez, Kelly Dineen, Barry R. Furrow, Kate Greenwood, Rebecca Stewart, and Sidney D. Watson offered insightful comments, for which I am most grateful. I thank Anne Traverse and Davor S. Vukadin for their insights and constant support. This research was made possible by a summer research grant generously provided by Thurgood Marshall School of Law at Texas Southern University. 1 Vukadin: Failure-to-Warn: Facing up to the Real Impact of Phamaceutical Ma Published by TU Law Digital Commons, 2014 76 TULSA LAW REVIEW [Vol. 50:75 A. Failure-To-Warn Liability Turns on the Presence of a “Reasonable” Warning 95 B. The Package Insert Should not be the Sole Focus 97 1. Focus on the Package Insert Ignores the Warning-Diluting Information that Reaches Physicians through Pharmaceutical Marketing 97 2. Information about Pharmaceuticals is Dynamic While the Package Insert is Slow to Change ......... 101 3. While the Package Insert is Easily Available, Marketing Information is Often Unavailable as Evidence 101 4. Exclusive Focus on the Package Insert Elevates the Regulations to De Facto Preemptive Status 102 C. The “Overpromotion” Exception to the Learned Intermediary Defense is Inadequate, Because the Bar is Impossibly High 104 IV. TOTAL MIX: THE FAILURE-TO-WARN ANALYSIS SHOULD CONSIDER ALL OF THE PHARMACEUTICAL COMPANY’S WARNING AND WARNING-DILUTING INFORMATION 106 A. Courts Analyzing the Reasonableness of a Warning Should Consider the Full Spectrum of Warning and Anti-Warning Information that Reaches Physicians—Not Just the Package Insert 106 B. In the Causation Analysis, a Physician’s Failure to Read the Package Insert Alone Should not be Sufficient to Defeat Causation 109 C. Social Psychology-Based Marketing Operates at a Subconscious Level, so a Physician’s Own Statement on its Effects Should not be Conclusive as to the Causation Element 110 V.CONCLUSION 111 “It’s my job to figure out what a physician’s price is . . . at the most basic level, everything is for sale and everything is an exchange.”1