Big Pharma's Heart of Darkness: The Alien Tort Statute and Preventing Clinical Trial Colonialism

Article excerpt

TABLE OF CONTENTS

  I. INTRODUCTION
 II. THE GLOBALIZATION OF U.S. CLINICAL TRIAL RESEARCH
     A. An Increase and an Explanation: Profit-Driven Motives
        1. Differences in FDA Requirements Encourage
           Globalization of Clinical Trial Research and
           Create a Greater Risk of Ethically Problematic
           Clinical Trials in Foreign Countries
     B. The Prevalence of Ethically Problematic Foreign Clinical
        Trial Research
        1. Reading In Between the Numbers: Recent
           Examples of Ethically Problematic Foreign
           Clinical Trials
            i. Lack of Informed Consent in the Argentinean Cariporide
               Trials and Nigerian Trovan Trials
           ii. Worldwide Lotronex Trials Continued Despite Drug
               Withdrawal from the Market
III. INCENTIVIZING ETHICAL RESEARCH THROUGH LEGAL CERTAINTY.
     A. The Economics of Tort Liability
     B. Deterring U.S. Pharmaceutical Companies from Conducting
        Ethically Problematic Foreign Clinical Trial Research
 IV. LEGAL UNCERTAINTY UNDER THE ALIEN TORT STATUTE
     A. Three Different Judicially-Created Barriers to Recovery that
        Render the A TS a Questionable Means of Recovery for
        Participants Harmed During Foreign Clinical Trial
        Research
        1. The Frequency of Forum Non Conveniens
           Dismissals of ATS Claims
        2. Judicial Confusion Regarding Sufficient
           Allegations of a Violation of "The Law of Nations"
           Under the ATS
            i. Background and History
           ii. Ineffective Guidance from the Supreme Court and
               the Current State of Uncertainty Under the A TS
               a) Unpacking the Sosa Holding and Its Intended
                  Consequences on Future Judicial
                  Treatment of ATS Claims
               b) Sosa's Shortcomings: How Subsequent Judicial
                  Treatment of ATS Claims Evidences
                  Enduring Uncertainty
        3. Corporate Civil Liability Under the ATS: A Matter
           of Subject Matter Jurisdiction or a Question on
           the Merits?
            i. Description of the Current State of the Law
     B. The Consequences of Judicial Uncertainty Under the ATS on
        U.S. Pharmaceutical Companies Conducting Foreign
        Clinical Trial Research
  V. KIOBEL AS AN OPPORTUNITY FOR CLARITY IN THE ATS
     A. Legal Error as the Basis for Overturning Kiobel
     B. Policy Arguments in Favor of Reversal
     C. Liability in Practice: Will Expansive Liability Under the
        ATS Actually Deter Drug Companies from Conducting
        Ethically Problematic Foreign Clinical Trial Research?
 VI. CONCLUSION

"The conquest of the earth, which mostly means the taking it away from those who have a different complexion or slightly flatter noses than ourselves, is not a pretty thing when you look into it too much. (1)

I. INTRODUCTION

At ten years old and forty-one pounds, future patient No. 6587-0069 stood in line at Kano's Infectious Disease Hospital (IDH). (2) She hoped to receive a cure for her bacterial meningitis, a disease that was sweeping through her home of Kano, Nigeria in April of 1996. (3) Research investigators for the U.S. drug company Pfizer occupied two wings of the IDH in order to conduct a clinical trial of a potential treatment on bacterial meningitis patients. (4) Pfizer researchers allegedly selected the patient out of the children awaiting treatment within the hospital. (5) After drawing fluid from the patient's spine, assessing her symptoms, and recording her in a patient database, research investigators gave the patient fifty-six milligrams of orally-administered Trovan, a projected blockbuster antibiotic that had not yet been FDA approved for this use in the United States. (6) Research investigators assigned each patient to one of two groups: the Trovan test group or the comparison group. (7) Allegedly, research investigators intentionally gave patients in the comparison group a low dose of the FDA-approved meningitis treatment Ceftriaxone in an effort to enhance the comparative results between Trovan and Ceftriaxone. …