09/06/2007
Clinical Trials: Emerging Issues Regarding Globalization of Pharmaceutical Research, Insurance, Informed Consent, Securities Litigation, and Public Policy
Erin Wallace – Summer Associate
INTRODUCTION
In the last few years, there have been important developments that bear on the law governing clinical trials and attendant liability, insurance, regulatory, and policy issues. The developments include the globalization of pharmaceutical research, increased news coverage, the emergence of various public policy questions, and a reported increase in litigation of clinical trial issues, see, e.g., Nora Lockwood Tooher, Clinical Trials Lawsuits on the Rise Across the Country, St. Louis Daily Record & St. Louis Countian, Aug. 31, 2005.
Key developments discussed in this article include[1]:
I. The Globalization of Pharmaceutical Research
A. Informed consent issues
B. Insurance coverage issues, including the question of "admitted" insurers
C. The EU Clinical Trial Directive
D. Good Clinical Practice
E. The French Law on Protection of Persons Undergoing Biomedical Research
F. The Issue of Extraterritorial Application of U.S. Laws and Regulations
G. Alien Torts Claims Act Issues, Including the Pfizer case and its Nigerian Clinical Trial
II. Tort Liability Issues
A. Products Liability, including Failure to Warn
B. Informed Consent, and Related Medical Malpractice Issues
C. Negligence Per Se
D. Fraud
E. Other Tort Theories: Trespass, Battery, Invasion of Privacy; Breach of Confidentiality
III. Possible Emerging Contract Third Party Beneficiary Theory
IV. Possible Methods of Avoiding or Mitigating Exposure to Liability
A. Quality Control, including Monitoring During the Clinical Trial
B. Increased Monitoring by IRBs
C. Compensation for Research-Related Injuries
D. The Possible Issue of a Physician Acting in the Dual Role of Treating Physician and Principal Investigator
V. Insurance Issues
A. Nondisclosure as a Ground for Rescission
B. Disclosure to Carrier in Connection with Reporting of Significant Adverse Events to the FDA
C. "Notice of Circumstances" under Certain Claims-Made Policies
D. Policy Condition of Compliance with FDA Protocol
VI. Securities Litigation and Action Issues: Recent Cases
A. In re Vaxgen
B. In re Entropin
C. In re IntraBiotics Pharmaceuticals
D. In re Regeneron
VII. Public Policy Issues
A. Abigail Alliance and the Claimed Constitutional Right to Take Unproven Experimental Drug
B. Underrepresentation of Women in Clinical Trials
C. Underrepresentation of Minorities in Clinical Trials
D. Reduced Protection of Persons in Military Service
E. Liability Shields Regarding Bioterrorism Countermeasures and Vaccines
F. Freedom of Information and Confidentiality of Clinical Trial Data
VIEW ARTICLE