<< Previous Section | < Previous Page | Next Page > | Next Section >> Litigation, the New Approach to Research Management When the tort bar finds a weakness in any of our industries or enterprises, the stakes immediately go up and the costs of paying out or preventing legal liability add substantial burdens. However, this system of management has played a significant role in the protection of citizens against malfeasance, much to the enrichment of the plaintiffs' lawyers involved. In recent years, the clinical research establishment has been subject to litigation and the results have been a great tightening up of subject protections. Historical - informed consent claims for medical treatment go back to 1914. Now the clinical research enterprise is subject to new legal claims, an increased number and types of defendants, and use of class action suit technique that can multiply the number of claims. Examples include: The Gelsinger case: Defective informed consent and process Product liability Fraud - failed to reveal that previous subjects died and that the investigators had serious conflicts of interest. Penn settled eventually for a substantial amount of money. Robertson vs Oklahoma- Melanoma Vaccine Consent failures Trial was negligently run -investigator malpractice Fraudulent representation of the purposes, risks and benefits Wright vs Hutchinson Clinic -preventing graft failure in bone marrow transplantation. Tried lymphocyte depletion, which didn't work. Seattle Times series called it "Uninformed Consent" They claimed that subjects were lured by greedy doctors into trials where they weren't told all the risks. They were applying current consent rules to 20 year old studies. The legal claims were: Defective consent, research malpractice, Failure to disclose COIs Failure to report deaths to IRB appropriately Failed to update consent forms "breach of the right to be treated with dignity" under due process clause of the 14th amendment The "Hutch" fought it and won in a landmark decision. This section derived from Mello, Studdert and Brennan: 2003 Ann Int Med; 139:40-45. Fraud cases can result in punitive damages and really big awards. Lawyers are now suing everyone including: The University, The teaching hospital, The PI, The sponsor Top university officials Individual IRB members The hospital's patient advocate (Abiomed) The additional defendants make the costs of litigation much higher and favor the plaintiffs. With many individuals in the same study, the conditions are ripe for class-action suits, which provide great rewards to the attorneys. Impacts of successful litigation: More suits are inevitable It has tightened up research on humans - a good thing It may make IRBs super-conservative, which is a bad thing It may make monitoring of research mandatory It may create a spate of rule-making << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 8 Quick Links Malfeasance and Misconduct Definitions Process Whistleblowing Litigation, the New Approach to Research Management The Importance of Trust Cases Bibliography Chapter 8 Download (PDF)