Over the past few years, litigation against the clinical trial industry has significantly increased. The most well-known suit was filed against the University of Pennsylvania by the family of Jesse Gelsinger, an 18-year-old man who died after participating in a 1999 gene therapy trial. Later information revealed that the investigator in charge of the trial held a majority interest in a biotech company that stood to make millions of dollars if the experiments proved successful. While some of the financial interests were disclosed to the family, major issues were raised regarding whether Gelsinger received unbiased medical information. Cases like Gelsinger can no longer be treated as isolated incidents.
Although only a few cases receive lots of publicity, many others are not usually publicized. The targets of litigation are most often the clinical investigators and research institutions that conducted the trials. However, the companies that sponsor trials also face risks when something goes wrong. For this reason, pharmaceutical companies need to take aggressive measures to make sure that the clinical trials they sponsor are not looked at with disfavor and to protect themselves against even the appearance of conflicts of interest. The more steps that sponsor companies take towards a best practice approach to conducting clinical trial, the better their insurance program may be, and the less likely they are to face a potential lawsuit.
Some companies may view the trend toward litigation as a short-term issue. But based on the growing number of clinical trial and the increasing level of interest in this form of litigation by plaintiff law firms, it is most likely a continuing trend. Thus, companies involved in the clinical trials and their sponsorship must take legal and other measures to protect themselves from potential liability and to avoid conflicts of interest. Clinical liability insurance can help to offset some, but not all, of the cost related to an occurrence that leads to an expensive liability lawsuit.
By following the best practice procedures, companies will have more leverage to obtain a better liability insurance program. Additionally, sponsor companies might have more success in finding subjects when they have a positive reputation for excellent clinical trial safety efforts. And finally, investors will place greater importance on the way that companies manage clinical trial liability exposures and will likely prefer those companies that show top-notch research processes and integrity.
 Wallund, Jill. Heading Off a Clinical Trial Liability Lawsuit, Applied Clinical Trials, vol. 12, no. 4, 50-53 (April 2003).