When Should you Be Able to Subpoena Clinical Trial Data? “Clinical Trials and the Right to Remain Silent” in JAMA Internal Medicine

I. Glenn Cohen Clinical Research, I. Glenn Cohen, Medical Safety, Pharmaceuticals, Publications

Should litigants in products liability or other litigation be able to subpoena data from clinical trials to help prove their case? Does it matter whether the clinical trial is ongoing, finished recruiting but still analyzing data, or published? Michelle Mello and I have an invited commentary on this issue in JAMA Internal Medicine “Clinical Trials and the Right to Remain Silent” with our analysis and recommendations. We are discussing a real case from Yale where a subpoena was sought for data from a placebo-controlled trial of pioglitazone conducted there, where the person seeking the data had sued the manufacturer and believed she had been injured by pioglitazone but was not a clinical trial participant. In the same issue of JAMA IM, Yale gives its own account about how it handled the case here.  Dr. Kernan (the investigator) and I also have a nice interview podcast on the issue. 

I. Glenn Cohen

I. Glenn Cohen is the James A. Attwood and Leslie Williams Professor of Law at Harvard Law School and current Faculty Director of the Petrie-Flom Center. A member of the inaugural cohort of Petrie-Flom Academic Fellows, Glenn was appointed to the Harvard Law School faculty in 2008. Glenn is one of the world's leading experts on the intersection of bioethics (sometimes also called "medical ethics") and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Glenn has spoken at legal, medical, and industry conferences around the world and his work has appeared in or been covered on PBS, NPR, ABC, CNN, MSNBC, Mother Jones, the New York Times, the New Republic, the Boston Globe, and several other media venues. He was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34).

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