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January 7, 2019

Clinical Trials: 2018 Litigation And Guidance Roundup

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Performing trials to evaluate the safety and efficacy of medicines and devices for a particular indication and patient population requires the navigation of complex medical, scientific, regulatory and ethical principles — and such trials, of course, often continue after approval as well, supporting additional indications and evaluating ongoing safety questions.

And so it is no surprise that issues relating to clinical trials feature prominently in many products liability lawsuits, as plaintiffs’ attorneys try to show that corners were cut and something was missed — or intentionally avoided — in the study process, and as defense attorneys demonstrate the extensive work performed to learn about the medicine or device. The clinical trials themselves can become the direct subject of litigation as well, if a subject in a study believes an injury resulted from the trial.

2018 brought us litigation of both sorts, in addition to new proposed guidance from the U.S. Food and Drug Administration about how clinical trials ought to be performed — guidance that will, if adopted, be an important part of the regulatory story in litigation in the future. 

This article was authored by partners Sheryl Bjork and William Childs, published in Law360. To read the full article, click here