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Real-world evidence, or RWE ― broadly defined by Congress as data based on the patient experience with drugs and devices from sources other than traditional clinical trials ― continues to grow in popularity in the drug and device industry.
The 21st Century Cures Act, passed in 2016, provides for expanded use of RWE in the drug approval process, and companies are getting on board in exploring new opportunities. While valuable to pharmaceutical and medical device development efforts, improper use of RWE in support of mass tort litigation could lead to dubious claims that product X caused condition Y.
The growth in RWE urged by the Cures Act leads to questions of whether this wave of RWE will propel mass tort litigation, how RWE and its counterpart, real-world data, or RWD, may be used in litigation, and what practitioners can do to prepare and respond. In this article, we offer insights into these questions.
Continue reading "Drug Cos. May Find Real-World Evidence Cuts Both Ways."