Adverse Event Reporting

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We’re so used to adverse decisions out of the District of Minnesota – what with the defibrillator MDLs “distinguishing” Buckman into near oblivion, and the heart valve MDL persisting in certifying classes despite being told not to by the Eighth Circuit – that good news from that district is like a breath of fresh air.

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Bexis spotted this one – because he’s compulsive and checks the Pennsylvania Supreme Court website every morning to see if any of his half-dozen pending matters have been decided. For the next however long you read this post, we want you to think of adverse drug or device experience reports (“ADEs”) as no different than

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Patients taking prescription drugs sometimes have bad reactions. Was the reaction caused by the drug, or was it mere coincidence? Was the nausea caused not by the drug, but by the taco for dinner last night?

For subjects enrolled in clinical trials, both the physicians conducting the trials (the “investigators”) and medical monitors overseeing the