Last Friday, the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) issued a long awaited (some three years long) decision in the Baycol case, Pauley v. Bayer. We’ve been interested in Pauley because the trial court opinion being appealed was probably the best Pennsylvania/state court generally authority on inadmissibility of anecdotal adverse event
Today we’re boldly going where lawyers usually fear to tread (at least alone) – into the realm of epidemiology, albeit perhaps loosely defined. Why? Well, we do have to come up with things to write about, and there’s only so much preemption theorizing that even we can do before it sounds like we’re babbling.
Also,
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.
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
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