Every drug or device product liability case involves issues involving adverse event (AE) reporting or adverse drug reaction (ADR) reporting. We have discussed some of the nuanced differences between ADRs and AEs in a previous post.  For purposes of the current post, we will use the general term ADR.

Of course, ADRs are uncontrolled anecdotal evidence and their existence should never be used as evidence of a causal relationship between a drug and an adverse health event. Nevertheless, their existence cannot be ignored and a good drug and device lawyer must be comfortable addressing what they can and what they cannot be used to demonstrate.

Common pro-defense arguments related to ADRs include the following:

• Unreliability of ADR reporting in ultimately determining causation

• The plaintiff’s condition differed from the ADRs in the FDA’s adverse event database (FAERS)

• Small number of ADRs fail to support general causation

• Good corporate responsibility by diligent ADR reporting

Common pro-plaintiff arguments that must be responded to include the following:

• Alleged failure of Defendant to capture ADRs in a timely fashion

• Alleged failure of defendant to respond to a safety signal based on ADRs

Whatever issues you confront as a drug and device lawyer, it is critical that you have a good handle on the scientific literature related to ADRs. We have put together a listing of what we consider to be the 25 most important articles published in the peer-reviewed scientific literature on this topic.

To download this literature list, simply fill out the form below.