Insights offered by Associate Marc Wagner while serving as a panelist at the Food and Drug Law Institute’s annual enforcement meeting led to a quote in a Regulatory Focus article, published Dec. 12, 2023. The article, “Experts Discuss Red Flags That Can Trigger Legal Action Against Drug and Device Makers,” covered analysis shared by legal observers at the meeting, including threats to healthcare product manufacturers and lessons learned following Medtronic’s 2015 consent decree related to its SynchroMed II infusion pump.
The article noted that Wagner told the audience to expect more consent decrees, which are linked to the FDA’s issuance of 483 reports and warning letters. “We are observing more 483s and warning letters. This is a partial signal that in the next couple of years, additional companies will be subject to consent decrees,” said Wagner.