The Importance of 510(k) Evidence to Ensuring a Fair Trial

Since the onset of the COVID-19 pandemic, the Food and Drug Administration (“FDA”) has received more attention than perhaps ever before. While Americans anxiously awaited for approval of a COVID-19 vaccine, the FDA and its regulatory scheme were ever-present topics on the news and in social media. The American population’s newfound familiarity with the FDA is especially pertinent in a medical device litigation context.  As litigators well know, jurors already enter a courtroom with preconceived notions of medical device companies, the FDA and the relationship between the two. So how will this newfound knowledge of the FDA influence juror opinions? Put another way, what would happen if a jury participating in a medical device trial failed to hear any reference to the FDA at all?  Potentially, the results would be catastrophic to device manufacturers.

To read the full text of this article co-authored by Duane Morris partner Sean Burke, please visit the AdvaMed website.

Third Circuit Seeks Help Deciphering Pennsylvania Strict Liability Law

On June 2, 2020, the Third Circuit, sitting en banc, took the unusual step of asking the Pennsylvania Supreme Court to decide a novel question of state law on strict liability for defective products sold through e-commerce websites in a case that will shape the future of products liability and online sales.

To read the full text of this Duane Morris Alert, please visit the firm website.